NDC properties for "5 ML SMX 80 MG/ML / TMP 16 MG/ML Injection" (RxCUI 1809083)
About this data
The tables show NDC propoerties for 5 ML SMX 80 MG/ML / TMP 16 MG/ML Injection with the RxCUI 1809083
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 5 ML SMX 80 MG/ML / TMP 16 MG/ML Injection (RxCUI 1809083)
| ANDA | ANDA073303 |
|---|---|
| ANDA | ANDA206607 |
| ANDA | ANDA212231 |
| MMSL_CODE | MTH_RXN_BD3230 |
| RxCUI | 1809083 |
| SPL_SET_ID | 24ff620f-d84d-43b8-a82b-97fc1a1a2916 |
| SPL_SET_ID | 793c75eb-dd65-4b6d-ac46-6e57ce1334f7 |
| SPL_SET_ID | b89b5502-ce87-45a6-a43c-9891da3cfca4 |
| SPL_SET_ID | ebb570bb-6e5e-489e-875c-9e7b3a6d716a |
| VUID | 4001956 |
| Prescribable Synonym | sulfamethoxazole 400 MG / trimethoprim 80 MG in 5 ML Injection |
| RXNAV_STR | 5 ML sulfamethoxazole 80 MG/ML / trimethoprim 16 MG/ML Injection |
| RxNorm Name | 5 ML sulfamethoxazole 80 MG/ML / trimethoprim 16 MG/ML Injection |
| RxNorm Synonym | 5 ML SMX 80 MG/ML / TMP 16 MG/ML Injection |
| RxNorm Synonym | sulfamethoxazole 400 MG / trimethoprim 80 MG per 5 ML Injection |
| Related queries | Interactions (for RxCUI 1809083) |
NDC Properties
NDC Item 00703950301
| NDC 9 | 0703-9503 |
|---|---|
| NDC 10 | 0703-9503-01 |
| NDC Item | 00703950301 |
| Packaging | 5 mL in 1 VIAL, SINGLE-DOSE |
| ANDA | ANDA073303 |
| FDA SPL set id | 716741 |
| Labeler | Teva Parenteral Medicines, Inc. |
| Label type | HUMAN PRESCRIPTION DRUG |
| Marketing category | ANDA |
| Marketing effective time low | 1991-11-01 |
| Marketing status | ACTIVE |
| Related queries | Properties for NDC 9 0703-9503 |
NDC Item 00703950303
| NDC 9 | 0703-9503 |
|---|---|
| NDC 10 | 0703-9503-03 |
| NDC Item | 00703950303 |
| Packaging | 10 VIAL, SINGLE-DOSE in 1 CARTON (0703-9503-03) / 5 mL in 1 VIAL, SINGLE-DOSE (0703-9503-01) |
| ANDA | ANDA073303 |
| FDA SPL set id | 716741 |
| Labeler | Teva Parenteral Medicines, Inc. |
| Label type | HUMAN PRESCRIPTION DRUG |
| Marketing category | ANDA |
| Marketing effective time low | 1991-11-01 |
| Marketing status | ACTIVE |
| Related queries | Properties for NDC 9 0703-9503 |
NDC Item 67457077800
| NDC 9 | 67457-778 |
|---|---|
| NDC 10 | 67457-778-00 |
| NDC Item | 67457077800 |
| Packaging | 5 mL in 1 VIAL, SINGLE-DOSE |
| ANDA | ANDA206607 |
| FDA SPL set id | 849345 |
| Labeler | Mylan Institutional LLC |
| Label type | HUMAN PRESCRIPTION DRUG |
| Marketing category | ANDA |
| Marketing effective time high | 2025-10-31 |
| Marketing effective time low | 2017-12-31 |
| Marketing status | COMPLETED |
| Related queries | Properties for NDC 9 67457-778 |
NDC Item 67457077805
| NDC 9 | 67457-778 |
|---|---|
| NDC 10 | 67457-778-05 |
| NDC Item | 67457077805 |
| Packaging | 10 VIAL, SINGLE-DOSE in 1 CARTON (67457-778-05) / 5 mL in 1 VIAL, SINGLE-DOSE (67457-778-00) |
| ANDA | ANDA206607 |
| FDA SPL set id | 849345 |
| Labeler | Mylan Institutional LLC |
| Label type | HUMAN PRESCRIPTION DRUG |
| Marketing category | ANDA |
| Marketing effective time high | 2025-10-31 |
| Marketing effective time low | 2017-12-31 |
| Marketing status | COMPLETED |
| Related queries | Properties for NDC 9 67457-778 |
NDC Item 67457092100
| NDC 9 | 67457-921 |
|---|---|
| NDC 10 | 67457-921-00 |
| NDC Item | 67457092100 |
| Packaging | 5 mL in 1 VIAL, SINGLE-DOSE |
| ANDA | ANDA206607 |
| FDA SPL set id | 825030 |
| Labeler | Mylan Institutional LLC |
| Label type | HUMAN PRESCRIPTION DRUG |
| Marketing category | ANDA |
| Marketing effective time high | 2025-03-31 |
| Marketing effective time low | 2020-10-12 |
| Marketing status | COMPLETED |
| Related queries | Properties for NDC 9 67457-921 |
NDC Item 67457092105
| NDC 9 | 67457-921 |
|---|---|
| NDC 10 | 67457-921-05 |
| NDC Item | 67457092105 |
| Packaging | 10 VIAL, SINGLE-DOSE in 1 CARTON (67457-921-05) / 5 mL in 1 VIAL, SINGLE-DOSE (67457-921-00) |
| ANDA | ANDA206607 |
| FDA SPL set id | 825030 |
| Labeler | Mylan Institutional LLC |
| Label type | HUMAN PRESCRIPTION DRUG |
| Marketing category | ANDA |
| Marketing effective time high | 2025-03-31 |
| Marketing effective time low | 2020-10-12 |
| Marketing status | COMPLETED |
| Related queries | Properties for NDC 9 67457-921 |
NDC Item 70069036101
| NDC 9 | 70069-361 |
|---|---|
| NDC 10 | 70069-361-01 |
| NDC Item | 70069036101 |
| Packaging | 5 mL in 1 VIAL |
| ANDA | ANDA212231 |
| COLORTEXT | YELLOW(Clear, colorless to pale yellow solution) |
| Color | C48330 __ |
| FDA SPL set id | 723076 |
| Labeler | Somerset Therapeutics, LLC |
| Label type | HUMAN PRESCRIPTION DRUG |
| Marketing category | ANDA |
| Marketing effective time low | 2019-08-29 |
| Marketing status | ACTIVE |
| Related queries | Properties for NDC 9 70069-361 |
NDC Item 70069036110
| NDC 9 | 70069-361 |
|---|---|
| NDC 10 | 70069-361-10 |
| NDC Item | 70069036110 |
| Packaging | 10 VIAL in 1 CARTON (70069-361-10) / 5 mL in 1 VIAL (70069-361-01) |
| ANDA | ANDA212231 |
| COLORTEXT | YELLOW(Clear, colorless to pale yellow solution) |
| Color | C48330 __ |
| FDA SPL set id | 723076 |
| Labeler | Somerset Therapeutics, LLC |
| Label type | HUMAN PRESCRIPTION DRUG |
| Marketing category | ANDA |
| Marketing effective time low | 2019-08-29 |
| Marketing status | ACTIVE |
| Related queries | Properties for NDC 9 70069-361 |
NDC Item 00703950301
| NDC 9 | 0703-9503 |
|---|---|
| NDC 10 | 0703-9503-01 |
| NDC Item | 00703950301 |
| Packaging | 5 mL in 1 VIAL, SINGLE-DOSE |
| ANDA | ANDA073303 |
| FDA SPL set id | 716741 |
| Labeler | Teva Parenteral Medicines, Inc. |
| Label type | HUMAN PRESCRIPTION DRUG |
| Marketing category | ANDA |
| Marketing effective time low | 1991-11-01 |
| Marketing status | ACTIVE |
| Related queries | Properties for NDC 9 0703-9503 |
NDC Item 00703950303
| NDC 9 | 0703-9503 |
|---|---|
| NDC 10 | 0703-9503-03 |
| NDC Item | 00703950303 |
| Packaging | 10 VIAL, SINGLE-DOSE in 1 CARTON (0703-9503-03) / 5 mL in 1 VIAL, SINGLE-DOSE (0703-9503-01) |
| ANDA | ANDA073303 |
| FDA SPL set id | 716741 |
| Labeler | Teva Parenteral Medicines, Inc. |
| Label type | HUMAN PRESCRIPTION DRUG |
| Marketing category | ANDA |
| Marketing effective time low | 1991-11-01 |
| Marketing status | ACTIVE |
| Related queries | Properties for NDC 9 0703-9503 |
NDC Item 67457077800
| NDC 9 | 67457-778 |
|---|---|
| NDC 10 | 67457-778-00 |
| NDC Item | 67457077800 |
| Packaging | 5 mL in 1 VIAL, SINGLE-DOSE |
| ANDA | ANDA206607 |
| FDA SPL set id | 849345 |
| Labeler | Mylan Institutional LLC |
| Label type | HUMAN PRESCRIPTION DRUG |
| Marketing category | ANDA |
| Marketing effective time high | 2025-10-31 |
| Marketing effective time low | 2017-12-31 |
| Marketing status | COMPLETED |
| Related queries | Properties for NDC 9 67457-778 |
NDC Item 67457077805
| NDC 9 | 67457-778 |
|---|---|
| NDC 10 | 67457-778-05 |
| NDC Item | 67457077805 |
| Packaging | 10 VIAL, SINGLE-DOSE in 1 CARTON (67457-778-05) / 5 mL in 1 VIAL, SINGLE-DOSE (67457-778-00) |
| ANDA | ANDA206607 |
| FDA SPL set id | 849345 |
| Labeler | Mylan Institutional LLC |
| Label type | HUMAN PRESCRIPTION DRUG |
| Marketing category | ANDA |
| Marketing effective time high | 2025-10-31 |
| Marketing effective time low | 2017-12-31 |
| Marketing status | COMPLETED |
| Related queries | Properties for NDC 9 67457-778 |
NDC Item 67457092100
| NDC 9 | 67457-921 |
|---|---|
| NDC 10 | 67457-921-00 |
| NDC Item | 67457092100 |
| Packaging | 5 mL in 1 VIAL, SINGLE-DOSE |
| ANDA | ANDA206607 |
| FDA SPL set id | 825030 |
| Labeler | Mylan Institutional LLC |
| Label type | HUMAN PRESCRIPTION DRUG |
| Marketing category | ANDA |
| Marketing effective time high | 2025-03-31 |
| Marketing effective time low | 2020-10-12 |
| Marketing status | COMPLETED |
| Related queries | Properties for NDC 9 67457-921 |
NDC Item 67457092105
| NDC 9 | 67457-921 |
|---|---|
| NDC 10 | 67457-921-05 |
| NDC Item | 67457092105 |
| Packaging | 10 VIAL, SINGLE-DOSE in 1 CARTON (67457-921-05) / 5 mL in 1 VIAL, SINGLE-DOSE (67457-921-00) |
| ANDA | ANDA206607 |
| FDA SPL set id | 825030 |
| Labeler | Mylan Institutional LLC |
| Label type | HUMAN PRESCRIPTION DRUG |
| Marketing category | ANDA |
| Marketing effective time high | 2025-03-31 |
| Marketing effective time low | 2020-10-12 |
| Marketing status | COMPLETED |
| Related queries | Properties for NDC 9 67457-921 |
NDC Item 70069036101
| NDC 9 | 70069-361 |
|---|---|
| NDC 10 | 70069-361-01 |
| NDC Item | 70069036101 |
| Packaging | 5 mL in 1 VIAL |
| ANDA | ANDA212231 |
| COLORTEXT | YELLOW(Clear, colorless to pale yellow solution) |
| Color | C48330 __ |
| FDA SPL set id | 723076 |
| Labeler | Somerset Therapeutics, LLC |
| Label type | HUMAN PRESCRIPTION DRUG |
| Marketing category | ANDA |
| Marketing effective time low | 2019-08-29 |
| Marketing status | ACTIVE |
| Related queries | Properties for NDC 9 70069-361 |
NDC Item 70069036110
| NDC 9 | 70069-361 |
|---|---|
| NDC 10 | 70069-361-10 |
| NDC Item | 70069036110 |
| Packaging | 10 VIAL in 1 CARTON (70069-361-10) / 5 mL in 1 VIAL (70069-361-01) |
| ANDA | ANDA212231 |
| COLORTEXT | YELLOW(Clear, colorless to pale yellow solution) |
| Color | C48330 __ |
| FDA SPL set id | 723076 |
| Labeler | Somerset Therapeutics, LLC |
| Label type | HUMAN PRESCRIPTION DRUG |
| Marketing category | ANDA |
| Marketing effective time low | 2019-08-29 |
| Marketing status | ACTIVE |
| Related queries | Properties for NDC 9 70069-361 |
NDC Item 00703950301
| NDC 9 | 0703-9503 |
|---|---|
| NDC 10 | 0703-9503-01 |
| NDC Item | 00703950301 |
| Packaging | 5 mL in 1 VIAL, SINGLE-DOSE |
| ANDA | ANDA073303 |
| FDA SPL set id | 716741 |
| Labeler | Teva Parenteral Medicines, Inc. |
| Label type | HUMAN PRESCRIPTION DRUG |
| Marketing category | ANDA |
| Marketing effective time low | 1991-11-01 |
| Marketing status | ACTIVE |
| Related queries | Properties for NDC 9 0703-9503 |
NDC Item 00703950303
| NDC 9 | 0703-9503 |
|---|---|
| NDC 10 | 0703-9503-03 |
| NDC Item | 00703950303 |
| Packaging | 10 VIAL, SINGLE-DOSE in 1 CARTON (0703-9503-03) / 5 mL in 1 VIAL, SINGLE-DOSE (0703-9503-01) |
| ANDA | ANDA073303 |
| FDA SPL set id | 716741 |
| Labeler | Teva Parenteral Medicines, Inc. |
| Label type | HUMAN PRESCRIPTION DRUG |
| Marketing category | ANDA |
| Marketing effective time low | 1991-11-01 |
| Marketing status | ACTIVE |
| Related queries | Properties for NDC 9 0703-9503 |
NDC Item 67457077800
| NDC 9 | 67457-778 |
|---|---|
| NDC 10 | 67457-778-00 |
| NDC Item | 67457077800 |
| Packaging | 5 mL in 1 VIAL, SINGLE-DOSE |
| ANDA | ANDA206607 |
| FDA SPL set id | 849345 |
| Labeler | Mylan Institutional LLC |
| Label type | HUMAN PRESCRIPTION DRUG |
| Marketing category | ANDA |
| Marketing effective time high | 2025-10-31 |
| Marketing effective time low | 2017-12-31 |
| Marketing status | COMPLETED |
| Related queries | Properties for NDC 9 67457-778 |
NDC Item 67457077805
| NDC 9 | 67457-778 |
|---|---|
| NDC 10 | 67457-778-05 |
| NDC Item | 67457077805 |
| Packaging | 10 VIAL, SINGLE-DOSE in 1 CARTON (67457-778-05) / 5 mL in 1 VIAL, SINGLE-DOSE (67457-778-00) |
| ANDA | ANDA206607 |
| FDA SPL set id | 849345 |
| Labeler | Mylan Institutional LLC |
| Label type | HUMAN PRESCRIPTION DRUG |
| Marketing category | ANDA |
| Marketing effective time high | 2025-10-31 |
| Marketing effective time low | 2017-12-31 |
| Marketing status | COMPLETED |
| Related queries | Properties for NDC 9 67457-778 |
NDC Item 67457092100
| NDC 9 | 67457-921 |
|---|---|
| NDC 10 | 67457-921-00 |
| NDC Item | 67457092100 |
| Packaging | 5 mL in 1 VIAL, SINGLE-DOSE |
| ANDA | ANDA206607 |
| FDA SPL set id | 825030 |
| Labeler | Mylan Institutional LLC |
| Label type | HUMAN PRESCRIPTION DRUG |
| Marketing category | ANDA |
| Marketing effective time high | 2025-03-31 |
| Marketing effective time low | 2020-10-12 |
| Marketing status | COMPLETED |
| Related queries | Properties for NDC 9 67457-921 |
NDC Item 67457092105
| NDC 9 | 67457-921 |
|---|---|
| NDC 10 | 67457-921-05 |
| NDC Item | 67457092105 |
| Packaging | 10 VIAL, SINGLE-DOSE in 1 CARTON (67457-921-05) / 5 mL in 1 VIAL, SINGLE-DOSE (67457-921-00) |
| ANDA | ANDA206607 |
| FDA SPL set id | 825030 |
| Labeler | Mylan Institutional LLC |
| Label type | HUMAN PRESCRIPTION DRUG |
| Marketing category | ANDA |
| Marketing effective time high | 2025-03-31 |
| Marketing effective time low | 2020-10-12 |
| Marketing status | COMPLETED |
| Related queries | Properties for NDC 9 67457-921 |
NDC Item 70069036101
| NDC 9 | 70069-361 |
|---|---|
| NDC 10 | 70069-361-01 |
| NDC Item | 70069036101 |
| Packaging | 5 mL in 1 VIAL |
| ANDA | ANDA212231 |
| COLORTEXT | YELLOW(Clear, colorless to pale yellow solution) |
| Color | C48330 __ |
| FDA SPL set id | 723076 |
| Labeler | Somerset Therapeutics, LLC |
| Label type | HUMAN PRESCRIPTION DRUG |
| Marketing category | ANDA |
| Marketing effective time low | 2019-08-29 |
| Marketing status | ACTIVE |
| Related queries | Properties for NDC 9 70069-361 |
NDC Item 70069036110
| NDC 9 | 70069-361 |
|---|---|
| NDC 10 | 70069-361-10 |
| NDC Item | 70069036110 |
| Packaging | 10 VIAL in 1 CARTON (70069-361-10) / 5 mL in 1 VIAL (70069-361-01) |
| ANDA | ANDA212231 |
| COLORTEXT | YELLOW(Clear, colorless to pale yellow solution) |
| Color | C48330 __ |
| FDA SPL set id | 723076 |
| Labeler | Somerset Therapeutics, LLC |
| Label type | HUMAN PRESCRIPTION DRUG |
| Marketing category | ANDA |
| Marketing effective time low | 2019-08-29 |
| Marketing status | ACTIVE |
| Related queries | Properties for NDC 9 70069-361 |
NDC Item 00703950301
| NDC 9 | 0703-9503 |
|---|---|
| NDC 10 | 0703-9503-01 |
| NDC Item | 00703950301 |
| Packaging | 5 mL in 1 VIAL, SINGLE-DOSE |
| ANDA | ANDA073303 |
| FDA SPL set id | 716741 |
| Labeler | Teva Parenteral Medicines, Inc. |
| Label type | HUMAN PRESCRIPTION DRUG |
| Marketing category | ANDA |
| Marketing effective time low | 1991-11-01 |
| Marketing status | ACTIVE |
| Related queries | Properties for NDC 9 0703-9503 |
NDC Item 00703950303
| NDC 9 | 0703-9503 |
|---|---|
| NDC 10 | 0703-9503-03 |
| NDC Item | 00703950303 |
| Packaging | 10 VIAL, SINGLE-DOSE in 1 CARTON (0703-9503-03) / 5 mL in 1 VIAL, SINGLE-DOSE (0703-9503-01) |
| ANDA | ANDA073303 |
| FDA SPL set id | 716741 |
| Labeler | Teva Parenteral Medicines, Inc. |
| Label type | HUMAN PRESCRIPTION DRUG |
| Marketing category | ANDA |
| Marketing effective time low | 1991-11-01 |
| Marketing status | ACTIVE |
| Related queries | Properties for NDC 9 0703-9503 |
NDC Item 67457077800
| NDC 9 | 67457-778 |
|---|---|
| NDC 10 | 67457-778-00 |
| NDC Item | 67457077800 |
| Packaging | 5 mL in 1 VIAL, SINGLE-DOSE |
| ANDA | ANDA206607 |
| FDA SPL set id | 849345 |
| Labeler | Mylan Institutional LLC |
| Label type | HUMAN PRESCRIPTION DRUG |
| Marketing category | ANDA |
| Marketing effective time high | 2025-10-31 |
| Marketing effective time low | 2017-12-31 |
| Marketing status | COMPLETED |
| Related queries | Properties for NDC 9 67457-778 |
NDC Item 67457077805
| NDC 9 | 67457-778 |
|---|---|
| NDC 10 | 67457-778-05 |
| NDC Item | 67457077805 |
| Packaging | 10 VIAL, SINGLE-DOSE in 1 CARTON (67457-778-05) / 5 mL in 1 VIAL, SINGLE-DOSE (67457-778-00) |
| ANDA | ANDA206607 |
| FDA SPL set id | 849345 |
| Labeler | Mylan Institutional LLC |
| Label type | HUMAN PRESCRIPTION DRUG |
| Marketing category | ANDA |
| Marketing effective time high | 2025-10-31 |
| Marketing effective time low | 2017-12-31 |
| Marketing status | COMPLETED |
| Related queries | Properties for NDC 9 67457-778 |
NDC Item 67457092100
| NDC 9 | 67457-921 |
|---|---|
| NDC 10 | 67457-921-00 |
| NDC Item | 67457092100 |
| Packaging | 5 mL in 1 VIAL, SINGLE-DOSE |
| ANDA | ANDA206607 |
| FDA SPL set id | 825030 |
| Labeler | Mylan Institutional LLC |
| Label type | HUMAN PRESCRIPTION DRUG |
| Marketing category | ANDA |
| Marketing effective time high | 2025-03-31 |
| Marketing effective time low | 2020-10-12 |
| Marketing status | COMPLETED |
| Related queries | Properties for NDC 9 67457-921 |
NDC Item 67457092105
| NDC 9 | 67457-921 |
|---|---|
| NDC 10 | 67457-921-05 |
| NDC Item | 67457092105 |
| Packaging | 10 VIAL, SINGLE-DOSE in 1 CARTON (67457-921-05) / 5 mL in 1 VIAL, SINGLE-DOSE (67457-921-00) |
| ANDA | ANDA206607 |
| FDA SPL set id | 825030 |
| Labeler | Mylan Institutional LLC |
| Label type | HUMAN PRESCRIPTION DRUG |
| Marketing category | ANDA |
| Marketing effective time high | 2025-03-31 |
| Marketing effective time low | 2020-10-12 |
| Marketing status | COMPLETED |
| Related queries | Properties for NDC 9 67457-921 |
NDC Item 70069036101
| NDC 9 | 70069-361 |
|---|---|
| NDC 10 | 70069-361-01 |
| NDC Item | 70069036101 |
| Packaging | 5 mL in 1 VIAL |
| ANDA | ANDA212231 |
| COLORTEXT | YELLOW(Clear, colorless to pale yellow solution) |
| Color | C48330 __ |
| FDA SPL set id | 723076 |
| Labeler | Somerset Therapeutics, LLC |
| Label type | HUMAN PRESCRIPTION DRUG |
| Marketing category | ANDA |
| Marketing effective time low | 2019-08-29 |
| Marketing status | ACTIVE |
| Related queries | Properties for NDC 9 70069-361 |
NDC Item 70069036110
| NDC 9 | 70069-361 |
|---|---|
| NDC 10 | 70069-361-10 |
| NDC Item | 70069036110 |
| Packaging | 10 VIAL in 1 CARTON (70069-361-10) / 5 mL in 1 VIAL (70069-361-01) |
| ANDA | ANDA212231 |
| COLORTEXT | YELLOW(Clear, colorless to pale yellow solution) |
| Color | C48330 __ |
| FDA SPL set id | 723076 |
| Labeler | Somerset Therapeutics, LLC |
| Label type | HUMAN PRESCRIPTION DRUG |
| Marketing category | ANDA |
| Marketing effective time low | 2019-08-29 |
| Marketing status | ACTIVE |
| Related queries | Properties for NDC 9 70069-361 |
NDC Item 00703950301
| NDC 9 | 0703-9503 |
|---|---|
| NDC 10 | 0703-9503-01 |
| NDC Item | 00703950301 |
| Packaging | 5 mL in 1 VIAL, SINGLE-DOSE |
| ANDA | ANDA073303 |
| FDA SPL set id | 716741 |
| Labeler | Teva Parenteral Medicines, Inc. |
| Label type | HUMAN PRESCRIPTION DRUG |
| Marketing category | ANDA |
| Marketing effective time low | 1991-11-01 |
| Marketing status | ACTIVE |
| Related queries | Properties for NDC 9 0703-9503 |
NDC Item 00703950303
| NDC 9 | 0703-9503 |
|---|---|
| NDC 10 | 0703-9503-03 |
| NDC Item | 00703950303 |
| Packaging | 10 VIAL, SINGLE-DOSE in 1 CARTON (0703-9503-03) / 5 mL in 1 VIAL, SINGLE-DOSE (0703-9503-01) |
| ANDA | ANDA073303 |
| FDA SPL set id | 716741 |
| Labeler | Teva Parenteral Medicines, Inc. |
| Label type | HUMAN PRESCRIPTION DRUG |
| Marketing category | ANDA |
| Marketing effective time low | 1991-11-01 |
| Marketing status | ACTIVE |
| Related queries | Properties for NDC 9 0703-9503 |
NDC Item 67457077800
| NDC 9 | 67457-778 |
|---|---|
| NDC 10 | 67457-778-00 |
| NDC Item | 67457077800 |
| Packaging | 5 mL in 1 VIAL, SINGLE-DOSE |
| ANDA | ANDA206607 |
| FDA SPL set id | 849345 |
| Labeler | Mylan Institutional LLC |
| Label type | HUMAN PRESCRIPTION DRUG |
| Marketing category | ANDA |
| Marketing effective time high | 2025-10-31 |
| Marketing effective time low | 2017-12-31 |
| Marketing status | COMPLETED |
| Related queries | Properties for NDC 9 67457-778 |
NDC Item 67457077805
| NDC 9 | 67457-778 |
|---|---|
| NDC 10 | 67457-778-05 |
| NDC Item | 67457077805 |
| Packaging | 10 VIAL, SINGLE-DOSE in 1 CARTON (67457-778-05) / 5 mL in 1 VIAL, SINGLE-DOSE (67457-778-00) |
| ANDA | ANDA206607 |
| FDA SPL set id | 849345 |
| Labeler | Mylan Institutional LLC |
| Label type | HUMAN PRESCRIPTION DRUG |
| Marketing category | ANDA |
| Marketing effective time high | 2025-10-31 |
| Marketing effective time low | 2017-12-31 |
| Marketing status | COMPLETED |
| Related queries | Properties for NDC 9 67457-778 |
NDC Item 67457092100
| NDC 9 | 67457-921 |
|---|---|
| NDC 10 | 67457-921-00 |
| NDC Item | 67457092100 |
| Packaging | 5 mL in 1 VIAL, SINGLE-DOSE |
| ANDA | ANDA206607 |
| FDA SPL set id | 825030 |
| Labeler | Mylan Institutional LLC |
| Label type | HUMAN PRESCRIPTION DRUG |
| Marketing category | ANDA |
| Marketing effective time high | 2025-03-31 |
| Marketing effective time low | 2020-10-12 |
| Marketing status | COMPLETED |
| Related queries | Properties for NDC 9 67457-921 |
NDC Item 67457092105
| NDC 9 | 67457-921 |
|---|---|
| NDC 10 | 67457-921-05 |
| NDC Item | 67457092105 |
| Packaging | 10 VIAL, SINGLE-DOSE in 1 CARTON (67457-921-05) / 5 mL in 1 VIAL, SINGLE-DOSE (67457-921-00) |
| ANDA | ANDA206607 |
| FDA SPL set id | 825030 |
| Labeler | Mylan Institutional LLC |
| Label type | HUMAN PRESCRIPTION DRUG |
| Marketing category | ANDA |
| Marketing effective time high | 2025-03-31 |
| Marketing effective time low | 2020-10-12 |
| Marketing status | COMPLETED |
| Related queries | Properties for NDC 9 67457-921 |
NDC Item 70069036101
| NDC 9 | 70069-361 |
|---|---|
| NDC 10 | 70069-361-01 |
| NDC Item | 70069036101 |
| Packaging | 5 mL in 1 VIAL |
| ANDA | ANDA212231 |
| COLORTEXT | YELLOW(Clear, colorless to pale yellow solution) |
| Color | C48330 __ |
| FDA SPL set id | 723076 |
| Labeler | Somerset Therapeutics, LLC |
| Label type | HUMAN PRESCRIPTION DRUG |
| Marketing category | ANDA |
| Marketing effective time low | 2019-08-29 |
| Marketing status | ACTIVE |
| Related queries | Properties for NDC 9 70069-361 |
NDC Item 70069036110
| NDC 9 | 70069-361 |
|---|---|
| NDC 10 | 70069-361-10 |
| NDC Item | 70069036110 |
| Packaging | 10 VIAL in 1 CARTON (70069-361-10) / 5 mL in 1 VIAL (70069-361-01) |
| ANDA | ANDA212231 |
| COLORTEXT | YELLOW(Clear, colorless to pale yellow solution) |
| Color | C48330 __ |
| FDA SPL set id | 723076 |
| Labeler | Somerset Therapeutics, LLC |
| Label type | HUMAN PRESCRIPTION DRUG |
| Marketing category | ANDA |
| Marketing effective time low | 2019-08-29 |
| Marketing status | ACTIVE |
| Related queries | Properties for NDC 9 70069-361 |
NDC Item 00703950301
| NDC 9 | 0703-9503 |
|---|---|
| NDC 10 | 0703-9503-01 |
| NDC Item | 00703950301 |
| Packaging | 5 mL in 1 VIAL, SINGLE-DOSE |
| ANDA | ANDA073303 |
| FDA SPL set id | 716741 |
| Labeler | Teva Parenteral Medicines, Inc. |
| Label type | HUMAN PRESCRIPTION DRUG |
| Marketing category | ANDA |
| Marketing effective time low | 1991-11-01 |
| Marketing status | ACTIVE |
| Related queries | Properties for NDC 9 0703-9503 |
NDC Item 00703950303
| NDC 9 | 0703-9503 |
|---|---|
| NDC 10 | 0703-9503-03 |
| NDC Item | 00703950303 |
| Packaging | 10 VIAL, SINGLE-DOSE in 1 CARTON (0703-9503-03) / 5 mL in 1 VIAL, SINGLE-DOSE (0703-9503-01) |
| ANDA | ANDA073303 |
| FDA SPL set id | 716741 |
| Labeler | Teva Parenteral Medicines, Inc. |
| Label type | HUMAN PRESCRIPTION DRUG |
| Marketing category | ANDA |
| Marketing effective time low | 1991-11-01 |
| Marketing status | ACTIVE |
| Related queries | Properties for NDC 9 0703-9503 |
NDC Item 67457077800
| NDC 9 | 67457-778 |
|---|---|
| NDC 10 | 67457-778-00 |
| NDC Item | 67457077800 |
| Packaging | 5 mL in 1 VIAL, SINGLE-DOSE |
| ANDA | ANDA206607 |
| FDA SPL set id | 849345 |
| Labeler | Mylan Institutional LLC |
| Label type | HUMAN PRESCRIPTION DRUG |
| Marketing category | ANDA |
| Marketing effective time high | 2025-10-31 |
| Marketing effective time low | 2017-12-31 |
| Marketing status | COMPLETED |
| Related queries | Properties for NDC 9 67457-778 |
NDC Item 67457077805
| NDC 9 | 67457-778 |
|---|---|
| NDC 10 | 67457-778-05 |
| NDC Item | 67457077805 |
| Packaging | 10 VIAL, SINGLE-DOSE in 1 CARTON (67457-778-05) / 5 mL in 1 VIAL, SINGLE-DOSE (67457-778-00) |
| ANDA | ANDA206607 |
| FDA SPL set id | 849345 |
| Labeler | Mylan Institutional LLC |
| Label type | HUMAN PRESCRIPTION DRUG |
| Marketing category | ANDA |
| Marketing effective time high | 2025-10-31 |
| Marketing effective time low | 2017-12-31 |
| Marketing status | COMPLETED |
| Related queries | Properties for NDC 9 67457-778 |
NDC Item 67457092100
| NDC 9 | 67457-921 |
|---|---|
| NDC 10 | 67457-921-00 |
| NDC Item | 67457092100 |
| Packaging | 5 mL in 1 VIAL, SINGLE-DOSE |
| ANDA | ANDA206607 |
| FDA SPL set id | 825030 |
| Labeler | Mylan Institutional LLC |
| Label type | HUMAN PRESCRIPTION DRUG |
| Marketing category | ANDA |
| Marketing effective time high | 2025-03-31 |
| Marketing effective time low | 2020-10-12 |
| Marketing status | COMPLETED |
| Related queries | Properties for NDC 9 67457-921 |
NDC Item 67457092105
| NDC 9 | 67457-921 |
|---|---|
| NDC 10 | 67457-921-05 |
| NDC Item | 67457092105 |
| Packaging | 10 VIAL, SINGLE-DOSE in 1 CARTON (67457-921-05) / 5 mL in 1 VIAL, SINGLE-DOSE (67457-921-00) |
| ANDA | ANDA206607 |
| FDA SPL set id | 825030 |
| Labeler | Mylan Institutional LLC |
| Label type | HUMAN PRESCRIPTION DRUG |
| Marketing category | ANDA |
| Marketing effective time high | 2025-03-31 |
| Marketing effective time low | 2020-10-12 |
| Marketing status | COMPLETED |
| Related queries | Properties for NDC 9 67457-921 |
NDC Item 70069036101
| NDC 9 | 70069-361 |
|---|---|
| NDC 10 | 70069-361-01 |
| NDC Item | 70069036101 |
| Packaging | 5 mL in 1 VIAL |
| ANDA | ANDA212231 |
| COLORTEXT | YELLOW(Clear, colorless to pale yellow solution) |
| Color | C48330 __ |
| FDA SPL set id | 723076 |
| Labeler | Somerset Therapeutics, LLC |
| Label type | HUMAN PRESCRIPTION DRUG |
| Marketing category | ANDA |
| Marketing effective time low | 2019-08-29 |
| Marketing status | ACTIVE |
| Related queries | Properties for NDC 9 70069-361 |
NDC Item 70069036110
| NDC 9 | 70069-361 |
|---|---|
| NDC 10 | 70069-361-10 |
| NDC Item | 70069036110 |
| Packaging | 10 VIAL in 1 CARTON (70069-361-10) / 5 mL in 1 VIAL (70069-361-01) |
| ANDA | ANDA212231 |
| COLORTEXT | YELLOW(Clear, colorless to pale yellow solution) |
| Color | C48330 __ |
| FDA SPL set id | 723076 |
| Labeler | Somerset Therapeutics, LLC |
| Label type | HUMAN PRESCRIPTION DRUG |
| Marketing category | ANDA |
| Marketing effective time low | 2019-08-29 |
| Marketing status | ACTIVE |
| Related queries | Properties for NDC 9 70069-361 |
NDC Item 00703950301
| NDC 9 | 0703-9503 |
|---|---|
| NDC 10 | 0703-9503-01 |
| NDC Item | 00703950301 |
| Packaging | 5 mL in 1 VIAL, SINGLE-DOSE |
| ANDA | ANDA073303 |
| FDA SPL set id | 716741 |
| Labeler | Teva Parenteral Medicines, Inc. |
| Label type | HUMAN PRESCRIPTION DRUG |
| Marketing category | ANDA |
| Marketing effective time low | 1991-11-01 |
| Marketing status | ACTIVE |
| Related queries | Properties for NDC 9 0703-9503 |
NDC Item 00703950303
| NDC 9 | 0703-9503 |
|---|---|
| NDC 10 | 0703-9503-03 |
| NDC Item | 00703950303 |
| Packaging | 10 VIAL, SINGLE-DOSE in 1 CARTON (0703-9503-03) / 5 mL in 1 VIAL, SINGLE-DOSE (0703-9503-01) |
| ANDA | ANDA073303 |
| FDA SPL set id | 716741 |
| Labeler | Teva Parenteral Medicines, Inc. |
| Label type | HUMAN PRESCRIPTION DRUG |
| Marketing category | ANDA |
| Marketing effective time low | 1991-11-01 |
| Marketing status | ACTIVE |
| Related queries | Properties for NDC 9 0703-9503 |
NDC Item 67457077800
| NDC 9 | 67457-778 |
|---|---|
| NDC 10 | 67457-778-00 |
| NDC Item | 67457077800 |
| Packaging | 5 mL in 1 VIAL, SINGLE-DOSE |
| ANDA | ANDA206607 |
| FDA SPL set id | 849345 |
| Labeler | Mylan Institutional LLC |
| Label type | HUMAN PRESCRIPTION DRUG |
| Marketing category | ANDA |
| Marketing effective time high | 2025-10-31 |
| Marketing effective time low | 2017-12-31 |
| Marketing status | COMPLETED |
| Related queries | Properties for NDC 9 67457-778 |
NDC Item 67457077805
| NDC 9 | 67457-778 |
|---|---|
| NDC 10 | 67457-778-05 |
| NDC Item | 67457077805 |
| Packaging | 10 VIAL, SINGLE-DOSE in 1 CARTON (67457-778-05) / 5 mL in 1 VIAL, SINGLE-DOSE (67457-778-00) |
| ANDA | ANDA206607 |
| FDA SPL set id | 849345 |
| Labeler | Mylan Institutional LLC |
| Label type | HUMAN PRESCRIPTION DRUG |
| Marketing category | ANDA |
| Marketing effective time high | 2025-10-31 |
| Marketing effective time low | 2017-12-31 |
| Marketing status | COMPLETED |
| Related queries | Properties for NDC 9 67457-778 |
NDC Item 67457092100
| NDC 9 | 67457-921 |
|---|---|
| NDC 10 | 67457-921-00 |
| NDC Item | 67457092100 |
| Packaging | 5 mL in 1 VIAL, SINGLE-DOSE |
| ANDA | ANDA206607 |
| FDA SPL set id | 825030 |
| Labeler | Mylan Institutional LLC |
| Label type | HUMAN PRESCRIPTION DRUG |
| Marketing category | ANDA |
| Marketing effective time high | 2025-03-31 |
| Marketing effective time low | 2020-10-12 |
| Marketing status | COMPLETED |
| Related queries | Properties for NDC 9 67457-921 |
NDC Item 67457092105
| NDC 9 | 67457-921 |
|---|---|
| NDC 10 | 67457-921-05 |
| NDC Item | 67457092105 |
| Packaging | 10 VIAL, SINGLE-DOSE in 1 CARTON (67457-921-05) / 5 mL in 1 VIAL, SINGLE-DOSE (67457-921-00) |
| ANDA | ANDA206607 |
| FDA SPL set id | 825030 |
| Labeler | Mylan Institutional LLC |
| Label type | HUMAN PRESCRIPTION DRUG |
| Marketing category | ANDA |
| Marketing effective time high | 2025-03-31 |
| Marketing effective time low | 2020-10-12 |
| Marketing status | COMPLETED |
| Related queries | Properties for NDC 9 67457-921 |
NDC Item 70069036101
| NDC 9 | 70069-361 |
|---|---|
| NDC 10 | 70069-361-01 |
| NDC Item | 70069036101 |
| Packaging | 5 mL in 1 VIAL |
| ANDA | ANDA212231 |
| COLORTEXT | YELLOW(Clear, colorless to pale yellow solution) |
| Color | C48330 __ |
| FDA SPL set id | 723076 |
| Labeler | Somerset Therapeutics, LLC |
| Label type | HUMAN PRESCRIPTION DRUG |
| Marketing category | ANDA |
| Marketing effective time low | 2019-08-29 |
| Marketing status | ACTIVE |
| Related queries | Properties for NDC 9 70069-361 |
NDC Item 70069036110
| NDC 9 | 70069-361 |
|---|---|
| NDC 10 | 70069-361-10 |
| NDC Item | 70069036110 |
| Packaging | 10 VIAL in 1 CARTON (70069-361-10) / 5 mL in 1 VIAL (70069-361-01) |
| ANDA | ANDA212231 |
| COLORTEXT | YELLOW(Clear, colorless to pale yellow solution) |
| Color | C48330 __ |
| FDA SPL set id | 723076 |
| Labeler | Somerset Therapeutics, LLC |
| Label type | HUMAN PRESCRIPTION DRUG |
| Marketing category | ANDA |
| Marketing effective time low | 2019-08-29 |
| Marketing status | ACTIVE |
| Related queries | Properties for NDC 9 70069-361 |
NDC Item 00703950301
| NDC 9 | 0703-9503 |
|---|---|
| NDC 10 | 0703-9503-01 |
| NDC Item | 00703950301 |
| Packaging | 5 mL in 1 VIAL, SINGLE-DOSE |
| ANDA | ANDA073303 |
| FDA SPL set id | 716741 |
| Labeler | Teva Parenteral Medicines, Inc. |
| Label type | HUMAN PRESCRIPTION DRUG |
| Marketing category | ANDA |
| Marketing effective time low | 1991-11-01 |
| Marketing status | ACTIVE |
| Related queries | Properties for NDC 9 0703-9503 |
NDC Item 00703950303
| NDC 9 | 0703-9503 |
|---|---|
| NDC 10 | 0703-9503-03 |
| NDC Item | 00703950303 |
| Packaging | 10 VIAL, SINGLE-DOSE in 1 CARTON (0703-9503-03) / 5 mL in 1 VIAL, SINGLE-DOSE (0703-9503-01) |
| ANDA | ANDA073303 |
| FDA SPL set id | 716741 |
| Labeler | Teva Parenteral Medicines, Inc. |
| Label type | HUMAN PRESCRIPTION DRUG |
| Marketing category | ANDA |
| Marketing effective time low | 1991-11-01 |
| Marketing status | ACTIVE |
| Related queries | Properties for NDC 9 0703-9503 |
NDC Item 67457077800
| NDC 9 | 67457-778 |
|---|---|
| NDC 10 | 67457-778-00 |
| NDC Item | 67457077800 |
| Packaging | 5 mL in 1 VIAL, SINGLE-DOSE |
| ANDA | ANDA206607 |
| FDA SPL set id | 849345 |
| Labeler | Mylan Institutional LLC |
| Label type | HUMAN PRESCRIPTION DRUG |
| Marketing category | ANDA |
| Marketing effective time high | 2025-10-31 |
| Marketing effective time low | 2017-12-31 |
| Marketing status | COMPLETED |
| Related queries | Properties for NDC 9 67457-778 |
NDC Item 67457077805
| NDC 9 | 67457-778 |
|---|---|
| NDC 10 | 67457-778-05 |
| NDC Item | 67457077805 |
| Packaging | 10 VIAL, SINGLE-DOSE in 1 CARTON (67457-778-05) / 5 mL in 1 VIAL, SINGLE-DOSE (67457-778-00) |
| ANDA | ANDA206607 |
| FDA SPL set id | 849345 |
| Labeler | Mylan Institutional LLC |
| Label type | HUMAN PRESCRIPTION DRUG |
| Marketing category | ANDA |
| Marketing effective time high | 2025-10-31 |
| Marketing effective time low | 2017-12-31 |
| Marketing status | COMPLETED |
| Related queries | Properties for NDC 9 67457-778 |
NDC Item 67457092100
| NDC 9 | 67457-921 |
|---|---|
| NDC 10 | 67457-921-00 |
| NDC Item | 67457092100 |
| Packaging | 5 mL in 1 VIAL, SINGLE-DOSE |
| ANDA | ANDA206607 |
| FDA SPL set id | 825030 |
| Labeler | Mylan Institutional LLC |
| Label type | HUMAN PRESCRIPTION DRUG |
| Marketing category | ANDA |
| Marketing effective time high | 2025-03-31 |
| Marketing effective time low | 2020-10-12 |
| Marketing status | COMPLETED |
| Related queries | Properties for NDC 9 67457-921 |
NDC Item 67457092105
| NDC 9 | 67457-921 |
|---|---|
| NDC 10 | 67457-921-05 |
| NDC Item | 67457092105 |
| Packaging | 10 VIAL, SINGLE-DOSE in 1 CARTON (67457-921-05) / 5 mL in 1 VIAL, SINGLE-DOSE (67457-921-00) |
| ANDA | ANDA206607 |
| FDA SPL set id | 825030 |
| Labeler | Mylan Institutional LLC |
| Label type | HUMAN PRESCRIPTION DRUG |
| Marketing category | ANDA |
| Marketing effective time high | 2025-03-31 |
| Marketing effective time low | 2020-10-12 |
| Marketing status | COMPLETED |
| Related queries | Properties for NDC 9 67457-921 |
NDC Item 70069036101
| NDC 9 | 70069-361 |
|---|---|
| NDC 10 | 70069-361-01 |
| NDC Item | 70069036101 |
| Packaging | 5 mL in 1 VIAL |
| ANDA | ANDA212231 |
| COLORTEXT | YELLOW(Clear, colorless to pale yellow solution) |
| Color | C48330 __ |
| FDA SPL set id | 723076 |
| Labeler | Somerset Therapeutics, LLC |
| Label type | HUMAN PRESCRIPTION DRUG |
| Marketing category | ANDA |
| Marketing effective time low | 2019-08-29 |
| Marketing status | ACTIVE |
| Related queries | Properties for NDC 9 70069-361 |
NDC Item 70069036110
| NDC 9 | 70069-361 |
|---|---|
| NDC 10 | 70069-361-10 |
| NDC Item | 70069036110 |
| Packaging | 10 VIAL in 1 CARTON (70069-361-10) / 5 mL in 1 VIAL (70069-361-01) |
| ANDA | ANDA212231 |
| COLORTEXT | YELLOW(Clear, colorless to pale yellow solution) |
| Color | C48330 __ |
| FDA SPL set id | 723076 |
| Labeler | Somerset Therapeutics, LLC |
| Label type | HUMAN PRESCRIPTION DRUG |
| Marketing category | ANDA |
| Marketing effective time low | 2019-08-29 |
| Marketing status | ACTIVE |
| Related queries | Properties for NDC 9 70069-361 |