NDC properties for "testosterone cypionate 200 MG per 1 ML Injection" (RxCUI 2047882)
About this data
The tables show NDC propoerties for testosterone cypionate 200 MG per 1 ML Injection with the RxCUI 2047882
This product uses publicly available data from the U.S. National Library of Medicine (NLM), National Institutes of Health, Department of Health and Human Services; NLM is not responsible for the product and does not endorse or recommend this or any other product
Details for testosterone cypionate 200 MG per 1 ML Injection (RxCUI 2047882)
| ANDA | ANDA040530 |
|---|---|
| ANDA | ANDA085635 |
| ANDA | ANDA091244 |
| ANDA | ANDA201720 |
| ANDA | ANDA206368 |
| ANDA | ANDA207742 |
| ANDA | ANDA210362 |
| ANDA | ANDA211817 |
| ANDA | ANDA215351 |
| MMSL_CODE | MTH_RXN_BD2937 |
| NDA | NDA216318 |
| RxCUI | 2047882 |
| SPL_SET_ID | 08f88e0e-d9a4-4a03-9286-46d9bf9a363e |
| SPL_SET_ID | 108facca-c6d2-48fa-ba48-667c9498c61b |
| SPL_SET_ID | 2db0a398-5512-431c-a952-b0290d4fe2d9 |
| SPL_SET_ID | 3653a602-4551-4e6c-84a7-31861f5dc482 |
| SPL_SET_ID | 4195516a-c8e6-457c-b805-43c9a3ca8b77 |
| SPL_SET_ID | 58ff6e0d-cc0a-4455-8254-d883d26a3b6d |
| SPL_SET_ID | 5a0bba6a-e8da-4b12-af63-eb27b1cca9e6 |
| SPL_SET_ID | 6909596e-4bf7-4e11-8029-b89740a30aec |
| SPL_SET_ID | 78d55bad-4a5b-4e21-aeb8-a4c6346208be |
| SPL_SET_ID | 9d0a1923-be39-41d9-8183-706b227f615c |
| SPL_SET_ID | b116d834-51f1-4b92-8e1e-a51dbd883c1f |
| SPL_SET_ID | b8ac5e07-b7e3-4a60-b0d1-8b1f3ad0c478 |
| SPL_SET_ID | c5efc1ed-dd50-48fe-81b6-4d691a178630 |
| SPL_SET_ID | cab949ca-fde9-c5a9-5561-21e98d86d078 |
| SPL_SET_ID | cb411b78-0072-42b0-b75d-85ee96cfbf3c |
| SPL_SET_ID | e3e2da65-4b2a-4210-a6ff-cc08c8567381 |
| SPL_SET_ID | ed65346b-31bc-f872-516d-78d5ab70229e |
| SPL_SET_ID | edcd5209-70db-4727-991e-3fdd185d9211 |
| SPL_SET_ID | f60c5520-b336-44a2-95d5-f274939fa595 |
| SPL_SET_ID | f901e2b2-f143-4237-8e95-0d134585490b |
| SPL_SET_ID | ffb1ae64-9026-44c9-83a0-32058957ecc9 |
| VUID | 4015139 |
| Prescribable Synonym | testosterone cypionate 200 MG in 1 ML Injection |
| RXNAV_STR | 1 ML testosterone cypionate 200 MG/ML Injection |
| RxNorm Name | 1 ML testosterone cypionate 200 MG/ML Injection |
| RxNorm Synonym | testosterone cypionate 200 MG per 1 ML Injection |
| Related queries | Interactions (for RxCUI 2047882) |
NDC Properties
NDC Item 00143965901
| NDC 9 | 0143-9659 |
|---|---|
| NDC 10 | 0143-9659-01 |
| NDC Item | 00143965901 |
| Packaging | 1 mL in 1 VIAL (0143-9659-01) |
| ANDA | ANDA091244 |
| DCSA | CIII |
| FDA SPL set id | 627057 |
| Labeler | Hikma Pharmaceuticals USA Inc. |
| Label type | HUMAN PRESCRIPTION DRUG |
| Marketing category | ANDA |
| Marketing effective time low | 2012-05-01 |
| Marketing status | ACTIVE |
| Related queries | Properties for NDC 9 0143-9659 |
NDC Item 00409656201
| NDC 9 | 0409-6562 |
|---|---|
| NDC 10 | 0409-6562-01 |
| NDC Item | 00409656201 |
| Packaging | 1 VIAL in 1 CARTON (0409-6562-01) / 1 mL in 1 VIAL |
| ANDA | ANDA085635 |
| DCSA | CIII |
| FDA SPL set id | 500095 |
| FDA SPL set id | 500287 |
| Labeler | Hospira, Inc. |
| Label type | HUMAN PRESCRIPTION DRUG |
| Marketing category | ANDA |
| Marketing effective time low | 2018-01-17 |
| Marketing status | ACTIVE |
| Related queries | Properties for NDC 9 0409-6562 |
NDC Item 00409656202
| NDC 9 | 0409-6562 |
|---|---|
| NDC 10 | 0409-6562-02 |
| NDC Item | 00409656202 |
| Packaging | 1 VIAL in 1 CARTON (0409-6562-02) / 1 mL in 1 VIAL |
| ANDA | ANDA085635 |
| DCSA | CIII |
| FDA SPL set id | 500095 |
| FDA SPL set id | 500287 |
| Labeler | Hospira, Inc. |
| Label type | HUMAN PRESCRIPTION DRUG |
| Marketing category | ANDA |
| Marketing effective time low | 2018-01-17 |
| Marketing status | ACTIVE |
| Related queries | Properties for NDC 9 0409-6562 |
NDC Item 00517183001
| NDC 9 | 0517-1830 |
|---|---|
| NDC 10 | 0517-1830-01 |
| NDC Item | 00517183001 |
| Packaging | 1 VIAL in 1 BOX (0517-1830-01) / 1 mL in 1 VIAL |
| ANDA | ANDA207742 |
| DCSA | CIII |
| FDA SPL set id | 674434 |
| Labeler | American Regent, Inc. |
| Label type | HUMAN PRESCRIPTION DRUG |
| Marketing category | ANDA |
| Marketing effective time low | 2019-07-19 |
| Marketing status | ACTIVE |
| Related queries | Properties for NDC 9 0517-1830 |
NDC Item 00574082001
| NDC 9 | 0574-0820 |
|---|---|
| NDC 10 | 0574-0820-01 |
| NDC Item | 00574082001 |
| Packaging | 1 VIAL, GLASS in 1 CARTON (0574-0820-01) / 1 mL in 1 VIAL, GLASS |
| ANDA | ANDA040530 |
| DCSA | CIII |
| FDA SPL set id | 768154 |
| FDA SPL set id | 791051 |
| Labeler | Padagis US LLC |
| Label type | HUMAN PRESCRIPTION DRUG |
| Marketing category | ANDA |
| Marketing effective time low | 2007-12-21 |
| Marketing status | ACTIVE |
| Related queries | Properties for NDC 9 0574-0820 |
NDC Item 00574082701
| NDC 9 | 0574-0827 |
|---|---|
| NDC 10 | 0574-0827-01 |
| NDC Item | 00574082701 |
| Packaging | 1 VIAL, GLASS in 1 CARTON (0574-0827-01) / 1 mL in 1 VIAL, GLASS |
| ANDA | ANDA091244 |
| DCSA | CIII |
| FDA SPL set id | 584573 |
| Labeler | Padagis US LLC |
| Label type | HUMAN PRESCRIPTION DRUG |
| Marketing category | ANDA |
| Marketing effective time low | 2014-05-01 |
| Marketing status | ACTIVE |
| Related queries | Properties for NDC 9 0574-0827 |
NDC Item 47781091193
| NDC 9 | 47781-911 |
|---|---|
| NDC 10 | 47781-911-93 |
| NDC Item | 47781091193 |
| Packaging | 1 VIAL, SINGLE-DOSE in 1 CARTON (47781-911-93) / 1 mL in 1 VIAL, SINGLE-DOSE |
| ANDA | ANDA207742 |
| DCSA | CIII |
| FDA SPL set id | 719526 |
| Labeler | Alvogen Inc. |
| Label type | HUMAN PRESCRIPTION DRUG |
| Marketing category | ANDA |
| Marketing effective time low | 2022-11-02 |
| Marketing status | ACTIVE |
| Related queries | Properties for NDC 9 47781-911 |
NDC Item 52536062501
| NDC 9 | 52536-625 |
|---|---|
| NDC 10 | 52536-625-01 |
| NDC Item | 52536062501 |
| Packaging | 1 VIAL, SINGLE-DOSE in 1 CARTON (52536-625-01) / 1 mL in 1 VIAL, SINGLE-DOSE |
| ANDA | ANDA206368 |
| COLORTEXT | WHITE(or creamy white) |
| Color | C48325 __ |
| DCSA | CIII |
| FDA SPL set id | 395393 |
| Labeler | Wilshire Pharmaceuticals |
| Label type | HUMAN PRESCRIPTION DRUG |
| Marketing category | ANDA |
| Marketing effective time low | 2019-05-31 |
| Marketing status | ACTIVE |
| Related queries | Properties for NDC 9 52536-625 |
NDC Item 55150027701
| NDC 9 | 55150-277 |
|---|---|
| NDC 10 | 55150-277-01 |
| NDC Item | 55150027701 |
| Packaging | 1 VIAL, GLASS in 1 CARTON (55150-277-01) / 1 mL in 1 VIAL, GLASS |
| ANDA | ANDA211817 |
| DCSA | CIII |
| FDA SPL set id | 739422 |
| Labeler | Eugia US LLC |
| Label type | HUMAN PRESCRIPTION DRUG |
| Marketing category | ANDA |
| Marketing effective time low | 2023-10-20 |
| Marketing status | ACTIVE |
| Related queries | Properties for NDC 9 55150-277 |
NDC Item 62756001540
| NDC 9 | 62756-015 |
|---|---|
| NDC 10 | 62756-015-40 |
| NDC Item | 62756001540 |
| Packaging | 1 VIAL in 1 CARTON (62756-015-40) / 1 mL in 1 VIAL |
| ANDA | ANDA201720 |
| DCSA | CIII |
| FDA SPL set id | 581578 |
| Labeler | Sun Pharmaceutical Industries, Inc. |
| Label type | HUMAN PRESCRIPTION DRUG |
| Marketing category | ANDA |
| Marketing effective time low | 2013-06-17 |
| Marketing status | ACTIVE |
| Related queries | Properties for NDC 9 62756-015 |
NDC Item 64980046799
| NDC 9 | 64980-467 |
|---|---|
| NDC 10 | 64980-467-99 |
| NDC Item | 64980046799 |
| Packaging | 1 VIAL, MULTI-DOSE in 1 CARTON (64980-467-99) / 1 mL in 1 VIAL, MULTI-DOSE |
| ANDA | ANDA207742 |
| DCSA | CIII |
| FDA SPL set id | 385892 |
| Labeler | Rising Pharma Holdings, Inc. |
| Label type | HUMAN PRESCRIPTION DRUG |
| Marketing category | ANDA |
| Marketing effective time high | 2020-06-30 |
| Marketing effective time low | 2018-12-01 |
| Marketing status | COMPLETED |
| Related queries | Properties for NDC 9 64980-467 |
NDC Item 69097053731
| NDC 9 | 69097-537 |
|---|---|
| NDC 10 | 69097-537-31 |
| NDC Item | 69097053731 |
| Packaging | 1 mL in 1 VIAL, GLASS (69097-537-31) |
| ANDA | ANDA210362 |
| COLORTEXT | WHITE("A clear colourless to pale yellow solution) |
| Color | C48325 __ |
| DCSA | CIII |
| FDA SPL set id | 729362 |
| Labeler | Cipla USA Inc. |
| Label type | HUMAN PRESCRIPTION DRUG |
| Marketing category | ANDA |
| Marketing effective time low | 2023-09-15 |
| Marketing status | ACTIVE |
| Related queries | Properties for NDC 9 69097-537 |
NDC Item 69097080232
| NDC 9 | 69097-802 |
|---|---|
| NDC 10 | 69097-802-32 |
| NDC Item | 69097080232 |
| Packaging | 1 VIAL, GLASS in 1 CARTON (69097-802-32) / 1 mL in 1 VIAL, GLASS |
| ANDA | ANDA091244 |
| DCSA | CIII |
| FDA SPL set id | 764872 |
| Labeler | Cipla USA Inc. |
| Label type | HUMAN PRESCRIPTION DRUG |
| Marketing category | ANDA |
| Marketing effective time low | 2019-03-26 |
| Marketing status | ACTIVE |
| Related queries | Properties for NDC 9 69097-802 |
NDC Item 70700028922
| NDC 9 | 70700-289 |
|---|---|
| NDC 10 | 70700-289-22 |
| NDC Item | 70700028922 |
| Packaging | 1 VIAL in 1 CARTON (70700-289-22) / 1 mL in 1 VIAL |
| ANDA | ANDA215351 |
| DCSA | CIII |
| FDA SPL set id | 708164 |
| Labeler | Xiromed LLC |
| Label type | HUMAN PRESCRIPTION DRUG |
| Marketing category | ANDA |
| Marketing effective time low | 2023-04-28 |
| Marketing status | ACTIVE |
| Related queries | Properties for NDC 9 70700-289 |
NDC Item 71205028901
| NDC 9 | 71205-289 |
|---|---|
| NDC 10 | 71205-289-01 |
| NDC Item | 71205028901 |
| Packaging | 1 mL in 1 VIAL (71205-289-01) |
| ANDA | ANDA091244 |
| DCSA | CIII |
| FDA SPL set id | 413320 |
| Labeler | Proficient Rx LP |
| Label type | HUMAN PRESCRIPTION DRUG |
| Marketing category | ANDA |
| Marketing effective time low | 2012-05-01 |
| Marketing status | ACTIVE |
| Related queries | Properties for NDC 9 71205-289 |
NDC Item 71225012701
| NDC 9 | 71225-127 |
|---|---|
| NDC 10 | 71225-127-01 |
| NDC Item | 71225012701 |
| Packaging | 1 VIAL in 1 CARTON (71225-127-01) / 1 mL in 1 VIAL |
| DCSA | CIII |
| FDA SPL set id | 642064 |
| Labeler | Slayback Pharma LLC |
| Label type | HUMAN PRESCRIPTION DRUG |
| Marketing category | NDA |
| Marketing effective time low | 2022-06-13 |
| Marketing status | ACTIVE |
| NDA | NDA216318 |
| Related queries | Properties for NDC 9 71225-127 |
NDC Item 72162234802
| NDC 9 | 72162-2348 |
|---|---|
| NDC 10 | 72162-2348-2 |
| NDC Item | 72162234802 |
| Packaging | 1 VIAL, SINGLE-DOSE in 1 CARTON (72162-2348-2) / 1 mL in 1 VIAL, SINGLE-DOSE |
| ANDA | ANDA206368 |
| COLORTEXT | WHITE(or creamy white) |
| Color | C48325 __ |
| DCSA | CIII |
| FDA SPL set id | 794476 |
| Labeler | Bryant Ranch Prepack |
| Label type | HUMAN PRESCRIPTION DRUG |
| Marketing category | ANDA |
| Marketing effective time low | 2019-05-31 |
| Marketing status | active |
| Related queries | Properties for NDC 9 72162-2348 |
NDC Item 72162234804
| NDC 9 | 72162-2348 |
|---|---|
| NDC 10 | 72162-2348-4 |
| NDC Item | 72162234804 |
| Packaging | 1 VIAL, MULTI-DOSE in 1 CARTON (72162-2348-4) / 10 mL in 1 VIAL, MULTI-DOSE |
| ANDA | ANDA206368 |
| COLORTEXT | WHITE(or creamy white) |
| Color | C48325 __ |
| DCSA | CIII |
| FDA SPL set id | 794476 |
| Labeler | Bryant Ranch Prepack |
| Label type | HUMAN PRESCRIPTION DRUG |
| Marketing category | ANDA |
| Marketing effective time low | 2019-05-31 |
| Marketing status | active |
| Related queries | Properties for NDC 9 72162-2348 |
NDC Item 72162237502
| NDC 9 | 72162-2375 |
|---|---|
| NDC 10 | 72162-2375-2 |
| NDC Item | 72162237502 |
| Packaging | 1 VIAL, GLASS in 1 CARTON (72162-2375-2) / 1 mL in 1 VIAL, GLASS |
| ANDA | ANDA040530 |
| DCSA | CIII |
| FDA SPL set id | 800677 |
| Labeler | Bryant Ranch Prepack |
| Label type | HUMAN PRESCRIPTION DRUG |
| Marketing category | ANDA |
| Marketing effective time low | 2007-12-21 |
| Marketing status | active |
| Related queries | Properties for NDC 9 72162-2375 |
NDC Item 76420074601
| NDC 9 | 76420-746 |
|---|---|
| NDC 10 | 76420-746-01 |
| NDC Item | 76420074601 |
| Packaging | 1 VIAL, GLASS in 1 CARTON (76420-746-01) / 1 mL in 1 VIAL, GLASS |
| ANDA | ANDA091244 |
| DCSA | CIII |
| FDA SPL set id | 791011 |
| Labeler | Asclemed USA, Inc. |
| Label type | HUMAN PRESCRIPTION DRUG |
| Marketing category | ANDA |
| Marketing effective time low | 2019-03-26 |
| Marketing status | ACTIVE |
| Related queries | Properties for NDC 9 76420-746 |
NDC Item 76420074701
| NDC 9 | 76420-747 |
|---|---|
| NDC 10 | 76420-747-01 |
| NDC Item | 76420074701 |
| Packaging | 1 VIAL, SINGLE-DOSE in 1 CARTON (76420-747-01) / 1 mL in 1 VIAL, SINGLE-DOSE |
| ANDA | ANDA207742 |
| DCSA | CIII |
| FDA SPL set id | 791057 |
| Labeler | Asclemed USA, Inc. |
| Label type | HUMAN PRESCRIPTION DRUG |
| Marketing category | ANDA |
| Marketing effective time low | 2022-11-02 |
| Marketing status | ACTIVE |
| Related queries | Properties for NDC 9 76420-747 |
NDC Item 00143965901
| NDC 9 | 0143-9659 |
|---|---|
| NDC 10 | 0143-9659-01 |
| NDC Item | 00143965901 |
| Packaging | 1 mL in 1 VIAL (0143-9659-01) |
| ANDA | ANDA091244 |
| DCSA | CIII |
| FDA SPL set id | 627057 |
| Labeler | Hikma Pharmaceuticals USA Inc. |
| Label type | HUMAN PRESCRIPTION DRUG |
| Marketing category | ANDA |
| Marketing effective time low | 2012-05-01 |
| Marketing status | ACTIVE |
| Related queries | Properties for NDC 9 0143-9659 |
NDC Item 00409656201
| NDC 9 | 0409-6562 |
|---|---|
| NDC 10 | 0409-6562-01 |
| NDC Item | 00409656201 |
| Packaging | 1 VIAL in 1 CARTON (0409-6562-01) / 1 mL in 1 VIAL |
| ANDA | ANDA085635 |
| DCSA | CIII |
| FDA SPL set id | 500095 |
| FDA SPL set id | 500287 |
| Labeler | Hospira, Inc. |
| Label type | HUMAN PRESCRIPTION DRUG |
| Marketing category | ANDA |
| Marketing effective time low | 2018-01-17 |
| Marketing status | ACTIVE |
| Related queries | Properties for NDC 9 0409-6562 |
NDC Item 00409656202
| NDC 9 | 0409-6562 |
|---|---|
| NDC 10 | 0409-6562-02 |
| NDC Item | 00409656202 |
| Packaging | 1 VIAL in 1 CARTON (0409-6562-02) / 1 mL in 1 VIAL |
| ANDA | ANDA085635 |
| DCSA | CIII |
| FDA SPL set id | 500095 |
| FDA SPL set id | 500287 |
| Labeler | Hospira, Inc. |
| Label type | HUMAN PRESCRIPTION DRUG |
| Marketing category | ANDA |
| Marketing effective time low | 2018-01-17 |
| Marketing status | ACTIVE |
| Related queries | Properties for NDC 9 0409-6562 |
NDC Item 00517183001
| NDC 9 | 0517-1830 |
|---|---|
| NDC 10 | 0517-1830-01 |
| NDC Item | 00517183001 |
| Packaging | 1 VIAL in 1 BOX (0517-1830-01) / 1 mL in 1 VIAL |
| ANDA | ANDA207742 |
| DCSA | CIII |
| FDA SPL set id | 674434 |
| Labeler | American Regent, Inc. |
| Label type | HUMAN PRESCRIPTION DRUG |
| Marketing category | ANDA |
| Marketing effective time low | 2019-07-19 |
| Marketing status | ACTIVE |
| Related queries | Properties for NDC 9 0517-1830 |
NDC Item 00574082001
| NDC 9 | 0574-0820 |
|---|---|
| NDC 10 | 0574-0820-01 |
| NDC Item | 00574082001 |
| Packaging | 1 VIAL, GLASS in 1 CARTON (0574-0820-01) / 1 mL in 1 VIAL, GLASS |
| ANDA | ANDA040530 |
| DCSA | CIII |
| FDA SPL set id | 768154 |
| FDA SPL set id | 791051 |
| Labeler | Padagis US LLC |
| Label type | HUMAN PRESCRIPTION DRUG |
| Marketing category | ANDA |
| Marketing effective time low | 2007-12-21 |
| Marketing status | ACTIVE |
| Related queries | Properties for NDC 9 0574-0820 |
NDC Item 00574082701
| NDC 9 | 0574-0827 |
|---|---|
| NDC 10 | 0574-0827-01 |
| NDC Item | 00574082701 |
| Packaging | 1 VIAL, GLASS in 1 CARTON (0574-0827-01) / 1 mL in 1 VIAL, GLASS |
| ANDA | ANDA091244 |
| DCSA | CIII |
| FDA SPL set id | 584573 |
| Labeler | Padagis US LLC |
| Label type | HUMAN PRESCRIPTION DRUG |
| Marketing category | ANDA |
| Marketing effective time low | 2014-05-01 |
| Marketing status | ACTIVE |
| Related queries | Properties for NDC 9 0574-0827 |
NDC Item 47781091193
| NDC 9 | 47781-911 |
|---|---|
| NDC 10 | 47781-911-93 |
| NDC Item | 47781091193 |
| Packaging | 1 VIAL, SINGLE-DOSE in 1 CARTON (47781-911-93) / 1 mL in 1 VIAL, SINGLE-DOSE |
| ANDA | ANDA207742 |
| DCSA | CIII |
| FDA SPL set id | 719526 |
| Labeler | Alvogen Inc. |
| Label type | HUMAN PRESCRIPTION DRUG |
| Marketing category | ANDA |
| Marketing effective time low | 2022-11-02 |
| Marketing status | ACTIVE |
| Related queries | Properties for NDC 9 47781-911 |
NDC Item 52536062501
| NDC 9 | 52536-625 |
|---|---|
| NDC 10 | 52536-625-01 |
| NDC Item | 52536062501 |
| Packaging | 1 VIAL, SINGLE-DOSE in 1 CARTON (52536-625-01) / 1 mL in 1 VIAL, SINGLE-DOSE |
| ANDA | ANDA206368 |
| COLORTEXT | WHITE(or creamy white) |
| Color | C48325 __ |
| DCSA | CIII |
| FDA SPL set id | 395393 |
| Labeler | Wilshire Pharmaceuticals |
| Label type | HUMAN PRESCRIPTION DRUG |
| Marketing category | ANDA |
| Marketing effective time low | 2019-05-31 |
| Marketing status | ACTIVE |
| Related queries | Properties for NDC 9 52536-625 |
NDC Item 55150027701
| NDC 9 | 55150-277 |
|---|---|
| NDC 10 | 55150-277-01 |
| NDC Item | 55150027701 |
| Packaging | 1 VIAL, GLASS in 1 CARTON (55150-277-01) / 1 mL in 1 VIAL, GLASS |
| ANDA | ANDA211817 |
| DCSA | CIII |
| FDA SPL set id | 739422 |
| Labeler | Eugia US LLC |
| Label type | HUMAN PRESCRIPTION DRUG |
| Marketing category | ANDA |
| Marketing effective time low | 2023-10-20 |
| Marketing status | ACTIVE |
| Related queries | Properties for NDC 9 55150-277 |
NDC Item 62756001540
| NDC 9 | 62756-015 |
|---|---|
| NDC 10 | 62756-015-40 |
| NDC Item | 62756001540 |
| Packaging | 1 VIAL in 1 CARTON (62756-015-40) / 1 mL in 1 VIAL |
| ANDA | ANDA201720 |
| DCSA | CIII |
| FDA SPL set id | 581578 |
| Labeler | Sun Pharmaceutical Industries, Inc. |
| Label type | HUMAN PRESCRIPTION DRUG |
| Marketing category | ANDA |
| Marketing effective time low | 2013-06-17 |
| Marketing status | ACTIVE |
| Related queries | Properties for NDC 9 62756-015 |
NDC Item 64980046799
| NDC 9 | 64980-467 |
|---|---|
| NDC 10 | 64980-467-99 |
| NDC Item | 64980046799 |
| Packaging | 1 VIAL, MULTI-DOSE in 1 CARTON (64980-467-99) / 1 mL in 1 VIAL, MULTI-DOSE |
| ANDA | ANDA207742 |
| DCSA | CIII |
| FDA SPL set id | 385892 |
| Labeler | Rising Pharma Holdings, Inc. |
| Label type | HUMAN PRESCRIPTION DRUG |
| Marketing category | ANDA |
| Marketing effective time high | 2020-06-30 |
| Marketing effective time low | 2018-12-01 |
| Marketing status | COMPLETED |
| Related queries | Properties for NDC 9 64980-467 |
NDC Item 69097053731
| NDC 9 | 69097-537 |
|---|---|
| NDC 10 | 69097-537-31 |
| NDC Item | 69097053731 |
| Packaging | 1 mL in 1 VIAL, GLASS (69097-537-31) |
| ANDA | ANDA210362 |
| COLORTEXT | WHITE("A clear colourless to pale yellow solution) |
| Color | C48325 __ |
| DCSA | CIII |
| FDA SPL set id | 729362 |
| Labeler | Cipla USA Inc. |
| Label type | HUMAN PRESCRIPTION DRUG |
| Marketing category | ANDA |
| Marketing effective time low | 2023-09-15 |
| Marketing status | ACTIVE |
| Related queries | Properties for NDC 9 69097-537 |
NDC Item 69097080232
| NDC 9 | 69097-802 |
|---|---|
| NDC 10 | 69097-802-32 |
| NDC Item | 69097080232 |
| Packaging | 1 VIAL, GLASS in 1 CARTON (69097-802-32) / 1 mL in 1 VIAL, GLASS |
| ANDA | ANDA091244 |
| DCSA | CIII |
| FDA SPL set id | 764872 |
| Labeler | Cipla USA Inc. |
| Label type | HUMAN PRESCRIPTION DRUG |
| Marketing category | ANDA |
| Marketing effective time low | 2019-03-26 |
| Marketing status | ACTIVE |
| Related queries | Properties for NDC 9 69097-802 |
NDC Item 70700028922
| NDC 9 | 70700-289 |
|---|---|
| NDC 10 | 70700-289-22 |
| NDC Item | 70700028922 |
| Packaging | 1 VIAL in 1 CARTON (70700-289-22) / 1 mL in 1 VIAL |
| ANDA | ANDA215351 |
| DCSA | CIII |
| FDA SPL set id | 708164 |
| Labeler | Xiromed LLC |
| Label type | HUMAN PRESCRIPTION DRUG |
| Marketing category | ANDA |
| Marketing effective time low | 2023-04-28 |
| Marketing status | ACTIVE |
| Related queries | Properties for NDC 9 70700-289 |
NDC Item 71205028901
| NDC 9 | 71205-289 |
|---|---|
| NDC 10 | 71205-289-01 |
| NDC Item | 71205028901 |
| Packaging | 1 mL in 1 VIAL (71205-289-01) |
| ANDA | ANDA091244 |
| DCSA | CIII |
| FDA SPL set id | 413320 |
| Labeler | Proficient Rx LP |
| Label type | HUMAN PRESCRIPTION DRUG |
| Marketing category | ANDA |
| Marketing effective time low | 2012-05-01 |
| Marketing status | ACTIVE |
| Related queries | Properties for NDC 9 71205-289 |
NDC Item 71225012701
| NDC 9 | 71225-127 |
|---|---|
| NDC 10 | 71225-127-01 |
| NDC Item | 71225012701 |
| Packaging | 1 VIAL in 1 CARTON (71225-127-01) / 1 mL in 1 VIAL |
| DCSA | CIII |
| FDA SPL set id | 642064 |
| Labeler | Slayback Pharma LLC |
| Label type | HUMAN PRESCRIPTION DRUG |
| Marketing category | NDA |
| Marketing effective time low | 2022-06-13 |
| Marketing status | ACTIVE |
| NDA | NDA216318 |
| Related queries | Properties for NDC 9 71225-127 |
NDC Item 72162234802
| NDC 9 | 72162-2348 |
|---|---|
| NDC 10 | 72162-2348-2 |
| NDC Item | 72162234802 |
| Packaging | 1 VIAL, SINGLE-DOSE in 1 CARTON (72162-2348-2) / 1 mL in 1 VIAL, SINGLE-DOSE |
| ANDA | ANDA206368 |
| COLORTEXT | WHITE(or creamy white) |
| Color | C48325 __ |
| DCSA | CIII |
| FDA SPL set id | 794476 |
| Labeler | Bryant Ranch Prepack |
| Label type | HUMAN PRESCRIPTION DRUG |
| Marketing category | ANDA |
| Marketing effective time low | 2019-05-31 |
| Marketing status | active |
| Related queries | Properties for NDC 9 72162-2348 |
NDC Item 72162234804
| NDC 9 | 72162-2348 |
|---|---|
| NDC 10 | 72162-2348-4 |
| NDC Item | 72162234804 |
| Packaging | 1 VIAL, MULTI-DOSE in 1 CARTON (72162-2348-4) / 10 mL in 1 VIAL, MULTI-DOSE |
| ANDA | ANDA206368 |
| COLORTEXT | WHITE(or creamy white) |
| Color | C48325 __ |
| DCSA | CIII |
| FDA SPL set id | 794476 |
| Labeler | Bryant Ranch Prepack |
| Label type | HUMAN PRESCRIPTION DRUG |
| Marketing category | ANDA |
| Marketing effective time low | 2019-05-31 |
| Marketing status | active |
| Related queries | Properties for NDC 9 72162-2348 |
NDC Item 72162237502
| NDC 9 | 72162-2375 |
|---|---|
| NDC 10 | 72162-2375-2 |
| NDC Item | 72162237502 |
| Packaging | 1 VIAL, GLASS in 1 CARTON (72162-2375-2) / 1 mL in 1 VIAL, GLASS |
| ANDA | ANDA040530 |
| DCSA | CIII |
| FDA SPL set id | 800677 |
| Labeler | Bryant Ranch Prepack |
| Label type | HUMAN PRESCRIPTION DRUG |
| Marketing category | ANDA |
| Marketing effective time low | 2007-12-21 |
| Marketing status | active |
| Related queries | Properties for NDC 9 72162-2375 |
NDC Item 76420074601
| NDC 9 | 76420-746 |
|---|---|
| NDC 10 | 76420-746-01 |
| NDC Item | 76420074601 |
| Packaging | 1 VIAL, GLASS in 1 CARTON (76420-746-01) / 1 mL in 1 VIAL, GLASS |
| ANDA | ANDA091244 |
| DCSA | CIII |
| FDA SPL set id | 791011 |
| Labeler | Asclemed USA, Inc. |
| Label type | HUMAN PRESCRIPTION DRUG |
| Marketing category | ANDA |
| Marketing effective time low | 2019-03-26 |
| Marketing status | ACTIVE |
| Related queries | Properties for NDC 9 76420-746 |
NDC Item 76420074701
| NDC 9 | 76420-747 |
|---|---|
| NDC 10 | 76420-747-01 |
| NDC Item | 76420074701 |
| Packaging | 1 VIAL, SINGLE-DOSE in 1 CARTON (76420-747-01) / 1 mL in 1 VIAL, SINGLE-DOSE |
| ANDA | ANDA207742 |
| DCSA | CIII |
| FDA SPL set id | 791057 |
| Labeler | Asclemed USA, Inc. |
| Label type | HUMAN PRESCRIPTION DRUG |
| Marketing category | ANDA |
| Marketing effective time low | 2022-11-02 |
| Marketing status | ACTIVE |
| Related queries | Properties for NDC 9 76420-747 |
NDC Item 00143965901
| NDC 9 | 0143-9659 |
|---|---|
| NDC 10 | 0143-9659-01 |
| NDC Item | 00143965901 |
| Packaging | 1 mL in 1 VIAL (0143-9659-01) |
| ANDA | ANDA091244 |
| DCSA | CIII |
| FDA SPL set id | 627057 |
| Labeler | Hikma Pharmaceuticals USA Inc. |
| Label type | HUMAN PRESCRIPTION DRUG |
| Marketing category | ANDA |
| Marketing effective time low | 2012-05-01 |
| Marketing status | ACTIVE |
| Related queries | Properties for NDC 9 0143-9659 |
NDC Item 00409656201
| NDC 9 | 0409-6562 |
|---|---|
| NDC 10 | 0409-6562-01 |
| NDC Item | 00409656201 |
| Packaging | 1 VIAL in 1 CARTON (0409-6562-01) / 1 mL in 1 VIAL |
| ANDA | ANDA085635 |
| DCSA | CIII |
| FDA SPL set id | 500095 |
| FDA SPL set id | 500287 |
| Labeler | Hospira, Inc. |
| Label type | HUMAN PRESCRIPTION DRUG |
| Marketing category | ANDA |
| Marketing effective time low | 2018-01-17 |
| Marketing status | ACTIVE |
| Related queries | Properties for NDC 9 0409-6562 |
NDC Item 00409656202
| NDC 9 | 0409-6562 |
|---|---|
| NDC 10 | 0409-6562-02 |
| NDC Item | 00409656202 |
| Packaging | 1 VIAL in 1 CARTON (0409-6562-02) / 1 mL in 1 VIAL |
| ANDA | ANDA085635 |
| DCSA | CIII |
| FDA SPL set id | 500095 |
| FDA SPL set id | 500287 |
| Labeler | Hospira, Inc. |
| Label type | HUMAN PRESCRIPTION DRUG |
| Marketing category | ANDA |
| Marketing effective time low | 2018-01-17 |
| Marketing status | ACTIVE |
| Related queries | Properties for NDC 9 0409-6562 |
NDC Item 00517183001
| NDC 9 | 0517-1830 |
|---|---|
| NDC 10 | 0517-1830-01 |
| NDC Item | 00517183001 |
| Packaging | 1 VIAL in 1 BOX (0517-1830-01) / 1 mL in 1 VIAL |
| ANDA | ANDA207742 |
| DCSA | CIII |
| FDA SPL set id | 674434 |
| Labeler | American Regent, Inc. |
| Label type | HUMAN PRESCRIPTION DRUG |
| Marketing category | ANDA |
| Marketing effective time low | 2019-07-19 |
| Marketing status | ACTIVE |
| Related queries | Properties for NDC 9 0517-1830 |
NDC Item 00574082001
| NDC 9 | 0574-0820 |
|---|---|
| NDC 10 | 0574-0820-01 |
| NDC Item | 00574082001 |
| Packaging | 1 VIAL, GLASS in 1 CARTON (0574-0820-01) / 1 mL in 1 VIAL, GLASS |
| ANDA | ANDA040530 |
| DCSA | CIII |
| FDA SPL set id | 768154 |
| FDA SPL set id | 791051 |
| Labeler | Padagis US LLC |
| Label type | HUMAN PRESCRIPTION DRUG |
| Marketing category | ANDA |
| Marketing effective time low | 2007-12-21 |
| Marketing status | ACTIVE |
| Related queries | Properties for NDC 9 0574-0820 |
NDC Item 00574082701
| NDC 9 | 0574-0827 |
|---|---|
| NDC 10 | 0574-0827-01 |
| NDC Item | 00574082701 |
| Packaging | 1 VIAL, GLASS in 1 CARTON (0574-0827-01) / 1 mL in 1 VIAL, GLASS |
| ANDA | ANDA091244 |
| DCSA | CIII |
| FDA SPL set id | 584573 |
| Labeler | Padagis US LLC |
| Label type | HUMAN PRESCRIPTION DRUG |
| Marketing category | ANDA |
| Marketing effective time low | 2014-05-01 |
| Marketing status | ACTIVE |
| Related queries | Properties for NDC 9 0574-0827 |
NDC Item 47781091193
| NDC 9 | 47781-911 |
|---|---|
| NDC 10 | 47781-911-93 |
| NDC Item | 47781091193 |
| Packaging | 1 VIAL, SINGLE-DOSE in 1 CARTON (47781-911-93) / 1 mL in 1 VIAL, SINGLE-DOSE |
| ANDA | ANDA207742 |
| DCSA | CIII |
| FDA SPL set id | 719526 |
| Labeler | Alvogen Inc. |
| Label type | HUMAN PRESCRIPTION DRUG |
| Marketing category | ANDA |
| Marketing effective time low | 2022-11-02 |
| Marketing status | ACTIVE |
| Related queries | Properties for NDC 9 47781-911 |
NDC Item 52536062501
| NDC 9 | 52536-625 |
|---|---|
| NDC 10 | 52536-625-01 |
| NDC Item | 52536062501 |
| Packaging | 1 VIAL, SINGLE-DOSE in 1 CARTON (52536-625-01) / 1 mL in 1 VIAL, SINGLE-DOSE |
| ANDA | ANDA206368 |
| COLORTEXT | WHITE(or creamy white) |
| Color | C48325 __ |
| DCSA | CIII |
| FDA SPL set id | 395393 |
| Labeler | Wilshire Pharmaceuticals |
| Label type | HUMAN PRESCRIPTION DRUG |
| Marketing category | ANDA |
| Marketing effective time low | 2019-05-31 |
| Marketing status | ACTIVE |
| Related queries | Properties for NDC 9 52536-625 |
NDC Item 55150027701
| NDC 9 | 55150-277 |
|---|---|
| NDC 10 | 55150-277-01 |
| NDC Item | 55150027701 |
| Packaging | 1 VIAL, GLASS in 1 CARTON (55150-277-01) / 1 mL in 1 VIAL, GLASS |
| ANDA | ANDA211817 |
| DCSA | CIII |
| FDA SPL set id | 739422 |
| Labeler | Eugia US LLC |
| Label type | HUMAN PRESCRIPTION DRUG |
| Marketing category | ANDA |
| Marketing effective time low | 2023-10-20 |
| Marketing status | ACTIVE |
| Related queries | Properties for NDC 9 55150-277 |
NDC Item 62756001540
| NDC 9 | 62756-015 |
|---|---|
| NDC 10 | 62756-015-40 |
| NDC Item | 62756001540 |
| Packaging | 1 VIAL in 1 CARTON (62756-015-40) / 1 mL in 1 VIAL |
| ANDA | ANDA201720 |
| DCSA | CIII |
| FDA SPL set id | 581578 |
| Labeler | Sun Pharmaceutical Industries, Inc. |
| Label type | HUMAN PRESCRIPTION DRUG |
| Marketing category | ANDA |
| Marketing effective time low | 2013-06-17 |
| Marketing status | ACTIVE |
| Related queries | Properties for NDC 9 62756-015 |
NDC Item 64980046799
| NDC 9 | 64980-467 |
|---|---|
| NDC 10 | 64980-467-99 |
| NDC Item | 64980046799 |
| Packaging | 1 VIAL, MULTI-DOSE in 1 CARTON (64980-467-99) / 1 mL in 1 VIAL, MULTI-DOSE |
| ANDA | ANDA207742 |
| DCSA | CIII |
| FDA SPL set id | 385892 |
| Labeler | Rising Pharma Holdings, Inc. |
| Label type | HUMAN PRESCRIPTION DRUG |
| Marketing category | ANDA |
| Marketing effective time high | 2020-06-30 |
| Marketing effective time low | 2018-12-01 |
| Marketing status | COMPLETED |
| Related queries | Properties for NDC 9 64980-467 |
NDC Item 69097053731
| NDC 9 | 69097-537 |
|---|---|
| NDC 10 | 69097-537-31 |
| NDC Item | 69097053731 |
| Packaging | 1 mL in 1 VIAL, GLASS (69097-537-31) |
| ANDA | ANDA210362 |
| COLORTEXT | WHITE("A clear colourless to pale yellow solution) |
| Color | C48325 __ |
| DCSA | CIII |
| FDA SPL set id | 729362 |
| Labeler | Cipla USA Inc. |
| Label type | HUMAN PRESCRIPTION DRUG |
| Marketing category | ANDA |
| Marketing effective time low | 2023-09-15 |
| Marketing status | ACTIVE |
| Related queries | Properties for NDC 9 69097-537 |
NDC Item 69097080232
| NDC 9 | 69097-802 |
|---|---|
| NDC 10 | 69097-802-32 |
| NDC Item | 69097080232 |
| Packaging | 1 VIAL, GLASS in 1 CARTON (69097-802-32) / 1 mL in 1 VIAL, GLASS |
| ANDA | ANDA091244 |
| DCSA | CIII |
| FDA SPL set id | 764872 |
| Labeler | Cipla USA Inc. |
| Label type | HUMAN PRESCRIPTION DRUG |
| Marketing category | ANDA |
| Marketing effective time low | 2019-03-26 |
| Marketing status | ACTIVE |
| Related queries | Properties for NDC 9 69097-802 |
NDC Item 70700028922
| NDC 9 | 70700-289 |
|---|---|
| NDC 10 | 70700-289-22 |
| NDC Item | 70700028922 |
| Packaging | 1 VIAL in 1 CARTON (70700-289-22) / 1 mL in 1 VIAL |
| ANDA | ANDA215351 |
| DCSA | CIII |
| FDA SPL set id | 708164 |
| Labeler | Xiromed LLC |
| Label type | HUMAN PRESCRIPTION DRUG |
| Marketing category | ANDA |
| Marketing effective time low | 2023-04-28 |
| Marketing status | ACTIVE |
| Related queries | Properties for NDC 9 70700-289 |
NDC Item 71205028901
| NDC 9 | 71205-289 |
|---|---|
| NDC 10 | 71205-289-01 |
| NDC Item | 71205028901 |
| Packaging | 1 mL in 1 VIAL (71205-289-01) |
| ANDA | ANDA091244 |
| DCSA | CIII |
| FDA SPL set id | 413320 |
| Labeler | Proficient Rx LP |
| Label type | HUMAN PRESCRIPTION DRUG |
| Marketing category | ANDA |
| Marketing effective time low | 2012-05-01 |
| Marketing status | ACTIVE |
| Related queries | Properties for NDC 9 71205-289 |
NDC Item 71225012701
| NDC 9 | 71225-127 |
|---|---|
| NDC 10 | 71225-127-01 |
| NDC Item | 71225012701 |
| Packaging | 1 VIAL in 1 CARTON (71225-127-01) / 1 mL in 1 VIAL |
| DCSA | CIII |
| FDA SPL set id | 642064 |
| Labeler | Slayback Pharma LLC |
| Label type | HUMAN PRESCRIPTION DRUG |
| Marketing category | NDA |
| Marketing effective time low | 2022-06-13 |
| Marketing status | ACTIVE |
| NDA | NDA216318 |
| Related queries | Properties for NDC 9 71225-127 |
NDC Item 72162234802
| NDC 9 | 72162-2348 |
|---|---|
| NDC 10 | 72162-2348-2 |
| NDC Item | 72162234802 |
| Packaging | 1 VIAL, SINGLE-DOSE in 1 CARTON (72162-2348-2) / 1 mL in 1 VIAL, SINGLE-DOSE |
| ANDA | ANDA206368 |
| COLORTEXT | WHITE(or creamy white) |
| Color | C48325 __ |
| DCSA | CIII |
| FDA SPL set id | 794476 |
| Labeler | Bryant Ranch Prepack |
| Label type | HUMAN PRESCRIPTION DRUG |
| Marketing category | ANDA |
| Marketing effective time low | 2019-05-31 |
| Marketing status | active |
| Related queries | Properties for NDC 9 72162-2348 |
NDC Item 72162234804
| NDC 9 | 72162-2348 |
|---|---|
| NDC 10 | 72162-2348-4 |
| NDC Item | 72162234804 |
| Packaging | 1 VIAL, MULTI-DOSE in 1 CARTON (72162-2348-4) / 10 mL in 1 VIAL, MULTI-DOSE |
| ANDA | ANDA206368 |
| COLORTEXT | WHITE(or creamy white) |
| Color | C48325 __ |
| DCSA | CIII |
| FDA SPL set id | 794476 |
| Labeler | Bryant Ranch Prepack |
| Label type | HUMAN PRESCRIPTION DRUG |
| Marketing category | ANDA |
| Marketing effective time low | 2019-05-31 |
| Marketing status | active |
| Related queries | Properties for NDC 9 72162-2348 |
NDC Item 72162237502
| NDC 9 | 72162-2375 |
|---|---|
| NDC 10 | 72162-2375-2 |
| NDC Item | 72162237502 |
| Packaging | 1 VIAL, GLASS in 1 CARTON (72162-2375-2) / 1 mL in 1 VIAL, GLASS |
| ANDA | ANDA040530 |
| DCSA | CIII |
| FDA SPL set id | 800677 |
| Labeler | Bryant Ranch Prepack |
| Label type | HUMAN PRESCRIPTION DRUG |
| Marketing category | ANDA |
| Marketing effective time low | 2007-12-21 |
| Marketing status | active |
| Related queries | Properties for NDC 9 72162-2375 |
NDC Item 76420074601
| NDC 9 | 76420-746 |
|---|---|
| NDC 10 | 76420-746-01 |
| NDC Item | 76420074601 |
| Packaging | 1 VIAL, GLASS in 1 CARTON (76420-746-01) / 1 mL in 1 VIAL, GLASS |
| ANDA | ANDA091244 |
| DCSA | CIII |
| FDA SPL set id | 791011 |
| Labeler | Asclemed USA, Inc. |
| Label type | HUMAN PRESCRIPTION DRUG |
| Marketing category | ANDA |
| Marketing effective time low | 2019-03-26 |
| Marketing status | ACTIVE |
| Related queries | Properties for NDC 9 76420-746 |
NDC Item 76420074701
| NDC 9 | 76420-747 |
|---|---|
| NDC 10 | 76420-747-01 |
| NDC Item | 76420074701 |
| Packaging | 1 VIAL, SINGLE-DOSE in 1 CARTON (76420-747-01) / 1 mL in 1 VIAL, SINGLE-DOSE |
| ANDA | ANDA207742 |
| DCSA | CIII |
| FDA SPL set id | 791057 |
| Labeler | Asclemed USA, Inc. |
| Label type | HUMAN PRESCRIPTION DRUG |
| Marketing category | ANDA |
| Marketing effective time low | 2022-11-02 |
| Marketing status | ACTIVE |
| Related queries | Properties for NDC 9 76420-747 |
NDC Item 00143965901
| NDC 9 | 0143-9659 |
|---|---|
| NDC 10 | 0143-9659-01 |
| NDC Item | 00143965901 |
| Packaging | 1 mL in 1 VIAL (0143-9659-01) |
| ANDA | ANDA091244 |
| DCSA | CIII |
| FDA SPL set id | 627057 |
| Labeler | Hikma Pharmaceuticals USA Inc. |
| Label type | HUMAN PRESCRIPTION DRUG |
| Marketing category | ANDA |
| Marketing effective time low | 2012-05-01 |
| Marketing status | ACTIVE |
| Related queries | Properties for NDC 9 0143-9659 |
NDC Item 00409656201
| NDC 9 | 0409-6562 |
|---|---|
| NDC 10 | 0409-6562-01 |
| NDC Item | 00409656201 |
| Packaging | 1 VIAL in 1 CARTON (0409-6562-01) / 1 mL in 1 VIAL |
| ANDA | ANDA085635 |
| DCSA | CIII |
| FDA SPL set id | 500095 |
| FDA SPL set id | 500287 |
| Labeler | Hospira, Inc. |
| Label type | HUMAN PRESCRIPTION DRUG |
| Marketing category | ANDA |
| Marketing effective time low | 2018-01-17 |
| Marketing status | ACTIVE |
| Related queries | Properties for NDC 9 0409-6562 |
NDC Item 00409656202
| NDC 9 | 0409-6562 |
|---|---|
| NDC 10 | 0409-6562-02 |
| NDC Item | 00409656202 |
| Packaging | 1 VIAL in 1 CARTON (0409-6562-02) / 1 mL in 1 VIAL |
| ANDA | ANDA085635 |
| DCSA | CIII |
| FDA SPL set id | 500095 |
| FDA SPL set id | 500287 |
| Labeler | Hospira, Inc. |
| Label type | HUMAN PRESCRIPTION DRUG |
| Marketing category | ANDA |
| Marketing effective time low | 2018-01-17 |
| Marketing status | ACTIVE |
| Related queries | Properties for NDC 9 0409-6562 |
NDC Item 00517183001
| NDC 9 | 0517-1830 |
|---|---|
| NDC 10 | 0517-1830-01 |
| NDC Item | 00517183001 |
| Packaging | 1 VIAL in 1 BOX (0517-1830-01) / 1 mL in 1 VIAL |
| ANDA | ANDA207742 |
| DCSA | CIII |
| FDA SPL set id | 674434 |
| Labeler | American Regent, Inc. |
| Label type | HUMAN PRESCRIPTION DRUG |
| Marketing category | ANDA |
| Marketing effective time low | 2019-07-19 |
| Marketing status | ACTIVE |
| Related queries | Properties for NDC 9 0517-1830 |
NDC Item 00574082001
| NDC 9 | 0574-0820 |
|---|---|
| NDC 10 | 0574-0820-01 |
| NDC Item | 00574082001 |
| Packaging | 1 VIAL, GLASS in 1 CARTON (0574-0820-01) / 1 mL in 1 VIAL, GLASS |
| ANDA | ANDA040530 |
| DCSA | CIII |
| FDA SPL set id | 768154 |
| FDA SPL set id | 791051 |
| Labeler | Padagis US LLC |
| Label type | HUMAN PRESCRIPTION DRUG |
| Marketing category | ANDA |
| Marketing effective time low | 2007-12-21 |
| Marketing status | ACTIVE |
| Related queries | Properties for NDC 9 0574-0820 |
NDC Item 00574082701
| NDC 9 | 0574-0827 |
|---|---|
| NDC 10 | 0574-0827-01 |
| NDC Item | 00574082701 |
| Packaging | 1 VIAL, GLASS in 1 CARTON (0574-0827-01) / 1 mL in 1 VIAL, GLASS |
| ANDA | ANDA091244 |
| DCSA | CIII |
| FDA SPL set id | 584573 |
| Labeler | Padagis US LLC |
| Label type | HUMAN PRESCRIPTION DRUG |
| Marketing category | ANDA |
| Marketing effective time low | 2014-05-01 |
| Marketing status | ACTIVE |
| Related queries | Properties for NDC 9 0574-0827 |
NDC Item 47781091193
| NDC 9 | 47781-911 |
|---|---|
| NDC 10 | 47781-911-93 |
| NDC Item | 47781091193 |
| Packaging | 1 VIAL, SINGLE-DOSE in 1 CARTON (47781-911-93) / 1 mL in 1 VIAL, SINGLE-DOSE |
| ANDA | ANDA207742 |
| DCSA | CIII |
| FDA SPL set id | 719526 |
| Labeler | Alvogen Inc. |
| Label type | HUMAN PRESCRIPTION DRUG |
| Marketing category | ANDA |
| Marketing effective time low | 2022-11-02 |
| Marketing status | ACTIVE |
| Related queries | Properties for NDC 9 47781-911 |
NDC Item 52536062501
| NDC 9 | 52536-625 |
|---|---|
| NDC 10 | 52536-625-01 |
| NDC Item | 52536062501 |
| Packaging | 1 VIAL, SINGLE-DOSE in 1 CARTON (52536-625-01) / 1 mL in 1 VIAL, SINGLE-DOSE |
| ANDA | ANDA206368 |
| COLORTEXT | WHITE(or creamy white) |
| Color | C48325 __ |
| DCSA | CIII |
| FDA SPL set id | 395393 |
| Labeler | Wilshire Pharmaceuticals |
| Label type | HUMAN PRESCRIPTION DRUG |
| Marketing category | ANDA |
| Marketing effective time low | 2019-05-31 |
| Marketing status | ACTIVE |
| Related queries | Properties for NDC 9 52536-625 |
NDC Item 55150027701
| NDC 9 | 55150-277 |
|---|---|
| NDC 10 | 55150-277-01 |
| NDC Item | 55150027701 |
| Packaging | 1 VIAL, GLASS in 1 CARTON (55150-277-01) / 1 mL in 1 VIAL, GLASS |
| ANDA | ANDA211817 |
| DCSA | CIII |
| FDA SPL set id | 739422 |
| Labeler | Eugia US LLC |
| Label type | HUMAN PRESCRIPTION DRUG |
| Marketing category | ANDA |
| Marketing effective time low | 2023-10-20 |
| Marketing status | ACTIVE |
| Related queries | Properties for NDC 9 55150-277 |
NDC Item 62756001540
| NDC 9 | 62756-015 |
|---|---|
| NDC 10 | 62756-015-40 |
| NDC Item | 62756001540 |
| Packaging | 1 VIAL in 1 CARTON (62756-015-40) / 1 mL in 1 VIAL |
| ANDA | ANDA201720 |
| DCSA | CIII |
| FDA SPL set id | 581578 |
| Labeler | Sun Pharmaceutical Industries, Inc. |
| Label type | HUMAN PRESCRIPTION DRUG |
| Marketing category | ANDA |
| Marketing effective time low | 2013-06-17 |
| Marketing status | ACTIVE |
| Related queries | Properties for NDC 9 62756-015 |
NDC Item 64980046799
| NDC 9 | 64980-467 |
|---|---|
| NDC 10 | 64980-467-99 |
| NDC Item | 64980046799 |
| Packaging | 1 VIAL, MULTI-DOSE in 1 CARTON (64980-467-99) / 1 mL in 1 VIAL, MULTI-DOSE |
| ANDA | ANDA207742 |
| DCSA | CIII |
| FDA SPL set id | 385892 |
| Labeler | Rising Pharma Holdings, Inc. |
| Label type | HUMAN PRESCRIPTION DRUG |
| Marketing category | ANDA |
| Marketing effective time high | 2020-06-30 |
| Marketing effective time low | 2018-12-01 |
| Marketing status | COMPLETED |
| Related queries | Properties for NDC 9 64980-467 |
NDC Item 69097053731
| NDC 9 | 69097-537 |
|---|---|
| NDC 10 | 69097-537-31 |
| NDC Item | 69097053731 |
| Packaging | 1 mL in 1 VIAL, GLASS (69097-537-31) |
| ANDA | ANDA210362 |
| COLORTEXT | WHITE("A clear colourless to pale yellow solution) |
| Color | C48325 __ |
| DCSA | CIII |
| FDA SPL set id | 729362 |
| Labeler | Cipla USA Inc. |
| Label type | HUMAN PRESCRIPTION DRUG |
| Marketing category | ANDA |
| Marketing effective time low | 2023-09-15 |
| Marketing status | ACTIVE |
| Related queries | Properties for NDC 9 69097-537 |
NDC Item 69097080232
| NDC 9 | 69097-802 |
|---|---|
| NDC 10 | 69097-802-32 |
| NDC Item | 69097080232 |
| Packaging | 1 VIAL, GLASS in 1 CARTON (69097-802-32) / 1 mL in 1 VIAL, GLASS |
| ANDA | ANDA091244 |
| DCSA | CIII |
| FDA SPL set id | 764872 |
| Labeler | Cipla USA Inc. |
| Label type | HUMAN PRESCRIPTION DRUG |
| Marketing category | ANDA |
| Marketing effective time low | 2019-03-26 |
| Marketing status | ACTIVE |
| Related queries | Properties for NDC 9 69097-802 |
NDC Item 70700028922
| NDC 9 | 70700-289 |
|---|---|
| NDC 10 | 70700-289-22 |
| NDC Item | 70700028922 |
| Packaging | 1 VIAL in 1 CARTON (70700-289-22) / 1 mL in 1 VIAL |
| ANDA | ANDA215351 |
| DCSA | CIII |
| FDA SPL set id | 708164 |
| Labeler | Xiromed LLC |
| Label type | HUMAN PRESCRIPTION DRUG |
| Marketing category | ANDA |
| Marketing effective time low | 2023-04-28 |
| Marketing status | ACTIVE |
| Related queries | Properties for NDC 9 70700-289 |
NDC Item 71205028901
| NDC 9 | 71205-289 |
|---|---|
| NDC 10 | 71205-289-01 |
| NDC Item | 71205028901 |
| Packaging | 1 mL in 1 VIAL (71205-289-01) |
| ANDA | ANDA091244 |
| DCSA | CIII |
| FDA SPL set id | 413320 |
| Labeler | Proficient Rx LP |
| Label type | HUMAN PRESCRIPTION DRUG |
| Marketing category | ANDA |
| Marketing effective time low | 2012-05-01 |
| Marketing status | ACTIVE |
| Related queries | Properties for NDC 9 71205-289 |
NDC Item 71225012701
| NDC 9 | 71225-127 |
|---|---|
| NDC 10 | 71225-127-01 |
| NDC Item | 71225012701 |
| Packaging | 1 VIAL in 1 CARTON (71225-127-01) / 1 mL in 1 VIAL |
| DCSA | CIII |
| FDA SPL set id | 642064 |
| Labeler | Slayback Pharma LLC |
| Label type | HUMAN PRESCRIPTION DRUG |
| Marketing category | NDA |
| Marketing effective time low | 2022-06-13 |
| Marketing status | ACTIVE |
| NDA | NDA216318 |
| Related queries | Properties for NDC 9 71225-127 |
NDC Item 72162234802
| NDC 9 | 72162-2348 |
|---|---|
| NDC 10 | 72162-2348-2 |
| NDC Item | 72162234802 |
| Packaging | 1 VIAL, SINGLE-DOSE in 1 CARTON (72162-2348-2) / 1 mL in 1 VIAL, SINGLE-DOSE |
| ANDA | ANDA206368 |
| COLORTEXT | WHITE(or creamy white) |
| Color | C48325 __ |
| DCSA | CIII |
| FDA SPL set id | 794476 |
| Labeler | Bryant Ranch Prepack |
| Label type | HUMAN PRESCRIPTION DRUG |
| Marketing category | ANDA |
| Marketing effective time low | 2019-05-31 |
| Marketing status | active |
| Related queries | Properties for NDC 9 72162-2348 |
NDC Item 72162234804
| NDC 9 | 72162-2348 |
|---|---|
| NDC 10 | 72162-2348-4 |
| NDC Item | 72162234804 |
| Packaging | 1 VIAL, MULTI-DOSE in 1 CARTON (72162-2348-4) / 10 mL in 1 VIAL, MULTI-DOSE |
| ANDA | ANDA206368 |
| COLORTEXT | WHITE(or creamy white) |
| Color | C48325 __ |
| DCSA | CIII |
| FDA SPL set id | 794476 |
| Labeler | Bryant Ranch Prepack |
| Label type | HUMAN PRESCRIPTION DRUG |
| Marketing category | ANDA |
| Marketing effective time low | 2019-05-31 |
| Marketing status | active |
| Related queries | Properties for NDC 9 72162-2348 |
NDC Item 72162237502
| NDC 9 | 72162-2375 |
|---|---|
| NDC 10 | 72162-2375-2 |
| NDC Item | 72162237502 |
| Packaging | 1 VIAL, GLASS in 1 CARTON (72162-2375-2) / 1 mL in 1 VIAL, GLASS |
| ANDA | ANDA040530 |
| DCSA | CIII |
| FDA SPL set id | 800677 |
| Labeler | Bryant Ranch Prepack |
| Label type | HUMAN PRESCRIPTION DRUG |
| Marketing category | ANDA |
| Marketing effective time low | 2007-12-21 |
| Marketing status | active |
| Related queries | Properties for NDC 9 72162-2375 |
NDC Item 76420074601
| NDC 9 | 76420-746 |
|---|---|
| NDC 10 | 76420-746-01 |
| NDC Item | 76420074601 |
| Packaging | 1 VIAL, GLASS in 1 CARTON (76420-746-01) / 1 mL in 1 VIAL, GLASS |
| ANDA | ANDA091244 |
| DCSA | CIII |
| FDA SPL set id | 791011 |
| Labeler | Asclemed USA, Inc. |
| Label type | HUMAN PRESCRIPTION DRUG |
| Marketing category | ANDA |
| Marketing effective time low | 2019-03-26 |
| Marketing status | ACTIVE |
| Related queries | Properties for NDC 9 76420-746 |
NDC Item 76420074701
| NDC 9 | 76420-747 |
|---|---|
| NDC 10 | 76420-747-01 |
| NDC Item | 76420074701 |
| Packaging | 1 VIAL, SINGLE-DOSE in 1 CARTON (76420-747-01) / 1 mL in 1 VIAL, SINGLE-DOSE |
| ANDA | ANDA207742 |
| DCSA | CIII |
| FDA SPL set id | 791057 |
| Labeler | Asclemed USA, Inc. |
| Label type | HUMAN PRESCRIPTION DRUG |
| Marketing category | ANDA |
| Marketing effective time low | 2022-11-02 |
| Marketing status | ACTIVE |
| Related queries | Properties for NDC 9 76420-747 |
NDC Item 00143965901
| NDC 9 | 0143-9659 |
|---|---|
| NDC 10 | 0143-9659-01 |
| NDC Item | 00143965901 |
| Packaging | 1 mL in 1 VIAL (0143-9659-01) |
| ANDA | ANDA091244 |
| DCSA | CIII |
| FDA SPL set id | 627057 |
| Labeler | Hikma Pharmaceuticals USA Inc. |
| Label type | HUMAN PRESCRIPTION DRUG |
| Marketing category | ANDA |
| Marketing effective time low | 2012-05-01 |
| Marketing status | ACTIVE |
| Related queries | Properties for NDC 9 0143-9659 |
NDC Item 00409656201
| NDC 9 | 0409-6562 |
|---|---|
| NDC 10 | 0409-6562-01 |
| NDC Item | 00409656201 |
| Packaging | 1 VIAL in 1 CARTON (0409-6562-01) / 1 mL in 1 VIAL |
| ANDA | ANDA085635 |
| DCSA | CIII |
| FDA SPL set id | 500095 |
| FDA SPL set id | 500287 |
| Labeler | Hospira, Inc. |
| Label type | HUMAN PRESCRIPTION DRUG |
| Marketing category | ANDA |
| Marketing effective time low | 2018-01-17 |
| Marketing status | ACTIVE |
| Related queries | Properties for NDC 9 0409-6562 |
NDC Item 00409656202
| NDC 9 | 0409-6562 |
|---|---|
| NDC 10 | 0409-6562-02 |
| NDC Item | 00409656202 |
| Packaging | 1 VIAL in 1 CARTON (0409-6562-02) / 1 mL in 1 VIAL |
| ANDA | ANDA085635 |
| DCSA | CIII |
| FDA SPL set id | 500095 |
| FDA SPL set id | 500287 |
| Labeler | Hospira, Inc. |
| Label type | HUMAN PRESCRIPTION DRUG |
| Marketing category | ANDA |
| Marketing effective time low | 2018-01-17 |
| Marketing status | ACTIVE |
| Related queries | Properties for NDC 9 0409-6562 |
NDC Item 00517183001
| NDC 9 | 0517-1830 |
|---|---|
| NDC 10 | 0517-1830-01 |
| NDC Item | 00517183001 |
| Packaging | 1 VIAL in 1 BOX (0517-1830-01) / 1 mL in 1 VIAL |
| ANDA | ANDA207742 |
| DCSA | CIII |
| FDA SPL set id | 674434 |
| Labeler | American Regent, Inc. |
| Label type | HUMAN PRESCRIPTION DRUG |
| Marketing category | ANDA |
| Marketing effective time low | 2019-07-19 |
| Marketing status | ACTIVE |
| Related queries | Properties for NDC 9 0517-1830 |
NDC Item 00574082001
| NDC 9 | 0574-0820 |
|---|---|
| NDC 10 | 0574-0820-01 |
| NDC Item | 00574082001 |
| Packaging | 1 VIAL, GLASS in 1 CARTON (0574-0820-01) / 1 mL in 1 VIAL, GLASS |
| ANDA | ANDA040530 |
| DCSA | CIII |
| FDA SPL set id | 768154 |
| FDA SPL set id | 791051 |
| Labeler | Padagis US LLC |
| Label type | HUMAN PRESCRIPTION DRUG |
| Marketing category | ANDA |
| Marketing effective time low | 2007-12-21 |
| Marketing status | ACTIVE |
| Related queries | Properties for NDC 9 0574-0820 |
NDC Item 00574082701
| NDC 9 | 0574-0827 |
|---|---|
| NDC 10 | 0574-0827-01 |
| NDC Item | 00574082701 |
| Packaging | 1 VIAL, GLASS in 1 CARTON (0574-0827-01) / 1 mL in 1 VIAL, GLASS |
| ANDA | ANDA091244 |
| DCSA | CIII |
| FDA SPL set id | 584573 |
| Labeler | Padagis US LLC |
| Label type | HUMAN PRESCRIPTION DRUG |
| Marketing category | ANDA |
| Marketing effective time low | 2014-05-01 |
| Marketing status | ACTIVE |
| Related queries | Properties for NDC 9 0574-0827 |
NDC Item 47781091193
| NDC 9 | 47781-911 |
|---|---|
| NDC 10 | 47781-911-93 |
| NDC Item | 47781091193 |
| Packaging | 1 VIAL, SINGLE-DOSE in 1 CARTON (47781-911-93) / 1 mL in 1 VIAL, SINGLE-DOSE |
| ANDA | ANDA207742 |
| DCSA | CIII |
| FDA SPL set id | 719526 |
| Labeler | Alvogen Inc. |
| Label type | HUMAN PRESCRIPTION DRUG |
| Marketing category | ANDA |
| Marketing effective time low | 2022-11-02 |
| Marketing status | ACTIVE |
| Related queries | Properties for NDC 9 47781-911 |
NDC Item 52536062501
| NDC 9 | 52536-625 |
|---|---|
| NDC 10 | 52536-625-01 |
| NDC Item | 52536062501 |
| Packaging | 1 VIAL, SINGLE-DOSE in 1 CARTON (52536-625-01) / 1 mL in 1 VIAL, SINGLE-DOSE |
| ANDA | ANDA206368 |
| COLORTEXT | WHITE(or creamy white) |
| Color | C48325 __ |
| DCSA | CIII |
| FDA SPL set id | 395393 |
| Labeler | Wilshire Pharmaceuticals |
| Label type | HUMAN PRESCRIPTION DRUG |
| Marketing category | ANDA |
| Marketing effective time low | 2019-05-31 |
| Marketing status | ACTIVE |
| Related queries | Properties for NDC 9 52536-625 |
NDC Item 55150027701
| NDC 9 | 55150-277 |
|---|---|
| NDC 10 | 55150-277-01 |
| NDC Item | 55150027701 |
| Packaging | 1 VIAL, GLASS in 1 CARTON (55150-277-01) / 1 mL in 1 VIAL, GLASS |
| ANDA | ANDA211817 |
| DCSA | CIII |
| FDA SPL set id | 739422 |
| Labeler | Eugia US LLC |
| Label type | HUMAN PRESCRIPTION DRUG |
| Marketing category | ANDA |
| Marketing effective time low | 2023-10-20 |
| Marketing status | ACTIVE |
| Related queries | Properties for NDC 9 55150-277 |
NDC Item 62756001540
| NDC 9 | 62756-015 |
|---|---|
| NDC 10 | 62756-015-40 |
| NDC Item | 62756001540 |
| Packaging | 1 VIAL in 1 CARTON (62756-015-40) / 1 mL in 1 VIAL |
| ANDA | ANDA201720 |
| DCSA | CIII |
| FDA SPL set id | 581578 |
| Labeler | Sun Pharmaceutical Industries, Inc. |
| Label type | HUMAN PRESCRIPTION DRUG |
| Marketing category | ANDA |
| Marketing effective time low | 2013-06-17 |
| Marketing status | ACTIVE |
| Related queries | Properties for NDC 9 62756-015 |
NDC Item 64980046799
| NDC 9 | 64980-467 |
|---|---|
| NDC 10 | 64980-467-99 |
| NDC Item | 64980046799 |
| Packaging | 1 VIAL, MULTI-DOSE in 1 CARTON (64980-467-99) / 1 mL in 1 VIAL, MULTI-DOSE |
| ANDA | ANDA207742 |
| DCSA | CIII |
| FDA SPL set id | 385892 |
| Labeler | Rising Pharma Holdings, Inc. |
| Label type | HUMAN PRESCRIPTION DRUG |
| Marketing category | ANDA |
| Marketing effective time high | 2020-06-30 |
| Marketing effective time low | 2018-12-01 |
| Marketing status | COMPLETED |
| Related queries | Properties for NDC 9 64980-467 |
NDC Item 69097053731
| NDC 9 | 69097-537 |
|---|---|
| NDC 10 | 69097-537-31 |
| NDC Item | 69097053731 |
| Packaging | 1 mL in 1 VIAL, GLASS (69097-537-31) |
| ANDA | ANDA210362 |
| COLORTEXT | WHITE("A clear colourless to pale yellow solution) |
| Color | C48325 __ |
| DCSA | CIII |
| FDA SPL set id | 729362 |
| Labeler | Cipla USA Inc. |
| Label type | HUMAN PRESCRIPTION DRUG |
| Marketing category | ANDA |
| Marketing effective time low | 2023-09-15 |
| Marketing status | ACTIVE |
| Related queries | Properties for NDC 9 69097-537 |
NDC Item 69097080232
| NDC 9 | 69097-802 |
|---|---|
| NDC 10 | 69097-802-32 |
| NDC Item | 69097080232 |
| Packaging | 1 VIAL, GLASS in 1 CARTON (69097-802-32) / 1 mL in 1 VIAL, GLASS |
| ANDA | ANDA091244 |
| DCSA | CIII |
| FDA SPL set id | 764872 |
| Labeler | Cipla USA Inc. |
| Label type | HUMAN PRESCRIPTION DRUG |
| Marketing category | ANDA |
| Marketing effective time low | 2019-03-26 |
| Marketing status | ACTIVE |
| Related queries | Properties for NDC 9 69097-802 |
NDC Item 70700028922
| NDC 9 | 70700-289 |
|---|---|
| NDC 10 | 70700-289-22 |
| NDC Item | 70700028922 |
| Packaging | 1 VIAL in 1 CARTON (70700-289-22) / 1 mL in 1 VIAL |
| ANDA | ANDA215351 |
| DCSA | CIII |
| FDA SPL set id | 708164 |
| Labeler | Xiromed LLC |
| Label type | HUMAN PRESCRIPTION DRUG |
| Marketing category | ANDA |
| Marketing effective time low | 2023-04-28 |
| Marketing status | ACTIVE |
| Related queries | Properties for NDC 9 70700-289 |
NDC Item 71205028901
| NDC 9 | 71205-289 |
|---|---|
| NDC 10 | 71205-289-01 |
| NDC Item | 71205028901 |
| Packaging | 1 mL in 1 VIAL (71205-289-01) |
| ANDA | ANDA091244 |
| DCSA | CIII |
| FDA SPL set id | 413320 |
| Labeler | Proficient Rx LP |
| Label type | HUMAN PRESCRIPTION DRUG |
| Marketing category | ANDA |
| Marketing effective time low | 2012-05-01 |
| Marketing status | ACTIVE |
| Related queries | Properties for NDC 9 71205-289 |
NDC Item 71225012701
| NDC 9 | 71225-127 |
|---|---|
| NDC 10 | 71225-127-01 |
| NDC Item | 71225012701 |
| Packaging | 1 VIAL in 1 CARTON (71225-127-01) / 1 mL in 1 VIAL |
| DCSA | CIII |
| FDA SPL set id | 642064 |
| Labeler | Slayback Pharma LLC |
| Label type | HUMAN PRESCRIPTION DRUG |
| Marketing category | NDA |
| Marketing effective time low | 2022-06-13 |
| Marketing status | ACTIVE |
| NDA | NDA216318 |
| Related queries | Properties for NDC 9 71225-127 |
NDC Item 72162234802
| NDC 9 | 72162-2348 |
|---|---|
| NDC 10 | 72162-2348-2 |
| NDC Item | 72162234802 |
| Packaging | 1 VIAL, SINGLE-DOSE in 1 CARTON (72162-2348-2) / 1 mL in 1 VIAL, SINGLE-DOSE |
| ANDA | ANDA206368 |
| COLORTEXT | WHITE(or creamy white) |
| Color | C48325 __ |
| DCSA | CIII |
| FDA SPL set id | 794476 |
| Labeler | Bryant Ranch Prepack |
| Label type | HUMAN PRESCRIPTION DRUG |
| Marketing category | ANDA |
| Marketing effective time low | 2019-05-31 |
| Marketing status | active |
| Related queries | Properties for NDC 9 72162-2348 |
NDC Item 72162234804
| NDC 9 | 72162-2348 |
|---|---|
| NDC 10 | 72162-2348-4 |
| NDC Item | 72162234804 |
| Packaging | 1 VIAL, MULTI-DOSE in 1 CARTON (72162-2348-4) / 10 mL in 1 VIAL, MULTI-DOSE |
| ANDA | ANDA206368 |
| COLORTEXT | WHITE(or creamy white) |
| Color | C48325 __ |
| DCSA | CIII |
| FDA SPL set id | 794476 |
| Labeler | Bryant Ranch Prepack |
| Label type | HUMAN PRESCRIPTION DRUG |
| Marketing category | ANDA |
| Marketing effective time low | 2019-05-31 |
| Marketing status | active |
| Related queries | Properties for NDC 9 72162-2348 |
NDC Item 72162237502
| NDC 9 | 72162-2375 |
|---|---|
| NDC 10 | 72162-2375-2 |
| NDC Item | 72162237502 |
| Packaging | 1 VIAL, GLASS in 1 CARTON (72162-2375-2) / 1 mL in 1 VIAL, GLASS |
| ANDA | ANDA040530 |
| DCSA | CIII |
| FDA SPL set id | 800677 |
| Labeler | Bryant Ranch Prepack |
| Label type | HUMAN PRESCRIPTION DRUG |
| Marketing category | ANDA |
| Marketing effective time low | 2007-12-21 |
| Marketing status | active |
| Related queries | Properties for NDC 9 72162-2375 |
NDC Item 76420074601
| NDC 9 | 76420-746 |
|---|---|
| NDC 10 | 76420-746-01 |
| NDC Item | 76420074601 |
| Packaging | 1 VIAL, GLASS in 1 CARTON (76420-746-01) / 1 mL in 1 VIAL, GLASS |
| ANDA | ANDA091244 |
| DCSA | CIII |
| FDA SPL set id | 791011 |
| Labeler | Asclemed USA, Inc. |
| Label type | HUMAN PRESCRIPTION DRUG |
| Marketing category | ANDA |
| Marketing effective time low | 2019-03-26 |
| Marketing status | ACTIVE |
| Related queries | Properties for NDC 9 76420-746 |
NDC Item 76420074701
| NDC 9 | 76420-747 |
|---|---|
| NDC 10 | 76420-747-01 |
| NDC Item | 76420074701 |
| Packaging | 1 VIAL, SINGLE-DOSE in 1 CARTON (76420-747-01) / 1 mL in 1 VIAL, SINGLE-DOSE |
| ANDA | ANDA207742 |
| DCSA | CIII |
| FDA SPL set id | 791057 |
| Labeler | Asclemed USA, Inc. |
| Label type | HUMAN PRESCRIPTION DRUG |
| Marketing category | ANDA |
| Marketing effective time low | 2022-11-02 |
| Marketing status | ACTIVE |
| Related queries | Properties for NDC 9 76420-747 |
NDC Item 00143965901
| NDC 9 | 0143-9659 |
|---|---|
| NDC 10 | 0143-9659-01 |
| NDC Item | 00143965901 |
| Packaging | 1 mL in 1 VIAL (0143-9659-01) |
| ANDA | ANDA091244 |
| DCSA | CIII |
| FDA SPL set id | 627057 |
| Labeler | Hikma Pharmaceuticals USA Inc. |
| Label type | HUMAN PRESCRIPTION DRUG |
| Marketing category | ANDA |
| Marketing effective time low | 2012-05-01 |
| Marketing status | ACTIVE |
| Related queries | Properties for NDC 9 0143-9659 |
NDC Item 00409656201
| NDC 9 | 0409-6562 |
|---|---|
| NDC 10 | 0409-6562-01 |
| NDC Item | 00409656201 |
| Packaging | 1 VIAL in 1 CARTON (0409-6562-01) / 1 mL in 1 VIAL |
| ANDA | ANDA085635 |
| DCSA | CIII |
| FDA SPL set id | 500095 |
| FDA SPL set id | 500287 |
| Labeler | Hospira, Inc. |
| Label type | HUMAN PRESCRIPTION DRUG |
| Marketing category | ANDA |
| Marketing effective time low | 2018-01-17 |
| Marketing status | ACTIVE |
| Related queries | Properties for NDC 9 0409-6562 |
NDC Item 00409656202
| NDC 9 | 0409-6562 |
|---|---|
| NDC 10 | 0409-6562-02 |
| NDC Item | 00409656202 |
| Packaging | 1 VIAL in 1 CARTON (0409-6562-02) / 1 mL in 1 VIAL |
| ANDA | ANDA085635 |
| DCSA | CIII |
| FDA SPL set id | 500095 |
| FDA SPL set id | 500287 |
| Labeler | Hospira, Inc. |
| Label type | HUMAN PRESCRIPTION DRUG |
| Marketing category | ANDA |
| Marketing effective time low | 2018-01-17 |
| Marketing status | ACTIVE |
| Related queries | Properties for NDC 9 0409-6562 |
NDC Item 00517183001
| NDC 9 | 0517-1830 |
|---|---|
| NDC 10 | 0517-1830-01 |
| NDC Item | 00517183001 |
| Packaging | 1 VIAL in 1 BOX (0517-1830-01) / 1 mL in 1 VIAL |
| ANDA | ANDA207742 |
| DCSA | CIII |
| FDA SPL set id | 674434 |
| Labeler | American Regent, Inc. |
| Label type | HUMAN PRESCRIPTION DRUG |
| Marketing category | ANDA |
| Marketing effective time low | 2019-07-19 |
| Marketing status | ACTIVE |
| Related queries | Properties for NDC 9 0517-1830 |
NDC Item 00574082001
| NDC 9 | 0574-0820 |
|---|---|
| NDC 10 | 0574-0820-01 |
| NDC Item | 00574082001 |
| Packaging | 1 VIAL, GLASS in 1 CARTON (0574-0820-01) / 1 mL in 1 VIAL, GLASS |
| ANDA | ANDA040530 |
| DCSA | CIII |
| FDA SPL set id | 768154 |
| FDA SPL set id | 791051 |
| Labeler | Padagis US LLC |
| Label type | HUMAN PRESCRIPTION DRUG |
| Marketing category | ANDA |
| Marketing effective time low | 2007-12-21 |
| Marketing status | ACTIVE |
| Related queries | Properties for NDC 9 0574-0820 |
NDC Item 00574082701
| NDC 9 | 0574-0827 |
|---|---|
| NDC 10 | 0574-0827-01 |
| NDC Item | 00574082701 |
| Packaging | 1 VIAL, GLASS in 1 CARTON (0574-0827-01) / 1 mL in 1 VIAL, GLASS |
| ANDA | ANDA091244 |
| DCSA | CIII |
| FDA SPL set id | 584573 |
| Labeler | Padagis US LLC |
| Label type | HUMAN PRESCRIPTION DRUG |
| Marketing category | ANDA |
| Marketing effective time low | 2014-05-01 |
| Marketing status | ACTIVE |
| Related queries | Properties for NDC 9 0574-0827 |
NDC Item 47781091193
| NDC 9 | 47781-911 |
|---|---|
| NDC 10 | 47781-911-93 |
| NDC Item | 47781091193 |
| Packaging | 1 VIAL, SINGLE-DOSE in 1 CARTON (47781-911-93) / 1 mL in 1 VIAL, SINGLE-DOSE |
| ANDA | ANDA207742 |
| DCSA | CIII |
| FDA SPL set id | 719526 |
| Labeler | Alvogen Inc. |
| Label type | HUMAN PRESCRIPTION DRUG |
| Marketing category | ANDA |
| Marketing effective time low | 2022-11-02 |
| Marketing status | ACTIVE |
| Related queries | Properties for NDC 9 47781-911 |
NDC Item 52536062501
| NDC 9 | 52536-625 |
|---|---|
| NDC 10 | 52536-625-01 |
| NDC Item | 52536062501 |
| Packaging | 1 VIAL, SINGLE-DOSE in 1 CARTON (52536-625-01) / 1 mL in 1 VIAL, SINGLE-DOSE |
| ANDA | ANDA206368 |
| COLORTEXT | WHITE(or creamy white) |
| Color | C48325 __ |
| DCSA | CIII |
| FDA SPL set id | 395393 |
| Labeler | Wilshire Pharmaceuticals |
| Label type | HUMAN PRESCRIPTION DRUG |
| Marketing category | ANDA |
| Marketing effective time low | 2019-05-31 |
| Marketing status | ACTIVE |
| Related queries | Properties for NDC 9 52536-625 |
NDC Item 55150027701
| NDC 9 | 55150-277 |
|---|---|
| NDC 10 | 55150-277-01 |
| NDC Item | 55150027701 |
| Packaging | 1 VIAL, GLASS in 1 CARTON (55150-277-01) / 1 mL in 1 VIAL, GLASS |
| ANDA | ANDA211817 |
| DCSA | CIII |
| FDA SPL set id | 739422 |
| Labeler | Eugia US LLC |
| Label type | HUMAN PRESCRIPTION DRUG |
| Marketing category | ANDA |
| Marketing effective time low | 2023-10-20 |
| Marketing status | ACTIVE |
| Related queries | Properties for NDC 9 55150-277 |
NDC Item 62756001540
| NDC 9 | 62756-015 |
|---|---|
| NDC 10 | 62756-015-40 |
| NDC Item | 62756001540 |
| Packaging | 1 VIAL in 1 CARTON (62756-015-40) / 1 mL in 1 VIAL |
| ANDA | ANDA201720 |
| DCSA | CIII |
| FDA SPL set id | 581578 |
| Labeler | Sun Pharmaceutical Industries, Inc. |
| Label type | HUMAN PRESCRIPTION DRUG |
| Marketing category | ANDA |
| Marketing effective time low | 2013-06-17 |
| Marketing status | ACTIVE |
| Related queries | Properties for NDC 9 62756-015 |
NDC Item 64980046799
| NDC 9 | 64980-467 |
|---|---|
| NDC 10 | 64980-467-99 |
| NDC Item | 64980046799 |
| Packaging | 1 VIAL, MULTI-DOSE in 1 CARTON (64980-467-99) / 1 mL in 1 VIAL, MULTI-DOSE |
| ANDA | ANDA207742 |
| DCSA | CIII |
| FDA SPL set id | 385892 |
| Labeler | Rising Pharma Holdings, Inc. |
| Label type | HUMAN PRESCRIPTION DRUG |
| Marketing category | ANDA |
| Marketing effective time high | 2020-06-30 |
| Marketing effective time low | 2018-12-01 |
| Marketing status | COMPLETED |
| Related queries | Properties for NDC 9 64980-467 |
NDC Item 69097053731
| NDC 9 | 69097-537 |
|---|---|
| NDC 10 | 69097-537-31 |
| NDC Item | 69097053731 |
| Packaging | 1 mL in 1 VIAL, GLASS (69097-537-31) |
| ANDA | ANDA210362 |
| COLORTEXT | WHITE("A clear colourless to pale yellow solution) |
| Color | C48325 __ |
| DCSA | CIII |
| FDA SPL set id | 729362 |
| Labeler | Cipla USA Inc. |
| Label type | HUMAN PRESCRIPTION DRUG |
| Marketing category | ANDA |
| Marketing effective time low | 2023-09-15 |
| Marketing status | ACTIVE |
| Related queries | Properties for NDC 9 69097-537 |
NDC Item 69097080232
| NDC 9 | 69097-802 |
|---|---|
| NDC 10 | 69097-802-32 |
| NDC Item | 69097080232 |
| Packaging | 1 VIAL, GLASS in 1 CARTON (69097-802-32) / 1 mL in 1 VIAL, GLASS |
| ANDA | ANDA091244 |
| DCSA | CIII |
| FDA SPL set id | 764872 |
| Labeler | Cipla USA Inc. |
| Label type | HUMAN PRESCRIPTION DRUG |
| Marketing category | ANDA |
| Marketing effective time low | 2019-03-26 |
| Marketing status | ACTIVE |
| Related queries | Properties for NDC 9 69097-802 |
NDC Item 70700028922
| NDC 9 | 70700-289 |
|---|---|
| NDC 10 | 70700-289-22 |
| NDC Item | 70700028922 |
| Packaging | 1 VIAL in 1 CARTON (70700-289-22) / 1 mL in 1 VIAL |
| ANDA | ANDA215351 |
| DCSA | CIII |
| FDA SPL set id | 708164 |
| Labeler | Xiromed LLC |
| Label type | HUMAN PRESCRIPTION DRUG |
| Marketing category | ANDA |
| Marketing effective time low | 2023-04-28 |
| Marketing status | ACTIVE |
| Related queries | Properties for NDC 9 70700-289 |
NDC Item 71205028901
| NDC 9 | 71205-289 |
|---|---|
| NDC 10 | 71205-289-01 |
| NDC Item | 71205028901 |
| Packaging | 1 mL in 1 VIAL (71205-289-01) |
| ANDA | ANDA091244 |
| DCSA | CIII |
| FDA SPL set id | 413320 |
| Labeler | Proficient Rx LP |
| Label type | HUMAN PRESCRIPTION DRUG |
| Marketing category | ANDA |
| Marketing effective time low | 2012-05-01 |
| Marketing status | ACTIVE |
| Related queries | Properties for NDC 9 71205-289 |
NDC Item 71225012701
| NDC 9 | 71225-127 |
|---|---|
| NDC 10 | 71225-127-01 |
| NDC Item | 71225012701 |
| Packaging | 1 VIAL in 1 CARTON (71225-127-01) / 1 mL in 1 VIAL |
| DCSA | CIII |
| FDA SPL set id | 642064 |
| Labeler | Slayback Pharma LLC |
| Label type | HUMAN PRESCRIPTION DRUG |
| Marketing category | NDA |
| Marketing effective time low | 2022-06-13 |
| Marketing status | ACTIVE |
| NDA | NDA216318 |
| Related queries | Properties for NDC 9 71225-127 |
NDC Item 72162234802
| NDC 9 | 72162-2348 |
|---|---|
| NDC 10 | 72162-2348-2 |
| NDC Item | 72162234802 |
| Packaging | 1 VIAL, SINGLE-DOSE in 1 CARTON (72162-2348-2) / 1 mL in 1 VIAL, SINGLE-DOSE |
| ANDA | ANDA206368 |
| COLORTEXT | WHITE(or creamy white) |
| Color | C48325 __ |
| DCSA | CIII |
| FDA SPL set id | 794476 |
| Labeler | Bryant Ranch Prepack |
| Label type | HUMAN PRESCRIPTION DRUG |
| Marketing category | ANDA |
| Marketing effective time low | 2019-05-31 |
| Marketing status | active |
| Related queries | Properties for NDC 9 72162-2348 |
NDC Item 72162234804
| NDC 9 | 72162-2348 |
|---|---|
| NDC 10 | 72162-2348-4 |
| NDC Item | 72162234804 |
| Packaging | 1 VIAL, MULTI-DOSE in 1 CARTON (72162-2348-4) / 10 mL in 1 VIAL, MULTI-DOSE |
| ANDA | ANDA206368 |
| COLORTEXT | WHITE(or creamy white) |
| Color | C48325 __ |
| DCSA | CIII |
| FDA SPL set id | 794476 |
| Labeler | Bryant Ranch Prepack |
| Label type | HUMAN PRESCRIPTION DRUG |
| Marketing category | ANDA |
| Marketing effective time low | 2019-05-31 |
| Marketing status | active |
| Related queries | Properties for NDC 9 72162-2348 |
NDC Item 72162237502
| NDC 9 | 72162-2375 |
|---|---|
| NDC 10 | 72162-2375-2 |
| NDC Item | 72162237502 |
| Packaging | 1 VIAL, GLASS in 1 CARTON (72162-2375-2) / 1 mL in 1 VIAL, GLASS |
| ANDA | ANDA040530 |
| DCSA | CIII |
| FDA SPL set id | 800677 |
| Labeler | Bryant Ranch Prepack |
| Label type | HUMAN PRESCRIPTION DRUG |
| Marketing category | ANDA |
| Marketing effective time low | 2007-12-21 |
| Marketing status | active |
| Related queries | Properties for NDC 9 72162-2375 |
NDC Item 76420074601
| NDC 9 | 76420-746 |
|---|---|
| NDC 10 | 76420-746-01 |
| NDC Item | 76420074601 |
| Packaging | 1 VIAL, GLASS in 1 CARTON (76420-746-01) / 1 mL in 1 VIAL, GLASS |
| ANDA | ANDA091244 |
| DCSA | CIII |
| FDA SPL set id | 791011 |
| Labeler | Asclemed USA, Inc. |
| Label type | HUMAN PRESCRIPTION DRUG |
| Marketing category | ANDA |
| Marketing effective time low | 2019-03-26 |
| Marketing status | ACTIVE |
| Related queries | Properties for NDC 9 76420-746 |
NDC Item 76420074701
| NDC 9 | 76420-747 |
|---|---|
| NDC 10 | 76420-747-01 |
| NDC Item | 76420074701 |
| Packaging | 1 VIAL, SINGLE-DOSE in 1 CARTON (76420-747-01) / 1 mL in 1 VIAL, SINGLE-DOSE |
| ANDA | ANDA207742 |
| DCSA | CIII |
| FDA SPL set id | 791057 |
| Labeler | Asclemed USA, Inc. |
| Label type | HUMAN PRESCRIPTION DRUG |
| Marketing category | ANDA |
| Marketing effective time low | 2022-11-02 |
| Marketing status | ACTIVE |
| Related queries | Properties for NDC 9 76420-747 |
NDC Item 00143965901
| NDC 9 | 0143-9659 |
|---|---|
| NDC 10 | 0143-9659-01 |
| NDC Item | 00143965901 |
| Packaging | 1 mL in 1 VIAL (0143-9659-01) |
| ANDA | ANDA091244 |
| DCSA | CIII |
| FDA SPL set id | 627057 |
| Labeler | Hikma Pharmaceuticals USA Inc. |
| Label type | HUMAN PRESCRIPTION DRUG |
| Marketing category | ANDA |
| Marketing effective time low | 2012-05-01 |
| Marketing status | ACTIVE |
| Related queries | Properties for NDC 9 0143-9659 |
NDC Item 00409656201
| NDC 9 | 0409-6562 |
|---|---|
| NDC 10 | 0409-6562-01 |
| NDC Item | 00409656201 |
| Packaging | 1 VIAL in 1 CARTON (0409-6562-01) / 1 mL in 1 VIAL |
| ANDA | ANDA085635 |
| DCSA | CIII |
| FDA SPL set id | 500095 |
| FDA SPL set id | 500287 |
| Labeler | Hospira, Inc. |
| Label type | HUMAN PRESCRIPTION DRUG |
| Marketing category | ANDA |
| Marketing effective time low | 2018-01-17 |
| Marketing status | ACTIVE |
| Related queries | Properties for NDC 9 0409-6562 |
NDC Item 00409656202
| NDC 9 | 0409-6562 |
|---|---|
| NDC 10 | 0409-6562-02 |
| NDC Item | 00409656202 |
| Packaging | 1 VIAL in 1 CARTON (0409-6562-02) / 1 mL in 1 VIAL |
| ANDA | ANDA085635 |
| DCSA | CIII |
| FDA SPL set id | 500095 |
| FDA SPL set id | 500287 |
| Labeler | Hospira, Inc. |
| Label type | HUMAN PRESCRIPTION DRUG |
| Marketing category | ANDA |
| Marketing effective time low | 2018-01-17 |
| Marketing status | ACTIVE |
| Related queries | Properties for NDC 9 0409-6562 |
NDC Item 00517183001
| NDC 9 | 0517-1830 |
|---|---|
| NDC 10 | 0517-1830-01 |
| NDC Item | 00517183001 |
| Packaging | 1 VIAL in 1 BOX (0517-1830-01) / 1 mL in 1 VIAL |
| ANDA | ANDA207742 |
| DCSA | CIII |
| FDA SPL set id | 674434 |
| Labeler | American Regent, Inc. |
| Label type | HUMAN PRESCRIPTION DRUG |
| Marketing category | ANDA |
| Marketing effective time low | 2019-07-19 |
| Marketing status | ACTIVE |
| Related queries | Properties for NDC 9 0517-1830 |
NDC Item 00574082001
| NDC 9 | 0574-0820 |
|---|---|
| NDC 10 | 0574-0820-01 |
| NDC Item | 00574082001 |
| Packaging | 1 VIAL, GLASS in 1 CARTON (0574-0820-01) / 1 mL in 1 VIAL, GLASS |
| ANDA | ANDA040530 |
| DCSA | CIII |
| FDA SPL set id | 768154 |
| FDA SPL set id | 791051 |
| Labeler | Padagis US LLC |
| Label type | HUMAN PRESCRIPTION DRUG |
| Marketing category | ANDA |
| Marketing effective time low | 2007-12-21 |
| Marketing status | ACTIVE |
| Related queries | Properties for NDC 9 0574-0820 |
NDC Item 00574082701
| NDC 9 | 0574-0827 |
|---|---|
| NDC 10 | 0574-0827-01 |
| NDC Item | 00574082701 |
| Packaging | 1 VIAL, GLASS in 1 CARTON (0574-0827-01) / 1 mL in 1 VIAL, GLASS |
| ANDA | ANDA091244 |
| DCSA | CIII |
| FDA SPL set id | 584573 |
| Labeler | Padagis US LLC |
| Label type | HUMAN PRESCRIPTION DRUG |
| Marketing category | ANDA |
| Marketing effective time low | 2014-05-01 |
| Marketing status | ACTIVE |
| Related queries | Properties for NDC 9 0574-0827 |
NDC Item 47781091193
| NDC 9 | 47781-911 |
|---|---|
| NDC 10 | 47781-911-93 |
| NDC Item | 47781091193 |
| Packaging | 1 VIAL, SINGLE-DOSE in 1 CARTON (47781-911-93) / 1 mL in 1 VIAL, SINGLE-DOSE |
| ANDA | ANDA207742 |
| DCSA | CIII |
| FDA SPL set id | 719526 |
| Labeler | Alvogen Inc. |
| Label type | HUMAN PRESCRIPTION DRUG |
| Marketing category | ANDA |
| Marketing effective time low | 2022-11-02 |
| Marketing status | ACTIVE |
| Related queries | Properties for NDC 9 47781-911 |
NDC Item 52536062501
| NDC 9 | 52536-625 |
|---|---|
| NDC 10 | 52536-625-01 |
| NDC Item | 52536062501 |
| Packaging | 1 VIAL, SINGLE-DOSE in 1 CARTON (52536-625-01) / 1 mL in 1 VIAL, SINGLE-DOSE |
| ANDA | ANDA206368 |
| COLORTEXT | WHITE(or creamy white) |
| Color | C48325 __ |
| DCSA | CIII |
| FDA SPL set id | 395393 |
| Labeler | Wilshire Pharmaceuticals |
| Label type | HUMAN PRESCRIPTION DRUG |
| Marketing category | ANDA |
| Marketing effective time low | 2019-05-31 |
| Marketing status | ACTIVE |
| Related queries | Properties for NDC 9 52536-625 |
NDC Item 55150027701
| NDC 9 | 55150-277 |
|---|---|
| NDC 10 | 55150-277-01 |
| NDC Item | 55150027701 |
| Packaging | 1 VIAL, GLASS in 1 CARTON (55150-277-01) / 1 mL in 1 VIAL, GLASS |
| ANDA | ANDA211817 |
| DCSA | CIII |
| FDA SPL set id | 739422 |
| Labeler | Eugia US LLC |
| Label type | HUMAN PRESCRIPTION DRUG |
| Marketing category | ANDA |
| Marketing effective time low | 2023-10-20 |
| Marketing status | ACTIVE |
| Related queries | Properties for NDC 9 55150-277 |
NDC Item 62756001540
| NDC 9 | 62756-015 |
|---|---|
| NDC 10 | 62756-015-40 |
| NDC Item | 62756001540 |
| Packaging | 1 VIAL in 1 CARTON (62756-015-40) / 1 mL in 1 VIAL |
| ANDA | ANDA201720 |
| DCSA | CIII |
| FDA SPL set id | 581578 |
| Labeler | Sun Pharmaceutical Industries, Inc. |
| Label type | HUMAN PRESCRIPTION DRUG |
| Marketing category | ANDA |
| Marketing effective time low | 2013-06-17 |
| Marketing status | ACTIVE |
| Related queries | Properties for NDC 9 62756-015 |
NDC Item 64980046799
| NDC 9 | 64980-467 |
|---|---|
| NDC 10 | 64980-467-99 |
| NDC Item | 64980046799 |
| Packaging | 1 VIAL, MULTI-DOSE in 1 CARTON (64980-467-99) / 1 mL in 1 VIAL, MULTI-DOSE |
| ANDA | ANDA207742 |
| DCSA | CIII |
| FDA SPL set id | 385892 |
| Labeler | Rising Pharma Holdings, Inc. |
| Label type | HUMAN PRESCRIPTION DRUG |
| Marketing category | ANDA |
| Marketing effective time high | 2020-06-30 |
| Marketing effective time low | 2018-12-01 |
| Marketing status | COMPLETED |
| Related queries | Properties for NDC 9 64980-467 |
NDC Item 69097053731
| NDC 9 | 69097-537 |
|---|---|
| NDC 10 | 69097-537-31 |
| NDC Item | 69097053731 |
| Packaging | 1 mL in 1 VIAL, GLASS (69097-537-31) |
| ANDA | ANDA210362 |
| COLORTEXT | WHITE("A clear colourless to pale yellow solution) |
| Color | C48325 __ |
| DCSA | CIII |
| FDA SPL set id | 729362 |
| Labeler | Cipla USA Inc. |
| Label type | HUMAN PRESCRIPTION DRUG |
| Marketing category | ANDA |
| Marketing effective time low | 2023-09-15 |
| Marketing status | ACTIVE |
| Related queries | Properties for NDC 9 69097-537 |
NDC Item 69097080232
| NDC 9 | 69097-802 |
|---|---|
| NDC 10 | 69097-802-32 |
| NDC Item | 69097080232 |
| Packaging | 1 VIAL, GLASS in 1 CARTON (69097-802-32) / 1 mL in 1 VIAL, GLASS |
| ANDA | ANDA091244 |
| DCSA | CIII |
| FDA SPL set id | 764872 |
| Labeler | Cipla USA Inc. |
| Label type | HUMAN PRESCRIPTION DRUG |
| Marketing category | ANDA |
| Marketing effective time low | 2019-03-26 |
| Marketing status | ACTIVE |
| Related queries | Properties for NDC 9 69097-802 |
NDC Item 70700028922
| NDC 9 | 70700-289 |
|---|---|
| NDC 10 | 70700-289-22 |
| NDC Item | 70700028922 |
| Packaging | 1 VIAL in 1 CARTON (70700-289-22) / 1 mL in 1 VIAL |
| ANDA | ANDA215351 |
| DCSA | CIII |
| FDA SPL set id | 708164 |
| Labeler | Xiromed LLC |
| Label type | HUMAN PRESCRIPTION DRUG |
| Marketing category | ANDA |
| Marketing effective time low | 2023-04-28 |
| Marketing status | ACTIVE |
| Related queries | Properties for NDC 9 70700-289 |
NDC Item 71205028901
| NDC 9 | 71205-289 |
|---|---|
| NDC 10 | 71205-289-01 |
| NDC Item | 71205028901 |
| Packaging | 1 mL in 1 VIAL (71205-289-01) |
| ANDA | ANDA091244 |
| DCSA | CIII |
| FDA SPL set id | 413320 |
| Labeler | Proficient Rx LP |
| Label type | HUMAN PRESCRIPTION DRUG |
| Marketing category | ANDA |
| Marketing effective time low | 2012-05-01 |
| Marketing status | ACTIVE |
| Related queries | Properties for NDC 9 71205-289 |
NDC Item 71225012701
| NDC 9 | 71225-127 |
|---|---|
| NDC 10 | 71225-127-01 |
| NDC Item | 71225012701 |
| Packaging | 1 VIAL in 1 CARTON (71225-127-01) / 1 mL in 1 VIAL |
| DCSA | CIII |
| FDA SPL set id | 642064 |
| Labeler | Slayback Pharma LLC |
| Label type | HUMAN PRESCRIPTION DRUG |
| Marketing category | NDA |
| Marketing effective time low | 2022-06-13 |
| Marketing status | ACTIVE |
| NDA | NDA216318 |
| Related queries | Properties for NDC 9 71225-127 |
NDC Item 72162234802
| NDC 9 | 72162-2348 |
|---|---|
| NDC 10 | 72162-2348-2 |
| NDC Item | 72162234802 |
| Packaging | 1 VIAL, SINGLE-DOSE in 1 CARTON (72162-2348-2) / 1 mL in 1 VIAL, SINGLE-DOSE |
| ANDA | ANDA206368 |
| COLORTEXT | WHITE(or creamy white) |
| Color | C48325 __ |
| DCSA | CIII |
| FDA SPL set id | 794476 |
| Labeler | Bryant Ranch Prepack |
| Label type | HUMAN PRESCRIPTION DRUG |
| Marketing category | ANDA |
| Marketing effective time low | 2019-05-31 |
| Marketing status | active |
| Related queries | Properties for NDC 9 72162-2348 |
NDC Item 72162234804
| NDC 9 | 72162-2348 |
|---|---|
| NDC 10 | 72162-2348-4 |
| NDC Item | 72162234804 |
| Packaging | 1 VIAL, MULTI-DOSE in 1 CARTON (72162-2348-4) / 10 mL in 1 VIAL, MULTI-DOSE |
| ANDA | ANDA206368 |
| COLORTEXT | WHITE(or creamy white) |
| Color | C48325 __ |
| DCSA | CIII |
| FDA SPL set id | 794476 |
| Labeler | Bryant Ranch Prepack |
| Label type | HUMAN PRESCRIPTION DRUG |
| Marketing category | ANDA |
| Marketing effective time low | 2019-05-31 |
| Marketing status | active |
| Related queries | Properties for NDC 9 72162-2348 |
NDC Item 72162237502
| NDC 9 | 72162-2375 |
|---|---|
| NDC 10 | 72162-2375-2 |
| NDC Item | 72162237502 |
| Packaging | 1 VIAL, GLASS in 1 CARTON (72162-2375-2) / 1 mL in 1 VIAL, GLASS |
| ANDA | ANDA040530 |
| DCSA | CIII |
| FDA SPL set id | 800677 |
| Labeler | Bryant Ranch Prepack |
| Label type | HUMAN PRESCRIPTION DRUG |
| Marketing category | ANDA |
| Marketing effective time low | 2007-12-21 |
| Marketing status | active |
| Related queries | Properties for NDC 9 72162-2375 |
NDC Item 76420074601
| NDC 9 | 76420-746 |
|---|---|
| NDC 10 | 76420-746-01 |
| NDC Item | 76420074601 |
| Packaging | 1 VIAL, GLASS in 1 CARTON (76420-746-01) / 1 mL in 1 VIAL, GLASS |
| ANDA | ANDA091244 |
| DCSA | CIII |
| FDA SPL set id | 791011 |
| Labeler | Asclemed USA, Inc. |
| Label type | HUMAN PRESCRIPTION DRUG |
| Marketing category | ANDA |
| Marketing effective time low | 2019-03-26 |
| Marketing status | ACTIVE |
| Related queries | Properties for NDC 9 76420-746 |
NDC Item 76420074701
| NDC 9 | 76420-747 |
|---|---|
| NDC 10 | 76420-747-01 |
| NDC Item | 76420074701 |
| Packaging | 1 VIAL, SINGLE-DOSE in 1 CARTON (76420-747-01) / 1 mL in 1 VIAL, SINGLE-DOSE |
| ANDA | ANDA207742 |
| DCSA | CIII |
| FDA SPL set id | 791057 |
| Labeler | Asclemed USA, Inc. |
| Label type | HUMAN PRESCRIPTION DRUG |
| Marketing category | ANDA |
| Marketing effective time low | 2022-11-02 |
| Marketing status | ACTIVE |
| Related queries | Properties for NDC 9 76420-747 |
NDC Item 00143965901
| NDC 9 | 0143-9659 |
|---|---|
| NDC 10 | 0143-9659-01 |
| NDC Item | 00143965901 |
| Packaging | 1 mL in 1 VIAL (0143-9659-01) |
| ANDA | ANDA091244 |
| DCSA | CIII |
| FDA SPL set id | 627057 |
| Labeler | Hikma Pharmaceuticals USA Inc. |
| Label type | HUMAN PRESCRIPTION DRUG |
| Marketing category | ANDA |
| Marketing effective time low | 2012-05-01 |
| Marketing status | ACTIVE |
| Related queries | Properties for NDC 9 0143-9659 |
NDC Item 00409656201
| NDC 9 | 0409-6562 |
|---|---|
| NDC 10 | 0409-6562-01 |
| NDC Item | 00409656201 |
| Packaging | 1 VIAL in 1 CARTON (0409-6562-01) / 1 mL in 1 VIAL |
| ANDA | ANDA085635 |
| DCSA | CIII |
| FDA SPL set id | 500095 |
| FDA SPL set id | 500287 |
| Labeler | Hospira, Inc. |
| Label type | HUMAN PRESCRIPTION DRUG |
| Marketing category | ANDA |
| Marketing effective time low | 2018-01-17 |
| Marketing status | ACTIVE |
| Related queries | Properties for NDC 9 0409-6562 |
NDC Item 00409656202
| NDC 9 | 0409-6562 |
|---|---|
| NDC 10 | 0409-6562-02 |
| NDC Item | 00409656202 |
| Packaging | 1 VIAL in 1 CARTON (0409-6562-02) / 1 mL in 1 VIAL |
| ANDA | ANDA085635 |
| DCSA | CIII |
| FDA SPL set id | 500095 |
| FDA SPL set id | 500287 |
| Labeler | Hospira, Inc. |
| Label type | HUMAN PRESCRIPTION DRUG |
| Marketing category | ANDA |
| Marketing effective time low | 2018-01-17 |
| Marketing status | ACTIVE |
| Related queries | Properties for NDC 9 0409-6562 |
NDC Item 00517183001
| NDC 9 | 0517-1830 |
|---|---|
| NDC 10 | 0517-1830-01 |
| NDC Item | 00517183001 |
| Packaging | 1 VIAL in 1 BOX (0517-1830-01) / 1 mL in 1 VIAL |
| ANDA | ANDA207742 |
| DCSA | CIII |
| FDA SPL set id | 674434 |
| Labeler | American Regent, Inc. |
| Label type | HUMAN PRESCRIPTION DRUG |
| Marketing category | ANDA |
| Marketing effective time low | 2019-07-19 |
| Marketing status | ACTIVE |
| Related queries | Properties for NDC 9 0517-1830 |
NDC Item 00574082001
| NDC 9 | 0574-0820 |
|---|---|
| NDC 10 | 0574-0820-01 |
| NDC Item | 00574082001 |
| Packaging | 1 VIAL, GLASS in 1 CARTON (0574-0820-01) / 1 mL in 1 VIAL, GLASS |
| ANDA | ANDA040530 |
| DCSA | CIII |
| FDA SPL set id | 768154 |
| FDA SPL set id | 791051 |
| Labeler | Padagis US LLC |
| Label type | HUMAN PRESCRIPTION DRUG |
| Marketing category | ANDA |
| Marketing effective time low | 2007-12-21 |
| Marketing status | ACTIVE |
| Related queries | Properties for NDC 9 0574-0820 |
NDC Item 00574082701
| NDC 9 | 0574-0827 |
|---|---|
| NDC 10 | 0574-0827-01 |
| NDC Item | 00574082701 |
| Packaging | 1 VIAL, GLASS in 1 CARTON (0574-0827-01) / 1 mL in 1 VIAL, GLASS |
| ANDA | ANDA091244 |
| DCSA | CIII |
| FDA SPL set id | 584573 |
| Labeler | Padagis US LLC |
| Label type | HUMAN PRESCRIPTION DRUG |
| Marketing category | ANDA |
| Marketing effective time low | 2014-05-01 |
| Marketing status | ACTIVE |
| Related queries | Properties for NDC 9 0574-0827 |
NDC Item 47781091193
| NDC 9 | 47781-911 |
|---|---|
| NDC 10 | 47781-911-93 |
| NDC Item | 47781091193 |
| Packaging | 1 VIAL, SINGLE-DOSE in 1 CARTON (47781-911-93) / 1 mL in 1 VIAL, SINGLE-DOSE |
| ANDA | ANDA207742 |
| DCSA | CIII |
| FDA SPL set id | 719526 |
| Labeler | Alvogen Inc. |
| Label type | HUMAN PRESCRIPTION DRUG |
| Marketing category | ANDA |
| Marketing effective time low | 2022-11-02 |
| Marketing status | ACTIVE |
| Related queries | Properties for NDC 9 47781-911 |
NDC Item 52536062501
| NDC 9 | 52536-625 |
|---|---|
| NDC 10 | 52536-625-01 |
| NDC Item | 52536062501 |
| Packaging | 1 VIAL, SINGLE-DOSE in 1 CARTON (52536-625-01) / 1 mL in 1 VIAL, SINGLE-DOSE |
| ANDA | ANDA206368 |
| COLORTEXT | WHITE(or creamy white) |
| Color | C48325 __ |
| DCSA | CIII |
| FDA SPL set id | 395393 |
| Labeler | Wilshire Pharmaceuticals |
| Label type | HUMAN PRESCRIPTION DRUG |
| Marketing category | ANDA |
| Marketing effective time low | 2019-05-31 |
| Marketing status | ACTIVE |
| Related queries | Properties for NDC 9 52536-625 |
NDC Item 55150027701
| NDC 9 | 55150-277 |
|---|---|
| NDC 10 | 55150-277-01 |
| NDC Item | 55150027701 |
| Packaging | 1 VIAL, GLASS in 1 CARTON (55150-277-01) / 1 mL in 1 VIAL, GLASS |
| ANDA | ANDA211817 |
| DCSA | CIII |
| FDA SPL set id | 739422 |
| Labeler | Eugia US LLC |
| Label type | HUMAN PRESCRIPTION DRUG |
| Marketing category | ANDA |
| Marketing effective time low | 2023-10-20 |
| Marketing status | ACTIVE |
| Related queries | Properties for NDC 9 55150-277 |
NDC Item 62756001540
| NDC 9 | 62756-015 |
|---|---|
| NDC 10 | 62756-015-40 |
| NDC Item | 62756001540 |
| Packaging | 1 VIAL in 1 CARTON (62756-015-40) / 1 mL in 1 VIAL |
| ANDA | ANDA201720 |
| DCSA | CIII |
| FDA SPL set id | 581578 |
| Labeler | Sun Pharmaceutical Industries, Inc. |
| Label type | HUMAN PRESCRIPTION DRUG |
| Marketing category | ANDA |
| Marketing effective time low | 2013-06-17 |
| Marketing status | ACTIVE |
| Related queries | Properties for NDC 9 62756-015 |
NDC Item 64980046799
| NDC 9 | 64980-467 |
|---|---|
| NDC 10 | 64980-467-99 |
| NDC Item | 64980046799 |
| Packaging | 1 VIAL, MULTI-DOSE in 1 CARTON (64980-467-99) / 1 mL in 1 VIAL, MULTI-DOSE |
| ANDA | ANDA207742 |
| DCSA | CIII |
| FDA SPL set id | 385892 |
| Labeler | Rising Pharma Holdings, Inc. |
| Label type | HUMAN PRESCRIPTION DRUG |
| Marketing category | ANDA |
| Marketing effective time high | 2020-06-30 |
| Marketing effective time low | 2018-12-01 |
| Marketing status | COMPLETED |
| Related queries | Properties for NDC 9 64980-467 |
NDC Item 69097053731
| NDC 9 | 69097-537 |
|---|---|
| NDC 10 | 69097-537-31 |
| NDC Item | 69097053731 |
| Packaging | 1 mL in 1 VIAL, GLASS (69097-537-31) |
| ANDA | ANDA210362 |
| COLORTEXT | WHITE("A clear colourless to pale yellow solution) |
| Color | C48325 __ |
| DCSA | CIII |
| FDA SPL set id | 729362 |
| Labeler | Cipla USA Inc. |
| Label type | HUMAN PRESCRIPTION DRUG |
| Marketing category | ANDA |
| Marketing effective time low | 2023-09-15 |
| Marketing status | ACTIVE |
| Related queries | Properties for NDC 9 69097-537 |
NDC Item 69097080232
| NDC 9 | 69097-802 |
|---|---|
| NDC 10 | 69097-802-32 |
| NDC Item | 69097080232 |
| Packaging | 1 VIAL, GLASS in 1 CARTON (69097-802-32) / 1 mL in 1 VIAL, GLASS |
| ANDA | ANDA091244 |
| DCSA | CIII |
| FDA SPL set id | 764872 |
| Labeler | Cipla USA Inc. |
| Label type | HUMAN PRESCRIPTION DRUG |
| Marketing category | ANDA |
| Marketing effective time low | 2019-03-26 |
| Marketing status | ACTIVE |
| Related queries | Properties for NDC 9 69097-802 |
NDC Item 70700028922
| NDC 9 | 70700-289 |
|---|---|
| NDC 10 | 70700-289-22 |
| NDC Item | 70700028922 |
| Packaging | 1 VIAL in 1 CARTON (70700-289-22) / 1 mL in 1 VIAL |
| ANDA | ANDA215351 |
| DCSA | CIII |
| FDA SPL set id | 708164 |
| Labeler | Xiromed LLC |
| Label type | HUMAN PRESCRIPTION DRUG |
| Marketing category | ANDA |
| Marketing effective time low | 2023-04-28 |
| Marketing status | ACTIVE |
| Related queries | Properties for NDC 9 70700-289 |
NDC Item 71205028901
| NDC 9 | 71205-289 |
|---|---|
| NDC 10 | 71205-289-01 |
| NDC Item | 71205028901 |
| Packaging | 1 mL in 1 VIAL (71205-289-01) |
| ANDA | ANDA091244 |
| DCSA | CIII |
| FDA SPL set id | 413320 |
| Labeler | Proficient Rx LP |
| Label type | HUMAN PRESCRIPTION DRUG |
| Marketing category | ANDA |
| Marketing effective time low | 2012-05-01 |
| Marketing status | ACTIVE |
| Related queries | Properties for NDC 9 71205-289 |
NDC Item 71225012701
| NDC 9 | 71225-127 |
|---|---|
| NDC 10 | 71225-127-01 |
| NDC Item | 71225012701 |
| Packaging | 1 VIAL in 1 CARTON (71225-127-01) / 1 mL in 1 VIAL |
| DCSA | CIII |
| FDA SPL set id | 642064 |
| Labeler | Slayback Pharma LLC |
| Label type | HUMAN PRESCRIPTION DRUG |
| Marketing category | NDA |
| Marketing effective time low | 2022-06-13 |
| Marketing status | ACTIVE |
| NDA | NDA216318 |
| Related queries | Properties for NDC 9 71225-127 |
NDC Item 72162234802
| NDC 9 | 72162-2348 |
|---|---|
| NDC 10 | 72162-2348-2 |
| NDC Item | 72162234802 |
| Packaging | 1 VIAL, SINGLE-DOSE in 1 CARTON (72162-2348-2) / 1 mL in 1 VIAL, SINGLE-DOSE |
| ANDA | ANDA206368 |
| COLORTEXT | WHITE(or creamy white) |
| Color | C48325 __ |
| DCSA | CIII |
| FDA SPL set id | 794476 |
| Labeler | Bryant Ranch Prepack |
| Label type | HUMAN PRESCRIPTION DRUG |
| Marketing category | ANDA |
| Marketing effective time low | 2019-05-31 |
| Marketing status | active |
| Related queries | Properties for NDC 9 72162-2348 |
NDC Item 72162234804
| NDC 9 | 72162-2348 |
|---|---|
| NDC 10 | 72162-2348-4 |
| NDC Item | 72162234804 |
| Packaging | 1 VIAL, MULTI-DOSE in 1 CARTON (72162-2348-4) / 10 mL in 1 VIAL, MULTI-DOSE |
| ANDA | ANDA206368 |
| COLORTEXT | WHITE(or creamy white) |
| Color | C48325 __ |
| DCSA | CIII |
| FDA SPL set id | 794476 |
| Labeler | Bryant Ranch Prepack |
| Label type | HUMAN PRESCRIPTION DRUG |
| Marketing category | ANDA |
| Marketing effective time low | 2019-05-31 |
| Marketing status | active |
| Related queries | Properties for NDC 9 72162-2348 |
NDC Item 72162237502
| NDC 9 | 72162-2375 |
|---|---|
| NDC 10 | 72162-2375-2 |
| NDC Item | 72162237502 |
| Packaging | 1 VIAL, GLASS in 1 CARTON (72162-2375-2) / 1 mL in 1 VIAL, GLASS |
| ANDA | ANDA040530 |
| DCSA | CIII |
| FDA SPL set id | 800677 |
| Labeler | Bryant Ranch Prepack |
| Label type | HUMAN PRESCRIPTION DRUG |
| Marketing category | ANDA |
| Marketing effective time low | 2007-12-21 |
| Marketing status | active |
| Related queries | Properties for NDC 9 72162-2375 |
NDC Item 76420074601
| NDC 9 | 76420-746 |
|---|---|
| NDC 10 | 76420-746-01 |
| NDC Item | 76420074601 |
| Packaging | 1 VIAL, GLASS in 1 CARTON (76420-746-01) / 1 mL in 1 VIAL, GLASS |
| ANDA | ANDA091244 |
| DCSA | CIII |
| FDA SPL set id | 791011 |
| Labeler | Asclemed USA, Inc. |
| Label type | HUMAN PRESCRIPTION DRUG |
| Marketing category | ANDA |
| Marketing effective time low | 2019-03-26 |
| Marketing status | ACTIVE |
| Related queries | Properties for NDC 9 76420-746 |
NDC Item 76420074701
| NDC 9 | 76420-747 |
|---|---|
| NDC 10 | 76420-747-01 |
| NDC Item | 76420074701 |
| Packaging | 1 VIAL, SINGLE-DOSE in 1 CARTON (76420-747-01) / 1 mL in 1 VIAL, SINGLE-DOSE |
| ANDA | ANDA207742 |
| DCSA | CIII |
| FDA SPL set id | 791057 |
| Labeler | Asclemed USA, Inc. |
| Label type | HUMAN PRESCRIPTION DRUG |
| Marketing category | ANDA |
| Marketing effective time low | 2022-11-02 |
| Marketing status | ACTIVE |
| Related queries | Properties for NDC 9 76420-747 |
NDC Item 00143965901
| NDC 9 | 0143-9659 |
|---|---|
| NDC 10 | 0143-9659-01 |
| NDC Item | 00143965901 |
| Packaging | 1 mL in 1 VIAL (0143-9659-01) |
| ANDA | ANDA091244 |
| DCSA | CIII |
| FDA SPL set id | 627057 |
| Labeler | Hikma Pharmaceuticals USA Inc. |
| Label type | HUMAN PRESCRIPTION DRUG |
| Marketing category | ANDA |
| Marketing effective time low | 2012-05-01 |
| Marketing status | ACTIVE |
| Related queries | Properties for NDC 9 0143-9659 |
NDC Item 00409656201
| NDC 9 | 0409-6562 |
|---|---|
| NDC 10 | 0409-6562-01 |
| NDC Item | 00409656201 |
| Packaging | 1 VIAL in 1 CARTON (0409-6562-01) / 1 mL in 1 VIAL |
| ANDA | ANDA085635 |
| DCSA | CIII |
| FDA SPL set id | 500095 |
| FDA SPL set id | 500287 |
| Labeler | Hospira, Inc. |
| Label type | HUMAN PRESCRIPTION DRUG |
| Marketing category | ANDA |
| Marketing effective time low | 2018-01-17 |
| Marketing status | ACTIVE |
| Related queries | Properties for NDC 9 0409-6562 |
NDC Item 00409656202
| NDC 9 | 0409-6562 |
|---|---|
| NDC 10 | 0409-6562-02 |
| NDC Item | 00409656202 |
| Packaging | 1 VIAL in 1 CARTON (0409-6562-02) / 1 mL in 1 VIAL |
| ANDA | ANDA085635 |
| DCSA | CIII |
| FDA SPL set id | 500095 |
| FDA SPL set id | 500287 |
| Labeler | Hospira, Inc. |
| Label type | HUMAN PRESCRIPTION DRUG |
| Marketing category | ANDA |
| Marketing effective time low | 2018-01-17 |
| Marketing status | ACTIVE |
| Related queries | Properties for NDC 9 0409-6562 |
NDC Item 00517183001
| NDC 9 | 0517-1830 |
|---|---|
| NDC 10 | 0517-1830-01 |
| NDC Item | 00517183001 |
| Packaging | 1 VIAL in 1 BOX (0517-1830-01) / 1 mL in 1 VIAL |
| ANDA | ANDA207742 |
| DCSA | CIII |
| FDA SPL set id | 674434 |
| Labeler | American Regent, Inc. |
| Label type | HUMAN PRESCRIPTION DRUG |
| Marketing category | ANDA |
| Marketing effective time low | 2019-07-19 |
| Marketing status | ACTIVE |
| Related queries | Properties for NDC 9 0517-1830 |
NDC Item 00574082001
| NDC 9 | 0574-0820 |
|---|---|
| NDC 10 | 0574-0820-01 |
| NDC Item | 00574082001 |
| Packaging | 1 VIAL, GLASS in 1 CARTON (0574-0820-01) / 1 mL in 1 VIAL, GLASS |
| ANDA | ANDA040530 |
| DCSA | CIII |
| FDA SPL set id | 768154 |
| FDA SPL set id | 791051 |
| Labeler | Padagis US LLC |
| Label type | HUMAN PRESCRIPTION DRUG |
| Marketing category | ANDA |
| Marketing effective time low | 2007-12-21 |
| Marketing status | ACTIVE |
| Related queries | Properties for NDC 9 0574-0820 |
NDC Item 00574082701
| NDC 9 | 0574-0827 |
|---|---|
| NDC 10 | 0574-0827-01 |
| NDC Item | 00574082701 |
| Packaging | 1 VIAL, GLASS in 1 CARTON (0574-0827-01) / 1 mL in 1 VIAL, GLASS |
| ANDA | ANDA091244 |
| DCSA | CIII |
| FDA SPL set id | 584573 |
| Labeler | Padagis US LLC |
| Label type | HUMAN PRESCRIPTION DRUG |
| Marketing category | ANDA |
| Marketing effective time low | 2014-05-01 |
| Marketing status | ACTIVE |
| Related queries | Properties for NDC 9 0574-0827 |
NDC Item 47781091193
| NDC 9 | 47781-911 |
|---|---|
| NDC 10 | 47781-911-93 |
| NDC Item | 47781091193 |
| Packaging | 1 VIAL, SINGLE-DOSE in 1 CARTON (47781-911-93) / 1 mL in 1 VIAL, SINGLE-DOSE |
| ANDA | ANDA207742 |
| DCSA | CIII |
| FDA SPL set id | 719526 |
| Labeler | Alvogen Inc. |
| Label type | HUMAN PRESCRIPTION DRUG |
| Marketing category | ANDA |
| Marketing effective time low | 2022-11-02 |
| Marketing status | ACTIVE |
| Related queries | Properties for NDC 9 47781-911 |
NDC Item 52536062501
| NDC 9 | 52536-625 |
|---|---|
| NDC 10 | 52536-625-01 |
| NDC Item | 52536062501 |
| Packaging | 1 VIAL, SINGLE-DOSE in 1 CARTON (52536-625-01) / 1 mL in 1 VIAL, SINGLE-DOSE |
| ANDA | ANDA206368 |
| COLORTEXT | WHITE(or creamy white) |
| Color | C48325 __ |
| DCSA | CIII |
| FDA SPL set id | 395393 |
| Labeler | Wilshire Pharmaceuticals |
| Label type | HUMAN PRESCRIPTION DRUG |
| Marketing category | ANDA |
| Marketing effective time low | 2019-05-31 |
| Marketing status | ACTIVE |
| Related queries | Properties for NDC 9 52536-625 |
NDC Item 55150027701
| NDC 9 | 55150-277 |
|---|---|
| NDC 10 | 55150-277-01 |
| NDC Item | 55150027701 |
| Packaging | 1 VIAL, GLASS in 1 CARTON (55150-277-01) / 1 mL in 1 VIAL, GLASS |
| ANDA | ANDA211817 |
| DCSA | CIII |
| FDA SPL set id | 739422 |
| Labeler | Eugia US LLC |
| Label type | HUMAN PRESCRIPTION DRUG |
| Marketing category | ANDA |
| Marketing effective time low | 2023-10-20 |
| Marketing status | ACTIVE |
| Related queries | Properties for NDC 9 55150-277 |
NDC Item 62756001540
| NDC 9 | 62756-015 |
|---|---|
| NDC 10 | 62756-015-40 |
| NDC Item | 62756001540 |
| Packaging | 1 VIAL in 1 CARTON (62756-015-40) / 1 mL in 1 VIAL |
| ANDA | ANDA201720 |
| DCSA | CIII |
| FDA SPL set id | 581578 |
| Labeler | Sun Pharmaceutical Industries, Inc. |
| Label type | HUMAN PRESCRIPTION DRUG |
| Marketing category | ANDA |
| Marketing effective time low | 2013-06-17 |
| Marketing status | ACTIVE |
| Related queries | Properties for NDC 9 62756-015 |
NDC Item 64980046799
| NDC 9 | 64980-467 |
|---|---|
| NDC 10 | 64980-467-99 |
| NDC Item | 64980046799 |
| Packaging | 1 VIAL, MULTI-DOSE in 1 CARTON (64980-467-99) / 1 mL in 1 VIAL, MULTI-DOSE |
| ANDA | ANDA207742 |
| DCSA | CIII |
| FDA SPL set id | 385892 |
| Labeler | Rising Pharma Holdings, Inc. |
| Label type | HUMAN PRESCRIPTION DRUG |
| Marketing category | ANDA |
| Marketing effective time high | 2020-06-30 |
| Marketing effective time low | 2018-12-01 |
| Marketing status | COMPLETED |
| Related queries | Properties for NDC 9 64980-467 |
NDC Item 69097053731
| NDC 9 | 69097-537 |
|---|---|
| NDC 10 | 69097-537-31 |
| NDC Item | 69097053731 |
| Packaging | 1 mL in 1 VIAL, GLASS (69097-537-31) |
| ANDA | ANDA210362 |
| COLORTEXT | WHITE("A clear colourless to pale yellow solution) |
| Color | C48325 __ |
| DCSA | CIII |
| FDA SPL set id | 729362 |
| Labeler | Cipla USA Inc. |
| Label type | HUMAN PRESCRIPTION DRUG |
| Marketing category | ANDA |
| Marketing effective time low | 2023-09-15 |
| Marketing status | ACTIVE |
| Related queries | Properties for NDC 9 69097-537 |
NDC Item 69097080232
| NDC 9 | 69097-802 |
|---|---|
| NDC 10 | 69097-802-32 |
| NDC Item | 69097080232 |
| Packaging | 1 VIAL, GLASS in 1 CARTON (69097-802-32) / 1 mL in 1 VIAL, GLASS |
| ANDA | ANDA091244 |
| DCSA | CIII |
| FDA SPL set id | 764872 |
| Labeler | Cipla USA Inc. |
| Label type | HUMAN PRESCRIPTION DRUG |
| Marketing category | ANDA |
| Marketing effective time low | 2019-03-26 |
| Marketing status | ACTIVE |
| Related queries | Properties for NDC 9 69097-802 |
NDC Item 70700028922
| NDC 9 | 70700-289 |
|---|---|
| NDC 10 | 70700-289-22 |
| NDC Item | 70700028922 |
| Packaging | 1 VIAL in 1 CARTON (70700-289-22) / 1 mL in 1 VIAL |
| ANDA | ANDA215351 |
| DCSA | CIII |
| FDA SPL set id | 708164 |
| Labeler | Xiromed LLC |
| Label type | HUMAN PRESCRIPTION DRUG |
| Marketing category | ANDA |
| Marketing effective time low | 2023-04-28 |
| Marketing status | ACTIVE |
| Related queries | Properties for NDC 9 70700-289 |
NDC Item 71205028901
| NDC 9 | 71205-289 |
|---|---|
| NDC 10 | 71205-289-01 |
| NDC Item | 71205028901 |
| Packaging | 1 mL in 1 VIAL (71205-289-01) |
| ANDA | ANDA091244 |
| DCSA | CIII |
| FDA SPL set id | 413320 |
| Labeler | Proficient Rx LP |
| Label type | HUMAN PRESCRIPTION DRUG |
| Marketing category | ANDA |
| Marketing effective time low | 2012-05-01 |
| Marketing status | ACTIVE |
| Related queries | Properties for NDC 9 71205-289 |
NDC Item 71225012701
| NDC 9 | 71225-127 |
|---|---|
| NDC 10 | 71225-127-01 |
| NDC Item | 71225012701 |
| Packaging | 1 VIAL in 1 CARTON (71225-127-01) / 1 mL in 1 VIAL |
| DCSA | CIII |
| FDA SPL set id | 642064 |
| Labeler | Slayback Pharma LLC |
| Label type | HUMAN PRESCRIPTION DRUG |
| Marketing category | NDA |
| Marketing effective time low | 2022-06-13 |
| Marketing status | ACTIVE |
| NDA | NDA216318 |
| Related queries | Properties for NDC 9 71225-127 |
NDC Item 72162234802
| NDC 9 | 72162-2348 |
|---|---|
| NDC 10 | 72162-2348-2 |
| NDC Item | 72162234802 |
| Packaging | 1 VIAL, SINGLE-DOSE in 1 CARTON (72162-2348-2) / 1 mL in 1 VIAL, SINGLE-DOSE |
| ANDA | ANDA206368 |
| COLORTEXT | WHITE(or creamy white) |
| Color | C48325 __ |
| DCSA | CIII |
| FDA SPL set id | 794476 |
| Labeler | Bryant Ranch Prepack |
| Label type | HUMAN PRESCRIPTION DRUG |
| Marketing category | ANDA |
| Marketing effective time low | 2019-05-31 |
| Marketing status | active |
| Related queries | Properties for NDC 9 72162-2348 |
NDC Item 72162234804
| NDC 9 | 72162-2348 |
|---|---|
| NDC 10 | 72162-2348-4 |
| NDC Item | 72162234804 |
| Packaging | 1 VIAL, MULTI-DOSE in 1 CARTON (72162-2348-4) / 10 mL in 1 VIAL, MULTI-DOSE |
| ANDA | ANDA206368 |
| COLORTEXT | WHITE(or creamy white) |
| Color | C48325 __ |
| DCSA | CIII |
| FDA SPL set id | 794476 |
| Labeler | Bryant Ranch Prepack |
| Label type | HUMAN PRESCRIPTION DRUG |
| Marketing category | ANDA |
| Marketing effective time low | 2019-05-31 |
| Marketing status | active |
| Related queries | Properties for NDC 9 72162-2348 |
NDC Item 72162237502
| NDC 9 | 72162-2375 |
|---|---|
| NDC 10 | 72162-2375-2 |
| NDC Item | 72162237502 |
| Packaging | 1 VIAL, GLASS in 1 CARTON (72162-2375-2) / 1 mL in 1 VIAL, GLASS |
| ANDA | ANDA040530 |
| DCSA | CIII |
| FDA SPL set id | 800677 |
| Labeler | Bryant Ranch Prepack |
| Label type | HUMAN PRESCRIPTION DRUG |
| Marketing category | ANDA |
| Marketing effective time low | 2007-12-21 |
| Marketing status | active |
| Related queries | Properties for NDC 9 72162-2375 |
NDC Item 76420074601
| NDC 9 | 76420-746 |
|---|---|
| NDC 10 | 76420-746-01 |
| NDC Item | 76420074601 |
| Packaging | 1 VIAL, GLASS in 1 CARTON (76420-746-01) / 1 mL in 1 VIAL, GLASS |
| ANDA | ANDA091244 |
| DCSA | CIII |
| FDA SPL set id | 791011 |
| Labeler | Asclemed USA, Inc. |
| Label type | HUMAN PRESCRIPTION DRUG |
| Marketing category | ANDA |
| Marketing effective time low | 2019-03-26 |
| Marketing status | ACTIVE |
| Related queries | Properties for NDC 9 76420-746 |
NDC Item 76420074701
| NDC 9 | 76420-747 |
|---|---|
| NDC 10 | 76420-747-01 |
| NDC Item | 76420074701 |
| Packaging | 1 VIAL, SINGLE-DOSE in 1 CARTON (76420-747-01) / 1 mL in 1 VIAL, SINGLE-DOSE |
| ANDA | ANDA207742 |
| DCSA | CIII |
| FDA SPL set id | 791057 |
| Labeler | Asclemed USA, Inc. |
| Label type | HUMAN PRESCRIPTION DRUG |
| Marketing category | ANDA |
| Marketing effective time low | 2022-11-02 |
| Marketing status | ACTIVE |
| Related queries | Properties for NDC 9 76420-747 |
NDC Item 00143965901
| NDC 9 | 0143-9659 |
|---|---|
| NDC 10 | 0143-9659-01 |
| NDC Item | 00143965901 |
| Packaging | 1 mL in 1 VIAL (0143-9659-01) |
| ANDA | ANDA091244 |
| DCSA | CIII |
| FDA SPL set id | 627057 |
| Labeler | Hikma Pharmaceuticals USA Inc. |
| Label type | HUMAN PRESCRIPTION DRUG |
| Marketing category | ANDA |
| Marketing effective time low | 2012-05-01 |
| Marketing status | ACTIVE |
| Related queries | Properties for NDC 9 0143-9659 |
NDC Item 00409656201
| NDC 9 | 0409-6562 |
|---|---|
| NDC 10 | 0409-6562-01 |
| NDC Item | 00409656201 |
| Packaging | 1 VIAL in 1 CARTON (0409-6562-01) / 1 mL in 1 VIAL |
| ANDA | ANDA085635 |
| DCSA | CIII |
| FDA SPL set id | 500095 |
| FDA SPL set id | 500287 |
| Labeler | Hospira, Inc. |
| Label type | HUMAN PRESCRIPTION DRUG |
| Marketing category | ANDA |
| Marketing effective time low | 2018-01-17 |
| Marketing status | ACTIVE |
| Related queries | Properties for NDC 9 0409-6562 |
NDC Item 00409656202
| NDC 9 | 0409-6562 |
|---|---|
| NDC 10 | 0409-6562-02 |
| NDC Item | 00409656202 |
| Packaging | 1 VIAL in 1 CARTON (0409-6562-02) / 1 mL in 1 VIAL |
| ANDA | ANDA085635 |
| DCSA | CIII |
| FDA SPL set id | 500095 |
| FDA SPL set id | 500287 |
| Labeler | Hospira, Inc. |
| Label type | HUMAN PRESCRIPTION DRUG |
| Marketing category | ANDA |
| Marketing effective time low | 2018-01-17 |
| Marketing status | ACTIVE |
| Related queries | Properties for NDC 9 0409-6562 |
NDC Item 00517183001
| NDC 9 | 0517-1830 |
|---|---|
| NDC 10 | 0517-1830-01 |
| NDC Item | 00517183001 |
| Packaging | 1 VIAL in 1 BOX (0517-1830-01) / 1 mL in 1 VIAL |
| ANDA | ANDA207742 |
| DCSA | CIII |
| FDA SPL set id | 674434 |
| Labeler | American Regent, Inc. |
| Label type | HUMAN PRESCRIPTION DRUG |
| Marketing category | ANDA |
| Marketing effective time low | 2019-07-19 |
| Marketing status | ACTIVE |
| Related queries | Properties for NDC 9 0517-1830 |
NDC Item 00574082001
| NDC 9 | 0574-0820 |
|---|---|
| NDC 10 | 0574-0820-01 |
| NDC Item | 00574082001 |
| Packaging | 1 VIAL, GLASS in 1 CARTON (0574-0820-01) / 1 mL in 1 VIAL, GLASS |
| ANDA | ANDA040530 |
| DCSA | CIII |
| FDA SPL set id | 768154 |
| FDA SPL set id | 791051 |
| Labeler | Padagis US LLC |
| Label type | HUMAN PRESCRIPTION DRUG |
| Marketing category | ANDA |
| Marketing effective time low | 2007-12-21 |
| Marketing status | ACTIVE |
| Related queries | Properties for NDC 9 0574-0820 |
NDC Item 00574082701
| NDC 9 | 0574-0827 |
|---|---|
| NDC 10 | 0574-0827-01 |
| NDC Item | 00574082701 |
| Packaging | 1 VIAL, GLASS in 1 CARTON (0574-0827-01) / 1 mL in 1 VIAL, GLASS |
| ANDA | ANDA091244 |
| DCSA | CIII |
| FDA SPL set id | 584573 |
| Labeler | Padagis US LLC |
| Label type | HUMAN PRESCRIPTION DRUG |
| Marketing category | ANDA |
| Marketing effective time low | 2014-05-01 |
| Marketing status | ACTIVE |
| Related queries | Properties for NDC 9 0574-0827 |
NDC Item 47781091193
| NDC 9 | 47781-911 |
|---|---|
| NDC 10 | 47781-911-93 |
| NDC Item | 47781091193 |
| Packaging | 1 VIAL, SINGLE-DOSE in 1 CARTON (47781-911-93) / 1 mL in 1 VIAL, SINGLE-DOSE |
| ANDA | ANDA207742 |
| DCSA | CIII |
| FDA SPL set id | 719526 |
| Labeler | Alvogen Inc. |
| Label type | HUMAN PRESCRIPTION DRUG |
| Marketing category | ANDA |
| Marketing effective time low | 2022-11-02 |
| Marketing status | ACTIVE |
| Related queries | Properties for NDC 9 47781-911 |
NDC Item 52536062501
| NDC 9 | 52536-625 |
|---|---|
| NDC 10 | 52536-625-01 |
| NDC Item | 52536062501 |
| Packaging | 1 VIAL, SINGLE-DOSE in 1 CARTON (52536-625-01) / 1 mL in 1 VIAL, SINGLE-DOSE |
| ANDA | ANDA206368 |
| COLORTEXT | WHITE(or creamy white) |
| Color | C48325 __ |
| DCSA | CIII |
| FDA SPL set id | 395393 |
| Labeler | Wilshire Pharmaceuticals |
| Label type | HUMAN PRESCRIPTION DRUG |
| Marketing category | ANDA |
| Marketing effective time low | 2019-05-31 |
| Marketing status | ACTIVE |
| Related queries | Properties for NDC 9 52536-625 |
NDC Item 55150027701
| NDC 9 | 55150-277 |
|---|---|
| NDC 10 | 55150-277-01 |
| NDC Item | 55150027701 |
| Packaging | 1 VIAL, GLASS in 1 CARTON (55150-277-01) / 1 mL in 1 VIAL, GLASS |
| ANDA | ANDA211817 |
| DCSA | CIII |
| FDA SPL set id | 739422 |
| Labeler | Eugia US LLC |
| Label type | HUMAN PRESCRIPTION DRUG |
| Marketing category | ANDA |
| Marketing effective time low | 2023-10-20 |
| Marketing status | ACTIVE |
| Related queries | Properties for NDC 9 55150-277 |
NDC Item 62756001540
| NDC 9 | 62756-015 |
|---|---|
| NDC 10 | 62756-015-40 |
| NDC Item | 62756001540 |
| Packaging | 1 VIAL in 1 CARTON (62756-015-40) / 1 mL in 1 VIAL |
| ANDA | ANDA201720 |
| DCSA | CIII |
| FDA SPL set id | 581578 |
| Labeler | Sun Pharmaceutical Industries, Inc. |
| Label type | HUMAN PRESCRIPTION DRUG |
| Marketing category | ANDA |
| Marketing effective time low | 2013-06-17 |
| Marketing status | ACTIVE |
| Related queries | Properties for NDC 9 62756-015 |
NDC Item 64980046799
| NDC 9 | 64980-467 |
|---|---|
| NDC 10 | 64980-467-99 |
| NDC Item | 64980046799 |
| Packaging | 1 VIAL, MULTI-DOSE in 1 CARTON (64980-467-99) / 1 mL in 1 VIAL, MULTI-DOSE |
| ANDA | ANDA207742 |
| DCSA | CIII |
| FDA SPL set id | 385892 |
| Labeler | Rising Pharma Holdings, Inc. |
| Label type | HUMAN PRESCRIPTION DRUG |
| Marketing category | ANDA |
| Marketing effective time high | 2020-06-30 |
| Marketing effective time low | 2018-12-01 |
| Marketing status | COMPLETED |
| Related queries | Properties for NDC 9 64980-467 |
NDC Item 69097053731
| NDC 9 | 69097-537 |
|---|---|
| NDC 10 | 69097-537-31 |
| NDC Item | 69097053731 |
| Packaging | 1 mL in 1 VIAL, GLASS (69097-537-31) |
| ANDA | ANDA210362 |
| COLORTEXT | WHITE("A clear colourless to pale yellow solution) |
| Color | C48325 __ |
| DCSA | CIII |
| FDA SPL set id | 729362 |
| Labeler | Cipla USA Inc. |
| Label type | HUMAN PRESCRIPTION DRUG |
| Marketing category | ANDA |
| Marketing effective time low | 2023-09-15 |
| Marketing status | ACTIVE |
| Related queries | Properties for NDC 9 69097-537 |
NDC Item 69097080232
| NDC 9 | 69097-802 |
|---|---|
| NDC 10 | 69097-802-32 |
| NDC Item | 69097080232 |
| Packaging | 1 VIAL, GLASS in 1 CARTON (69097-802-32) / 1 mL in 1 VIAL, GLASS |
| ANDA | ANDA091244 |
| DCSA | CIII |
| FDA SPL set id | 764872 |
| Labeler | Cipla USA Inc. |
| Label type | HUMAN PRESCRIPTION DRUG |
| Marketing category | ANDA |
| Marketing effective time low | 2019-03-26 |
| Marketing status | ACTIVE |
| Related queries | Properties for NDC 9 69097-802 |
NDC Item 70700028922
| NDC 9 | 70700-289 |
|---|---|
| NDC 10 | 70700-289-22 |
| NDC Item | 70700028922 |
| Packaging | 1 VIAL in 1 CARTON (70700-289-22) / 1 mL in 1 VIAL |
| ANDA | ANDA215351 |
| DCSA | CIII |
| FDA SPL set id | 708164 |
| Labeler | Xiromed LLC |
| Label type | HUMAN PRESCRIPTION DRUG |
| Marketing category | ANDA |
| Marketing effective time low | 2023-04-28 |
| Marketing status | ACTIVE |
| Related queries | Properties for NDC 9 70700-289 |
NDC Item 71205028901
| NDC 9 | 71205-289 |
|---|---|
| NDC 10 | 71205-289-01 |
| NDC Item | 71205028901 |
| Packaging | 1 mL in 1 VIAL (71205-289-01) |
| ANDA | ANDA091244 |
| DCSA | CIII |
| FDA SPL set id | 413320 |
| Labeler | Proficient Rx LP |
| Label type | HUMAN PRESCRIPTION DRUG |
| Marketing category | ANDA |
| Marketing effective time low | 2012-05-01 |
| Marketing status | ACTIVE |
| Related queries | Properties for NDC 9 71205-289 |
NDC Item 71225012701
| NDC 9 | 71225-127 |
|---|---|
| NDC 10 | 71225-127-01 |
| NDC Item | 71225012701 |
| Packaging | 1 VIAL in 1 CARTON (71225-127-01) / 1 mL in 1 VIAL |
| DCSA | CIII |
| FDA SPL set id | 642064 |
| Labeler | Slayback Pharma LLC |
| Label type | HUMAN PRESCRIPTION DRUG |
| Marketing category | NDA |
| Marketing effective time low | 2022-06-13 |
| Marketing status | ACTIVE |
| NDA | NDA216318 |
| Related queries | Properties for NDC 9 71225-127 |
NDC Item 72162234802
| NDC 9 | 72162-2348 |
|---|---|
| NDC 10 | 72162-2348-2 |
| NDC Item | 72162234802 |
| Packaging | 1 VIAL, SINGLE-DOSE in 1 CARTON (72162-2348-2) / 1 mL in 1 VIAL, SINGLE-DOSE |
| ANDA | ANDA206368 |
| COLORTEXT | WHITE(or creamy white) |
| Color | C48325 __ |
| DCSA | CIII |
| FDA SPL set id | 794476 |
| Labeler | Bryant Ranch Prepack |
| Label type | HUMAN PRESCRIPTION DRUG |
| Marketing category | ANDA |
| Marketing effective time low | 2019-05-31 |
| Marketing status | active |
| Related queries | Properties for NDC 9 72162-2348 |
NDC Item 72162234804
| NDC 9 | 72162-2348 |
|---|---|
| NDC 10 | 72162-2348-4 |
| NDC Item | 72162234804 |
| Packaging | 1 VIAL, MULTI-DOSE in 1 CARTON (72162-2348-4) / 10 mL in 1 VIAL, MULTI-DOSE |
| ANDA | ANDA206368 |
| COLORTEXT | WHITE(or creamy white) |
| Color | C48325 __ |
| DCSA | CIII |
| FDA SPL set id | 794476 |
| Labeler | Bryant Ranch Prepack |
| Label type | HUMAN PRESCRIPTION DRUG |
| Marketing category | ANDA |
| Marketing effective time low | 2019-05-31 |
| Marketing status | active |
| Related queries | Properties for NDC 9 72162-2348 |
NDC Item 72162237502
| NDC 9 | 72162-2375 |
|---|---|
| NDC 10 | 72162-2375-2 |
| NDC Item | 72162237502 |
| Packaging | 1 VIAL, GLASS in 1 CARTON (72162-2375-2) / 1 mL in 1 VIAL, GLASS |
| ANDA | ANDA040530 |
| DCSA | CIII |
| FDA SPL set id | 800677 |
| Labeler | Bryant Ranch Prepack |
| Label type | HUMAN PRESCRIPTION DRUG |
| Marketing category | ANDA |
| Marketing effective time low | 2007-12-21 |
| Marketing status | active |
| Related queries | Properties for NDC 9 72162-2375 |
NDC Item 76420074601
| NDC 9 | 76420-746 |
|---|---|
| NDC 10 | 76420-746-01 |
| NDC Item | 76420074601 |
| Packaging | 1 VIAL, GLASS in 1 CARTON (76420-746-01) / 1 mL in 1 VIAL, GLASS |
| ANDA | ANDA091244 |
| DCSA | CIII |
| FDA SPL set id | 791011 |
| Labeler | Asclemed USA, Inc. |
| Label type | HUMAN PRESCRIPTION DRUG |
| Marketing category | ANDA |
| Marketing effective time low | 2019-03-26 |
| Marketing status | ACTIVE |
| Related queries | Properties for NDC 9 76420-746 |
NDC Item 76420074701
| NDC 9 | 76420-747 |
|---|---|
| NDC 10 | 76420-747-01 |
| NDC Item | 76420074701 |
| Packaging | 1 VIAL, SINGLE-DOSE in 1 CARTON (76420-747-01) / 1 mL in 1 VIAL, SINGLE-DOSE |
| ANDA | ANDA207742 |
| DCSA | CIII |
| FDA SPL set id | 791057 |
| Labeler | Asclemed USA, Inc. |
| Label type | HUMAN PRESCRIPTION DRUG |
| Marketing category | ANDA |
| Marketing effective time low | 2022-11-02 |
| Marketing status | ACTIVE |
| Related queries | Properties for NDC 9 76420-747 |
NDC Item 00143965901
| NDC 9 | 0143-9659 |
|---|---|
| NDC 10 | 0143-9659-01 |
| NDC Item | 00143965901 |
| Packaging | 1 mL in 1 VIAL (0143-9659-01) |
| ANDA | ANDA091244 |
| DCSA | CIII |
| FDA SPL set id | 627057 |
| Labeler | Hikma Pharmaceuticals USA Inc. |
| Label type | HUMAN PRESCRIPTION DRUG |
| Marketing category | ANDA |
| Marketing effective time low | 2012-05-01 |
| Marketing status | ACTIVE |
| Related queries | Properties for NDC 9 0143-9659 |
NDC Item 00409656201
| NDC 9 | 0409-6562 |
|---|---|
| NDC 10 | 0409-6562-01 |
| NDC Item | 00409656201 |
| Packaging | 1 VIAL in 1 CARTON (0409-6562-01) / 1 mL in 1 VIAL |
| ANDA | ANDA085635 |
| DCSA | CIII |
| FDA SPL set id | 500095 |
| FDA SPL set id | 500287 |
| Labeler | Hospira, Inc. |
| Label type | HUMAN PRESCRIPTION DRUG |
| Marketing category | ANDA |
| Marketing effective time low | 2018-01-17 |
| Marketing status | ACTIVE |
| Related queries | Properties for NDC 9 0409-6562 |
NDC Item 00409656202
| NDC 9 | 0409-6562 |
|---|---|
| NDC 10 | 0409-6562-02 |
| NDC Item | 00409656202 |
| Packaging | 1 VIAL in 1 CARTON (0409-6562-02) / 1 mL in 1 VIAL |
| ANDA | ANDA085635 |
| DCSA | CIII |
| FDA SPL set id | 500095 |
| FDA SPL set id | 500287 |
| Labeler | Hospira, Inc. |
| Label type | HUMAN PRESCRIPTION DRUG |
| Marketing category | ANDA |
| Marketing effective time low | 2018-01-17 |
| Marketing status | ACTIVE |
| Related queries | Properties for NDC 9 0409-6562 |
NDC Item 00517183001
| NDC 9 | 0517-1830 |
|---|---|
| NDC 10 | 0517-1830-01 |
| NDC Item | 00517183001 |
| Packaging | 1 VIAL in 1 BOX (0517-1830-01) / 1 mL in 1 VIAL |
| ANDA | ANDA207742 |
| DCSA | CIII |
| FDA SPL set id | 674434 |
| Labeler | American Regent, Inc. |
| Label type | HUMAN PRESCRIPTION DRUG |
| Marketing category | ANDA |
| Marketing effective time low | 2019-07-19 |
| Marketing status | ACTIVE |
| Related queries | Properties for NDC 9 0517-1830 |
NDC Item 00574082001
| NDC 9 | 0574-0820 |
|---|---|
| NDC 10 | 0574-0820-01 |
| NDC Item | 00574082001 |
| Packaging | 1 VIAL, GLASS in 1 CARTON (0574-0820-01) / 1 mL in 1 VIAL, GLASS |
| ANDA | ANDA040530 |
| DCSA | CIII |
| FDA SPL set id | 768154 |
| FDA SPL set id | 791051 |
| Labeler | Padagis US LLC |
| Label type | HUMAN PRESCRIPTION DRUG |
| Marketing category | ANDA |
| Marketing effective time low | 2007-12-21 |
| Marketing status | ACTIVE |
| Related queries | Properties for NDC 9 0574-0820 |
NDC Item 00574082701
| NDC 9 | 0574-0827 |
|---|---|
| NDC 10 | 0574-0827-01 |
| NDC Item | 00574082701 |
| Packaging | 1 VIAL, GLASS in 1 CARTON (0574-0827-01) / 1 mL in 1 VIAL, GLASS |
| ANDA | ANDA091244 |
| DCSA | CIII |
| FDA SPL set id | 584573 |
| Labeler | Padagis US LLC |
| Label type | HUMAN PRESCRIPTION DRUG |
| Marketing category | ANDA |
| Marketing effective time low | 2014-05-01 |
| Marketing status | ACTIVE |
| Related queries | Properties for NDC 9 0574-0827 |
NDC Item 47781091193
| NDC 9 | 47781-911 |
|---|---|
| NDC 10 | 47781-911-93 |
| NDC Item | 47781091193 |
| Packaging | 1 VIAL, SINGLE-DOSE in 1 CARTON (47781-911-93) / 1 mL in 1 VIAL, SINGLE-DOSE |
| ANDA | ANDA207742 |
| DCSA | CIII |
| FDA SPL set id | 719526 |
| Labeler | Alvogen Inc. |
| Label type | HUMAN PRESCRIPTION DRUG |
| Marketing category | ANDA |
| Marketing effective time low | 2022-11-02 |
| Marketing status | ACTIVE |
| Related queries | Properties for NDC 9 47781-911 |
NDC Item 52536062501
| NDC 9 | 52536-625 |
|---|---|
| NDC 10 | 52536-625-01 |
| NDC Item | 52536062501 |
| Packaging | 1 VIAL, SINGLE-DOSE in 1 CARTON (52536-625-01) / 1 mL in 1 VIAL, SINGLE-DOSE |
| ANDA | ANDA206368 |
| COLORTEXT | WHITE(or creamy white) |
| Color | C48325 __ |
| DCSA | CIII |
| FDA SPL set id | 395393 |
| Labeler | Wilshire Pharmaceuticals |
| Label type | HUMAN PRESCRIPTION DRUG |
| Marketing category | ANDA |
| Marketing effective time low | 2019-05-31 |
| Marketing status | ACTIVE |
| Related queries | Properties for NDC 9 52536-625 |
NDC Item 55150027701
| NDC 9 | 55150-277 |
|---|---|
| NDC 10 | 55150-277-01 |
| NDC Item | 55150027701 |
| Packaging | 1 VIAL, GLASS in 1 CARTON (55150-277-01) / 1 mL in 1 VIAL, GLASS |
| ANDA | ANDA211817 |
| DCSA | CIII |
| FDA SPL set id | 739422 |
| Labeler | Eugia US LLC |
| Label type | HUMAN PRESCRIPTION DRUG |
| Marketing category | ANDA |
| Marketing effective time low | 2023-10-20 |
| Marketing status | ACTIVE |
| Related queries | Properties for NDC 9 55150-277 |
NDC Item 62756001540
| NDC 9 | 62756-015 |
|---|---|
| NDC 10 | 62756-015-40 |
| NDC Item | 62756001540 |
| Packaging | 1 VIAL in 1 CARTON (62756-015-40) / 1 mL in 1 VIAL |
| ANDA | ANDA201720 |
| DCSA | CIII |
| FDA SPL set id | 581578 |
| Labeler | Sun Pharmaceutical Industries, Inc. |
| Label type | HUMAN PRESCRIPTION DRUG |
| Marketing category | ANDA |
| Marketing effective time low | 2013-06-17 |
| Marketing status | ACTIVE |
| Related queries | Properties for NDC 9 62756-015 |
NDC Item 64980046799
| NDC 9 | 64980-467 |
|---|---|
| NDC 10 | 64980-467-99 |
| NDC Item | 64980046799 |
| Packaging | 1 VIAL, MULTI-DOSE in 1 CARTON (64980-467-99) / 1 mL in 1 VIAL, MULTI-DOSE |
| ANDA | ANDA207742 |
| DCSA | CIII |
| FDA SPL set id | 385892 |
| Labeler | Rising Pharma Holdings, Inc. |
| Label type | HUMAN PRESCRIPTION DRUG |
| Marketing category | ANDA |
| Marketing effective time high | 2020-06-30 |
| Marketing effective time low | 2018-12-01 |
| Marketing status | COMPLETED |
| Related queries | Properties for NDC 9 64980-467 |
NDC Item 69097053731
| NDC 9 | 69097-537 |
|---|---|
| NDC 10 | 69097-537-31 |
| NDC Item | 69097053731 |
| Packaging | 1 mL in 1 VIAL, GLASS (69097-537-31) |
| ANDA | ANDA210362 |
| COLORTEXT | WHITE("A clear colourless to pale yellow solution) |
| Color | C48325 __ |
| DCSA | CIII |
| FDA SPL set id | 729362 |
| Labeler | Cipla USA Inc. |
| Label type | HUMAN PRESCRIPTION DRUG |
| Marketing category | ANDA |
| Marketing effective time low | 2023-09-15 |
| Marketing status | ACTIVE |
| Related queries | Properties for NDC 9 69097-537 |
NDC Item 69097080232
| NDC 9 | 69097-802 |
|---|---|
| NDC 10 | 69097-802-32 |
| NDC Item | 69097080232 |
| Packaging | 1 VIAL, GLASS in 1 CARTON (69097-802-32) / 1 mL in 1 VIAL, GLASS |
| ANDA | ANDA091244 |
| DCSA | CIII |
| FDA SPL set id | 764872 |
| Labeler | Cipla USA Inc. |
| Label type | HUMAN PRESCRIPTION DRUG |
| Marketing category | ANDA |
| Marketing effective time low | 2019-03-26 |
| Marketing status | ACTIVE |
| Related queries | Properties for NDC 9 69097-802 |
NDC Item 70700028922
| NDC 9 | 70700-289 |
|---|---|
| NDC 10 | 70700-289-22 |
| NDC Item | 70700028922 |
| Packaging | 1 VIAL in 1 CARTON (70700-289-22) / 1 mL in 1 VIAL |
| ANDA | ANDA215351 |
| DCSA | CIII |
| FDA SPL set id | 708164 |
| Labeler | Xiromed LLC |
| Label type | HUMAN PRESCRIPTION DRUG |
| Marketing category | ANDA |
| Marketing effective time low | 2023-04-28 |
| Marketing status | ACTIVE |
| Related queries | Properties for NDC 9 70700-289 |
NDC Item 71205028901
| NDC 9 | 71205-289 |
|---|---|
| NDC 10 | 71205-289-01 |
| NDC Item | 71205028901 |
| Packaging | 1 mL in 1 VIAL (71205-289-01) |
| ANDA | ANDA091244 |
| DCSA | CIII |
| FDA SPL set id | 413320 |
| Labeler | Proficient Rx LP |
| Label type | HUMAN PRESCRIPTION DRUG |
| Marketing category | ANDA |
| Marketing effective time low | 2012-05-01 |
| Marketing status | ACTIVE |
| Related queries | Properties for NDC 9 71205-289 |
NDC Item 71225012701
| NDC 9 | 71225-127 |
|---|---|
| NDC 10 | 71225-127-01 |
| NDC Item | 71225012701 |
| Packaging | 1 VIAL in 1 CARTON (71225-127-01) / 1 mL in 1 VIAL |
| DCSA | CIII |
| FDA SPL set id | 642064 |
| Labeler | Slayback Pharma LLC |
| Label type | HUMAN PRESCRIPTION DRUG |
| Marketing category | NDA |
| Marketing effective time low | 2022-06-13 |
| Marketing status | ACTIVE |
| NDA | NDA216318 |
| Related queries | Properties for NDC 9 71225-127 |
NDC Item 72162234802
| NDC 9 | 72162-2348 |
|---|---|
| NDC 10 | 72162-2348-2 |
| NDC Item | 72162234802 |
| Packaging | 1 VIAL, SINGLE-DOSE in 1 CARTON (72162-2348-2) / 1 mL in 1 VIAL, SINGLE-DOSE |
| ANDA | ANDA206368 |
| COLORTEXT | WHITE(or creamy white) |
| Color | C48325 __ |
| DCSA | CIII |
| FDA SPL set id | 794476 |
| Labeler | Bryant Ranch Prepack |
| Label type | HUMAN PRESCRIPTION DRUG |
| Marketing category | ANDA |
| Marketing effective time low | 2019-05-31 |
| Marketing status | active |
| Related queries | Properties for NDC 9 72162-2348 |
NDC Item 72162234804
| NDC 9 | 72162-2348 |
|---|---|
| NDC 10 | 72162-2348-4 |
| NDC Item | 72162234804 |
| Packaging | 1 VIAL, MULTI-DOSE in 1 CARTON (72162-2348-4) / 10 mL in 1 VIAL, MULTI-DOSE |
| ANDA | ANDA206368 |
| COLORTEXT | WHITE(or creamy white) |
| Color | C48325 __ |
| DCSA | CIII |
| FDA SPL set id | 794476 |
| Labeler | Bryant Ranch Prepack |
| Label type | HUMAN PRESCRIPTION DRUG |
| Marketing category | ANDA |
| Marketing effective time low | 2019-05-31 |
| Marketing status | active |
| Related queries | Properties for NDC 9 72162-2348 |
NDC Item 72162237502
| NDC 9 | 72162-2375 |
|---|---|
| NDC 10 | 72162-2375-2 |
| NDC Item | 72162237502 |
| Packaging | 1 VIAL, GLASS in 1 CARTON (72162-2375-2) / 1 mL in 1 VIAL, GLASS |
| ANDA | ANDA040530 |
| DCSA | CIII |
| FDA SPL set id | 800677 |
| Labeler | Bryant Ranch Prepack |
| Label type | HUMAN PRESCRIPTION DRUG |
| Marketing category | ANDA |
| Marketing effective time low | 2007-12-21 |
| Marketing status | active |
| Related queries | Properties for NDC 9 72162-2375 |
NDC Item 76420074601
| NDC 9 | 76420-746 |
|---|---|
| NDC 10 | 76420-746-01 |
| NDC Item | 76420074601 |
| Packaging | 1 VIAL, GLASS in 1 CARTON (76420-746-01) / 1 mL in 1 VIAL, GLASS |
| ANDA | ANDA091244 |
| DCSA | CIII |
| FDA SPL set id | 791011 |
| Labeler | Asclemed USA, Inc. |
| Label type | HUMAN PRESCRIPTION DRUG |
| Marketing category | ANDA |
| Marketing effective time low | 2019-03-26 |
| Marketing status | ACTIVE |
| Related queries | Properties for NDC 9 76420-746 |
NDC Item 76420074701
| NDC 9 | 76420-747 |
|---|---|
| NDC 10 | 76420-747-01 |
| NDC Item | 76420074701 |
| Packaging | 1 VIAL, SINGLE-DOSE in 1 CARTON (76420-747-01) / 1 mL in 1 VIAL, SINGLE-DOSE |
| ANDA | ANDA207742 |
| DCSA | CIII |
| FDA SPL set id | 791057 |
| Labeler | Asclemed USA, Inc. |
| Label type | HUMAN PRESCRIPTION DRUG |
| Marketing category | ANDA |
| Marketing effective time low | 2022-11-02 |
| Marketing status | ACTIVE |
| Related queries | Properties for NDC 9 76420-747 |
NDC Item 00143965901
| NDC 9 | 0143-9659 |
|---|---|
| NDC 10 | 0143-9659-01 |
| NDC Item | 00143965901 |
| Packaging | 1 mL in 1 VIAL (0143-9659-01) |
| ANDA | ANDA091244 |
| DCSA | CIII |
| FDA SPL set id | 627057 |
| Labeler | Hikma Pharmaceuticals USA Inc. |
| Label type | HUMAN PRESCRIPTION DRUG |
| Marketing category | ANDA |
| Marketing effective time low | 2012-05-01 |
| Marketing status | ACTIVE |
| Related queries | Properties for NDC 9 0143-9659 |
NDC Item 00409656201
| NDC 9 | 0409-6562 |
|---|---|
| NDC 10 | 0409-6562-01 |
| NDC Item | 00409656201 |
| Packaging | 1 VIAL in 1 CARTON (0409-6562-01) / 1 mL in 1 VIAL |
| ANDA | ANDA085635 |
| DCSA | CIII |
| FDA SPL set id | 500095 |
| FDA SPL set id | 500287 |
| Labeler | Hospira, Inc. |
| Label type | HUMAN PRESCRIPTION DRUG |
| Marketing category | ANDA |
| Marketing effective time low | 2018-01-17 |
| Marketing status | ACTIVE |
| Related queries | Properties for NDC 9 0409-6562 |
NDC Item 00409656202
| NDC 9 | 0409-6562 |
|---|---|
| NDC 10 | 0409-6562-02 |
| NDC Item | 00409656202 |
| Packaging | 1 VIAL in 1 CARTON (0409-6562-02) / 1 mL in 1 VIAL |
| ANDA | ANDA085635 |
| DCSA | CIII |
| FDA SPL set id | 500095 |
| FDA SPL set id | 500287 |
| Labeler | Hospira, Inc. |
| Label type | HUMAN PRESCRIPTION DRUG |
| Marketing category | ANDA |
| Marketing effective time low | 2018-01-17 |
| Marketing status | ACTIVE |
| Related queries | Properties for NDC 9 0409-6562 |
NDC Item 00517183001
| NDC 9 | 0517-1830 |
|---|---|
| NDC 10 | 0517-1830-01 |
| NDC Item | 00517183001 |
| Packaging | 1 VIAL in 1 BOX (0517-1830-01) / 1 mL in 1 VIAL |
| ANDA | ANDA207742 |
| DCSA | CIII |
| FDA SPL set id | 674434 |
| Labeler | American Regent, Inc. |
| Label type | HUMAN PRESCRIPTION DRUG |
| Marketing category | ANDA |
| Marketing effective time low | 2019-07-19 |
| Marketing status | ACTIVE |
| Related queries | Properties for NDC 9 0517-1830 |
NDC Item 00574082001
| NDC 9 | 0574-0820 |
|---|---|
| NDC 10 | 0574-0820-01 |
| NDC Item | 00574082001 |
| Packaging | 1 VIAL, GLASS in 1 CARTON (0574-0820-01) / 1 mL in 1 VIAL, GLASS |
| ANDA | ANDA040530 |
| DCSA | CIII |
| FDA SPL set id | 768154 |
| FDA SPL set id | 791051 |
| Labeler | Padagis US LLC |
| Label type | HUMAN PRESCRIPTION DRUG |
| Marketing category | ANDA |
| Marketing effective time low | 2007-12-21 |
| Marketing status | ACTIVE |
| Related queries | Properties for NDC 9 0574-0820 |
NDC Item 00574082701
| NDC 9 | 0574-0827 |
|---|---|
| NDC 10 | 0574-0827-01 |
| NDC Item | 00574082701 |
| Packaging | 1 VIAL, GLASS in 1 CARTON (0574-0827-01) / 1 mL in 1 VIAL, GLASS |
| ANDA | ANDA091244 |
| DCSA | CIII |
| FDA SPL set id | 584573 |
| Labeler | Padagis US LLC |
| Label type | HUMAN PRESCRIPTION DRUG |
| Marketing category | ANDA |
| Marketing effective time low | 2014-05-01 |
| Marketing status | ACTIVE |
| Related queries | Properties for NDC 9 0574-0827 |
NDC Item 47781091193
| NDC 9 | 47781-911 |
|---|---|
| NDC 10 | 47781-911-93 |
| NDC Item | 47781091193 |
| Packaging | 1 VIAL, SINGLE-DOSE in 1 CARTON (47781-911-93) / 1 mL in 1 VIAL, SINGLE-DOSE |
| ANDA | ANDA207742 |
| DCSA | CIII |
| FDA SPL set id | 719526 |
| Labeler | Alvogen Inc. |
| Label type | HUMAN PRESCRIPTION DRUG |
| Marketing category | ANDA |
| Marketing effective time low | 2022-11-02 |
| Marketing status | ACTIVE |
| Related queries | Properties for NDC 9 47781-911 |
NDC Item 52536062501
| NDC 9 | 52536-625 |
|---|---|
| NDC 10 | 52536-625-01 |
| NDC Item | 52536062501 |
| Packaging | 1 VIAL, SINGLE-DOSE in 1 CARTON (52536-625-01) / 1 mL in 1 VIAL, SINGLE-DOSE |
| ANDA | ANDA206368 |
| COLORTEXT | WHITE(or creamy white) |
| Color | C48325 __ |
| DCSA | CIII |
| FDA SPL set id | 395393 |
| Labeler | Wilshire Pharmaceuticals |
| Label type | HUMAN PRESCRIPTION DRUG |
| Marketing category | ANDA |
| Marketing effective time low | 2019-05-31 |
| Marketing status | ACTIVE |
| Related queries | Properties for NDC 9 52536-625 |
NDC Item 55150027701
| NDC 9 | 55150-277 |
|---|---|
| NDC 10 | 55150-277-01 |
| NDC Item | 55150027701 |
| Packaging | 1 VIAL, GLASS in 1 CARTON (55150-277-01) / 1 mL in 1 VIAL, GLASS |
| ANDA | ANDA211817 |
| DCSA | CIII |
| FDA SPL set id | 739422 |
| Labeler | Eugia US LLC |
| Label type | HUMAN PRESCRIPTION DRUG |
| Marketing category | ANDA |
| Marketing effective time low | 2023-10-20 |
| Marketing status | ACTIVE |
| Related queries | Properties for NDC 9 55150-277 |
NDC Item 62756001540
| NDC 9 | 62756-015 |
|---|---|
| NDC 10 | 62756-015-40 |
| NDC Item | 62756001540 |
| Packaging | 1 VIAL in 1 CARTON (62756-015-40) / 1 mL in 1 VIAL |
| ANDA | ANDA201720 |
| DCSA | CIII |
| FDA SPL set id | 581578 |
| Labeler | Sun Pharmaceutical Industries, Inc. |
| Label type | HUMAN PRESCRIPTION DRUG |
| Marketing category | ANDA |
| Marketing effective time low | 2013-06-17 |
| Marketing status | ACTIVE |
| Related queries | Properties for NDC 9 62756-015 |
NDC Item 64980046799
| NDC 9 | 64980-467 |
|---|---|
| NDC 10 | 64980-467-99 |
| NDC Item | 64980046799 |
| Packaging | 1 VIAL, MULTI-DOSE in 1 CARTON (64980-467-99) / 1 mL in 1 VIAL, MULTI-DOSE |
| ANDA | ANDA207742 |
| DCSA | CIII |
| FDA SPL set id | 385892 |
| Labeler | Rising Pharma Holdings, Inc. |
| Label type | HUMAN PRESCRIPTION DRUG |
| Marketing category | ANDA |
| Marketing effective time high | 2020-06-30 |
| Marketing effective time low | 2018-12-01 |
| Marketing status | COMPLETED |
| Related queries | Properties for NDC 9 64980-467 |
NDC Item 69097053731
| NDC 9 | 69097-537 |
|---|---|
| NDC 10 | 69097-537-31 |
| NDC Item | 69097053731 |
| Packaging | 1 mL in 1 VIAL, GLASS (69097-537-31) |
| ANDA | ANDA210362 |
| COLORTEXT | WHITE("A clear colourless to pale yellow solution) |
| Color | C48325 __ |
| DCSA | CIII |
| FDA SPL set id | 729362 |
| Labeler | Cipla USA Inc. |
| Label type | HUMAN PRESCRIPTION DRUG |
| Marketing category | ANDA |
| Marketing effective time low | 2023-09-15 |
| Marketing status | ACTIVE |
| Related queries | Properties for NDC 9 69097-537 |
NDC Item 69097080232
| NDC 9 | 69097-802 |
|---|---|
| NDC 10 | 69097-802-32 |
| NDC Item | 69097080232 |
| Packaging | 1 VIAL, GLASS in 1 CARTON (69097-802-32) / 1 mL in 1 VIAL, GLASS |
| ANDA | ANDA091244 |
| DCSA | CIII |
| FDA SPL set id | 764872 |
| Labeler | Cipla USA Inc. |
| Label type | HUMAN PRESCRIPTION DRUG |
| Marketing category | ANDA |
| Marketing effective time low | 2019-03-26 |
| Marketing status | ACTIVE |
| Related queries | Properties for NDC 9 69097-802 |
NDC Item 70700028922
| NDC 9 | 70700-289 |
|---|---|
| NDC 10 | 70700-289-22 |
| NDC Item | 70700028922 |
| Packaging | 1 VIAL in 1 CARTON (70700-289-22) / 1 mL in 1 VIAL |
| ANDA | ANDA215351 |
| DCSA | CIII |
| FDA SPL set id | 708164 |
| Labeler | Xiromed LLC |
| Label type | HUMAN PRESCRIPTION DRUG |
| Marketing category | ANDA |
| Marketing effective time low | 2023-04-28 |
| Marketing status | ACTIVE |
| Related queries | Properties for NDC 9 70700-289 |
NDC Item 71205028901
| NDC 9 | 71205-289 |
|---|---|
| NDC 10 | 71205-289-01 |
| NDC Item | 71205028901 |
| Packaging | 1 mL in 1 VIAL (71205-289-01) |
| ANDA | ANDA091244 |
| DCSA | CIII |
| FDA SPL set id | 413320 |
| Labeler | Proficient Rx LP |
| Label type | HUMAN PRESCRIPTION DRUG |
| Marketing category | ANDA |
| Marketing effective time low | 2012-05-01 |
| Marketing status | ACTIVE |
| Related queries | Properties for NDC 9 71205-289 |
NDC Item 71225012701
| NDC 9 | 71225-127 |
|---|---|
| NDC 10 | 71225-127-01 |
| NDC Item | 71225012701 |
| Packaging | 1 VIAL in 1 CARTON (71225-127-01) / 1 mL in 1 VIAL |
| DCSA | CIII |
| FDA SPL set id | 642064 |
| Labeler | Slayback Pharma LLC |
| Label type | HUMAN PRESCRIPTION DRUG |
| Marketing category | NDA |
| Marketing effective time low | 2022-06-13 |
| Marketing status | ACTIVE |
| NDA | NDA216318 |
| Related queries | Properties for NDC 9 71225-127 |
NDC Item 72162234802
| NDC 9 | 72162-2348 |
|---|---|
| NDC 10 | 72162-2348-2 |
| NDC Item | 72162234802 |
| Packaging | 1 VIAL, SINGLE-DOSE in 1 CARTON (72162-2348-2) / 1 mL in 1 VIAL, SINGLE-DOSE |
| ANDA | ANDA206368 |
| COLORTEXT | WHITE(or creamy white) |
| Color | C48325 __ |
| DCSA | CIII |
| FDA SPL set id | 794476 |
| Labeler | Bryant Ranch Prepack |
| Label type | HUMAN PRESCRIPTION DRUG |
| Marketing category | ANDA |
| Marketing effective time low | 2019-05-31 |
| Marketing status | active |
| Related queries | Properties for NDC 9 72162-2348 |
NDC Item 72162234804
| NDC 9 | 72162-2348 |
|---|---|
| NDC 10 | 72162-2348-4 |
| NDC Item | 72162234804 |
| Packaging | 1 VIAL, MULTI-DOSE in 1 CARTON (72162-2348-4) / 10 mL in 1 VIAL, MULTI-DOSE |
| ANDA | ANDA206368 |
| COLORTEXT | WHITE(or creamy white) |
| Color | C48325 __ |
| DCSA | CIII |
| FDA SPL set id | 794476 |
| Labeler | Bryant Ranch Prepack |
| Label type | HUMAN PRESCRIPTION DRUG |
| Marketing category | ANDA |
| Marketing effective time low | 2019-05-31 |
| Marketing status | active |
| Related queries | Properties for NDC 9 72162-2348 |
NDC Item 72162237502
| NDC 9 | 72162-2375 |
|---|---|
| NDC 10 | 72162-2375-2 |
| NDC Item | 72162237502 |
| Packaging | 1 VIAL, GLASS in 1 CARTON (72162-2375-2) / 1 mL in 1 VIAL, GLASS |
| ANDA | ANDA040530 |
| DCSA | CIII |
| FDA SPL set id | 800677 |
| Labeler | Bryant Ranch Prepack |
| Label type | HUMAN PRESCRIPTION DRUG |
| Marketing category | ANDA |
| Marketing effective time low | 2007-12-21 |
| Marketing status | active |
| Related queries | Properties for NDC 9 72162-2375 |
NDC Item 76420074601
| NDC 9 | 76420-746 |
|---|---|
| NDC 10 | 76420-746-01 |
| NDC Item | 76420074601 |
| Packaging | 1 VIAL, GLASS in 1 CARTON (76420-746-01) / 1 mL in 1 VIAL, GLASS |
| ANDA | ANDA091244 |
| DCSA | CIII |
| FDA SPL set id | 791011 |
| Labeler | Asclemed USA, Inc. |
| Label type | HUMAN PRESCRIPTION DRUG |
| Marketing category | ANDA |
| Marketing effective time low | 2019-03-26 |
| Marketing status | ACTIVE |
| Related queries | Properties for NDC 9 76420-746 |
NDC Item 76420074701
| NDC 9 | 76420-747 |
|---|---|
| NDC 10 | 76420-747-01 |
| NDC Item | 76420074701 |
| Packaging | 1 VIAL, SINGLE-DOSE in 1 CARTON (76420-747-01) / 1 mL in 1 VIAL, SINGLE-DOSE |
| ANDA | ANDA207742 |
| DCSA | CIII |
| FDA SPL set id | 791057 |
| Labeler | Asclemed USA, Inc. |
| Label type | HUMAN PRESCRIPTION DRUG |
| Marketing category | ANDA |
| Marketing effective time low | 2022-11-02 |
| Marketing status | ACTIVE |
| Related queries | Properties for NDC 9 76420-747 |
NDC Item 00143965901
| NDC 9 | 0143-9659 |
|---|---|
| NDC 10 | 0143-9659-01 |
| NDC Item | 00143965901 |
| Packaging | 1 mL in 1 VIAL (0143-9659-01) |
| ANDA | ANDA091244 |
| DCSA | CIII |
| FDA SPL set id | 627057 |
| Labeler | Hikma Pharmaceuticals USA Inc. |
| Label type | HUMAN PRESCRIPTION DRUG |
| Marketing category | ANDA |
| Marketing effective time low | 2012-05-01 |
| Marketing status | ACTIVE |
| Related queries | Properties for NDC 9 0143-9659 |
NDC Item 00409656201
| NDC 9 | 0409-6562 |
|---|---|
| NDC 10 | 0409-6562-01 |
| NDC Item | 00409656201 |
| Packaging | 1 VIAL in 1 CARTON (0409-6562-01) / 1 mL in 1 VIAL |
| ANDA | ANDA085635 |
| DCSA | CIII |
| FDA SPL set id | 500095 |
| FDA SPL set id | 500287 |
| Labeler | Hospira, Inc. |
| Label type | HUMAN PRESCRIPTION DRUG |
| Marketing category | ANDA |
| Marketing effective time low | 2018-01-17 |
| Marketing status | ACTIVE |
| Related queries | Properties for NDC 9 0409-6562 |
NDC Item 00409656202
| NDC 9 | 0409-6562 |
|---|---|
| NDC 10 | 0409-6562-02 |
| NDC Item | 00409656202 |
| Packaging | 1 VIAL in 1 CARTON (0409-6562-02) / 1 mL in 1 VIAL |
| ANDA | ANDA085635 |
| DCSA | CIII |
| FDA SPL set id | 500095 |
| FDA SPL set id | 500287 |
| Labeler | Hospira, Inc. |
| Label type | HUMAN PRESCRIPTION DRUG |
| Marketing category | ANDA |
| Marketing effective time low | 2018-01-17 |
| Marketing status | ACTIVE |
| Related queries | Properties for NDC 9 0409-6562 |
NDC Item 00517183001
| NDC 9 | 0517-1830 |
|---|---|
| NDC 10 | 0517-1830-01 |
| NDC Item | 00517183001 |
| Packaging | 1 VIAL in 1 BOX (0517-1830-01) / 1 mL in 1 VIAL |
| ANDA | ANDA207742 |
| DCSA | CIII |
| FDA SPL set id | 674434 |
| Labeler | American Regent, Inc. |
| Label type | HUMAN PRESCRIPTION DRUG |
| Marketing category | ANDA |
| Marketing effective time low | 2019-07-19 |
| Marketing status | ACTIVE |
| Related queries | Properties for NDC 9 0517-1830 |
NDC Item 00574082001
| NDC 9 | 0574-0820 |
|---|---|
| NDC 10 | 0574-0820-01 |
| NDC Item | 00574082001 |
| Packaging | 1 VIAL, GLASS in 1 CARTON (0574-0820-01) / 1 mL in 1 VIAL, GLASS |
| ANDA | ANDA040530 |
| DCSA | CIII |
| FDA SPL set id | 768154 |
| FDA SPL set id | 791051 |
| Labeler | Padagis US LLC |
| Label type | HUMAN PRESCRIPTION DRUG |
| Marketing category | ANDA |
| Marketing effective time low | 2007-12-21 |
| Marketing status | ACTIVE |
| Related queries | Properties for NDC 9 0574-0820 |
NDC Item 00574082701
| NDC 9 | 0574-0827 |
|---|---|
| NDC 10 | 0574-0827-01 |
| NDC Item | 00574082701 |
| Packaging | 1 VIAL, GLASS in 1 CARTON (0574-0827-01) / 1 mL in 1 VIAL, GLASS |
| ANDA | ANDA091244 |
| DCSA | CIII |
| FDA SPL set id | 584573 |
| Labeler | Padagis US LLC |
| Label type | HUMAN PRESCRIPTION DRUG |
| Marketing category | ANDA |
| Marketing effective time low | 2014-05-01 |
| Marketing status | ACTIVE |
| Related queries | Properties for NDC 9 0574-0827 |
NDC Item 47781091193
| NDC 9 | 47781-911 |
|---|---|
| NDC 10 | 47781-911-93 |
| NDC Item | 47781091193 |
| Packaging | 1 VIAL, SINGLE-DOSE in 1 CARTON (47781-911-93) / 1 mL in 1 VIAL, SINGLE-DOSE |
| ANDA | ANDA207742 |
| DCSA | CIII |
| FDA SPL set id | 719526 |
| Labeler | Alvogen Inc. |
| Label type | HUMAN PRESCRIPTION DRUG |
| Marketing category | ANDA |
| Marketing effective time low | 2022-11-02 |
| Marketing status | ACTIVE |
| Related queries | Properties for NDC 9 47781-911 |
NDC Item 52536062501
| NDC 9 | 52536-625 |
|---|---|
| NDC 10 | 52536-625-01 |
| NDC Item | 52536062501 |
| Packaging | 1 VIAL, SINGLE-DOSE in 1 CARTON (52536-625-01) / 1 mL in 1 VIAL, SINGLE-DOSE |
| ANDA | ANDA206368 |
| COLORTEXT | WHITE(or creamy white) |
| Color | C48325 __ |
| DCSA | CIII |
| FDA SPL set id | 395393 |
| Labeler | Wilshire Pharmaceuticals |
| Label type | HUMAN PRESCRIPTION DRUG |
| Marketing category | ANDA |
| Marketing effective time low | 2019-05-31 |
| Marketing status | ACTIVE |
| Related queries | Properties for NDC 9 52536-625 |
NDC Item 55150027701
| NDC 9 | 55150-277 |
|---|---|
| NDC 10 | 55150-277-01 |
| NDC Item | 55150027701 |
| Packaging | 1 VIAL, GLASS in 1 CARTON (55150-277-01) / 1 mL in 1 VIAL, GLASS |
| ANDA | ANDA211817 |
| DCSA | CIII |
| FDA SPL set id | 739422 |
| Labeler | Eugia US LLC |
| Label type | HUMAN PRESCRIPTION DRUG |
| Marketing category | ANDA |
| Marketing effective time low | 2023-10-20 |
| Marketing status | ACTIVE |
| Related queries | Properties for NDC 9 55150-277 |
NDC Item 62756001540
| NDC 9 | 62756-015 |
|---|---|
| NDC 10 | 62756-015-40 |
| NDC Item | 62756001540 |
| Packaging | 1 VIAL in 1 CARTON (62756-015-40) / 1 mL in 1 VIAL |
| ANDA | ANDA201720 |
| DCSA | CIII |
| FDA SPL set id | 581578 |
| Labeler | Sun Pharmaceutical Industries, Inc. |
| Label type | HUMAN PRESCRIPTION DRUG |
| Marketing category | ANDA |
| Marketing effective time low | 2013-06-17 |
| Marketing status | ACTIVE |
| Related queries | Properties for NDC 9 62756-015 |
NDC Item 64980046799
| NDC 9 | 64980-467 |
|---|---|
| NDC 10 | 64980-467-99 |
| NDC Item | 64980046799 |
| Packaging | 1 VIAL, MULTI-DOSE in 1 CARTON (64980-467-99) / 1 mL in 1 VIAL, MULTI-DOSE |
| ANDA | ANDA207742 |
| DCSA | CIII |
| FDA SPL set id | 385892 |
| Labeler | Rising Pharma Holdings, Inc. |
| Label type | HUMAN PRESCRIPTION DRUG |
| Marketing category | ANDA |
| Marketing effective time high | 2020-06-30 |
| Marketing effective time low | 2018-12-01 |
| Marketing status | COMPLETED |
| Related queries | Properties for NDC 9 64980-467 |
NDC Item 69097053731
| NDC 9 | 69097-537 |
|---|---|
| NDC 10 | 69097-537-31 |
| NDC Item | 69097053731 |
| Packaging | 1 mL in 1 VIAL, GLASS (69097-537-31) |
| ANDA | ANDA210362 |
| COLORTEXT | WHITE("A clear colourless to pale yellow solution) |
| Color | C48325 __ |
| DCSA | CIII |
| FDA SPL set id | 729362 |
| Labeler | Cipla USA Inc. |
| Label type | HUMAN PRESCRIPTION DRUG |
| Marketing category | ANDA |
| Marketing effective time low | 2023-09-15 |
| Marketing status | ACTIVE |
| Related queries | Properties for NDC 9 69097-537 |
NDC Item 69097080232
| NDC 9 | 69097-802 |
|---|---|
| NDC 10 | 69097-802-32 |
| NDC Item | 69097080232 |
| Packaging | 1 VIAL, GLASS in 1 CARTON (69097-802-32) / 1 mL in 1 VIAL, GLASS |
| ANDA | ANDA091244 |
| DCSA | CIII |
| FDA SPL set id | 764872 |
| Labeler | Cipla USA Inc. |
| Label type | HUMAN PRESCRIPTION DRUG |
| Marketing category | ANDA |
| Marketing effective time low | 2019-03-26 |
| Marketing status | ACTIVE |
| Related queries | Properties for NDC 9 69097-802 |
NDC Item 70700028922
| NDC 9 | 70700-289 |
|---|---|
| NDC 10 | 70700-289-22 |
| NDC Item | 70700028922 |
| Packaging | 1 VIAL in 1 CARTON (70700-289-22) / 1 mL in 1 VIAL |
| ANDA | ANDA215351 |
| DCSA | CIII |
| FDA SPL set id | 708164 |
| Labeler | Xiromed LLC |
| Label type | HUMAN PRESCRIPTION DRUG |
| Marketing category | ANDA |
| Marketing effective time low | 2023-04-28 |
| Marketing status | ACTIVE |
| Related queries | Properties for NDC 9 70700-289 |
NDC Item 71205028901
| NDC 9 | 71205-289 |
|---|---|
| NDC 10 | 71205-289-01 |
| NDC Item | 71205028901 |
| Packaging | 1 mL in 1 VIAL (71205-289-01) |
| ANDA | ANDA091244 |
| DCSA | CIII |
| FDA SPL set id | 413320 |
| Labeler | Proficient Rx LP |
| Label type | HUMAN PRESCRIPTION DRUG |
| Marketing category | ANDA |
| Marketing effective time low | 2012-05-01 |
| Marketing status | ACTIVE |
| Related queries | Properties for NDC 9 71205-289 |
NDC Item 71225012701
| NDC 9 | 71225-127 |
|---|---|
| NDC 10 | 71225-127-01 |
| NDC Item | 71225012701 |
| Packaging | 1 VIAL in 1 CARTON (71225-127-01) / 1 mL in 1 VIAL |
| DCSA | CIII |
| FDA SPL set id | 642064 |
| Labeler | Slayback Pharma LLC |
| Label type | HUMAN PRESCRIPTION DRUG |
| Marketing category | NDA |
| Marketing effective time low | 2022-06-13 |
| Marketing status | ACTIVE |
| NDA | NDA216318 |
| Related queries | Properties for NDC 9 71225-127 |
NDC Item 72162234802
| NDC 9 | 72162-2348 |
|---|---|
| NDC 10 | 72162-2348-2 |
| NDC Item | 72162234802 |
| Packaging | 1 VIAL, SINGLE-DOSE in 1 CARTON (72162-2348-2) / 1 mL in 1 VIAL, SINGLE-DOSE |
| ANDA | ANDA206368 |
| COLORTEXT | WHITE(or creamy white) |
| Color | C48325 __ |
| DCSA | CIII |
| FDA SPL set id | 794476 |
| Labeler | Bryant Ranch Prepack |
| Label type | HUMAN PRESCRIPTION DRUG |
| Marketing category | ANDA |
| Marketing effective time low | 2019-05-31 |
| Marketing status | active |
| Related queries | Properties for NDC 9 72162-2348 |
NDC Item 72162234804
| NDC 9 | 72162-2348 |
|---|---|
| NDC 10 | 72162-2348-4 |
| NDC Item | 72162234804 |
| Packaging | 1 VIAL, MULTI-DOSE in 1 CARTON (72162-2348-4) / 10 mL in 1 VIAL, MULTI-DOSE |
| ANDA | ANDA206368 |
| COLORTEXT | WHITE(or creamy white) |
| Color | C48325 __ |
| DCSA | CIII |
| FDA SPL set id | 794476 |
| Labeler | Bryant Ranch Prepack |
| Label type | HUMAN PRESCRIPTION DRUG |
| Marketing category | ANDA |
| Marketing effective time low | 2019-05-31 |
| Marketing status | active |
| Related queries | Properties for NDC 9 72162-2348 |
NDC Item 72162237502
| NDC 9 | 72162-2375 |
|---|---|
| NDC 10 | 72162-2375-2 |
| NDC Item | 72162237502 |
| Packaging | 1 VIAL, GLASS in 1 CARTON (72162-2375-2) / 1 mL in 1 VIAL, GLASS |
| ANDA | ANDA040530 |
| DCSA | CIII |
| FDA SPL set id | 800677 |
| Labeler | Bryant Ranch Prepack |
| Label type | HUMAN PRESCRIPTION DRUG |
| Marketing category | ANDA |
| Marketing effective time low | 2007-12-21 |
| Marketing status | active |
| Related queries | Properties for NDC 9 72162-2375 |
NDC Item 76420074601
| NDC 9 | 76420-746 |
|---|---|
| NDC 10 | 76420-746-01 |
| NDC Item | 76420074601 |
| Packaging | 1 VIAL, GLASS in 1 CARTON (76420-746-01) / 1 mL in 1 VIAL, GLASS |
| ANDA | ANDA091244 |
| DCSA | CIII |
| FDA SPL set id | 791011 |
| Labeler | Asclemed USA, Inc. |
| Label type | HUMAN PRESCRIPTION DRUG |
| Marketing category | ANDA |
| Marketing effective time low | 2019-03-26 |
| Marketing status | ACTIVE |
| Related queries | Properties for NDC 9 76420-746 |
NDC Item 76420074701
| NDC 9 | 76420-747 |
|---|---|
| NDC 10 | 76420-747-01 |
| NDC Item | 76420074701 |
| Packaging | 1 VIAL, SINGLE-DOSE in 1 CARTON (76420-747-01) / 1 mL in 1 VIAL, SINGLE-DOSE |
| ANDA | ANDA207742 |
| DCSA | CIII |
| FDA SPL set id | 791057 |
| Labeler | Asclemed USA, Inc. |
| Label type | HUMAN PRESCRIPTION DRUG |
| Marketing category | ANDA |
| Marketing effective time low | 2022-11-02 |
| Marketing status | ACTIVE |
| Related queries | Properties for NDC 9 76420-747 |
NDC Item 00143965901
| NDC 9 | 0143-9659 |
|---|---|
| NDC 10 | 0143-9659-01 |
| NDC Item | 00143965901 |
| Packaging | 1 mL in 1 VIAL (0143-9659-01) |
| ANDA | ANDA091244 |
| DCSA | CIII |
| FDA SPL set id | 627057 |
| Labeler | Hikma Pharmaceuticals USA Inc. |
| Label type | HUMAN PRESCRIPTION DRUG |
| Marketing category | ANDA |
| Marketing effective time low | 2012-05-01 |
| Marketing status | ACTIVE |
| Related queries | Properties for NDC 9 0143-9659 |
NDC Item 00409656201
| NDC 9 | 0409-6562 |
|---|---|
| NDC 10 | 0409-6562-01 |
| NDC Item | 00409656201 |
| Packaging | 1 VIAL in 1 CARTON (0409-6562-01) / 1 mL in 1 VIAL |
| ANDA | ANDA085635 |
| DCSA | CIII |
| FDA SPL set id | 500095 |
| FDA SPL set id | 500287 |
| Labeler | Hospira, Inc. |
| Label type | HUMAN PRESCRIPTION DRUG |
| Marketing category | ANDA |
| Marketing effective time low | 2018-01-17 |
| Marketing status | ACTIVE |
| Related queries | Properties for NDC 9 0409-6562 |
NDC Item 00409656202
| NDC 9 | 0409-6562 |
|---|---|
| NDC 10 | 0409-6562-02 |
| NDC Item | 00409656202 |
| Packaging | 1 VIAL in 1 CARTON (0409-6562-02) / 1 mL in 1 VIAL |
| ANDA | ANDA085635 |
| DCSA | CIII |
| FDA SPL set id | 500095 |
| FDA SPL set id | 500287 |
| Labeler | Hospira, Inc. |
| Label type | HUMAN PRESCRIPTION DRUG |
| Marketing category | ANDA |
| Marketing effective time low | 2018-01-17 |
| Marketing status | ACTIVE |
| Related queries | Properties for NDC 9 0409-6562 |
NDC Item 00517183001
| NDC 9 | 0517-1830 |
|---|---|
| NDC 10 | 0517-1830-01 |
| NDC Item | 00517183001 |
| Packaging | 1 VIAL in 1 BOX (0517-1830-01) / 1 mL in 1 VIAL |
| ANDA | ANDA207742 |
| DCSA | CIII |
| FDA SPL set id | 674434 |
| Labeler | American Regent, Inc. |
| Label type | HUMAN PRESCRIPTION DRUG |
| Marketing category | ANDA |
| Marketing effective time low | 2019-07-19 |
| Marketing status | ACTIVE |
| Related queries | Properties for NDC 9 0517-1830 |
NDC Item 00574082001
| NDC 9 | 0574-0820 |
|---|---|
| NDC 10 | 0574-0820-01 |
| NDC Item | 00574082001 |
| Packaging | 1 VIAL, GLASS in 1 CARTON (0574-0820-01) / 1 mL in 1 VIAL, GLASS |
| ANDA | ANDA040530 |
| DCSA | CIII |
| FDA SPL set id | 768154 |
| FDA SPL set id | 791051 |
| Labeler | Padagis US LLC |
| Label type | HUMAN PRESCRIPTION DRUG |
| Marketing category | ANDA |
| Marketing effective time low | 2007-12-21 |
| Marketing status | ACTIVE |
| Related queries | Properties for NDC 9 0574-0820 |
NDC Item 00574082701
| NDC 9 | 0574-0827 |
|---|---|
| NDC 10 | 0574-0827-01 |
| NDC Item | 00574082701 |
| Packaging | 1 VIAL, GLASS in 1 CARTON (0574-0827-01) / 1 mL in 1 VIAL, GLASS |
| ANDA | ANDA091244 |
| DCSA | CIII |
| FDA SPL set id | 584573 |
| Labeler | Padagis US LLC |
| Label type | HUMAN PRESCRIPTION DRUG |
| Marketing category | ANDA |
| Marketing effective time low | 2014-05-01 |
| Marketing status | ACTIVE |
| Related queries | Properties for NDC 9 0574-0827 |
NDC Item 47781091193
| NDC 9 | 47781-911 |
|---|---|
| NDC 10 | 47781-911-93 |
| NDC Item | 47781091193 |
| Packaging | 1 VIAL, SINGLE-DOSE in 1 CARTON (47781-911-93) / 1 mL in 1 VIAL, SINGLE-DOSE |
| ANDA | ANDA207742 |
| DCSA | CIII |
| FDA SPL set id | 719526 |
| Labeler | Alvogen Inc. |
| Label type | HUMAN PRESCRIPTION DRUG |
| Marketing category | ANDA |
| Marketing effective time low | 2022-11-02 |
| Marketing status | ACTIVE |
| Related queries | Properties for NDC 9 47781-911 |
NDC Item 52536062501
| NDC 9 | 52536-625 |
|---|---|
| NDC 10 | 52536-625-01 |
| NDC Item | 52536062501 |
| Packaging | 1 VIAL, SINGLE-DOSE in 1 CARTON (52536-625-01) / 1 mL in 1 VIAL, SINGLE-DOSE |
| ANDA | ANDA206368 |
| COLORTEXT | WHITE(or creamy white) |
| Color | C48325 __ |
| DCSA | CIII |
| FDA SPL set id | 395393 |
| Labeler | Wilshire Pharmaceuticals |
| Label type | HUMAN PRESCRIPTION DRUG |
| Marketing category | ANDA |
| Marketing effective time low | 2019-05-31 |
| Marketing status | ACTIVE |
| Related queries | Properties for NDC 9 52536-625 |
NDC Item 55150027701
| NDC 9 | 55150-277 |
|---|---|
| NDC 10 | 55150-277-01 |
| NDC Item | 55150027701 |
| Packaging | 1 VIAL, GLASS in 1 CARTON (55150-277-01) / 1 mL in 1 VIAL, GLASS |
| ANDA | ANDA211817 |
| DCSA | CIII |
| FDA SPL set id | 739422 |
| Labeler | Eugia US LLC |
| Label type | HUMAN PRESCRIPTION DRUG |
| Marketing category | ANDA |
| Marketing effective time low | 2023-10-20 |
| Marketing status | ACTIVE |
| Related queries | Properties for NDC 9 55150-277 |
NDC Item 62756001540
| NDC 9 | 62756-015 |
|---|---|
| NDC 10 | 62756-015-40 |
| NDC Item | 62756001540 |
| Packaging | 1 VIAL in 1 CARTON (62756-015-40) / 1 mL in 1 VIAL |
| ANDA | ANDA201720 |
| DCSA | CIII |
| FDA SPL set id | 581578 |
| Labeler | Sun Pharmaceutical Industries, Inc. |
| Label type | HUMAN PRESCRIPTION DRUG |
| Marketing category | ANDA |
| Marketing effective time low | 2013-06-17 |
| Marketing status | ACTIVE |
| Related queries | Properties for NDC 9 62756-015 |
NDC Item 64980046799
| NDC 9 | 64980-467 |
|---|---|
| NDC 10 | 64980-467-99 |
| NDC Item | 64980046799 |
| Packaging | 1 VIAL, MULTI-DOSE in 1 CARTON (64980-467-99) / 1 mL in 1 VIAL, MULTI-DOSE |
| ANDA | ANDA207742 |
| DCSA | CIII |
| FDA SPL set id | 385892 |
| Labeler | Rising Pharma Holdings, Inc. |
| Label type | HUMAN PRESCRIPTION DRUG |
| Marketing category | ANDA |
| Marketing effective time high | 2020-06-30 |
| Marketing effective time low | 2018-12-01 |
| Marketing status | COMPLETED |
| Related queries | Properties for NDC 9 64980-467 |
NDC Item 69097053731
| NDC 9 | 69097-537 |
|---|---|
| NDC 10 | 69097-537-31 |
| NDC Item | 69097053731 |
| Packaging | 1 mL in 1 VIAL, GLASS (69097-537-31) |
| ANDA | ANDA210362 |
| COLORTEXT | WHITE("A clear colourless to pale yellow solution) |
| Color | C48325 __ |
| DCSA | CIII |
| FDA SPL set id | 729362 |
| Labeler | Cipla USA Inc. |
| Label type | HUMAN PRESCRIPTION DRUG |
| Marketing category | ANDA |
| Marketing effective time low | 2023-09-15 |
| Marketing status | ACTIVE |
| Related queries | Properties for NDC 9 69097-537 |
NDC Item 69097080232
| NDC 9 | 69097-802 |
|---|---|
| NDC 10 | 69097-802-32 |
| NDC Item | 69097080232 |
| Packaging | 1 VIAL, GLASS in 1 CARTON (69097-802-32) / 1 mL in 1 VIAL, GLASS |
| ANDA | ANDA091244 |
| DCSA | CIII |
| FDA SPL set id | 764872 |
| Labeler | Cipla USA Inc. |
| Label type | HUMAN PRESCRIPTION DRUG |
| Marketing category | ANDA |
| Marketing effective time low | 2019-03-26 |
| Marketing status | ACTIVE |
| Related queries | Properties for NDC 9 69097-802 |
NDC Item 70700028922
| NDC 9 | 70700-289 |
|---|---|
| NDC 10 | 70700-289-22 |
| NDC Item | 70700028922 |
| Packaging | 1 VIAL in 1 CARTON (70700-289-22) / 1 mL in 1 VIAL |
| ANDA | ANDA215351 |
| DCSA | CIII |
| FDA SPL set id | 708164 |
| Labeler | Xiromed LLC |
| Label type | HUMAN PRESCRIPTION DRUG |
| Marketing category | ANDA |
| Marketing effective time low | 2023-04-28 |
| Marketing status | ACTIVE |
| Related queries | Properties for NDC 9 70700-289 |
NDC Item 71205028901
| NDC 9 | 71205-289 |
|---|---|
| NDC 10 | 71205-289-01 |
| NDC Item | 71205028901 |
| Packaging | 1 mL in 1 VIAL (71205-289-01) |
| ANDA | ANDA091244 |
| DCSA | CIII |
| FDA SPL set id | 413320 |
| Labeler | Proficient Rx LP |
| Label type | HUMAN PRESCRIPTION DRUG |
| Marketing category | ANDA |
| Marketing effective time low | 2012-05-01 |
| Marketing status | ACTIVE |
| Related queries | Properties for NDC 9 71205-289 |
NDC Item 71225012701
| NDC 9 | 71225-127 |
|---|---|
| NDC 10 | 71225-127-01 |
| NDC Item | 71225012701 |
| Packaging | 1 VIAL in 1 CARTON (71225-127-01) / 1 mL in 1 VIAL |
| DCSA | CIII |
| FDA SPL set id | 642064 |
| Labeler | Slayback Pharma LLC |
| Label type | HUMAN PRESCRIPTION DRUG |
| Marketing category | NDA |
| Marketing effective time low | 2022-06-13 |
| Marketing status | ACTIVE |
| NDA | NDA216318 |
| Related queries | Properties for NDC 9 71225-127 |
NDC Item 72162234802
| NDC 9 | 72162-2348 |
|---|---|
| NDC 10 | 72162-2348-2 |
| NDC Item | 72162234802 |
| Packaging | 1 VIAL, SINGLE-DOSE in 1 CARTON (72162-2348-2) / 1 mL in 1 VIAL, SINGLE-DOSE |
| ANDA | ANDA206368 |
| COLORTEXT | WHITE(or creamy white) |
| Color | C48325 __ |
| DCSA | CIII |
| FDA SPL set id | 794476 |
| Labeler | Bryant Ranch Prepack |
| Label type | HUMAN PRESCRIPTION DRUG |
| Marketing category | ANDA |
| Marketing effective time low | 2019-05-31 |
| Marketing status | active |
| Related queries | Properties for NDC 9 72162-2348 |
NDC Item 72162234804
| NDC 9 | 72162-2348 |
|---|---|
| NDC 10 | 72162-2348-4 |
| NDC Item | 72162234804 |
| Packaging | 1 VIAL, MULTI-DOSE in 1 CARTON (72162-2348-4) / 10 mL in 1 VIAL, MULTI-DOSE |
| ANDA | ANDA206368 |
| COLORTEXT | WHITE(or creamy white) |
| Color | C48325 __ |
| DCSA | CIII |
| FDA SPL set id | 794476 |
| Labeler | Bryant Ranch Prepack |
| Label type | HUMAN PRESCRIPTION DRUG |
| Marketing category | ANDA |
| Marketing effective time low | 2019-05-31 |
| Marketing status | active |
| Related queries | Properties for NDC 9 72162-2348 |
NDC Item 72162237502
| NDC 9 | 72162-2375 |
|---|---|
| NDC 10 | 72162-2375-2 |
| NDC Item | 72162237502 |
| Packaging | 1 VIAL, GLASS in 1 CARTON (72162-2375-2) / 1 mL in 1 VIAL, GLASS |
| ANDA | ANDA040530 |
| DCSA | CIII |
| FDA SPL set id | 800677 |
| Labeler | Bryant Ranch Prepack |
| Label type | HUMAN PRESCRIPTION DRUG |
| Marketing category | ANDA |
| Marketing effective time low | 2007-12-21 |
| Marketing status | active |
| Related queries | Properties for NDC 9 72162-2375 |
NDC Item 76420074601
| NDC 9 | 76420-746 |
|---|---|
| NDC 10 | 76420-746-01 |
| NDC Item | 76420074601 |
| Packaging | 1 VIAL, GLASS in 1 CARTON (76420-746-01) / 1 mL in 1 VIAL, GLASS |
| ANDA | ANDA091244 |
| DCSA | CIII |
| FDA SPL set id | 791011 |
| Labeler | Asclemed USA, Inc. |
| Label type | HUMAN PRESCRIPTION DRUG |
| Marketing category | ANDA |
| Marketing effective time low | 2019-03-26 |
| Marketing status | ACTIVE |
| Related queries | Properties for NDC 9 76420-746 |
NDC Item 76420074701
| NDC 9 | 76420-747 |
|---|---|
| NDC 10 | 76420-747-01 |
| NDC Item | 76420074701 |
| Packaging | 1 VIAL, SINGLE-DOSE in 1 CARTON (76420-747-01) / 1 mL in 1 VIAL, SINGLE-DOSE |
| ANDA | ANDA207742 |
| DCSA | CIII |
| FDA SPL set id | 791057 |
| Labeler | Asclemed USA, Inc. |
| Label type | HUMAN PRESCRIPTION DRUG |
| Marketing category | ANDA |
| Marketing effective time low | 2022-11-02 |
| Marketing status | ACTIVE |
| Related queries | Properties for NDC 9 76420-747 |
NDC Item 00143965901
| NDC 9 | 0143-9659 |
|---|---|
| NDC 10 | 0143-9659-01 |
| NDC Item | 00143965901 |
| Packaging | 1 mL in 1 VIAL (0143-9659-01) |
| ANDA | ANDA091244 |
| DCSA | CIII |
| FDA SPL set id | 627057 |
| Labeler | Hikma Pharmaceuticals USA Inc. |
| Label type | HUMAN PRESCRIPTION DRUG |
| Marketing category | ANDA |
| Marketing effective time low | 2012-05-01 |
| Marketing status | ACTIVE |
| Related queries | Properties for NDC 9 0143-9659 |
NDC Item 00409656201
| NDC 9 | 0409-6562 |
|---|---|
| NDC 10 | 0409-6562-01 |
| NDC Item | 00409656201 |
| Packaging | 1 VIAL in 1 CARTON (0409-6562-01) / 1 mL in 1 VIAL |
| ANDA | ANDA085635 |
| DCSA | CIII |
| FDA SPL set id | 500095 |
| FDA SPL set id | 500287 |
| Labeler | Hospira, Inc. |
| Label type | HUMAN PRESCRIPTION DRUG |
| Marketing category | ANDA |
| Marketing effective time low | 2018-01-17 |
| Marketing status | ACTIVE |
| Related queries | Properties for NDC 9 0409-6562 |
NDC Item 00409656202
| NDC 9 | 0409-6562 |
|---|---|
| NDC 10 | 0409-6562-02 |
| NDC Item | 00409656202 |
| Packaging | 1 VIAL in 1 CARTON (0409-6562-02) / 1 mL in 1 VIAL |
| ANDA | ANDA085635 |
| DCSA | CIII |
| FDA SPL set id | 500095 |
| FDA SPL set id | 500287 |
| Labeler | Hospira, Inc. |
| Label type | HUMAN PRESCRIPTION DRUG |
| Marketing category | ANDA |
| Marketing effective time low | 2018-01-17 |
| Marketing status | ACTIVE |
| Related queries | Properties for NDC 9 0409-6562 |
NDC Item 00517183001
| NDC 9 | 0517-1830 |
|---|---|
| NDC 10 | 0517-1830-01 |
| NDC Item | 00517183001 |
| Packaging | 1 VIAL in 1 BOX (0517-1830-01) / 1 mL in 1 VIAL |
| ANDA | ANDA207742 |
| DCSA | CIII |
| FDA SPL set id | 674434 |
| Labeler | American Regent, Inc. |
| Label type | HUMAN PRESCRIPTION DRUG |
| Marketing category | ANDA |
| Marketing effective time low | 2019-07-19 |
| Marketing status | ACTIVE |
| Related queries | Properties for NDC 9 0517-1830 |
NDC Item 00574082001
| NDC 9 | 0574-0820 |
|---|---|
| NDC 10 | 0574-0820-01 |
| NDC Item | 00574082001 |
| Packaging | 1 VIAL, GLASS in 1 CARTON (0574-0820-01) / 1 mL in 1 VIAL, GLASS |
| ANDA | ANDA040530 |
| DCSA | CIII |
| FDA SPL set id | 768154 |
| FDA SPL set id | 791051 |
| Labeler | Padagis US LLC |
| Label type | HUMAN PRESCRIPTION DRUG |
| Marketing category | ANDA |
| Marketing effective time low | 2007-12-21 |
| Marketing status | ACTIVE |
| Related queries | Properties for NDC 9 0574-0820 |
NDC Item 00574082701
| NDC 9 | 0574-0827 |
|---|---|
| NDC 10 | 0574-0827-01 |
| NDC Item | 00574082701 |
| Packaging | 1 VIAL, GLASS in 1 CARTON (0574-0827-01) / 1 mL in 1 VIAL, GLASS |
| ANDA | ANDA091244 |
| DCSA | CIII |
| FDA SPL set id | 584573 |
| Labeler | Padagis US LLC |
| Label type | HUMAN PRESCRIPTION DRUG |
| Marketing category | ANDA |
| Marketing effective time low | 2014-05-01 |
| Marketing status | ACTIVE |
| Related queries | Properties for NDC 9 0574-0827 |
NDC Item 47781091193
| NDC 9 | 47781-911 |
|---|---|
| NDC 10 | 47781-911-93 |
| NDC Item | 47781091193 |
| Packaging | 1 VIAL, SINGLE-DOSE in 1 CARTON (47781-911-93) / 1 mL in 1 VIAL, SINGLE-DOSE |
| ANDA | ANDA207742 |
| DCSA | CIII |
| FDA SPL set id | 719526 |
| Labeler | Alvogen Inc. |
| Label type | HUMAN PRESCRIPTION DRUG |
| Marketing category | ANDA |
| Marketing effective time low | 2022-11-02 |
| Marketing status | ACTIVE |
| Related queries | Properties for NDC 9 47781-911 |
NDC Item 52536062501
| NDC 9 | 52536-625 |
|---|---|
| NDC 10 | 52536-625-01 |
| NDC Item | 52536062501 |
| Packaging | 1 VIAL, SINGLE-DOSE in 1 CARTON (52536-625-01) / 1 mL in 1 VIAL, SINGLE-DOSE |
| ANDA | ANDA206368 |
| COLORTEXT | WHITE(or creamy white) |
| Color | C48325 __ |
| DCSA | CIII |
| FDA SPL set id | 395393 |
| Labeler | Wilshire Pharmaceuticals |
| Label type | HUMAN PRESCRIPTION DRUG |
| Marketing category | ANDA |
| Marketing effective time low | 2019-05-31 |
| Marketing status | ACTIVE |
| Related queries | Properties for NDC 9 52536-625 |
NDC Item 55150027701
| NDC 9 | 55150-277 |
|---|---|
| NDC 10 | 55150-277-01 |
| NDC Item | 55150027701 |
| Packaging | 1 VIAL, GLASS in 1 CARTON (55150-277-01) / 1 mL in 1 VIAL, GLASS |
| ANDA | ANDA211817 |
| DCSA | CIII |
| FDA SPL set id | 739422 |
| Labeler | Eugia US LLC |
| Label type | HUMAN PRESCRIPTION DRUG |
| Marketing category | ANDA |
| Marketing effective time low | 2023-10-20 |
| Marketing status | ACTIVE |
| Related queries | Properties for NDC 9 55150-277 |
NDC Item 62756001540
| NDC 9 | 62756-015 |
|---|---|
| NDC 10 | 62756-015-40 |
| NDC Item | 62756001540 |
| Packaging | 1 VIAL in 1 CARTON (62756-015-40) / 1 mL in 1 VIAL |
| ANDA | ANDA201720 |
| DCSA | CIII |
| FDA SPL set id | 581578 |
| Labeler | Sun Pharmaceutical Industries, Inc. |
| Label type | HUMAN PRESCRIPTION DRUG |
| Marketing category | ANDA |
| Marketing effective time low | 2013-06-17 |
| Marketing status | ACTIVE |
| Related queries | Properties for NDC 9 62756-015 |
NDC Item 64980046799
| NDC 9 | 64980-467 |
|---|---|
| NDC 10 | 64980-467-99 |
| NDC Item | 64980046799 |
| Packaging | 1 VIAL, MULTI-DOSE in 1 CARTON (64980-467-99) / 1 mL in 1 VIAL, MULTI-DOSE |
| ANDA | ANDA207742 |
| DCSA | CIII |
| FDA SPL set id | 385892 |
| Labeler | Rising Pharma Holdings, Inc. |
| Label type | HUMAN PRESCRIPTION DRUG |
| Marketing category | ANDA |
| Marketing effective time high | 2020-06-30 |
| Marketing effective time low | 2018-12-01 |
| Marketing status | COMPLETED |
| Related queries | Properties for NDC 9 64980-467 |
NDC Item 69097053731
| NDC 9 | 69097-537 |
|---|---|
| NDC 10 | 69097-537-31 |
| NDC Item | 69097053731 |
| Packaging | 1 mL in 1 VIAL, GLASS (69097-537-31) |
| ANDA | ANDA210362 |
| COLORTEXT | WHITE("A clear colourless to pale yellow solution) |
| Color | C48325 __ |
| DCSA | CIII |
| FDA SPL set id | 729362 |
| Labeler | Cipla USA Inc. |
| Label type | HUMAN PRESCRIPTION DRUG |
| Marketing category | ANDA |
| Marketing effective time low | 2023-09-15 |
| Marketing status | ACTIVE |
| Related queries | Properties for NDC 9 69097-537 |
NDC Item 69097080232
| NDC 9 | 69097-802 |
|---|---|
| NDC 10 | 69097-802-32 |
| NDC Item | 69097080232 |
| Packaging | 1 VIAL, GLASS in 1 CARTON (69097-802-32) / 1 mL in 1 VIAL, GLASS |
| ANDA | ANDA091244 |
| DCSA | CIII |
| FDA SPL set id | 764872 |
| Labeler | Cipla USA Inc. |
| Label type | HUMAN PRESCRIPTION DRUG |
| Marketing category | ANDA |
| Marketing effective time low | 2019-03-26 |
| Marketing status | ACTIVE |
| Related queries | Properties for NDC 9 69097-802 |
NDC Item 70700028922
| NDC 9 | 70700-289 |
|---|---|
| NDC 10 | 70700-289-22 |
| NDC Item | 70700028922 |
| Packaging | 1 VIAL in 1 CARTON (70700-289-22) / 1 mL in 1 VIAL |
| ANDA | ANDA215351 |
| DCSA | CIII |
| FDA SPL set id | 708164 |
| Labeler | Xiromed LLC |
| Label type | HUMAN PRESCRIPTION DRUG |
| Marketing category | ANDA |
| Marketing effective time low | 2023-04-28 |
| Marketing status | ACTIVE |
| Related queries | Properties for NDC 9 70700-289 |
NDC Item 71205028901
| NDC 9 | 71205-289 |
|---|---|
| NDC 10 | 71205-289-01 |
| NDC Item | 71205028901 |
| Packaging | 1 mL in 1 VIAL (71205-289-01) |
| ANDA | ANDA091244 |
| DCSA | CIII |
| FDA SPL set id | 413320 |
| Labeler | Proficient Rx LP |
| Label type | HUMAN PRESCRIPTION DRUG |
| Marketing category | ANDA |
| Marketing effective time low | 2012-05-01 |
| Marketing status | ACTIVE |
| Related queries | Properties for NDC 9 71205-289 |
NDC Item 71225012701
| NDC 9 | 71225-127 |
|---|---|
| NDC 10 | 71225-127-01 |
| NDC Item | 71225012701 |
| Packaging | 1 VIAL in 1 CARTON (71225-127-01) / 1 mL in 1 VIAL |
| DCSA | CIII |
| FDA SPL set id | 642064 |
| Labeler | Slayback Pharma LLC |
| Label type | HUMAN PRESCRIPTION DRUG |
| Marketing category | NDA |
| Marketing effective time low | 2022-06-13 |
| Marketing status | ACTIVE |
| NDA | NDA216318 |
| Related queries | Properties for NDC 9 71225-127 |
NDC Item 72162234802
| NDC 9 | 72162-2348 |
|---|---|
| NDC 10 | 72162-2348-2 |
| NDC Item | 72162234802 |
| Packaging | 1 VIAL, SINGLE-DOSE in 1 CARTON (72162-2348-2) / 1 mL in 1 VIAL, SINGLE-DOSE |
| ANDA | ANDA206368 |
| COLORTEXT | WHITE(or creamy white) |
| Color | C48325 __ |
| DCSA | CIII |
| FDA SPL set id | 794476 |
| Labeler | Bryant Ranch Prepack |
| Label type | HUMAN PRESCRIPTION DRUG |
| Marketing category | ANDA |
| Marketing effective time low | 2019-05-31 |
| Marketing status | active |
| Related queries | Properties for NDC 9 72162-2348 |
NDC Item 72162234804
| NDC 9 | 72162-2348 |
|---|---|
| NDC 10 | 72162-2348-4 |
| NDC Item | 72162234804 |
| Packaging | 1 VIAL, MULTI-DOSE in 1 CARTON (72162-2348-4) / 10 mL in 1 VIAL, MULTI-DOSE |
| ANDA | ANDA206368 |
| COLORTEXT | WHITE(or creamy white) |
| Color | C48325 __ |
| DCSA | CIII |
| FDA SPL set id | 794476 |
| Labeler | Bryant Ranch Prepack |
| Label type | HUMAN PRESCRIPTION DRUG |
| Marketing category | ANDA |
| Marketing effective time low | 2019-05-31 |
| Marketing status | active |
| Related queries | Properties for NDC 9 72162-2348 |
NDC Item 72162237502
| NDC 9 | 72162-2375 |
|---|---|
| NDC 10 | 72162-2375-2 |
| NDC Item | 72162237502 |
| Packaging | 1 VIAL, GLASS in 1 CARTON (72162-2375-2) / 1 mL in 1 VIAL, GLASS |
| ANDA | ANDA040530 |
| DCSA | CIII |
| FDA SPL set id | 800677 |
| Labeler | Bryant Ranch Prepack |
| Label type | HUMAN PRESCRIPTION DRUG |
| Marketing category | ANDA |
| Marketing effective time low | 2007-12-21 |
| Marketing status | active |
| Related queries | Properties for NDC 9 72162-2375 |
NDC Item 76420074601
| NDC 9 | 76420-746 |
|---|---|
| NDC 10 | 76420-746-01 |
| NDC Item | 76420074601 |
| Packaging | 1 VIAL, GLASS in 1 CARTON (76420-746-01) / 1 mL in 1 VIAL, GLASS |
| ANDA | ANDA091244 |
| DCSA | CIII |
| FDA SPL set id | 791011 |
| Labeler | Asclemed USA, Inc. |
| Label type | HUMAN PRESCRIPTION DRUG |
| Marketing category | ANDA |
| Marketing effective time low | 2019-03-26 |
| Marketing status | ACTIVE |
| Related queries | Properties for NDC 9 76420-746 |
NDC Item 76420074701
| NDC 9 | 76420-747 |
|---|---|
| NDC 10 | 76420-747-01 |
| NDC Item | 76420074701 |
| Packaging | 1 VIAL, SINGLE-DOSE in 1 CARTON (76420-747-01) / 1 mL in 1 VIAL, SINGLE-DOSE |
| ANDA | ANDA207742 |
| DCSA | CIII |
| FDA SPL set id | 791057 |
| Labeler | Asclemed USA, Inc. |
| Label type | HUMAN PRESCRIPTION DRUG |
| Marketing category | ANDA |
| Marketing effective time low | 2022-11-02 |
| Marketing status | ACTIVE |
| Related queries | Properties for NDC 9 76420-747 |
NDC Item 00143965901
| NDC 9 | 0143-9659 |
|---|---|
| NDC 10 | 0143-9659-01 |
| NDC Item | 00143965901 |
| Packaging | 1 mL in 1 VIAL (0143-9659-01) |
| ANDA | ANDA091244 |
| DCSA | CIII |
| FDA SPL set id | 627057 |
| Labeler | Hikma Pharmaceuticals USA Inc. |
| Label type | HUMAN PRESCRIPTION DRUG |
| Marketing category | ANDA |
| Marketing effective time low | 2012-05-01 |
| Marketing status | ACTIVE |
| Related queries | Properties for NDC 9 0143-9659 |
NDC Item 00409656201
| NDC 9 | 0409-6562 |
|---|---|
| NDC 10 | 0409-6562-01 |
| NDC Item | 00409656201 |
| Packaging | 1 VIAL in 1 CARTON (0409-6562-01) / 1 mL in 1 VIAL |
| ANDA | ANDA085635 |
| DCSA | CIII |
| FDA SPL set id | 500095 |
| FDA SPL set id | 500287 |
| Labeler | Hospira, Inc. |
| Label type | HUMAN PRESCRIPTION DRUG |
| Marketing category | ANDA |
| Marketing effective time low | 2018-01-17 |
| Marketing status | ACTIVE |
| Related queries | Properties for NDC 9 0409-6562 |
NDC Item 00409656202
| NDC 9 | 0409-6562 |
|---|---|
| NDC 10 | 0409-6562-02 |
| NDC Item | 00409656202 |
| Packaging | 1 VIAL in 1 CARTON (0409-6562-02) / 1 mL in 1 VIAL |
| ANDA | ANDA085635 |
| DCSA | CIII |
| FDA SPL set id | 500095 |
| FDA SPL set id | 500287 |
| Labeler | Hospira, Inc. |
| Label type | HUMAN PRESCRIPTION DRUG |
| Marketing category | ANDA |
| Marketing effective time low | 2018-01-17 |
| Marketing status | ACTIVE |
| Related queries | Properties for NDC 9 0409-6562 |
NDC Item 00517183001
| NDC 9 | 0517-1830 |
|---|---|
| NDC 10 | 0517-1830-01 |
| NDC Item | 00517183001 |
| Packaging | 1 VIAL in 1 BOX (0517-1830-01) / 1 mL in 1 VIAL |
| ANDA | ANDA207742 |
| DCSA | CIII |
| FDA SPL set id | 674434 |
| Labeler | American Regent, Inc. |
| Label type | HUMAN PRESCRIPTION DRUG |
| Marketing category | ANDA |
| Marketing effective time low | 2019-07-19 |
| Marketing status | ACTIVE |
| Related queries | Properties for NDC 9 0517-1830 |
NDC Item 00574082001
| NDC 9 | 0574-0820 |
|---|---|
| NDC 10 | 0574-0820-01 |
| NDC Item | 00574082001 |
| Packaging | 1 VIAL, GLASS in 1 CARTON (0574-0820-01) / 1 mL in 1 VIAL, GLASS |
| ANDA | ANDA040530 |
| DCSA | CIII |
| FDA SPL set id | 768154 |
| FDA SPL set id | 791051 |
| Labeler | Padagis US LLC |
| Label type | HUMAN PRESCRIPTION DRUG |
| Marketing category | ANDA |
| Marketing effective time low | 2007-12-21 |
| Marketing status | ACTIVE |
| Related queries | Properties for NDC 9 0574-0820 |
NDC Item 00574082701
| NDC 9 | 0574-0827 |
|---|---|
| NDC 10 | 0574-0827-01 |
| NDC Item | 00574082701 |
| Packaging | 1 VIAL, GLASS in 1 CARTON (0574-0827-01) / 1 mL in 1 VIAL, GLASS |
| ANDA | ANDA091244 |
| DCSA | CIII |
| FDA SPL set id | 584573 |
| Labeler | Padagis US LLC |
| Label type | HUMAN PRESCRIPTION DRUG |
| Marketing category | ANDA |
| Marketing effective time low | 2014-05-01 |
| Marketing status | ACTIVE |
| Related queries | Properties for NDC 9 0574-0827 |
NDC Item 47781091193
| NDC 9 | 47781-911 |
|---|---|
| NDC 10 | 47781-911-93 |
| NDC Item | 47781091193 |
| Packaging | 1 VIAL, SINGLE-DOSE in 1 CARTON (47781-911-93) / 1 mL in 1 VIAL, SINGLE-DOSE |
| ANDA | ANDA207742 |
| DCSA | CIII |
| FDA SPL set id | 719526 |
| Labeler | Alvogen Inc. |
| Label type | HUMAN PRESCRIPTION DRUG |
| Marketing category | ANDA |
| Marketing effective time low | 2022-11-02 |
| Marketing status | ACTIVE |
| Related queries | Properties for NDC 9 47781-911 |
NDC Item 52536062501
| NDC 9 | 52536-625 |
|---|---|
| NDC 10 | 52536-625-01 |
| NDC Item | 52536062501 |
| Packaging | 1 VIAL, SINGLE-DOSE in 1 CARTON (52536-625-01) / 1 mL in 1 VIAL, SINGLE-DOSE |
| ANDA | ANDA206368 |
| COLORTEXT | WHITE(or creamy white) |
| Color | C48325 __ |
| DCSA | CIII |
| FDA SPL set id | 395393 |
| Labeler | Wilshire Pharmaceuticals |
| Label type | HUMAN PRESCRIPTION DRUG |
| Marketing category | ANDA |
| Marketing effective time low | 2019-05-31 |
| Marketing status | ACTIVE |
| Related queries | Properties for NDC 9 52536-625 |
NDC Item 55150027701
| NDC 9 | 55150-277 |
|---|---|
| NDC 10 | 55150-277-01 |
| NDC Item | 55150027701 |
| Packaging | 1 VIAL, GLASS in 1 CARTON (55150-277-01) / 1 mL in 1 VIAL, GLASS |
| ANDA | ANDA211817 |
| DCSA | CIII |
| FDA SPL set id | 739422 |
| Labeler | Eugia US LLC |
| Label type | HUMAN PRESCRIPTION DRUG |
| Marketing category | ANDA |
| Marketing effective time low | 2023-10-20 |
| Marketing status | ACTIVE |
| Related queries | Properties for NDC 9 55150-277 |
NDC Item 62756001540
| NDC 9 | 62756-015 |
|---|---|
| NDC 10 | 62756-015-40 |
| NDC Item | 62756001540 |
| Packaging | 1 VIAL in 1 CARTON (62756-015-40) / 1 mL in 1 VIAL |
| ANDA | ANDA201720 |
| DCSA | CIII |
| FDA SPL set id | 581578 |
| Labeler | Sun Pharmaceutical Industries, Inc. |
| Label type | HUMAN PRESCRIPTION DRUG |
| Marketing category | ANDA |
| Marketing effective time low | 2013-06-17 |
| Marketing status | ACTIVE |
| Related queries | Properties for NDC 9 62756-015 |
NDC Item 64980046799
| NDC 9 | 64980-467 |
|---|---|
| NDC 10 | 64980-467-99 |
| NDC Item | 64980046799 |
| Packaging | 1 VIAL, MULTI-DOSE in 1 CARTON (64980-467-99) / 1 mL in 1 VIAL, MULTI-DOSE |
| ANDA | ANDA207742 |
| DCSA | CIII |
| FDA SPL set id | 385892 |
| Labeler | Rising Pharma Holdings, Inc. |
| Label type | HUMAN PRESCRIPTION DRUG |
| Marketing category | ANDA |
| Marketing effective time high | 2020-06-30 |
| Marketing effective time low | 2018-12-01 |
| Marketing status | COMPLETED |
| Related queries | Properties for NDC 9 64980-467 |
NDC Item 69097053731
| NDC 9 | 69097-537 |
|---|---|
| NDC 10 | 69097-537-31 |
| NDC Item | 69097053731 |
| Packaging | 1 mL in 1 VIAL, GLASS (69097-537-31) |
| ANDA | ANDA210362 |
| COLORTEXT | WHITE("A clear colourless to pale yellow solution) |
| Color | C48325 __ |
| DCSA | CIII |
| FDA SPL set id | 729362 |
| Labeler | Cipla USA Inc. |
| Label type | HUMAN PRESCRIPTION DRUG |
| Marketing category | ANDA |
| Marketing effective time low | 2023-09-15 |
| Marketing status | ACTIVE |
| Related queries | Properties for NDC 9 69097-537 |
NDC Item 69097080232
| NDC 9 | 69097-802 |
|---|---|
| NDC 10 | 69097-802-32 |
| NDC Item | 69097080232 |
| Packaging | 1 VIAL, GLASS in 1 CARTON (69097-802-32) / 1 mL in 1 VIAL, GLASS |
| ANDA | ANDA091244 |
| DCSA | CIII |
| FDA SPL set id | 764872 |
| Labeler | Cipla USA Inc. |
| Label type | HUMAN PRESCRIPTION DRUG |
| Marketing category | ANDA |
| Marketing effective time low | 2019-03-26 |
| Marketing status | ACTIVE |
| Related queries | Properties for NDC 9 69097-802 |
NDC Item 70700028922
| NDC 9 | 70700-289 |
|---|---|
| NDC 10 | 70700-289-22 |
| NDC Item | 70700028922 |
| Packaging | 1 VIAL in 1 CARTON (70700-289-22) / 1 mL in 1 VIAL |
| ANDA | ANDA215351 |
| DCSA | CIII |
| FDA SPL set id | 708164 |
| Labeler | Xiromed LLC |
| Label type | HUMAN PRESCRIPTION DRUG |
| Marketing category | ANDA |
| Marketing effective time low | 2023-04-28 |
| Marketing status | ACTIVE |
| Related queries | Properties for NDC 9 70700-289 |
NDC Item 71205028901
| NDC 9 | 71205-289 |
|---|---|
| NDC 10 | 71205-289-01 |
| NDC Item | 71205028901 |
| Packaging | 1 mL in 1 VIAL (71205-289-01) |
| ANDA | ANDA091244 |
| DCSA | CIII |
| FDA SPL set id | 413320 |
| Labeler | Proficient Rx LP |
| Label type | HUMAN PRESCRIPTION DRUG |
| Marketing category | ANDA |
| Marketing effective time low | 2012-05-01 |
| Marketing status | ACTIVE |
| Related queries | Properties for NDC 9 71205-289 |
NDC Item 71225012701
| NDC 9 | 71225-127 |
|---|---|
| NDC 10 | 71225-127-01 |
| NDC Item | 71225012701 |
| Packaging | 1 VIAL in 1 CARTON (71225-127-01) / 1 mL in 1 VIAL |
| DCSA | CIII |
| FDA SPL set id | 642064 |
| Labeler | Slayback Pharma LLC |
| Label type | HUMAN PRESCRIPTION DRUG |
| Marketing category | NDA |
| Marketing effective time low | 2022-06-13 |
| Marketing status | ACTIVE |
| NDA | NDA216318 |
| Related queries | Properties for NDC 9 71225-127 |
NDC Item 72162234802
| NDC 9 | 72162-2348 |
|---|---|
| NDC 10 | 72162-2348-2 |
| NDC Item | 72162234802 |
| Packaging | 1 VIAL, SINGLE-DOSE in 1 CARTON (72162-2348-2) / 1 mL in 1 VIAL, SINGLE-DOSE |
| ANDA | ANDA206368 |
| COLORTEXT | WHITE(or creamy white) |
| Color | C48325 __ |
| DCSA | CIII |
| FDA SPL set id | 794476 |
| Labeler | Bryant Ranch Prepack |
| Label type | HUMAN PRESCRIPTION DRUG |
| Marketing category | ANDA |
| Marketing effective time low | 2019-05-31 |
| Marketing status | active |
| Related queries | Properties for NDC 9 72162-2348 |
NDC Item 72162234804
| NDC 9 | 72162-2348 |
|---|---|
| NDC 10 | 72162-2348-4 |
| NDC Item | 72162234804 |
| Packaging | 1 VIAL, MULTI-DOSE in 1 CARTON (72162-2348-4) / 10 mL in 1 VIAL, MULTI-DOSE |
| ANDA | ANDA206368 |
| COLORTEXT | WHITE(or creamy white) |
| Color | C48325 __ |
| DCSA | CIII |
| FDA SPL set id | 794476 |
| Labeler | Bryant Ranch Prepack |
| Label type | HUMAN PRESCRIPTION DRUG |
| Marketing category | ANDA |
| Marketing effective time low | 2019-05-31 |
| Marketing status | active |
| Related queries | Properties for NDC 9 72162-2348 |
NDC Item 72162237502
| NDC 9 | 72162-2375 |
|---|---|
| NDC 10 | 72162-2375-2 |
| NDC Item | 72162237502 |
| Packaging | 1 VIAL, GLASS in 1 CARTON (72162-2375-2) / 1 mL in 1 VIAL, GLASS |
| ANDA | ANDA040530 |
| DCSA | CIII |
| FDA SPL set id | 800677 |
| Labeler | Bryant Ranch Prepack |
| Label type | HUMAN PRESCRIPTION DRUG |
| Marketing category | ANDA |
| Marketing effective time low | 2007-12-21 |
| Marketing status | active |
| Related queries | Properties for NDC 9 72162-2375 |
NDC Item 76420074601
| NDC 9 | 76420-746 |
|---|---|
| NDC 10 | 76420-746-01 |
| NDC Item | 76420074601 |
| Packaging | 1 VIAL, GLASS in 1 CARTON (76420-746-01) / 1 mL in 1 VIAL, GLASS |
| ANDA | ANDA091244 |
| DCSA | CIII |
| FDA SPL set id | 791011 |
| Labeler | Asclemed USA, Inc. |
| Label type | HUMAN PRESCRIPTION DRUG |
| Marketing category | ANDA |
| Marketing effective time low | 2019-03-26 |
| Marketing status | ACTIVE |
| Related queries | Properties for NDC 9 76420-746 |
NDC Item 76420074701
| NDC 9 | 76420-747 |
|---|---|
| NDC 10 | 76420-747-01 |
| NDC Item | 76420074701 |
| Packaging | 1 VIAL, SINGLE-DOSE in 1 CARTON (76420-747-01) / 1 mL in 1 VIAL, SINGLE-DOSE |
| ANDA | ANDA207742 |
| DCSA | CIII |
| FDA SPL set id | 791057 |
| Labeler | Asclemed USA, Inc. |
| Label type | HUMAN PRESCRIPTION DRUG |
| Marketing category | ANDA |
| Marketing effective time low | 2022-11-02 |
| Marketing status | ACTIVE |
| Related queries | Properties for NDC 9 76420-747 |
NDC Item 00143965901
| NDC 9 | 0143-9659 |
|---|---|
| NDC 10 | 0143-9659-01 |
| NDC Item | 00143965901 |
| Packaging | 1 mL in 1 VIAL (0143-9659-01) |
| ANDA | ANDA091244 |
| DCSA | CIII |
| FDA SPL set id | 627057 |
| Labeler | Hikma Pharmaceuticals USA Inc. |
| Label type | HUMAN PRESCRIPTION DRUG |
| Marketing category | ANDA |
| Marketing effective time low | 2012-05-01 |
| Marketing status | ACTIVE |
| Related queries | Properties for NDC 9 0143-9659 |
NDC Item 00409656201
| NDC 9 | 0409-6562 |
|---|---|
| NDC 10 | 0409-6562-01 |
| NDC Item | 00409656201 |
| Packaging | 1 VIAL in 1 CARTON (0409-6562-01) / 1 mL in 1 VIAL |
| ANDA | ANDA085635 |
| DCSA | CIII |
| FDA SPL set id | 500095 |
| FDA SPL set id | 500287 |
| Labeler | Hospira, Inc. |
| Label type | HUMAN PRESCRIPTION DRUG |
| Marketing category | ANDA |
| Marketing effective time low | 2018-01-17 |
| Marketing status | ACTIVE |
| Related queries | Properties for NDC 9 0409-6562 |
NDC Item 00409656202
| NDC 9 | 0409-6562 |
|---|---|
| NDC 10 | 0409-6562-02 |
| NDC Item | 00409656202 |
| Packaging | 1 VIAL in 1 CARTON (0409-6562-02) / 1 mL in 1 VIAL |
| ANDA | ANDA085635 |
| DCSA | CIII |
| FDA SPL set id | 500095 |
| FDA SPL set id | 500287 |
| Labeler | Hospira, Inc. |
| Label type | HUMAN PRESCRIPTION DRUG |
| Marketing category | ANDA |
| Marketing effective time low | 2018-01-17 |
| Marketing status | ACTIVE |
| Related queries | Properties for NDC 9 0409-6562 |
NDC Item 00517183001
| NDC 9 | 0517-1830 |
|---|---|
| NDC 10 | 0517-1830-01 |
| NDC Item | 00517183001 |
| Packaging | 1 VIAL in 1 BOX (0517-1830-01) / 1 mL in 1 VIAL |
| ANDA | ANDA207742 |
| DCSA | CIII |
| FDA SPL set id | 674434 |
| Labeler | American Regent, Inc. |
| Label type | HUMAN PRESCRIPTION DRUG |
| Marketing category | ANDA |
| Marketing effective time low | 2019-07-19 |
| Marketing status | ACTIVE |
| Related queries | Properties for NDC 9 0517-1830 |
NDC Item 00574082001
| NDC 9 | 0574-0820 |
|---|---|
| NDC 10 | 0574-0820-01 |
| NDC Item | 00574082001 |
| Packaging | 1 VIAL, GLASS in 1 CARTON (0574-0820-01) / 1 mL in 1 VIAL, GLASS |
| ANDA | ANDA040530 |
| DCSA | CIII |
| FDA SPL set id | 768154 |
| FDA SPL set id | 791051 |
| Labeler | Padagis US LLC |
| Label type | HUMAN PRESCRIPTION DRUG |
| Marketing category | ANDA |
| Marketing effective time low | 2007-12-21 |
| Marketing status | ACTIVE |
| Related queries | Properties for NDC 9 0574-0820 |
NDC Item 00574082701
| NDC 9 | 0574-0827 |
|---|---|
| NDC 10 | 0574-0827-01 |
| NDC Item | 00574082701 |
| Packaging | 1 VIAL, GLASS in 1 CARTON (0574-0827-01) / 1 mL in 1 VIAL, GLASS |
| ANDA | ANDA091244 |
| DCSA | CIII |
| FDA SPL set id | 584573 |
| Labeler | Padagis US LLC |
| Label type | HUMAN PRESCRIPTION DRUG |
| Marketing category | ANDA |
| Marketing effective time low | 2014-05-01 |
| Marketing status | ACTIVE |
| Related queries | Properties for NDC 9 0574-0827 |
NDC Item 47781091193
| NDC 9 | 47781-911 |
|---|---|
| NDC 10 | 47781-911-93 |
| NDC Item | 47781091193 |
| Packaging | 1 VIAL, SINGLE-DOSE in 1 CARTON (47781-911-93) / 1 mL in 1 VIAL, SINGLE-DOSE |
| ANDA | ANDA207742 |
| DCSA | CIII |
| FDA SPL set id | 719526 |
| Labeler | Alvogen Inc. |
| Label type | HUMAN PRESCRIPTION DRUG |
| Marketing category | ANDA |
| Marketing effective time low | 2022-11-02 |
| Marketing status | ACTIVE |
| Related queries | Properties for NDC 9 47781-911 |
NDC Item 52536062501
| NDC 9 | 52536-625 |
|---|---|
| NDC 10 | 52536-625-01 |
| NDC Item | 52536062501 |
| Packaging | 1 VIAL, SINGLE-DOSE in 1 CARTON (52536-625-01) / 1 mL in 1 VIAL, SINGLE-DOSE |
| ANDA | ANDA206368 |
| COLORTEXT | WHITE(or creamy white) |
| Color | C48325 __ |
| DCSA | CIII |
| FDA SPL set id | 395393 |
| Labeler | Wilshire Pharmaceuticals |
| Label type | HUMAN PRESCRIPTION DRUG |
| Marketing category | ANDA |
| Marketing effective time low | 2019-05-31 |
| Marketing status | ACTIVE |
| Related queries | Properties for NDC 9 52536-625 |
NDC Item 55150027701
| NDC 9 | 55150-277 |
|---|---|
| NDC 10 | 55150-277-01 |
| NDC Item | 55150027701 |
| Packaging | 1 VIAL, GLASS in 1 CARTON (55150-277-01) / 1 mL in 1 VIAL, GLASS |
| ANDA | ANDA211817 |
| DCSA | CIII |
| FDA SPL set id | 739422 |
| Labeler | Eugia US LLC |
| Label type | HUMAN PRESCRIPTION DRUG |
| Marketing category | ANDA |
| Marketing effective time low | 2023-10-20 |
| Marketing status | ACTIVE |
| Related queries | Properties for NDC 9 55150-277 |
NDC Item 62756001540
| NDC 9 | 62756-015 |
|---|---|
| NDC 10 | 62756-015-40 |
| NDC Item | 62756001540 |
| Packaging | 1 VIAL in 1 CARTON (62756-015-40) / 1 mL in 1 VIAL |
| ANDA | ANDA201720 |
| DCSA | CIII |
| FDA SPL set id | 581578 |
| Labeler | Sun Pharmaceutical Industries, Inc. |
| Label type | HUMAN PRESCRIPTION DRUG |
| Marketing category | ANDA |
| Marketing effective time low | 2013-06-17 |
| Marketing status | ACTIVE |
| Related queries | Properties for NDC 9 62756-015 |
NDC Item 64980046799
| NDC 9 | 64980-467 |
|---|---|
| NDC 10 | 64980-467-99 |
| NDC Item | 64980046799 |
| Packaging | 1 VIAL, MULTI-DOSE in 1 CARTON (64980-467-99) / 1 mL in 1 VIAL, MULTI-DOSE |
| ANDA | ANDA207742 |
| DCSA | CIII |
| FDA SPL set id | 385892 |
| Labeler | Rising Pharma Holdings, Inc. |
| Label type | HUMAN PRESCRIPTION DRUG |
| Marketing category | ANDA |
| Marketing effective time high | 2020-06-30 |
| Marketing effective time low | 2018-12-01 |
| Marketing status | COMPLETED |
| Related queries | Properties for NDC 9 64980-467 |
NDC Item 69097053731
| NDC 9 | 69097-537 |
|---|---|
| NDC 10 | 69097-537-31 |
| NDC Item | 69097053731 |
| Packaging | 1 mL in 1 VIAL, GLASS (69097-537-31) |
| ANDA | ANDA210362 |
| COLORTEXT | WHITE("A clear colourless to pale yellow solution) |
| Color | C48325 __ |
| DCSA | CIII |
| FDA SPL set id | 729362 |
| Labeler | Cipla USA Inc. |
| Label type | HUMAN PRESCRIPTION DRUG |
| Marketing category | ANDA |
| Marketing effective time low | 2023-09-15 |
| Marketing status | ACTIVE |
| Related queries | Properties for NDC 9 69097-537 |
NDC Item 69097080232
| NDC 9 | 69097-802 |
|---|---|
| NDC 10 | 69097-802-32 |
| NDC Item | 69097080232 |
| Packaging | 1 VIAL, GLASS in 1 CARTON (69097-802-32) / 1 mL in 1 VIAL, GLASS |
| ANDA | ANDA091244 |
| DCSA | CIII |
| FDA SPL set id | 764872 |
| Labeler | Cipla USA Inc. |
| Label type | HUMAN PRESCRIPTION DRUG |
| Marketing category | ANDA |
| Marketing effective time low | 2019-03-26 |
| Marketing status | ACTIVE |
| Related queries | Properties for NDC 9 69097-802 |
NDC Item 70700028922
| NDC 9 | 70700-289 |
|---|---|
| NDC 10 | 70700-289-22 |
| NDC Item | 70700028922 |
| Packaging | 1 VIAL in 1 CARTON (70700-289-22) / 1 mL in 1 VIAL |
| ANDA | ANDA215351 |
| DCSA | CIII |
| FDA SPL set id | 708164 |
| Labeler | Xiromed LLC |
| Label type | HUMAN PRESCRIPTION DRUG |
| Marketing category | ANDA |
| Marketing effective time low | 2023-04-28 |
| Marketing status | ACTIVE |
| Related queries | Properties for NDC 9 70700-289 |
NDC Item 71205028901
| NDC 9 | 71205-289 |
|---|---|
| NDC 10 | 71205-289-01 |
| NDC Item | 71205028901 |
| Packaging | 1 mL in 1 VIAL (71205-289-01) |
| ANDA | ANDA091244 |
| DCSA | CIII |
| FDA SPL set id | 413320 |
| Labeler | Proficient Rx LP |
| Label type | HUMAN PRESCRIPTION DRUG |
| Marketing category | ANDA |
| Marketing effective time low | 2012-05-01 |
| Marketing status | ACTIVE |
| Related queries | Properties for NDC 9 71205-289 |
NDC Item 71225012701
| NDC 9 | 71225-127 |
|---|---|
| NDC 10 | 71225-127-01 |
| NDC Item | 71225012701 |
| Packaging | 1 VIAL in 1 CARTON (71225-127-01) / 1 mL in 1 VIAL |
| DCSA | CIII |
| FDA SPL set id | 642064 |
| Labeler | Slayback Pharma LLC |
| Label type | HUMAN PRESCRIPTION DRUG |
| Marketing category | NDA |
| Marketing effective time low | 2022-06-13 |
| Marketing status | ACTIVE |
| NDA | NDA216318 |
| Related queries | Properties for NDC 9 71225-127 |
NDC Item 72162234802
| NDC 9 | 72162-2348 |
|---|---|
| NDC 10 | 72162-2348-2 |
| NDC Item | 72162234802 |
| Packaging | 1 VIAL, SINGLE-DOSE in 1 CARTON (72162-2348-2) / 1 mL in 1 VIAL, SINGLE-DOSE |
| ANDA | ANDA206368 |
| COLORTEXT | WHITE(or creamy white) |
| Color | C48325 __ |
| DCSA | CIII |
| FDA SPL set id | 794476 |
| Labeler | Bryant Ranch Prepack |
| Label type | HUMAN PRESCRIPTION DRUG |
| Marketing category | ANDA |
| Marketing effective time low | 2019-05-31 |
| Marketing status | active |
| Related queries | Properties for NDC 9 72162-2348 |
NDC Item 72162234804
| NDC 9 | 72162-2348 |
|---|---|
| NDC 10 | 72162-2348-4 |
| NDC Item | 72162234804 |
| Packaging | 1 VIAL, MULTI-DOSE in 1 CARTON (72162-2348-4) / 10 mL in 1 VIAL, MULTI-DOSE |
| ANDA | ANDA206368 |
| COLORTEXT | WHITE(or creamy white) |
| Color | C48325 __ |
| DCSA | CIII |
| FDA SPL set id | 794476 |
| Labeler | Bryant Ranch Prepack |
| Label type | HUMAN PRESCRIPTION DRUG |
| Marketing category | ANDA |
| Marketing effective time low | 2019-05-31 |
| Marketing status | active |
| Related queries | Properties for NDC 9 72162-2348 |
NDC Item 72162237502
| NDC 9 | 72162-2375 |
|---|---|
| NDC 10 | 72162-2375-2 |
| NDC Item | 72162237502 |
| Packaging | 1 VIAL, GLASS in 1 CARTON (72162-2375-2) / 1 mL in 1 VIAL, GLASS |
| ANDA | ANDA040530 |
| DCSA | CIII |
| FDA SPL set id | 800677 |
| Labeler | Bryant Ranch Prepack |
| Label type | HUMAN PRESCRIPTION DRUG |
| Marketing category | ANDA |
| Marketing effective time low | 2007-12-21 |
| Marketing status | active |
| Related queries | Properties for NDC 9 72162-2375 |
NDC Item 76420074601
| NDC 9 | 76420-746 |
|---|---|
| NDC 10 | 76420-746-01 |
| NDC Item | 76420074601 |
| Packaging | 1 VIAL, GLASS in 1 CARTON (76420-746-01) / 1 mL in 1 VIAL, GLASS |
| ANDA | ANDA091244 |
| DCSA | CIII |
| FDA SPL set id | 791011 |
| Labeler | Asclemed USA, Inc. |
| Label type | HUMAN PRESCRIPTION DRUG |
| Marketing category | ANDA |
| Marketing effective time low | 2019-03-26 |
| Marketing status | ACTIVE |
| Related queries | Properties for NDC 9 76420-746 |
NDC Item 76420074701
| NDC 9 | 76420-747 |
|---|---|
| NDC 10 | 76420-747-01 |
| NDC Item | 76420074701 |
| Packaging | 1 VIAL, SINGLE-DOSE in 1 CARTON (76420-747-01) / 1 mL in 1 VIAL, SINGLE-DOSE |
| ANDA | ANDA207742 |
| DCSA | CIII |
| FDA SPL set id | 791057 |
| Labeler | Asclemed USA, Inc. |
| Label type | HUMAN PRESCRIPTION DRUG |
| Marketing category | ANDA |
| Marketing effective time low | 2022-11-02 |
| Marketing status | ACTIVE |
| Related queries | Properties for NDC 9 76420-747 |
NDC Item 00143965901
| NDC 9 | 0143-9659 |
|---|---|
| NDC 10 | 0143-9659-01 |
| NDC Item | 00143965901 |
| Packaging | 1 mL in 1 VIAL (0143-9659-01) |
| ANDA | ANDA091244 |
| DCSA | CIII |
| FDA SPL set id | 627057 |
| Labeler | Hikma Pharmaceuticals USA Inc. |
| Label type | HUMAN PRESCRIPTION DRUG |
| Marketing category | ANDA |
| Marketing effective time low | 2012-05-01 |
| Marketing status | ACTIVE |
| Related queries | Properties for NDC 9 0143-9659 |
NDC Item 00409656201
| NDC 9 | 0409-6562 |
|---|---|
| NDC 10 | 0409-6562-01 |
| NDC Item | 00409656201 |
| Packaging | 1 VIAL in 1 CARTON (0409-6562-01) / 1 mL in 1 VIAL |
| ANDA | ANDA085635 |
| DCSA | CIII |
| FDA SPL set id | 500095 |
| FDA SPL set id | 500287 |
| Labeler | Hospira, Inc. |
| Label type | HUMAN PRESCRIPTION DRUG |
| Marketing category | ANDA |
| Marketing effective time low | 2018-01-17 |
| Marketing status | ACTIVE |
| Related queries | Properties for NDC 9 0409-6562 |
NDC Item 00409656202
| NDC 9 | 0409-6562 |
|---|---|
| NDC 10 | 0409-6562-02 |
| NDC Item | 00409656202 |
| Packaging | 1 VIAL in 1 CARTON (0409-6562-02) / 1 mL in 1 VIAL |
| ANDA | ANDA085635 |
| DCSA | CIII |
| FDA SPL set id | 500095 |
| FDA SPL set id | 500287 |
| Labeler | Hospira, Inc. |
| Label type | HUMAN PRESCRIPTION DRUG |
| Marketing category | ANDA |
| Marketing effective time low | 2018-01-17 |
| Marketing status | ACTIVE |
| Related queries | Properties for NDC 9 0409-6562 |
NDC Item 00517183001
| NDC 9 | 0517-1830 |
|---|---|
| NDC 10 | 0517-1830-01 |
| NDC Item | 00517183001 |
| Packaging | 1 VIAL in 1 BOX (0517-1830-01) / 1 mL in 1 VIAL |
| ANDA | ANDA207742 |
| DCSA | CIII |
| FDA SPL set id | 674434 |
| Labeler | American Regent, Inc. |
| Label type | HUMAN PRESCRIPTION DRUG |
| Marketing category | ANDA |
| Marketing effective time low | 2019-07-19 |
| Marketing status | ACTIVE |
| Related queries | Properties for NDC 9 0517-1830 |
NDC Item 00574082001
| NDC 9 | 0574-0820 |
|---|---|
| NDC 10 | 0574-0820-01 |
| NDC Item | 00574082001 |
| Packaging | 1 VIAL, GLASS in 1 CARTON (0574-0820-01) / 1 mL in 1 VIAL, GLASS |
| ANDA | ANDA040530 |
| DCSA | CIII |
| FDA SPL set id | 768154 |
| FDA SPL set id | 791051 |
| Labeler | Padagis US LLC |
| Label type | HUMAN PRESCRIPTION DRUG |
| Marketing category | ANDA |
| Marketing effective time low | 2007-12-21 |
| Marketing status | ACTIVE |
| Related queries | Properties for NDC 9 0574-0820 |
NDC Item 00574082701
| NDC 9 | 0574-0827 |
|---|---|
| NDC 10 | 0574-0827-01 |
| NDC Item | 00574082701 |
| Packaging | 1 VIAL, GLASS in 1 CARTON (0574-0827-01) / 1 mL in 1 VIAL, GLASS |
| ANDA | ANDA091244 |
| DCSA | CIII |
| FDA SPL set id | 584573 |
| Labeler | Padagis US LLC |
| Label type | HUMAN PRESCRIPTION DRUG |
| Marketing category | ANDA |
| Marketing effective time low | 2014-05-01 |
| Marketing status | ACTIVE |
| Related queries | Properties for NDC 9 0574-0827 |
NDC Item 47781091193
| NDC 9 | 47781-911 |
|---|---|
| NDC 10 | 47781-911-93 |
| NDC Item | 47781091193 |
| Packaging | 1 VIAL, SINGLE-DOSE in 1 CARTON (47781-911-93) / 1 mL in 1 VIAL, SINGLE-DOSE |
| ANDA | ANDA207742 |
| DCSA | CIII |
| FDA SPL set id | 719526 |
| Labeler | Alvogen Inc. |
| Label type | HUMAN PRESCRIPTION DRUG |
| Marketing category | ANDA |
| Marketing effective time low | 2022-11-02 |
| Marketing status | ACTIVE |
| Related queries | Properties for NDC 9 47781-911 |
NDC Item 52536062501
| NDC 9 | 52536-625 |
|---|---|
| NDC 10 | 52536-625-01 |
| NDC Item | 52536062501 |
| Packaging | 1 VIAL, SINGLE-DOSE in 1 CARTON (52536-625-01) / 1 mL in 1 VIAL, SINGLE-DOSE |
| ANDA | ANDA206368 |
| COLORTEXT | WHITE(or creamy white) |
| Color | C48325 __ |
| DCSA | CIII |
| FDA SPL set id | 395393 |
| Labeler | Wilshire Pharmaceuticals |
| Label type | HUMAN PRESCRIPTION DRUG |
| Marketing category | ANDA |
| Marketing effective time low | 2019-05-31 |
| Marketing status | ACTIVE |
| Related queries | Properties for NDC 9 52536-625 |
NDC Item 55150027701
| NDC 9 | 55150-277 |
|---|---|
| NDC 10 | 55150-277-01 |
| NDC Item | 55150027701 |
| Packaging | 1 VIAL, GLASS in 1 CARTON (55150-277-01) / 1 mL in 1 VIAL, GLASS |
| ANDA | ANDA211817 |
| DCSA | CIII |
| FDA SPL set id | 739422 |
| Labeler | Eugia US LLC |
| Label type | HUMAN PRESCRIPTION DRUG |
| Marketing category | ANDA |
| Marketing effective time low | 2023-10-20 |
| Marketing status | ACTIVE |
| Related queries | Properties for NDC 9 55150-277 |
NDC Item 62756001540
| NDC 9 | 62756-015 |
|---|---|
| NDC 10 | 62756-015-40 |
| NDC Item | 62756001540 |
| Packaging | 1 VIAL in 1 CARTON (62756-015-40) / 1 mL in 1 VIAL |
| ANDA | ANDA201720 |
| DCSA | CIII |
| FDA SPL set id | 581578 |
| Labeler | Sun Pharmaceutical Industries, Inc. |
| Label type | HUMAN PRESCRIPTION DRUG |
| Marketing category | ANDA |
| Marketing effective time low | 2013-06-17 |
| Marketing status | ACTIVE |
| Related queries | Properties for NDC 9 62756-015 |
NDC Item 64980046799
| NDC 9 | 64980-467 |
|---|---|
| NDC 10 | 64980-467-99 |
| NDC Item | 64980046799 |
| Packaging | 1 VIAL, MULTI-DOSE in 1 CARTON (64980-467-99) / 1 mL in 1 VIAL, MULTI-DOSE |
| ANDA | ANDA207742 |
| DCSA | CIII |
| FDA SPL set id | 385892 |
| Labeler | Rising Pharma Holdings, Inc. |
| Label type | HUMAN PRESCRIPTION DRUG |
| Marketing category | ANDA |
| Marketing effective time high | 2020-06-30 |
| Marketing effective time low | 2018-12-01 |
| Marketing status | COMPLETED |
| Related queries | Properties for NDC 9 64980-467 |
NDC Item 69097053731
| NDC 9 | 69097-537 |
|---|---|
| NDC 10 | 69097-537-31 |
| NDC Item | 69097053731 |
| Packaging | 1 mL in 1 VIAL, GLASS (69097-537-31) |
| ANDA | ANDA210362 |
| COLORTEXT | WHITE("A clear colourless to pale yellow solution) |
| Color | C48325 __ |
| DCSA | CIII |
| FDA SPL set id | 729362 |
| Labeler | Cipla USA Inc. |
| Label type | HUMAN PRESCRIPTION DRUG |
| Marketing category | ANDA |
| Marketing effective time low | 2023-09-15 |
| Marketing status | ACTIVE |
| Related queries | Properties for NDC 9 69097-537 |
NDC Item 69097080232
| NDC 9 | 69097-802 |
|---|---|
| NDC 10 | 69097-802-32 |
| NDC Item | 69097080232 |
| Packaging | 1 VIAL, GLASS in 1 CARTON (69097-802-32) / 1 mL in 1 VIAL, GLASS |
| ANDA | ANDA091244 |
| DCSA | CIII |
| FDA SPL set id | 764872 |
| Labeler | Cipla USA Inc. |
| Label type | HUMAN PRESCRIPTION DRUG |
| Marketing category | ANDA |
| Marketing effective time low | 2019-03-26 |
| Marketing status | ACTIVE |
| Related queries | Properties for NDC 9 69097-802 |
NDC Item 70700028922
| NDC 9 | 70700-289 |
|---|---|
| NDC 10 | 70700-289-22 |
| NDC Item | 70700028922 |
| Packaging | 1 VIAL in 1 CARTON (70700-289-22) / 1 mL in 1 VIAL |
| ANDA | ANDA215351 |
| DCSA | CIII |
| FDA SPL set id | 708164 |
| Labeler | Xiromed LLC |
| Label type | HUMAN PRESCRIPTION DRUG |
| Marketing category | ANDA |
| Marketing effective time low | 2023-04-28 |
| Marketing status | ACTIVE |
| Related queries | Properties for NDC 9 70700-289 |
NDC Item 71205028901
| NDC 9 | 71205-289 |
|---|---|
| NDC 10 | 71205-289-01 |
| NDC Item | 71205028901 |
| Packaging | 1 mL in 1 VIAL (71205-289-01) |
| ANDA | ANDA091244 |
| DCSA | CIII |
| FDA SPL set id | 413320 |
| Labeler | Proficient Rx LP |
| Label type | HUMAN PRESCRIPTION DRUG |
| Marketing category | ANDA |
| Marketing effective time low | 2012-05-01 |
| Marketing status | ACTIVE |
| Related queries | Properties for NDC 9 71205-289 |
NDC Item 71225012701
| NDC 9 | 71225-127 |
|---|---|
| NDC 10 | 71225-127-01 |
| NDC Item | 71225012701 |
| Packaging | 1 VIAL in 1 CARTON (71225-127-01) / 1 mL in 1 VIAL |
| DCSA | CIII |
| FDA SPL set id | 642064 |
| Labeler | Slayback Pharma LLC |
| Label type | HUMAN PRESCRIPTION DRUG |
| Marketing category | NDA |
| Marketing effective time low | 2022-06-13 |
| Marketing status | ACTIVE |
| NDA | NDA216318 |
| Related queries | Properties for NDC 9 71225-127 |
NDC Item 72162234802
| NDC 9 | 72162-2348 |
|---|---|
| NDC 10 | 72162-2348-2 |
| NDC Item | 72162234802 |
| Packaging | 1 VIAL, SINGLE-DOSE in 1 CARTON (72162-2348-2) / 1 mL in 1 VIAL, SINGLE-DOSE |
| ANDA | ANDA206368 |
| COLORTEXT | WHITE(or creamy white) |
| Color | C48325 __ |
| DCSA | CIII |
| FDA SPL set id | 794476 |
| Labeler | Bryant Ranch Prepack |
| Label type | HUMAN PRESCRIPTION DRUG |
| Marketing category | ANDA |
| Marketing effective time low | 2019-05-31 |
| Marketing status | active |
| Related queries | Properties for NDC 9 72162-2348 |
NDC Item 72162234804
| NDC 9 | 72162-2348 |
|---|---|
| NDC 10 | 72162-2348-4 |
| NDC Item | 72162234804 |
| Packaging | 1 VIAL, MULTI-DOSE in 1 CARTON (72162-2348-4) / 10 mL in 1 VIAL, MULTI-DOSE |
| ANDA | ANDA206368 |
| COLORTEXT | WHITE(or creamy white) |
| Color | C48325 __ |
| DCSA | CIII |
| FDA SPL set id | 794476 |
| Labeler | Bryant Ranch Prepack |
| Label type | HUMAN PRESCRIPTION DRUG |
| Marketing category | ANDA |
| Marketing effective time low | 2019-05-31 |
| Marketing status | active |
| Related queries | Properties for NDC 9 72162-2348 |
NDC Item 72162237502
| NDC 9 | 72162-2375 |
|---|---|
| NDC 10 | 72162-2375-2 |
| NDC Item | 72162237502 |
| Packaging | 1 VIAL, GLASS in 1 CARTON (72162-2375-2) / 1 mL in 1 VIAL, GLASS |
| ANDA | ANDA040530 |
| DCSA | CIII |
| FDA SPL set id | 800677 |
| Labeler | Bryant Ranch Prepack |
| Label type | HUMAN PRESCRIPTION DRUG |
| Marketing category | ANDA |
| Marketing effective time low | 2007-12-21 |
| Marketing status | active |
| Related queries | Properties for NDC 9 72162-2375 |
NDC Item 76420074601
| NDC 9 | 76420-746 |
|---|---|
| NDC 10 | 76420-746-01 |
| NDC Item | 76420074601 |
| Packaging | 1 VIAL, GLASS in 1 CARTON (76420-746-01) / 1 mL in 1 VIAL, GLASS |
| ANDA | ANDA091244 |
| DCSA | CIII |
| FDA SPL set id | 791011 |
| Labeler | Asclemed USA, Inc. |
| Label type | HUMAN PRESCRIPTION DRUG |
| Marketing category | ANDA |
| Marketing effective time low | 2019-03-26 |
| Marketing status | ACTIVE |
| Related queries | Properties for NDC 9 76420-746 |
NDC Item 76420074701
| NDC 9 | 76420-747 |
|---|---|
| NDC 10 | 76420-747-01 |
| NDC Item | 76420074701 |
| Packaging | 1 VIAL, SINGLE-DOSE in 1 CARTON (76420-747-01) / 1 mL in 1 VIAL, SINGLE-DOSE |
| ANDA | ANDA207742 |
| DCSA | CIII |
| FDA SPL set id | 791057 |
| Labeler | Asclemed USA, Inc. |
| Label type | HUMAN PRESCRIPTION DRUG |
| Marketing category | ANDA |
| Marketing effective time low | 2022-11-02 |
| Marketing status | ACTIVE |
| Related queries | Properties for NDC 9 76420-747 |
NDC Item 00143965901
| NDC 9 | 0143-9659 |
|---|---|
| NDC 10 | 0143-9659-01 |
| NDC Item | 00143965901 |
| Packaging | 1 mL in 1 VIAL (0143-9659-01) |
| ANDA | ANDA091244 |
| DCSA | CIII |
| FDA SPL set id | 627057 |
| Labeler | Hikma Pharmaceuticals USA Inc. |
| Label type | HUMAN PRESCRIPTION DRUG |
| Marketing category | ANDA |
| Marketing effective time low | 2012-05-01 |
| Marketing status | ACTIVE |
| Related queries | Properties for NDC 9 0143-9659 |
NDC Item 00409656201
| NDC 9 | 0409-6562 |
|---|---|
| NDC 10 | 0409-6562-01 |
| NDC Item | 00409656201 |
| Packaging | 1 VIAL in 1 CARTON (0409-6562-01) / 1 mL in 1 VIAL |
| ANDA | ANDA085635 |
| DCSA | CIII |
| FDA SPL set id | 500095 |
| FDA SPL set id | 500287 |
| Labeler | Hospira, Inc. |
| Label type | HUMAN PRESCRIPTION DRUG |
| Marketing category | ANDA |
| Marketing effective time low | 2018-01-17 |
| Marketing status | ACTIVE |
| Related queries | Properties for NDC 9 0409-6562 |
NDC Item 00409656202
| NDC 9 | 0409-6562 |
|---|---|
| NDC 10 | 0409-6562-02 |
| NDC Item | 00409656202 |
| Packaging | 1 VIAL in 1 CARTON (0409-6562-02) / 1 mL in 1 VIAL |
| ANDA | ANDA085635 |
| DCSA | CIII |
| FDA SPL set id | 500095 |
| FDA SPL set id | 500287 |
| Labeler | Hospira, Inc. |
| Label type | HUMAN PRESCRIPTION DRUG |
| Marketing category | ANDA |
| Marketing effective time low | 2018-01-17 |
| Marketing status | ACTIVE |
| Related queries | Properties for NDC 9 0409-6562 |
NDC Item 00517183001
| NDC 9 | 0517-1830 |
|---|---|
| NDC 10 | 0517-1830-01 |
| NDC Item | 00517183001 |
| Packaging | 1 VIAL in 1 BOX (0517-1830-01) / 1 mL in 1 VIAL |
| ANDA | ANDA207742 |
| DCSA | CIII |
| FDA SPL set id | 674434 |
| Labeler | American Regent, Inc. |
| Label type | HUMAN PRESCRIPTION DRUG |
| Marketing category | ANDA |
| Marketing effective time low | 2019-07-19 |
| Marketing status | ACTIVE |
| Related queries | Properties for NDC 9 0517-1830 |
NDC Item 00574082001
| NDC 9 | 0574-0820 |
|---|---|
| NDC 10 | 0574-0820-01 |
| NDC Item | 00574082001 |
| Packaging | 1 VIAL, GLASS in 1 CARTON (0574-0820-01) / 1 mL in 1 VIAL, GLASS |
| ANDA | ANDA040530 |
| DCSA | CIII |
| FDA SPL set id | 768154 |
| FDA SPL set id | 791051 |
| Labeler | Padagis US LLC |
| Label type | HUMAN PRESCRIPTION DRUG |
| Marketing category | ANDA |
| Marketing effective time low | 2007-12-21 |
| Marketing status | ACTIVE |
| Related queries | Properties for NDC 9 0574-0820 |
NDC Item 00574082701
| NDC 9 | 0574-0827 |
|---|---|
| NDC 10 | 0574-0827-01 |
| NDC Item | 00574082701 |
| Packaging | 1 VIAL, GLASS in 1 CARTON (0574-0827-01) / 1 mL in 1 VIAL, GLASS |
| ANDA | ANDA091244 |
| DCSA | CIII |
| FDA SPL set id | 584573 |
| Labeler | Padagis US LLC |
| Label type | HUMAN PRESCRIPTION DRUG |
| Marketing category | ANDA |
| Marketing effective time low | 2014-05-01 |
| Marketing status | ACTIVE |
| Related queries | Properties for NDC 9 0574-0827 |
NDC Item 47781091193
| NDC 9 | 47781-911 |
|---|---|
| NDC 10 | 47781-911-93 |
| NDC Item | 47781091193 |
| Packaging | 1 VIAL, SINGLE-DOSE in 1 CARTON (47781-911-93) / 1 mL in 1 VIAL, SINGLE-DOSE |
| ANDA | ANDA207742 |
| DCSA | CIII |
| FDA SPL set id | 719526 |
| Labeler | Alvogen Inc. |
| Label type | HUMAN PRESCRIPTION DRUG |
| Marketing category | ANDA |
| Marketing effective time low | 2022-11-02 |
| Marketing status | ACTIVE |
| Related queries | Properties for NDC 9 47781-911 |
NDC Item 52536062501
| NDC 9 | 52536-625 |
|---|---|
| NDC 10 | 52536-625-01 |
| NDC Item | 52536062501 |
| Packaging | 1 VIAL, SINGLE-DOSE in 1 CARTON (52536-625-01) / 1 mL in 1 VIAL, SINGLE-DOSE |
| ANDA | ANDA206368 |
| COLORTEXT | WHITE(or creamy white) |
| Color | C48325 __ |
| DCSA | CIII |
| FDA SPL set id | 395393 |
| Labeler | Wilshire Pharmaceuticals |
| Label type | HUMAN PRESCRIPTION DRUG |
| Marketing category | ANDA |
| Marketing effective time low | 2019-05-31 |
| Marketing status | ACTIVE |
| Related queries | Properties for NDC 9 52536-625 |
NDC Item 55150027701
| NDC 9 | 55150-277 |
|---|---|
| NDC 10 | 55150-277-01 |
| NDC Item | 55150027701 |
| Packaging | 1 VIAL, GLASS in 1 CARTON (55150-277-01) / 1 mL in 1 VIAL, GLASS |
| ANDA | ANDA211817 |
| DCSA | CIII |
| FDA SPL set id | 739422 |
| Labeler | Eugia US LLC |
| Label type | HUMAN PRESCRIPTION DRUG |
| Marketing category | ANDA |
| Marketing effective time low | 2023-10-20 |
| Marketing status | ACTIVE |
| Related queries | Properties for NDC 9 55150-277 |
NDC Item 62756001540
| NDC 9 | 62756-015 |
|---|---|
| NDC 10 | 62756-015-40 |
| NDC Item | 62756001540 |
| Packaging | 1 VIAL in 1 CARTON (62756-015-40) / 1 mL in 1 VIAL |
| ANDA | ANDA201720 |
| DCSA | CIII |
| FDA SPL set id | 581578 |
| Labeler | Sun Pharmaceutical Industries, Inc. |
| Label type | HUMAN PRESCRIPTION DRUG |
| Marketing category | ANDA |
| Marketing effective time low | 2013-06-17 |
| Marketing status | ACTIVE |
| Related queries | Properties for NDC 9 62756-015 |
NDC Item 64980046799
| NDC 9 | 64980-467 |
|---|---|
| NDC 10 | 64980-467-99 |
| NDC Item | 64980046799 |
| Packaging | 1 VIAL, MULTI-DOSE in 1 CARTON (64980-467-99) / 1 mL in 1 VIAL, MULTI-DOSE |
| ANDA | ANDA207742 |
| DCSA | CIII |
| FDA SPL set id | 385892 |
| Labeler | Rising Pharma Holdings, Inc. |
| Label type | HUMAN PRESCRIPTION DRUG |
| Marketing category | ANDA |
| Marketing effective time high | 2020-06-30 |
| Marketing effective time low | 2018-12-01 |
| Marketing status | COMPLETED |
| Related queries | Properties for NDC 9 64980-467 |
NDC Item 69097053731
| NDC 9 | 69097-537 |
|---|---|
| NDC 10 | 69097-537-31 |
| NDC Item | 69097053731 |
| Packaging | 1 mL in 1 VIAL, GLASS (69097-537-31) |
| ANDA | ANDA210362 |
| COLORTEXT | WHITE("A clear colourless to pale yellow solution) |
| Color | C48325 __ |
| DCSA | CIII |
| FDA SPL set id | 729362 |
| Labeler | Cipla USA Inc. |
| Label type | HUMAN PRESCRIPTION DRUG |
| Marketing category | ANDA |
| Marketing effective time low | 2023-09-15 |
| Marketing status | ACTIVE |
| Related queries | Properties for NDC 9 69097-537 |
NDC Item 69097080232
| NDC 9 | 69097-802 |
|---|---|
| NDC 10 | 69097-802-32 |
| NDC Item | 69097080232 |
| Packaging | 1 VIAL, GLASS in 1 CARTON (69097-802-32) / 1 mL in 1 VIAL, GLASS |
| ANDA | ANDA091244 |
| DCSA | CIII |
| FDA SPL set id | 764872 |
| Labeler | Cipla USA Inc. |
| Label type | HUMAN PRESCRIPTION DRUG |
| Marketing category | ANDA |
| Marketing effective time low | 2019-03-26 |
| Marketing status | ACTIVE |
| Related queries | Properties for NDC 9 69097-802 |
NDC Item 70700028922
| NDC 9 | 70700-289 |
|---|---|
| NDC 10 | 70700-289-22 |
| NDC Item | 70700028922 |
| Packaging | 1 VIAL in 1 CARTON (70700-289-22) / 1 mL in 1 VIAL |
| ANDA | ANDA215351 |
| DCSA | CIII |
| FDA SPL set id | 708164 |
| Labeler | Xiromed LLC |
| Label type | HUMAN PRESCRIPTION DRUG |
| Marketing category | ANDA |
| Marketing effective time low | 2023-04-28 |
| Marketing status | ACTIVE |
| Related queries | Properties for NDC 9 70700-289 |
NDC Item 71205028901
| NDC 9 | 71205-289 |
|---|---|
| NDC 10 | 71205-289-01 |
| NDC Item | 71205028901 |
| Packaging | 1 mL in 1 VIAL (71205-289-01) |
| ANDA | ANDA091244 |
| DCSA | CIII |
| FDA SPL set id | 413320 |
| Labeler | Proficient Rx LP |
| Label type | HUMAN PRESCRIPTION DRUG |
| Marketing category | ANDA |
| Marketing effective time low | 2012-05-01 |
| Marketing status | ACTIVE |
| Related queries | Properties for NDC 9 71205-289 |
NDC Item 71225012701
| NDC 9 | 71225-127 |
|---|---|
| NDC 10 | 71225-127-01 |
| NDC Item | 71225012701 |
| Packaging | 1 VIAL in 1 CARTON (71225-127-01) / 1 mL in 1 VIAL |
| DCSA | CIII |
| FDA SPL set id | 642064 |
| Labeler | Slayback Pharma LLC |
| Label type | HUMAN PRESCRIPTION DRUG |
| Marketing category | NDA |
| Marketing effective time low | 2022-06-13 |
| Marketing status | ACTIVE |
| NDA | NDA216318 |
| Related queries | Properties for NDC 9 71225-127 |
NDC Item 72162234802
| NDC 9 | 72162-2348 |
|---|---|
| NDC 10 | 72162-2348-2 |
| NDC Item | 72162234802 |
| Packaging | 1 VIAL, SINGLE-DOSE in 1 CARTON (72162-2348-2) / 1 mL in 1 VIAL, SINGLE-DOSE |
| ANDA | ANDA206368 |
| COLORTEXT | WHITE(or creamy white) |
| Color | C48325 __ |
| DCSA | CIII |
| FDA SPL set id | 794476 |
| Labeler | Bryant Ranch Prepack |
| Label type | HUMAN PRESCRIPTION DRUG |
| Marketing category | ANDA |
| Marketing effective time low | 2019-05-31 |
| Marketing status | active |
| Related queries | Properties for NDC 9 72162-2348 |
NDC Item 72162234804
| NDC 9 | 72162-2348 |
|---|---|
| NDC 10 | 72162-2348-4 |
| NDC Item | 72162234804 |
| Packaging | 1 VIAL, MULTI-DOSE in 1 CARTON (72162-2348-4) / 10 mL in 1 VIAL, MULTI-DOSE |
| ANDA | ANDA206368 |
| COLORTEXT | WHITE(or creamy white) |
| Color | C48325 __ |
| DCSA | CIII |
| FDA SPL set id | 794476 |
| Labeler | Bryant Ranch Prepack |
| Label type | HUMAN PRESCRIPTION DRUG |
| Marketing category | ANDA |
| Marketing effective time low | 2019-05-31 |
| Marketing status | active |
| Related queries | Properties for NDC 9 72162-2348 |
NDC Item 72162237502
| NDC 9 | 72162-2375 |
|---|---|
| NDC 10 | 72162-2375-2 |
| NDC Item | 72162237502 |
| Packaging | 1 VIAL, GLASS in 1 CARTON (72162-2375-2) / 1 mL in 1 VIAL, GLASS |
| ANDA | ANDA040530 |
| DCSA | CIII |
| FDA SPL set id | 800677 |
| Labeler | Bryant Ranch Prepack |
| Label type | HUMAN PRESCRIPTION DRUG |
| Marketing category | ANDA |
| Marketing effective time low | 2007-12-21 |
| Marketing status | active |
| Related queries | Properties for NDC 9 72162-2375 |
NDC Item 76420074601
| NDC 9 | 76420-746 |
|---|---|
| NDC 10 | 76420-746-01 |
| NDC Item | 76420074601 |
| Packaging | 1 VIAL, GLASS in 1 CARTON (76420-746-01) / 1 mL in 1 VIAL, GLASS |
| ANDA | ANDA091244 |
| DCSA | CIII |
| FDA SPL set id | 791011 |
| Labeler | Asclemed USA, Inc. |
| Label type | HUMAN PRESCRIPTION DRUG |
| Marketing category | ANDA |
| Marketing effective time low | 2019-03-26 |
| Marketing status | ACTIVE |
| Related queries | Properties for NDC 9 76420-746 |
NDC Item 76420074701
| NDC 9 | 76420-747 |
|---|---|
| NDC 10 | 76420-747-01 |
| NDC Item | 76420074701 |
| Packaging | 1 VIAL, SINGLE-DOSE in 1 CARTON (76420-747-01) / 1 mL in 1 VIAL, SINGLE-DOSE |
| ANDA | ANDA207742 |
| DCSA | CIII |
| FDA SPL set id | 791057 |
| Labeler | Asclemed USA, Inc. |
| Label type | HUMAN PRESCRIPTION DRUG |
| Marketing category | ANDA |
| Marketing effective time low | 2022-11-02 |
| Marketing status | ACTIVE |
| Related queries | Properties for NDC 9 76420-747 |
NDC Item 00143965901
| NDC 9 | 0143-9659 |
|---|---|
| NDC 10 | 0143-9659-01 |
| NDC Item | 00143965901 |
| Packaging | 1 mL in 1 VIAL (0143-9659-01) |
| ANDA | ANDA091244 |
| DCSA | CIII |
| FDA SPL set id | 627057 |
| Labeler | Hikma Pharmaceuticals USA Inc. |
| Label type | HUMAN PRESCRIPTION DRUG |
| Marketing category | ANDA |
| Marketing effective time low | 2012-05-01 |
| Marketing status | ACTIVE |
| Related queries | Properties for NDC 9 0143-9659 |
NDC Item 00409656201
| NDC 9 | 0409-6562 |
|---|---|
| NDC 10 | 0409-6562-01 |
| NDC Item | 00409656201 |
| Packaging | 1 VIAL in 1 CARTON (0409-6562-01) / 1 mL in 1 VIAL |
| ANDA | ANDA085635 |
| DCSA | CIII |
| FDA SPL set id | 500095 |
| FDA SPL set id | 500287 |
| Labeler | Hospira, Inc. |
| Label type | HUMAN PRESCRIPTION DRUG |
| Marketing category | ANDA |
| Marketing effective time low | 2018-01-17 |
| Marketing status | ACTIVE |
| Related queries | Properties for NDC 9 0409-6562 |
NDC Item 00409656202
| NDC 9 | 0409-6562 |
|---|---|
| NDC 10 | 0409-6562-02 |
| NDC Item | 00409656202 |
| Packaging | 1 VIAL in 1 CARTON (0409-6562-02) / 1 mL in 1 VIAL |
| ANDA | ANDA085635 |
| DCSA | CIII |
| FDA SPL set id | 500095 |
| FDA SPL set id | 500287 |
| Labeler | Hospira, Inc. |
| Label type | HUMAN PRESCRIPTION DRUG |
| Marketing category | ANDA |
| Marketing effective time low | 2018-01-17 |
| Marketing status | ACTIVE |
| Related queries | Properties for NDC 9 0409-6562 |
NDC Item 00517183001
| NDC 9 | 0517-1830 |
|---|---|
| NDC 10 | 0517-1830-01 |
| NDC Item | 00517183001 |
| Packaging | 1 VIAL in 1 BOX (0517-1830-01) / 1 mL in 1 VIAL |
| ANDA | ANDA207742 |
| DCSA | CIII |
| FDA SPL set id | 674434 |
| Labeler | American Regent, Inc. |
| Label type | HUMAN PRESCRIPTION DRUG |
| Marketing category | ANDA |
| Marketing effective time low | 2019-07-19 |
| Marketing status | ACTIVE |
| Related queries | Properties for NDC 9 0517-1830 |
NDC Item 00574082001
| NDC 9 | 0574-0820 |
|---|---|
| NDC 10 | 0574-0820-01 |
| NDC Item | 00574082001 |
| Packaging | 1 VIAL, GLASS in 1 CARTON (0574-0820-01) / 1 mL in 1 VIAL, GLASS |
| ANDA | ANDA040530 |
| DCSA | CIII |
| FDA SPL set id | 768154 |
| FDA SPL set id | 791051 |
| Labeler | Padagis US LLC |
| Label type | HUMAN PRESCRIPTION DRUG |
| Marketing category | ANDA |
| Marketing effective time low | 2007-12-21 |
| Marketing status | ACTIVE |
| Related queries | Properties for NDC 9 0574-0820 |
NDC Item 00574082701
| NDC 9 | 0574-0827 |
|---|---|
| NDC 10 | 0574-0827-01 |
| NDC Item | 00574082701 |
| Packaging | 1 VIAL, GLASS in 1 CARTON (0574-0827-01) / 1 mL in 1 VIAL, GLASS |
| ANDA | ANDA091244 |
| DCSA | CIII |
| FDA SPL set id | 584573 |
| Labeler | Padagis US LLC |
| Label type | HUMAN PRESCRIPTION DRUG |
| Marketing category | ANDA |
| Marketing effective time low | 2014-05-01 |
| Marketing status | ACTIVE |
| Related queries | Properties for NDC 9 0574-0827 |
NDC Item 47781091193
| NDC 9 | 47781-911 |
|---|---|
| NDC 10 | 47781-911-93 |
| NDC Item | 47781091193 |
| Packaging | 1 VIAL, SINGLE-DOSE in 1 CARTON (47781-911-93) / 1 mL in 1 VIAL, SINGLE-DOSE |
| ANDA | ANDA207742 |
| DCSA | CIII |
| FDA SPL set id | 719526 |
| Labeler | Alvogen Inc. |
| Label type | HUMAN PRESCRIPTION DRUG |
| Marketing category | ANDA |
| Marketing effective time low | 2022-11-02 |
| Marketing status | ACTIVE |
| Related queries | Properties for NDC 9 47781-911 |
NDC Item 52536062501
| NDC 9 | 52536-625 |
|---|---|
| NDC 10 | 52536-625-01 |
| NDC Item | 52536062501 |
| Packaging | 1 VIAL, SINGLE-DOSE in 1 CARTON (52536-625-01) / 1 mL in 1 VIAL, SINGLE-DOSE |
| ANDA | ANDA206368 |
| COLORTEXT | WHITE(or creamy white) |
| Color | C48325 __ |
| DCSA | CIII |
| FDA SPL set id | 395393 |
| Labeler | Wilshire Pharmaceuticals |
| Label type | HUMAN PRESCRIPTION DRUG |
| Marketing category | ANDA |
| Marketing effective time low | 2019-05-31 |
| Marketing status | ACTIVE |
| Related queries | Properties for NDC 9 52536-625 |
NDC Item 55150027701
| NDC 9 | 55150-277 |
|---|---|
| NDC 10 | 55150-277-01 |
| NDC Item | 55150027701 |
| Packaging | 1 VIAL, GLASS in 1 CARTON (55150-277-01) / 1 mL in 1 VIAL, GLASS |
| ANDA | ANDA211817 |
| DCSA | CIII |
| FDA SPL set id | 739422 |
| Labeler | Eugia US LLC |
| Label type | HUMAN PRESCRIPTION DRUG |
| Marketing category | ANDA |
| Marketing effective time low | 2023-10-20 |
| Marketing status | ACTIVE |
| Related queries | Properties for NDC 9 55150-277 |
NDC Item 62756001540
| NDC 9 | 62756-015 |
|---|---|
| NDC 10 | 62756-015-40 |
| NDC Item | 62756001540 |
| Packaging | 1 VIAL in 1 CARTON (62756-015-40) / 1 mL in 1 VIAL |
| ANDA | ANDA201720 |
| DCSA | CIII |
| FDA SPL set id | 581578 |
| Labeler | Sun Pharmaceutical Industries, Inc. |
| Label type | HUMAN PRESCRIPTION DRUG |
| Marketing category | ANDA |
| Marketing effective time low | 2013-06-17 |
| Marketing status | ACTIVE |
| Related queries | Properties for NDC 9 62756-015 |
NDC Item 64980046799
| NDC 9 | 64980-467 |
|---|---|
| NDC 10 | 64980-467-99 |
| NDC Item | 64980046799 |
| Packaging | 1 VIAL, MULTI-DOSE in 1 CARTON (64980-467-99) / 1 mL in 1 VIAL, MULTI-DOSE |
| ANDA | ANDA207742 |
| DCSA | CIII |
| FDA SPL set id | 385892 |
| Labeler | Rising Pharma Holdings, Inc. |
| Label type | HUMAN PRESCRIPTION DRUG |
| Marketing category | ANDA |
| Marketing effective time high | 2020-06-30 |
| Marketing effective time low | 2018-12-01 |
| Marketing status | COMPLETED |
| Related queries | Properties for NDC 9 64980-467 |
NDC Item 69097053731
| NDC 9 | 69097-537 |
|---|---|
| NDC 10 | 69097-537-31 |
| NDC Item | 69097053731 |
| Packaging | 1 mL in 1 VIAL, GLASS (69097-537-31) |
| ANDA | ANDA210362 |
| COLORTEXT | WHITE("A clear colourless to pale yellow solution) |
| Color | C48325 __ |
| DCSA | CIII |
| FDA SPL set id | 729362 |
| Labeler | Cipla USA Inc. |
| Label type | HUMAN PRESCRIPTION DRUG |
| Marketing category | ANDA |
| Marketing effective time low | 2023-09-15 |
| Marketing status | ACTIVE |
| Related queries | Properties for NDC 9 69097-537 |
NDC Item 69097080232
| NDC 9 | 69097-802 |
|---|---|
| NDC 10 | 69097-802-32 |
| NDC Item | 69097080232 |
| Packaging | 1 VIAL, GLASS in 1 CARTON (69097-802-32) / 1 mL in 1 VIAL, GLASS |
| ANDA | ANDA091244 |
| DCSA | CIII |
| FDA SPL set id | 764872 |
| Labeler | Cipla USA Inc. |
| Label type | HUMAN PRESCRIPTION DRUG |
| Marketing category | ANDA |
| Marketing effective time low | 2019-03-26 |
| Marketing status | ACTIVE |
| Related queries | Properties for NDC 9 69097-802 |
NDC Item 70700028922
| NDC 9 | 70700-289 |
|---|---|
| NDC 10 | 70700-289-22 |
| NDC Item | 70700028922 |
| Packaging | 1 VIAL in 1 CARTON (70700-289-22) / 1 mL in 1 VIAL |
| ANDA | ANDA215351 |
| DCSA | CIII |
| FDA SPL set id | 708164 |
| Labeler | Xiromed LLC |
| Label type | HUMAN PRESCRIPTION DRUG |
| Marketing category | ANDA |
| Marketing effective time low | 2023-04-28 |
| Marketing status | ACTIVE |
| Related queries | Properties for NDC 9 70700-289 |
NDC Item 71205028901
| NDC 9 | 71205-289 |
|---|---|
| NDC 10 | 71205-289-01 |
| NDC Item | 71205028901 |
| Packaging | 1 mL in 1 VIAL (71205-289-01) |
| ANDA | ANDA091244 |
| DCSA | CIII |
| FDA SPL set id | 413320 |
| Labeler | Proficient Rx LP |
| Label type | HUMAN PRESCRIPTION DRUG |
| Marketing category | ANDA |
| Marketing effective time low | 2012-05-01 |
| Marketing status | ACTIVE |
| Related queries | Properties for NDC 9 71205-289 |
NDC Item 71225012701
| NDC 9 | 71225-127 |
|---|---|
| NDC 10 | 71225-127-01 |
| NDC Item | 71225012701 |
| Packaging | 1 VIAL in 1 CARTON (71225-127-01) / 1 mL in 1 VIAL |
| DCSA | CIII |
| FDA SPL set id | 642064 |
| Labeler | Slayback Pharma LLC |
| Label type | HUMAN PRESCRIPTION DRUG |
| Marketing category | NDA |
| Marketing effective time low | 2022-06-13 |
| Marketing status | ACTIVE |
| NDA | NDA216318 |
| Related queries | Properties for NDC 9 71225-127 |
NDC Item 72162234802
| NDC 9 | 72162-2348 |
|---|---|
| NDC 10 | 72162-2348-2 |
| NDC Item | 72162234802 |
| Packaging | 1 VIAL, SINGLE-DOSE in 1 CARTON (72162-2348-2) / 1 mL in 1 VIAL, SINGLE-DOSE |
| ANDA | ANDA206368 |
| COLORTEXT | WHITE(or creamy white) |
| Color | C48325 __ |
| DCSA | CIII |
| FDA SPL set id | 794476 |
| Labeler | Bryant Ranch Prepack |
| Label type | HUMAN PRESCRIPTION DRUG |
| Marketing category | ANDA |
| Marketing effective time low | 2019-05-31 |
| Marketing status | active |
| Related queries | Properties for NDC 9 72162-2348 |
NDC Item 72162234804
| NDC 9 | 72162-2348 |
|---|---|
| NDC 10 | 72162-2348-4 |
| NDC Item | 72162234804 |
| Packaging | 1 VIAL, MULTI-DOSE in 1 CARTON (72162-2348-4) / 10 mL in 1 VIAL, MULTI-DOSE |
| ANDA | ANDA206368 |
| COLORTEXT | WHITE(or creamy white) |
| Color | C48325 __ |
| DCSA | CIII |
| FDA SPL set id | 794476 |
| Labeler | Bryant Ranch Prepack |
| Label type | HUMAN PRESCRIPTION DRUG |
| Marketing category | ANDA |
| Marketing effective time low | 2019-05-31 |
| Marketing status | active |
| Related queries | Properties for NDC 9 72162-2348 |
NDC Item 72162237502
| NDC 9 | 72162-2375 |
|---|---|
| NDC 10 | 72162-2375-2 |
| NDC Item | 72162237502 |
| Packaging | 1 VIAL, GLASS in 1 CARTON (72162-2375-2) / 1 mL in 1 VIAL, GLASS |
| ANDA | ANDA040530 |
| DCSA | CIII |
| FDA SPL set id | 800677 |
| Labeler | Bryant Ranch Prepack |
| Label type | HUMAN PRESCRIPTION DRUG |
| Marketing category | ANDA |
| Marketing effective time low | 2007-12-21 |
| Marketing status | active |
| Related queries | Properties for NDC 9 72162-2375 |
NDC Item 76420074601
| NDC 9 | 76420-746 |
|---|---|
| NDC 10 | 76420-746-01 |
| NDC Item | 76420074601 |
| Packaging | 1 VIAL, GLASS in 1 CARTON (76420-746-01) / 1 mL in 1 VIAL, GLASS |
| ANDA | ANDA091244 |
| DCSA | CIII |
| FDA SPL set id | 791011 |
| Labeler | Asclemed USA, Inc. |
| Label type | HUMAN PRESCRIPTION DRUG |
| Marketing category | ANDA |
| Marketing effective time low | 2019-03-26 |
| Marketing status | ACTIVE |
| Related queries | Properties for NDC 9 76420-746 |
NDC Item 76420074701
| NDC 9 | 76420-747 |
|---|---|
| NDC 10 | 76420-747-01 |
| NDC Item | 76420074701 |
| Packaging | 1 VIAL, SINGLE-DOSE in 1 CARTON (76420-747-01) / 1 mL in 1 VIAL, SINGLE-DOSE |
| ANDA | ANDA207742 |
| DCSA | CIII |
| FDA SPL set id | 791057 |
| Labeler | Asclemed USA, Inc. |
| Label type | HUMAN PRESCRIPTION DRUG |
| Marketing category | ANDA |
| Marketing effective time low | 2022-11-02 |
| Marketing status | ACTIVE |
| Related queries | Properties for NDC 9 76420-747 |
NDC Item 00143965901
| NDC 9 | 0143-9659 |
|---|---|
| NDC 10 | 0143-9659-01 |
| NDC Item | 00143965901 |
| Packaging | 1 mL in 1 VIAL (0143-9659-01) |
| ANDA | ANDA091244 |
| DCSA | CIII |
| FDA SPL set id | 627057 |
| Labeler | Hikma Pharmaceuticals USA Inc. |
| Label type | HUMAN PRESCRIPTION DRUG |
| Marketing category | ANDA |
| Marketing effective time low | 2012-05-01 |
| Marketing status | ACTIVE |
| Related queries | Properties for NDC 9 0143-9659 |
NDC Item 00409656201
| NDC 9 | 0409-6562 |
|---|---|
| NDC 10 | 0409-6562-01 |
| NDC Item | 00409656201 |
| Packaging | 1 VIAL in 1 CARTON (0409-6562-01) / 1 mL in 1 VIAL |
| ANDA | ANDA085635 |
| DCSA | CIII |
| FDA SPL set id | 500095 |
| FDA SPL set id | 500287 |
| Labeler | Hospira, Inc. |
| Label type | HUMAN PRESCRIPTION DRUG |
| Marketing category | ANDA |
| Marketing effective time low | 2018-01-17 |
| Marketing status | ACTIVE |
| Related queries | Properties for NDC 9 0409-6562 |
NDC Item 00409656202
| NDC 9 | 0409-6562 |
|---|---|
| NDC 10 | 0409-6562-02 |
| NDC Item | 00409656202 |
| Packaging | 1 VIAL in 1 CARTON (0409-6562-02) / 1 mL in 1 VIAL |
| ANDA | ANDA085635 |
| DCSA | CIII |
| FDA SPL set id | 500095 |
| FDA SPL set id | 500287 |
| Labeler | Hospira, Inc. |
| Label type | HUMAN PRESCRIPTION DRUG |
| Marketing category | ANDA |
| Marketing effective time low | 2018-01-17 |
| Marketing status | ACTIVE |
| Related queries | Properties for NDC 9 0409-6562 |
NDC Item 00517183001
| NDC 9 | 0517-1830 |
|---|---|
| NDC 10 | 0517-1830-01 |
| NDC Item | 00517183001 |
| Packaging | 1 VIAL in 1 BOX (0517-1830-01) / 1 mL in 1 VIAL |
| ANDA | ANDA207742 |
| DCSA | CIII |
| FDA SPL set id | 674434 |
| Labeler | American Regent, Inc. |
| Label type | HUMAN PRESCRIPTION DRUG |
| Marketing category | ANDA |
| Marketing effective time low | 2019-07-19 |
| Marketing status | ACTIVE |
| Related queries | Properties for NDC 9 0517-1830 |
NDC Item 00574082001
| NDC 9 | 0574-0820 |
|---|---|
| NDC 10 | 0574-0820-01 |
| NDC Item | 00574082001 |
| Packaging | 1 VIAL, GLASS in 1 CARTON (0574-0820-01) / 1 mL in 1 VIAL, GLASS |
| ANDA | ANDA040530 |
| DCSA | CIII |
| FDA SPL set id | 768154 |
| FDA SPL set id | 791051 |
| Labeler | Padagis US LLC |
| Label type | HUMAN PRESCRIPTION DRUG |
| Marketing category | ANDA |
| Marketing effective time low | 2007-12-21 |
| Marketing status | ACTIVE |
| Related queries | Properties for NDC 9 0574-0820 |
NDC Item 00574082701
| NDC 9 | 0574-0827 |
|---|---|
| NDC 10 | 0574-0827-01 |
| NDC Item | 00574082701 |
| Packaging | 1 VIAL, GLASS in 1 CARTON (0574-0827-01) / 1 mL in 1 VIAL, GLASS |
| ANDA | ANDA091244 |
| DCSA | CIII |
| FDA SPL set id | 584573 |
| Labeler | Padagis US LLC |
| Label type | HUMAN PRESCRIPTION DRUG |
| Marketing category | ANDA |
| Marketing effective time low | 2014-05-01 |
| Marketing status | ACTIVE |
| Related queries | Properties for NDC 9 0574-0827 |
NDC Item 47781091193
| NDC 9 | 47781-911 |
|---|---|
| NDC 10 | 47781-911-93 |
| NDC Item | 47781091193 |
| Packaging | 1 VIAL, SINGLE-DOSE in 1 CARTON (47781-911-93) / 1 mL in 1 VIAL, SINGLE-DOSE |
| ANDA | ANDA207742 |
| DCSA | CIII |
| FDA SPL set id | 719526 |
| Labeler | Alvogen Inc. |
| Label type | HUMAN PRESCRIPTION DRUG |
| Marketing category | ANDA |
| Marketing effective time low | 2022-11-02 |
| Marketing status | ACTIVE |
| Related queries | Properties for NDC 9 47781-911 |
NDC Item 52536062501
| NDC 9 | 52536-625 |
|---|---|
| NDC 10 | 52536-625-01 |
| NDC Item | 52536062501 |
| Packaging | 1 VIAL, SINGLE-DOSE in 1 CARTON (52536-625-01) / 1 mL in 1 VIAL, SINGLE-DOSE |
| ANDA | ANDA206368 |
| COLORTEXT | WHITE(or creamy white) |
| Color | C48325 __ |
| DCSA | CIII |
| FDA SPL set id | 395393 |
| Labeler | Wilshire Pharmaceuticals |
| Label type | HUMAN PRESCRIPTION DRUG |
| Marketing category | ANDA |
| Marketing effective time low | 2019-05-31 |
| Marketing status | ACTIVE |
| Related queries | Properties for NDC 9 52536-625 |
NDC Item 55150027701
| NDC 9 | 55150-277 |
|---|---|
| NDC 10 | 55150-277-01 |
| NDC Item | 55150027701 |
| Packaging | 1 VIAL, GLASS in 1 CARTON (55150-277-01) / 1 mL in 1 VIAL, GLASS |
| ANDA | ANDA211817 |
| DCSA | CIII |
| FDA SPL set id | 739422 |
| Labeler | Eugia US LLC |
| Label type | HUMAN PRESCRIPTION DRUG |
| Marketing category | ANDA |
| Marketing effective time low | 2023-10-20 |
| Marketing status | ACTIVE |
| Related queries | Properties for NDC 9 55150-277 |
NDC Item 62756001540
| NDC 9 | 62756-015 |
|---|---|
| NDC 10 | 62756-015-40 |
| NDC Item | 62756001540 |
| Packaging | 1 VIAL in 1 CARTON (62756-015-40) / 1 mL in 1 VIAL |
| ANDA | ANDA201720 |
| DCSA | CIII |
| FDA SPL set id | 581578 |
| Labeler | Sun Pharmaceutical Industries, Inc. |
| Label type | HUMAN PRESCRIPTION DRUG |
| Marketing category | ANDA |
| Marketing effective time low | 2013-06-17 |
| Marketing status | ACTIVE |
| Related queries | Properties for NDC 9 62756-015 |
NDC Item 64980046799
| NDC 9 | 64980-467 |
|---|---|
| NDC 10 | 64980-467-99 |
| NDC Item | 64980046799 |
| Packaging | 1 VIAL, MULTI-DOSE in 1 CARTON (64980-467-99) / 1 mL in 1 VIAL, MULTI-DOSE |
| ANDA | ANDA207742 |
| DCSA | CIII |
| FDA SPL set id | 385892 |
| Labeler | Rising Pharma Holdings, Inc. |
| Label type | HUMAN PRESCRIPTION DRUG |
| Marketing category | ANDA |
| Marketing effective time high | 2020-06-30 |
| Marketing effective time low | 2018-12-01 |
| Marketing status | COMPLETED |
| Related queries | Properties for NDC 9 64980-467 |
NDC Item 69097053731
| NDC 9 | 69097-537 |
|---|---|
| NDC 10 | 69097-537-31 |
| NDC Item | 69097053731 |
| Packaging | 1 mL in 1 VIAL, GLASS (69097-537-31) |
| ANDA | ANDA210362 |
| COLORTEXT | WHITE("A clear colourless to pale yellow solution) |
| Color | C48325 __ |
| DCSA | CIII |
| FDA SPL set id | 729362 |
| Labeler | Cipla USA Inc. |
| Label type | HUMAN PRESCRIPTION DRUG |
| Marketing category | ANDA |
| Marketing effective time low | 2023-09-15 |
| Marketing status | ACTIVE |
| Related queries | Properties for NDC 9 69097-537 |
NDC Item 69097080232
| NDC 9 | 69097-802 |
|---|---|
| NDC 10 | 69097-802-32 |
| NDC Item | 69097080232 |
| Packaging | 1 VIAL, GLASS in 1 CARTON (69097-802-32) / 1 mL in 1 VIAL, GLASS |
| ANDA | ANDA091244 |
| DCSA | CIII |
| FDA SPL set id | 764872 |
| Labeler | Cipla USA Inc. |
| Label type | HUMAN PRESCRIPTION DRUG |
| Marketing category | ANDA |
| Marketing effective time low | 2019-03-26 |
| Marketing status | ACTIVE |
| Related queries | Properties for NDC 9 69097-802 |
NDC Item 70700028922
| NDC 9 | 70700-289 |
|---|---|
| NDC 10 | 70700-289-22 |
| NDC Item | 70700028922 |
| Packaging | 1 VIAL in 1 CARTON (70700-289-22) / 1 mL in 1 VIAL |
| ANDA | ANDA215351 |
| DCSA | CIII |
| FDA SPL set id | 708164 |
| Labeler | Xiromed LLC |
| Label type | HUMAN PRESCRIPTION DRUG |
| Marketing category | ANDA |
| Marketing effective time low | 2023-04-28 |
| Marketing status | ACTIVE |
| Related queries | Properties for NDC 9 70700-289 |
NDC Item 71205028901
| NDC 9 | 71205-289 |
|---|---|
| NDC 10 | 71205-289-01 |
| NDC Item | 71205028901 |
| Packaging | 1 mL in 1 VIAL (71205-289-01) |
| ANDA | ANDA091244 |
| DCSA | CIII |
| FDA SPL set id | 413320 |
| Labeler | Proficient Rx LP |
| Label type | HUMAN PRESCRIPTION DRUG |
| Marketing category | ANDA |
| Marketing effective time low | 2012-05-01 |
| Marketing status | ACTIVE |
| Related queries | Properties for NDC 9 71205-289 |
NDC Item 71225012701
| NDC 9 | 71225-127 |
|---|---|
| NDC 10 | 71225-127-01 |
| NDC Item | 71225012701 |
| Packaging | 1 VIAL in 1 CARTON (71225-127-01) / 1 mL in 1 VIAL |
| DCSA | CIII |
| FDA SPL set id | 642064 |
| Labeler | Slayback Pharma LLC |
| Label type | HUMAN PRESCRIPTION DRUG |
| Marketing category | NDA |
| Marketing effective time low | 2022-06-13 |
| Marketing status | ACTIVE |
| NDA | NDA216318 |
| Related queries | Properties for NDC 9 71225-127 |
NDC Item 72162234802
| NDC 9 | 72162-2348 |
|---|---|
| NDC 10 | 72162-2348-2 |
| NDC Item | 72162234802 |
| Packaging | 1 VIAL, SINGLE-DOSE in 1 CARTON (72162-2348-2) / 1 mL in 1 VIAL, SINGLE-DOSE |
| ANDA | ANDA206368 |
| COLORTEXT | WHITE(or creamy white) |
| Color | C48325 __ |
| DCSA | CIII |
| FDA SPL set id | 794476 |
| Labeler | Bryant Ranch Prepack |
| Label type | HUMAN PRESCRIPTION DRUG |
| Marketing category | ANDA |
| Marketing effective time low | 2019-05-31 |
| Marketing status | active |
| Related queries | Properties for NDC 9 72162-2348 |
NDC Item 72162234804
| NDC 9 | 72162-2348 |
|---|---|
| NDC 10 | 72162-2348-4 |
| NDC Item | 72162234804 |
| Packaging | 1 VIAL, MULTI-DOSE in 1 CARTON (72162-2348-4) / 10 mL in 1 VIAL, MULTI-DOSE |
| ANDA | ANDA206368 |
| COLORTEXT | WHITE(or creamy white) |
| Color | C48325 __ |
| DCSA | CIII |
| FDA SPL set id | 794476 |
| Labeler | Bryant Ranch Prepack |
| Label type | HUMAN PRESCRIPTION DRUG |
| Marketing category | ANDA |
| Marketing effective time low | 2019-05-31 |
| Marketing status | active |
| Related queries | Properties for NDC 9 72162-2348 |
NDC Item 72162237502
| NDC 9 | 72162-2375 |
|---|---|
| NDC 10 | 72162-2375-2 |
| NDC Item | 72162237502 |
| Packaging | 1 VIAL, GLASS in 1 CARTON (72162-2375-2) / 1 mL in 1 VIAL, GLASS |
| ANDA | ANDA040530 |
| DCSA | CIII |
| FDA SPL set id | 800677 |
| Labeler | Bryant Ranch Prepack |
| Label type | HUMAN PRESCRIPTION DRUG |
| Marketing category | ANDA |
| Marketing effective time low | 2007-12-21 |
| Marketing status | active |
| Related queries | Properties for NDC 9 72162-2375 |
NDC Item 76420074601
| NDC 9 | 76420-746 |
|---|---|
| NDC 10 | 76420-746-01 |
| NDC Item | 76420074601 |
| Packaging | 1 VIAL, GLASS in 1 CARTON (76420-746-01) / 1 mL in 1 VIAL, GLASS |
| ANDA | ANDA091244 |
| DCSA | CIII |
| FDA SPL set id | 791011 |
| Labeler | Asclemed USA, Inc. |
| Label type | HUMAN PRESCRIPTION DRUG |
| Marketing category | ANDA |
| Marketing effective time low | 2019-03-26 |
| Marketing status | ACTIVE |
| Related queries | Properties for NDC 9 76420-746 |
NDC Item 76420074701
| NDC 9 | 76420-747 |
|---|---|
| NDC 10 | 76420-747-01 |
| NDC Item | 76420074701 |
| Packaging | 1 VIAL, SINGLE-DOSE in 1 CARTON (76420-747-01) / 1 mL in 1 VIAL, SINGLE-DOSE |
| ANDA | ANDA207742 |
| DCSA | CIII |
| FDA SPL set id | 791057 |
| Labeler | Asclemed USA, Inc. |
| Label type | HUMAN PRESCRIPTION DRUG |
| Marketing category | ANDA |
| Marketing effective time low | 2022-11-02 |
| Marketing status | ACTIVE |
| Related queries | Properties for NDC 9 76420-747 |