NDC properties for "TSPA 100 MG Injection" (RxCUI 1660004)
About this data
The tables show NDC propoerties for TSPA 100 MG Injection with the RxCUI 1660004
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 TSPA 100 MG Injection (RxCUI 1660004)
| ANDA | ANDA211755 |
|---|---|
| ANDA | ANDA213049 |
| ANDA | ANDA214222 |
| ANDA | ANDA216037 |
| MMSL_CODE | BD30174 |
| MMSL_CODE | CD27083 |
| MMSL_CODE | CD30174 |
| RxCUI | 1660004 |
| SNOMEDCT | 1254816009 |
| SPL_SET_ID | 493410f3-0733-4f76-8050-6529d96f2a5b |
| SPL_SET_ID | 4b4725eb-95f1-45cc-852f-152beb5f1e2c |
| SPL_SET_ID | 6cb2e63c-1180-4201-b596-233d1b1a5dc8 |
| SPL_SET_ID | 6cd6ae89-c553-4328-9262-4363610a1f19 |
| SPL_SET_ID | 9ae8063c-ba28-4da2-a94c-8e1a5f75e4b3 |
| SPL_SET_ID | a8c8bb14-0423-e4a3-8bf0-8a66ce05b1bb |
| SPL_SET_ID | b702dcc9-dd0e-4386-b1e2-f20562fd2ad9 |
| VUID | 4036644 |
| Prescribable Synonym | thiotepa 100 MG Injection |
| RXNAV_STR | thiotepa 100 MG Injection |
| RxNorm Name | thiotepa 100 MG Injection |
| RxNorm Synonym | TSPA 100 MG Injection |
| Related queries | Interactions (for RxCUI 1660004) |
NDC Properties
NDC Item 00143929201
| NDC 9 | 0143-9292 |
|---|---|
| NDC 10 | 0143-9292-01 |
| NDC Item | 00143929201 |
| Packaging | 1 VIAL in 1 BOX, UNIT-DOSE (0143-9292-01) / 1 INJECTION, POWDER, LYOPHILIZED, FOR SOLUTION in 1 VIAL |
| ANDA | ANDA211755 |
| FDA SPL set id | 732107 |
| Labeler | Hikma Pharmaceuticals USA Inc. |
| Label type | HUMAN PRESCRIPTION DRUG |
| Marketing category | ANDA |
| Marketing effective time low | 2023-09-29 |
| Marketing status | ACTIVE |
| Related queries | Properties for NDC 9 0143-9292 |
NDC Item 43598017111
| NDC 9 | 43598-171 |
|---|---|
| NDC 10 | 43598-171-11 |
| NDC Item | 43598017111 |
| Packaging | 1 VIAL in 1 CARTON (43598-171-11) / 1 INJECTION, POWDER, LYOPHILIZED, FOR SOLUTION in 1 VIAL |
| ANDA | ANDA214222 |
| FDA SPL set id | 793662 |
| Labeler | Dr.Reddy's Laboratories Inc., |
| Label type | HUMAN PRESCRIPTION DRUG |
| Marketing category | ANDA |
| Marketing effective time low | 2022-11-01 |
| Marketing status | ACTIVE |
| Related queries | Properties for NDC 9 43598-171 |
NDC Item 65219002920
| NDC 9 | 65219-029 |
|---|---|
| NDC 10 | 65219-029-20 |
| NDC Item | 65219002920 |
| Packaging | 1 VIAL in 1 CARTON (65219-029-20) / 1 INJECTION, POWDER, LYOPHILIZED, FOR SOLUTION in 1 VIAL |
| ANDA | ANDA214222 |
| FDA SPL set id | 632402 |
| Labeler | Fresenius Kabi USA, LLC |
| Label type | HUMAN PRESCRIPTION DRUG |
| Marketing category | ANDA |
| Marketing effective time low | 2022-04-11 |
| Marketing status | ACTIVE |
| Related queries | Properties for NDC 9 65219-029 |
NDC Item 68083050301
| NDC 9 | 68083-503 |
|---|---|
| NDC 10 | 68083-503-01 |
| NDC Item | 68083050301 |
| Packaging | 1 VIAL in 1 CARTON (68083-503-01) / 1 INJECTION, POWDER, LYOPHILIZED, FOR SOLUTION in 1 VIAL |
| ANDA | ANDA214222 |
| FDA SPL set id | 609541 |
| Labeler | Gland Pharma Limited |
| Label type | HUMAN PRESCRIPTION DRUG |
| Marketing category | ANDA |
| Marketing effective time low | 2022-01-03 |
| Marketing status | ACTIVE |
| Related queries | Properties for NDC 9 68083-503 |
NDC Item 69539012401
| NDC 9 | 69539-124 |
|---|---|
| NDC 10 | 69539-124-01 |
| NDC Item | 69539012401 |
| Packaging | 1 VIAL, GLASS in 1 BOX (69539-124-01) / 1 INJECTION, POWDER, FOR SOLUTION in 1 VIAL, GLASS |
| ANDA | ANDA213049 |
| COLORTEXT | WHITE |
| Color | C48325 __ |
| FDA SPL set id | 456772 |
| Labeler | MSN LABORATORIES PRIVATE LIMITED |
| Label type | HUMAN PRESCRIPTION DRUG |
| Marketing category | ANDA |
| Marketing effective time low | 2020-03-04 |
| Marketing status | ACTIVE |
| Related queries | Properties for NDC 9 69539-124 |
NDC Item 71288015710
| NDC 9 | 71288-157 |
|---|---|
| NDC 10 | 71288-157-10 |
| NDC Item | 71288015710 |
| Packaging | 1 VIAL, SINGLE-DOSE in 1 CARTON (71288-157-10) / 1 INJECTION, POWDER, FOR SOLUTION in 1 VIAL, SINGLE-DOSE |
| ANDA | ANDA216037 |
| FDA SPL set id | 758393 |
| Labeler | Meitheal Pharmaceuticals Inc |
| Label type | HUMAN PRESCRIPTION DRUG |
| Marketing category | ANDA |
| Marketing effective time low | 2023-12-26 |
| Marketing status | ACTIVE |
| Related queries | Properties for NDC 9 71288-157 |
NDC Item 72205004601
| NDC 9 | 72205-046 |
|---|---|
| NDC 10 | 72205-046-01 |
| NDC Item | 72205004601 |
| Packaging | 1 VIAL, GLASS in 1 BOX (72205-046-01) / 1 INJECTION, POWDER, LYOPHILIZED, FOR SOLUTION in 1 VIAL, GLASS |
| ANDA | ANDA213049 |
| COLORTEXT | WHITE |
| Color | C48325 __ |
| FDA SPL set id | 463379 |
| Labeler | Novadoz Pharmaceuticals LLC |
| Label type | HUMAN PRESCRIPTION DRUG |
| Marketing category | ANDA |
| Marketing effective time low | 2020-02-01 |
| Marketing status | ACTIVE |
| Related queries | Properties for NDC 9 72205-046 |
NDC Item 00143929201
| NDC 9 | 0143-9292 |
|---|---|
| NDC 10 | 0143-9292-01 |
| NDC Item | 00143929201 |
| Packaging | 1 VIAL in 1 BOX, UNIT-DOSE (0143-9292-01) / 1 INJECTION, POWDER, LYOPHILIZED, FOR SOLUTION in 1 VIAL |
| ANDA | ANDA211755 |
| FDA SPL set id | 732107 |
| Labeler | Hikma Pharmaceuticals USA Inc. |
| Label type | HUMAN PRESCRIPTION DRUG |
| Marketing category | ANDA |
| Marketing effective time low | 2023-09-29 |
| Marketing status | ACTIVE |
| Related queries | Properties for NDC 9 0143-9292 |
NDC Item 43598017111
| NDC 9 | 43598-171 |
|---|---|
| NDC 10 | 43598-171-11 |
| NDC Item | 43598017111 |
| Packaging | 1 VIAL in 1 CARTON (43598-171-11) / 1 INJECTION, POWDER, LYOPHILIZED, FOR SOLUTION in 1 VIAL |
| ANDA | ANDA214222 |
| FDA SPL set id | 793662 |
| Labeler | Dr.Reddy's Laboratories Inc., |
| Label type | HUMAN PRESCRIPTION DRUG |
| Marketing category | ANDA |
| Marketing effective time low | 2022-11-01 |
| Marketing status | ACTIVE |
| Related queries | Properties for NDC 9 43598-171 |
NDC Item 65219002920
| NDC 9 | 65219-029 |
|---|---|
| NDC 10 | 65219-029-20 |
| NDC Item | 65219002920 |
| Packaging | 1 VIAL in 1 CARTON (65219-029-20) / 1 INJECTION, POWDER, LYOPHILIZED, FOR SOLUTION in 1 VIAL |
| ANDA | ANDA214222 |
| FDA SPL set id | 632402 |
| Labeler | Fresenius Kabi USA, LLC |
| Label type | HUMAN PRESCRIPTION DRUG |
| Marketing category | ANDA |
| Marketing effective time low | 2022-04-11 |
| Marketing status | ACTIVE |
| Related queries | Properties for NDC 9 65219-029 |
NDC Item 68083050301
| NDC 9 | 68083-503 |
|---|---|
| NDC 10 | 68083-503-01 |
| NDC Item | 68083050301 |
| Packaging | 1 VIAL in 1 CARTON (68083-503-01) / 1 INJECTION, POWDER, LYOPHILIZED, FOR SOLUTION in 1 VIAL |
| ANDA | ANDA214222 |
| FDA SPL set id | 609541 |
| Labeler | Gland Pharma Limited |
| Label type | HUMAN PRESCRIPTION DRUG |
| Marketing category | ANDA |
| Marketing effective time low | 2022-01-03 |
| Marketing status | ACTIVE |
| Related queries | Properties for NDC 9 68083-503 |
NDC Item 69539012401
| NDC 9 | 69539-124 |
|---|---|
| NDC 10 | 69539-124-01 |
| NDC Item | 69539012401 |
| Packaging | 1 VIAL, GLASS in 1 BOX (69539-124-01) / 1 INJECTION, POWDER, FOR SOLUTION in 1 VIAL, GLASS |
| ANDA | ANDA213049 |
| COLORTEXT | WHITE |
| Color | C48325 __ |
| FDA SPL set id | 456772 |
| Labeler | MSN LABORATORIES PRIVATE LIMITED |
| Label type | HUMAN PRESCRIPTION DRUG |
| Marketing category | ANDA |
| Marketing effective time low | 2020-03-04 |
| Marketing status | ACTIVE |
| Related queries | Properties for NDC 9 69539-124 |
NDC Item 71288015710
| NDC 9 | 71288-157 |
|---|---|
| NDC 10 | 71288-157-10 |
| NDC Item | 71288015710 |
| Packaging | 1 VIAL, SINGLE-DOSE in 1 CARTON (71288-157-10) / 1 INJECTION, POWDER, FOR SOLUTION in 1 VIAL, SINGLE-DOSE |
| ANDA | ANDA216037 |
| FDA SPL set id | 758393 |
| Labeler | Meitheal Pharmaceuticals Inc |
| Label type | HUMAN PRESCRIPTION DRUG |
| Marketing category | ANDA |
| Marketing effective time low | 2023-12-26 |
| Marketing status | ACTIVE |
| Related queries | Properties for NDC 9 71288-157 |
NDC Item 72205004601
| NDC 9 | 72205-046 |
|---|---|
| NDC 10 | 72205-046-01 |
| NDC Item | 72205004601 |
| Packaging | 1 VIAL, GLASS in 1 BOX (72205-046-01) / 1 INJECTION, POWDER, LYOPHILIZED, FOR SOLUTION in 1 VIAL, GLASS |
| ANDA | ANDA213049 |
| COLORTEXT | WHITE |
| Color | C48325 __ |
| FDA SPL set id | 463379 |
| Labeler | Novadoz Pharmaceuticals LLC |
| Label type | HUMAN PRESCRIPTION DRUG |
| Marketing category | ANDA |
| Marketing effective time low | 2020-02-01 |
| Marketing status | ACTIVE |
| Related queries | Properties for NDC 9 72205-046 |
NDC Item 00143929201
| NDC 9 | 0143-9292 |
|---|---|
| NDC 10 | 0143-9292-01 |
| NDC Item | 00143929201 |
| Packaging | 1 VIAL in 1 BOX, UNIT-DOSE (0143-9292-01) / 1 INJECTION, POWDER, LYOPHILIZED, FOR SOLUTION in 1 VIAL |
| ANDA | ANDA211755 |
| FDA SPL set id | 732107 |
| Labeler | Hikma Pharmaceuticals USA Inc. |
| Label type | HUMAN PRESCRIPTION DRUG |
| Marketing category | ANDA |
| Marketing effective time low | 2023-09-29 |
| Marketing status | ACTIVE |
| Related queries | Properties for NDC 9 0143-9292 |
NDC Item 43598017111
| NDC 9 | 43598-171 |
|---|---|
| NDC 10 | 43598-171-11 |
| NDC Item | 43598017111 |
| Packaging | 1 VIAL in 1 CARTON (43598-171-11) / 1 INJECTION, POWDER, LYOPHILIZED, FOR SOLUTION in 1 VIAL |
| ANDA | ANDA214222 |
| FDA SPL set id | 793662 |
| Labeler | Dr.Reddy's Laboratories Inc., |
| Label type | HUMAN PRESCRIPTION DRUG |
| Marketing category | ANDA |
| Marketing effective time low | 2022-11-01 |
| Marketing status | ACTIVE |
| Related queries | Properties for NDC 9 43598-171 |
NDC Item 65219002920
| NDC 9 | 65219-029 |
|---|---|
| NDC 10 | 65219-029-20 |
| NDC Item | 65219002920 |
| Packaging | 1 VIAL in 1 CARTON (65219-029-20) / 1 INJECTION, POWDER, LYOPHILIZED, FOR SOLUTION in 1 VIAL |
| ANDA | ANDA214222 |
| FDA SPL set id | 632402 |
| Labeler | Fresenius Kabi USA, LLC |
| Label type | HUMAN PRESCRIPTION DRUG |
| Marketing category | ANDA |
| Marketing effective time low | 2022-04-11 |
| Marketing status | ACTIVE |
| Related queries | Properties for NDC 9 65219-029 |
NDC Item 68083050301
| NDC 9 | 68083-503 |
|---|---|
| NDC 10 | 68083-503-01 |
| NDC Item | 68083050301 |
| Packaging | 1 VIAL in 1 CARTON (68083-503-01) / 1 INJECTION, POWDER, LYOPHILIZED, FOR SOLUTION in 1 VIAL |
| ANDA | ANDA214222 |
| FDA SPL set id | 609541 |
| Labeler | Gland Pharma Limited |
| Label type | HUMAN PRESCRIPTION DRUG |
| Marketing category | ANDA |
| Marketing effective time low | 2022-01-03 |
| Marketing status | ACTIVE |
| Related queries | Properties for NDC 9 68083-503 |
NDC Item 69539012401
| NDC 9 | 69539-124 |
|---|---|
| NDC 10 | 69539-124-01 |
| NDC Item | 69539012401 |
| Packaging | 1 VIAL, GLASS in 1 BOX (69539-124-01) / 1 INJECTION, POWDER, FOR SOLUTION in 1 VIAL, GLASS |
| ANDA | ANDA213049 |
| COLORTEXT | WHITE |
| Color | C48325 __ |
| FDA SPL set id | 456772 |
| Labeler | MSN LABORATORIES PRIVATE LIMITED |
| Label type | HUMAN PRESCRIPTION DRUG |
| Marketing category | ANDA |
| Marketing effective time low | 2020-03-04 |
| Marketing status | ACTIVE |
| Related queries | Properties for NDC 9 69539-124 |
NDC Item 71288015710
| NDC 9 | 71288-157 |
|---|---|
| NDC 10 | 71288-157-10 |
| NDC Item | 71288015710 |
| Packaging | 1 VIAL, SINGLE-DOSE in 1 CARTON (71288-157-10) / 1 INJECTION, POWDER, FOR SOLUTION in 1 VIAL, SINGLE-DOSE |
| ANDA | ANDA216037 |
| FDA SPL set id | 758393 |
| Labeler | Meitheal Pharmaceuticals Inc |
| Label type | HUMAN PRESCRIPTION DRUG |
| Marketing category | ANDA |
| Marketing effective time low | 2023-12-26 |
| Marketing status | ACTIVE |
| Related queries | Properties for NDC 9 71288-157 |
NDC Item 72205004601
| NDC 9 | 72205-046 |
|---|---|
| NDC 10 | 72205-046-01 |
| NDC Item | 72205004601 |
| Packaging | 1 VIAL, GLASS in 1 BOX (72205-046-01) / 1 INJECTION, POWDER, LYOPHILIZED, FOR SOLUTION in 1 VIAL, GLASS |
| ANDA | ANDA213049 |
| COLORTEXT | WHITE |
| Color | C48325 __ |
| FDA SPL set id | 463379 |
| Labeler | Novadoz Pharmaceuticals LLC |
| Label type | HUMAN PRESCRIPTION DRUG |
| Marketing category | ANDA |
| Marketing effective time low | 2020-02-01 |
| Marketing status | ACTIVE |
| Related queries | Properties for NDC 9 72205-046 |
NDC Item 00143929201
| NDC 9 | 0143-9292 |
|---|---|
| NDC 10 | 0143-9292-01 |
| NDC Item | 00143929201 |
| Packaging | 1 VIAL in 1 BOX, UNIT-DOSE (0143-9292-01) / 1 INJECTION, POWDER, LYOPHILIZED, FOR SOLUTION in 1 VIAL |
| ANDA | ANDA211755 |
| FDA SPL set id | 732107 |
| Labeler | Hikma Pharmaceuticals USA Inc. |
| Label type | HUMAN PRESCRIPTION DRUG |
| Marketing category | ANDA |
| Marketing effective time low | 2023-09-29 |
| Marketing status | ACTIVE |
| Related queries | Properties for NDC 9 0143-9292 |
NDC Item 43598017111
| NDC 9 | 43598-171 |
|---|---|
| NDC 10 | 43598-171-11 |
| NDC Item | 43598017111 |
| Packaging | 1 VIAL in 1 CARTON (43598-171-11) / 1 INJECTION, POWDER, LYOPHILIZED, FOR SOLUTION in 1 VIAL |
| ANDA | ANDA214222 |
| FDA SPL set id | 793662 |
| Labeler | Dr.Reddy's Laboratories Inc., |
| Label type | HUMAN PRESCRIPTION DRUG |
| Marketing category | ANDA |
| Marketing effective time low | 2022-11-01 |
| Marketing status | ACTIVE |
| Related queries | Properties for NDC 9 43598-171 |
NDC Item 65219002920
| NDC 9 | 65219-029 |
|---|---|
| NDC 10 | 65219-029-20 |
| NDC Item | 65219002920 |
| Packaging | 1 VIAL in 1 CARTON (65219-029-20) / 1 INJECTION, POWDER, LYOPHILIZED, FOR SOLUTION in 1 VIAL |
| ANDA | ANDA214222 |
| FDA SPL set id | 632402 |
| Labeler | Fresenius Kabi USA, LLC |
| Label type | HUMAN PRESCRIPTION DRUG |
| Marketing category | ANDA |
| Marketing effective time low | 2022-04-11 |
| Marketing status | ACTIVE |
| Related queries | Properties for NDC 9 65219-029 |
NDC Item 68083050301
| NDC 9 | 68083-503 |
|---|---|
| NDC 10 | 68083-503-01 |
| NDC Item | 68083050301 |
| Packaging | 1 VIAL in 1 CARTON (68083-503-01) / 1 INJECTION, POWDER, LYOPHILIZED, FOR SOLUTION in 1 VIAL |
| ANDA | ANDA214222 |
| FDA SPL set id | 609541 |
| Labeler | Gland Pharma Limited |
| Label type | HUMAN PRESCRIPTION DRUG |
| Marketing category | ANDA |
| Marketing effective time low | 2022-01-03 |
| Marketing status | ACTIVE |
| Related queries | Properties for NDC 9 68083-503 |
NDC Item 69539012401
| NDC 9 | 69539-124 |
|---|---|
| NDC 10 | 69539-124-01 |
| NDC Item | 69539012401 |
| Packaging | 1 VIAL, GLASS in 1 BOX (69539-124-01) / 1 INJECTION, POWDER, FOR SOLUTION in 1 VIAL, GLASS |
| ANDA | ANDA213049 |
| COLORTEXT | WHITE |
| Color | C48325 __ |
| FDA SPL set id | 456772 |
| Labeler | MSN LABORATORIES PRIVATE LIMITED |
| Label type | HUMAN PRESCRIPTION DRUG |
| Marketing category | ANDA |
| Marketing effective time low | 2020-03-04 |
| Marketing status | ACTIVE |
| Related queries | Properties for NDC 9 69539-124 |
NDC Item 71288015710
| NDC 9 | 71288-157 |
|---|---|
| NDC 10 | 71288-157-10 |
| NDC Item | 71288015710 |
| Packaging | 1 VIAL, SINGLE-DOSE in 1 CARTON (71288-157-10) / 1 INJECTION, POWDER, FOR SOLUTION in 1 VIAL, SINGLE-DOSE |
| ANDA | ANDA216037 |
| FDA SPL set id | 758393 |
| Labeler | Meitheal Pharmaceuticals Inc |
| Label type | HUMAN PRESCRIPTION DRUG |
| Marketing category | ANDA |
| Marketing effective time low | 2023-12-26 |
| Marketing status | ACTIVE |
| Related queries | Properties for NDC 9 71288-157 |
NDC Item 72205004601
| NDC 9 | 72205-046 |
|---|---|
| NDC 10 | 72205-046-01 |
| NDC Item | 72205004601 |
| Packaging | 1 VIAL, GLASS in 1 BOX (72205-046-01) / 1 INJECTION, POWDER, LYOPHILIZED, FOR SOLUTION in 1 VIAL, GLASS |
| ANDA | ANDA213049 |
| COLORTEXT | WHITE |
| Color | C48325 __ |
| FDA SPL set id | 463379 |
| Labeler | Novadoz Pharmaceuticals LLC |
| Label type | HUMAN PRESCRIPTION DRUG |
| Marketing category | ANDA |
| Marketing effective time low | 2020-02-01 |
| Marketing status | ACTIVE |
| Related queries | Properties for NDC 9 72205-046 |
NDC Item 00143929201
| NDC 9 | 0143-9292 |
|---|---|
| NDC 10 | 0143-9292-01 |
| NDC Item | 00143929201 |
| Packaging | 1 VIAL in 1 BOX, UNIT-DOSE (0143-9292-01) / 1 INJECTION, POWDER, LYOPHILIZED, FOR SOLUTION in 1 VIAL |
| ANDA | ANDA211755 |
| FDA SPL set id | 732107 |
| Labeler | Hikma Pharmaceuticals USA Inc. |
| Label type | HUMAN PRESCRIPTION DRUG |
| Marketing category | ANDA |
| Marketing effective time low | 2023-09-29 |
| Marketing status | ACTIVE |
| Related queries | Properties for NDC 9 0143-9292 |
NDC Item 43598017111
| NDC 9 | 43598-171 |
|---|---|
| NDC 10 | 43598-171-11 |
| NDC Item | 43598017111 |
| Packaging | 1 VIAL in 1 CARTON (43598-171-11) / 1 INJECTION, POWDER, LYOPHILIZED, FOR SOLUTION in 1 VIAL |
| ANDA | ANDA214222 |
| FDA SPL set id | 793662 |
| Labeler | Dr.Reddy's Laboratories Inc., |
| Label type | HUMAN PRESCRIPTION DRUG |
| Marketing category | ANDA |
| Marketing effective time low | 2022-11-01 |
| Marketing status | ACTIVE |
| Related queries | Properties for NDC 9 43598-171 |
NDC Item 65219002920
| NDC 9 | 65219-029 |
|---|---|
| NDC 10 | 65219-029-20 |
| NDC Item | 65219002920 |
| Packaging | 1 VIAL in 1 CARTON (65219-029-20) / 1 INJECTION, POWDER, LYOPHILIZED, FOR SOLUTION in 1 VIAL |
| ANDA | ANDA214222 |
| FDA SPL set id | 632402 |
| Labeler | Fresenius Kabi USA, LLC |
| Label type | HUMAN PRESCRIPTION DRUG |
| Marketing category | ANDA |
| Marketing effective time low | 2022-04-11 |
| Marketing status | ACTIVE |
| Related queries | Properties for NDC 9 65219-029 |
NDC Item 68083050301
| NDC 9 | 68083-503 |
|---|---|
| NDC 10 | 68083-503-01 |
| NDC Item | 68083050301 |
| Packaging | 1 VIAL in 1 CARTON (68083-503-01) / 1 INJECTION, POWDER, LYOPHILIZED, FOR SOLUTION in 1 VIAL |
| ANDA | ANDA214222 |
| FDA SPL set id | 609541 |
| Labeler | Gland Pharma Limited |
| Label type | HUMAN PRESCRIPTION DRUG |
| Marketing category | ANDA |
| Marketing effective time low | 2022-01-03 |
| Marketing status | ACTIVE |
| Related queries | Properties for NDC 9 68083-503 |
NDC Item 69539012401
| NDC 9 | 69539-124 |
|---|---|
| NDC 10 | 69539-124-01 |
| NDC Item | 69539012401 |
| Packaging | 1 VIAL, GLASS in 1 BOX (69539-124-01) / 1 INJECTION, POWDER, FOR SOLUTION in 1 VIAL, GLASS |
| ANDA | ANDA213049 |
| COLORTEXT | WHITE |
| Color | C48325 __ |
| FDA SPL set id | 456772 |
| Labeler | MSN LABORATORIES PRIVATE LIMITED |
| Label type | HUMAN PRESCRIPTION DRUG |
| Marketing category | ANDA |
| Marketing effective time low | 2020-03-04 |
| Marketing status | ACTIVE |
| Related queries | Properties for NDC 9 69539-124 |
NDC Item 71288015710
| NDC 9 | 71288-157 |
|---|---|
| NDC 10 | 71288-157-10 |
| NDC Item | 71288015710 |
| Packaging | 1 VIAL, SINGLE-DOSE in 1 CARTON (71288-157-10) / 1 INJECTION, POWDER, FOR SOLUTION in 1 VIAL, SINGLE-DOSE |
| ANDA | ANDA216037 |
| FDA SPL set id | 758393 |
| Labeler | Meitheal Pharmaceuticals Inc |
| Label type | HUMAN PRESCRIPTION DRUG |
| Marketing category | ANDA |
| Marketing effective time low | 2023-12-26 |
| Marketing status | ACTIVE |
| Related queries | Properties for NDC 9 71288-157 |
NDC Item 72205004601
| NDC 9 | 72205-046 |
|---|---|
| NDC 10 | 72205-046-01 |
| NDC Item | 72205004601 |
| Packaging | 1 VIAL, GLASS in 1 BOX (72205-046-01) / 1 INJECTION, POWDER, LYOPHILIZED, FOR SOLUTION in 1 VIAL, GLASS |
| ANDA | ANDA213049 |
| COLORTEXT | WHITE |
| Color | C48325 __ |
| FDA SPL set id | 463379 |
| Labeler | Novadoz Pharmaceuticals LLC |
| Label type | HUMAN PRESCRIPTION DRUG |
| Marketing category | ANDA |
| Marketing effective time low | 2020-02-01 |
| Marketing status | ACTIVE |
| Related queries | Properties for NDC 9 72205-046 |
NDC Item 00143929201
| NDC 9 | 0143-9292 |
|---|---|
| NDC 10 | 0143-9292-01 |
| NDC Item | 00143929201 |
| Packaging | 1 VIAL in 1 BOX, UNIT-DOSE (0143-9292-01) / 1 INJECTION, POWDER, LYOPHILIZED, FOR SOLUTION in 1 VIAL |
| ANDA | ANDA211755 |
| FDA SPL set id | 732107 |
| Labeler | Hikma Pharmaceuticals USA Inc. |
| Label type | HUMAN PRESCRIPTION DRUG |
| Marketing category | ANDA |
| Marketing effective time low | 2023-09-29 |
| Marketing status | ACTIVE |
| Related queries | Properties for NDC 9 0143-9292 |
NDC Item 43598017111
| NDC 9 | 43598-171 |
|---|---|
| NDC 10 | 43598-171-11 |
| NDC Item | 43598017111 |
| Packaging | 1 VIAL in 1 CARTON (43598-171-11) / 1 INJECTION, POWDER, LYOPHILIZED, FOR SOLUTION in 1 VIAL |
| ANDA | ANDA214222 |
| FDA SPL set id | 793662 |
| Labeler | Dr.Reddy's Laboratories Inc., |
| Label type | HUMAN PRESCRIPTION DRUG |
| Marketing category | ANDA |
| Marketing effective time low | 2022-11-01 |
| Marketing status | ACTIVE |
| Related queries | Properties for NDC 9 43598-171 |
NDC Item 65219002920
| NDC 9 | 65219-029 |
|---|---|
| NDC 10 | 65219-029-20 |
| NDC Item | 65219002920 |
| Packaging | 1 VIAL in 1 CARTON (65219-029-20) / 1 INJECTION, POWDER, LYOPHILIZED, FOR SOLUTION in 1 VIAL |
| ANDA | ANDA214222 |
| FDA SPL set id | 632402 |
| Labeler | Fresenius Kabi USA, LLC |
| Label type | HUMAN PRESCRIPTION DRUG |
| Marketing category | ANDA |
| Marketing effective time low | 2022-04-11 |
| Marketing status | ACTIVE |
| Related queries | Properties for NDC 9 65219-029 |
NDC Item 68083050301
| NDC 9 | 68083-503 |
|---|---|
| NDC 10 | 68083-503-01 |
| NDC Item | 68083050301 |
| Packaging | 1 VIAL in 1 CARTON (68083-503-01) / 1 INJECTION, POWDER, LYOPHILIZED, FOR SOLUTION in 1 VIAL |
| ANDA | ANDA214222 |
| FDA SPL set id | 609541 |
| Labeler | Gland Pharma Limited |
| Label type | HUMAN PRESCRIPTION DRUG |
| Marketing category | ANDA |
| Marketing effective time low | 2022-01-03 |
| Marketing status | ACTIVE |
| Related queries | Properties for NDC 9 68083-503 |
NDC Item 69539012401
| NDC 9 | 69539-124 |
|---|---|
| NDC 10 | 69539-124-01 |
| NDC Item | 69539012401 |
| Packaging | 1 VIAL, GLASS in 1 BOX (69539-124-01) / 1 INJECTION, POWDER, FOR SOLUTION in 1 VIAL, GLASS |
| ANDA | ANDA213049 |
| COLORTEXT | WHITE |
| Color | C48325 __ |
| FDA SPL set id | 456772 |
| Labeler | MSN LABORATORIES PRIVATE LIMITED |
| Label type | HUMAN PRESCRIPTION DRUG |
| Marketing category | ANDA |
| Marketing effective time low | 2020-03-04 |
| Marketing status | ACTIVE |
| Related queries | Properties for NDC 9 69539-124 |
NDC Item 71288015710
| NDC 9 | 71288-157 |
|---|---|
| NDC 10 | 71288-157-10 |
| NDC Item | 71288015710 |
| Packaging | 1 VIAL, SINGLE-DOSE in 1 CARTON (71288-157-10) / 1 INJECTION, POWDER, FOR SOLUTION in 1 VIAL, SINGLE-DOSE |
| ANDA | ANDA216037 |
| FDA SPL set id | 758393 |
| Labeler | Meitheal Pharmaceuticals Inc |
| Label type | HUMAN PRESCRIPTION DRUG |
| Marketing category | ANDA |
| Marketing effective time low | 2023-12-26 |
| Marketing status | ACTIVE |
| Related queries | Properties for NDC 9 71288-157 |
NDC Item 72205004601
| NDC 9 | 72205-046 |
|---|---|
| NDC 10 | 72205-046-01 |
| NDC Item | 72205004601 |
| Packaging | 1 VIAL, GLASS in 1 BOX (72205-046-01) / 1 INJECTION, POWDER, LYOPHILIZED, FOR SOLUTION in 1 VIAL, GLASS |
| ANDA | ANDA213049 |
| COLORTEXT | WHITE |
| Color | C48325 __ |
| FDA SPL set id | 463379 |
| Labeler | Novadoz Pharmaceuticals LLC |
| Label type | HUMAN PRESCRIPTION DRUG |
| Marketing category | ANDA |
| Marketing effective time low | 2020-02-01 |
| Marketing status | ACTIVE |
| Related queries | Properties for NDC 9 72205-046 |
NDC Item 00143929201
| NDC 9 | 0143-9292 |
|---|---|
| NDC 10 | 0143-9292-01 |
| NDC Item | 00143929201 |
| Packaging | 1 VIAL in 1 BOX, UNIT-DOSE (0143-9292-01) / 1 INJECTION, POWDER, LYOPHILIZED, FOR SOLUTION in 1 VIAL |
| ANDA | ANDA211755 |
| FDA SPL set id | 732107 |
| Labeler | Hikma Pharmaceuticals USA Inc. |
| Label type | HUMAN PRESCRIPTION DRUG |
| Marketing category | ANDA |
| Marketing effective time low | 2023-09-29 |
| Marketing status | ACTIVE |
| Related queries | Properties for NDC 9 0143-9292 |
NDC Item 43598017111
| NDC 9 | 43598-171 |
|---|---|
| NDC 10 | 43598-171-11 |
| NDC Item | 43598017111 |
| Packaging | 1 VIAL in 1 CARTON (43598-171-11) / 1 INJECTION, POWDER, LYOPHILIZED, FOR SOLUTION in 1 VIAL |
| ANDA | ANDA214222 |
| FDA SPL set id | 793662 |
| Labeler | Dr.Reddy's Laboratories Inc., |
| Label type | HUMAN PRESCRIPTION DRUG |
| Marketing category | ANDA |
| Marketing effective time low | 2022-11-01 |
| Marketing status | ACTIVE |
| Related queries | Properties for NDC 9 43598-171 |
NDC Item 65219002920
| NDC 9 | 65219-029 |
|---|---|
| NDC 10 | 65219-029-20 |
| NDC Item | 65219002920 |
| Packaging | 1 VIAL in 1 CARTON (65219-029-20) / 1 INJECTION, POWDER, LYOPHILIZED, FOR SOLUTION in 1 VIAL |
| ANDA | ANDA214222 |
| FDA SPL set id | 632402 |
| Labeler | Fresenius Kabi USA, LLC |
| Label type | HUMAN PRESCRIPTION DRUG |
| Marketing category | ANDA |
| Marketing effective time low | 2022-04-11 |
| Marketing status | ACTIVE |
| Related queries | Properties for NDC 9 65219-029 |
NDC Item 68083050301
| NDC 9 | 68083-503 |
|---|---|
| NDC 10 | 68083-503-01 |
| NDC Item | 68083050301 |
| Packaging | 1 VIAL in 1 CARTON (68083-503-01) / 1 INJECTION, POWDER, LYOPHILIZED, FOR SOLUTION in 1 VIAL |
| ANDA | ANDA214222 |
| FDA SPL set id | 609541 |
| Labeler | Gland Pharma Limited |
| Label type | HUMAN PRESCRIPTION DRUG |
| Marketing category | ANDA |
| Marketing effective time low | 2022-01-03 |
| Marketing status | ACTIVE |
| Related queries | Properties for NDC 9 68083-503 |
NDC Item 69539012401
| NDC 9 | 69539-124 |
|---|---|
| NDC 10 | 69539-124-01 |
| NDC Item | 69539012401 |
| Packaging | 1 VIAL, GLASS in 1 BOX (69539-124-01) / 1 INJECTION, POWDER, FOR SOLUTION in 1 VIAL, GLASS |
| ANDA | ANDA213049 |
| COLORTEXT | WHITE |
| Color | C48325 __ |
| FDA SPL set id | 456772 |
| Labeler | MSN LABORATORIES PRIVATE LIMITED |
| Label type | HUMAN PRESCRIPTION DRUG |
| Marketing category | ANDA |
| Marketing effective time low | 2020-03-04 |
| Marketing status | ACTIVE |
| Related queries | Properties for NDC 9 69539-124 |
NDC Item 71288015710
| NDC 9 | 71288-157 |
|---|---|
| NDC 10 | 71288-157-10 |
| NDC Item | 71288015710 |
| Packaging | 1 VIAL, SINGLE-DOSE in 1 CARTON (71288-157-10) / 1 INJECTION, POWDER, FOR SOLUTION in 1 VIAL, SINGLE-DOSE |
| ANDA | ANDA216037 |
| FDA SPL set id | 758393 |
| Labeler | Meitheal Pharmaceuticals Inc |
| Label type | HUMAN PRESCRIPTION DRUG |
| Marketing category | ANDA |
| Marketing effective time low | 2023-12-26 |
| Marketing status | ACTIVE |
| Related queries | Properties for NDC 9 71288-157 |
NDC Item 72205004601
| NDC 9 | 72205-046 |
|---|---|
| NDC 10 | 72205-046-01 |
| NDC Item | 72205004601 |
| Packaging | 1 VIAL, GLASS in 1 BOX (72205-046-01) / 1 INJECTION, POWDER, LYOPHILIZED, FOR SOLUTION in 1 VIAL, GLASS |
| ANDA | ANDA213049 |
| COLORTEXT | WHITE |
| Color | C48325 __ |
| FDA SPL set id | 463379 |
| Labeler | Novadoz Pharmaceuticals LLC |
| Label type | HUMAN PRESCRIPTION DRUG |
| Marketing category | ANDA |
| Marketing effective time low | 2020-02-01 |
| Marketing status | ACTIVE |
| Related queries | Properties for NDC 9 72205-046 |