Lamivudine and Zidovudine
- Product NDC
- 31722-739
- 11-digit product format
- 317220739
- Labeler code
- 31722
- Product ID
- 31722-739_4cd27be5-81ed-ccb6-e063-6294a90a1798
- Type
- HUMAN PRESCRIPTION DRUG
- Nonproprietary name
- Lamivudine and Zidovudine
- Dosage form
- TABLET, FILM COATED
- Route
- ORAL
- Labeler
- Camber Pharmaceuticals, Inc.
- Application
- ANDA203259
- Marketing category
- ANDA
- Marketing start
- 2014-02-06
- Substance
- LAMIVUDINE; ZIDOVUDINE
- Active strength
- 150; 300 mg/1; mg/1
- Pharmacologic classes
- Hepatitis B Virus Nucleoside Analog Reverse Transcriptase Inhibitor [EPC], Human Immunodeficiency Virus Nucleoside Analog Reverse Transcriptase Inhibitor [EPC], Human Immunodeficiency Virus Nucleoside Analog Reverse Transcriptase Inhibitor [EPC], Nucleoside Reverse Transcriptase Inhibitors [MoA], Nucleoside Reverse Transcriptase Inhibitors [MoA]
- NDC exclude flag
- No
- Listing certified through
- 2027-12-31
- Current FDA listing
- Yes
Additional Listing Data#
- Finished product
- Yes
- Brand name base
- Lamivudine and Zidovudine
- Listing expiration
- 2027-12-31
Active Ingredients#
Ingredient, Strength table| Ingredient | Strength |
|---|
| LAMIVUDINE | 150 mg/1 |
| ZIDOVUDINE | 300 mg/1 |
Harmonized Identifiers#
Field, Values table| Field | Values |
|---|
| Unii | 2T8Q726O95, 4B9XT59T7S |
| Rxcui | 200082 |
DailyMed Product Concepts#
FDA-Initiated Inactive NDC Indexing#
NDC, Effective, Action table| NDC | Effective | Action | Document | Indexing SPL | Related label |
|---|
| 31722-739-05 | 2026-01-29 | C162847 | 48780-1 | 9d75b9d0-683e-f424-e053-dadaa90a57ce | These highlights do not include all the information needed to use LAMIVUDINE AND ZIDOVUDINE TABLETS safely and effectively. See full prescribing information for LAMIVUDINE AND ZIDOVUDINE TABLETS. LAMIVUDINE and ZIDOVUDINE tablets, for oral use Initial U.S. Approval: 1997 |
| 31722-739-31 | 2026-01-29 | C162847 | 48780-1 | 9d75b9d0-683e-f424-e053-dadaa90a57ce | These highlights do not include all the information needed to use LAMIVUDINE AND ZIDOVUDINE TABLETS safely and effectively. See full prescribing information for LAMIVUDINE AND ZIDOVUDINE TABLETS. LAMIVUDINE and ZIDOVUDINE tablets, for oral use Initial U.S. Approval: 1997 |
| 31722-739-60 | 2026-01-29 | C162847 | 48780-1 | 9d75b9d0-683e-f424-e053-dadaa90a57ce | These highlights do not include all the information needed to use LAMIVUDINE AND ZIDOVUDINE TABLETS safely and effectively. See full prescribing information for LAMIVUDINE AND ZIDOVUDINE TABLETS. LAMIVUDINE and ZIDOVUDINE tablets, for oral use Initial U.S. Approval: 1997 |
| 31722-739-05 | 2021-02-19 | C162847 | 48780-1 | 9d75b9d0-683e-f424-e053-dadaa90a57ce | These highlights do not include all the information needed to use LAMIVUDINE AND ZIDOVUDINE TABLETS safely and effectively. See full prescribing information for LAMIVUDINE AND ZIDOVUDINE TABLETS. LAMIVUDINE and ZIDOVUDINE tablets, for oral use Initial U.S. Approval: 1997 |
| 31722-739-31 | 2021-02-19 | C162847 | 48780-1 | 9d75b9d0-683e-f424-e053-dadaa90a57ce | These highlights do not include all the information needed to use LAMIVUDINE AND ZIDOVUDINE TABLETS safely and effectively. See full prescribing information for LAMIVUDINE AND ZIDOVUDINE TABLETS. LAMIVUDINE and ZIDOVUDINE tablets, for oral use Initial U.S. Approval: 1997 |
| 31722-739-60 | 2021-02-19 | C162847 | 48780-1 | 9d75b9d0-683e-f424-e053-dadaa90a57ce | These highlights do not include all the information needed to use LAMIVUDINE AND ZIDOVUDINE TABLETS safely and effectively. See full prescribing information for LAMIVUDINE AND ZIDOVUDINE TABLETS. LAMIVUDINE and ZIDOVUDINE tablets, for oral use Initial U.S. Approval: 1997 |
| 31722-739-05 | 2020-01-31 | C162847 | 48780-1 | 9d75b9d0-683e-f424-e053-dadaa90a57ce | These highlights do not include all the information needed to use LAMIVUDINE AND ZIDOVUDINE TABLETS safely and effectively. See full prescribing information for LAMIVUDINE AND ZIDOVUDINE TABLETS. LAMIVUDINE and ZIDOVUDINE tablets, for oral use Initial U.S. Approval: 1997 |
| 31722-739-31 | 2020-01-31 | C162847 | 48780-1 | 9d75b9d0-683e-f424-e053-dadaa90a57ce | These highlights do not include all the information needed to use LAMIVUDINE AND ZIDOVUDINE TABLETS safely and effectively. See full prescribing information for LAMIVUDINE AND ZIDOVUDINE TABLETS. LAMIVUDINE and ZIDOVUDINE tablets, for oral use Initial U.S. Approval: 1997 |
| 31722-739-60 | 2020-01-31 | C162847 | 48780-1 | 9d75b9d0-683e-f424-e053-dadaa90a57ce | These highlights do not include all the information needed to use LAMIVUDINE AND ZIDOVUDINE TABLETS safely and effectively. See full prescribing information for LAMIVUDINE AND ZIDOVUDINE TABLETS. LAMIVUDINE and ZIDOVUDINE tablets, for oral use Initial U.S. Approval: 1997 |
DailyMed Package Descriptions#
Package NDC, Product, Description table| Package NDC | Product | Description | Form | Quantity | Strength | SPL version |
|---|
| 31722-739-05 | Lamivudine and Zidovudine | 500 in 1 BOTTLE | TABLET, FILM COATED | 500 | | 7 |
| 31722-739-31 | Lamivudine and Zidovudine | 100 in 1 BLISTER PACK | TABLET, FILM COATED | 100 | | 7 |
| 31722-739-60 | Lamivudine and Zidovudine | 60 in 1 BOTTLE | TABLET, FILM COATED | 60 | | 7 |
DailyMed Socrata Ingredients#
Ingredient, Type, UNII table| Ingredient | Type | UNII | DailyMed label | SPL version | Uploaded |
|---|
| LAMIVUDINE | ACTIVE INGREDIENT | 2T8Q726O95 | LAMIVUDINE AND ZIDOVUDINE TABLET, FILM COATED [CAMBER PHARMACEUTICALS, INC.] | 1 | |
| ZIDOVUDINE | ACTIVE INGREDIENT | 4B9XT59T7S | LAMIVUDINE AND ZIDOVUDINE TABLET, FILM COATED [CAMBER PHARMACEUTICALS, INC.] | 1 | |
| LAMIVUDINE | ACTIVE MOIETY | 2T8Q726O95 | LAMIVUDINE AND ZIDOVUDINE TABLET, FILM COATED [CAMBER PHARMACEUTICALS, INC.] | 1 | |
| ZIDOVUDINE | ACTIVE MOIETY | 4B9XT59T7S | LAMIVUDINE AND ZIDOVUDINE TABLET, FILM COATED [CAMBER PHARMACEUTICALS, INC.] | 1 | |
| CELLULOSE, MICROCRYSTALLINE | INACTIVE INGREDIENT | OP1R32D61U | LAMIVUDINE AND ZIDOVUDINE TABLET, FILM COATED [CAMBER PHARMACEUTICALS, INC.] | 1 | |
| HYPROMELLOSES | INACTIVE INGREDIENT | 3NXW29V3WO | LAMIVUDINE AND ZIDOVUDINE TABLET, FILM COATED [CAMBER PHARMACEUTICALS, INC.] | 1 | |
| MAGNESIUM STEARATE | INACTIVE INGREDIENT | 70097M6I30 | LAMIVUDINE AND ZIDOVUDINE TABLET, FILM COATED [CAMBER PHARMACEUTICALS, INC.] | 1 | |
| POLYETHYLENE GLYCOLS | INACTIVE INGREDIENT | 3WJQ0SDW1A | LAMIVUDINE AND ZIDOVUDINE TABLET, FILM COATED [CAMBER PHARMACEUTICALS, INC.] | 1 | |
| POLYSORBATE 80 | INACTIVE INGREDIENT | 6OZP39ZG8H | LAMIVUDINE AND ZIDOVUDINE TABLET, FILM COATED [CAMBER PHARMACEUTICALS, INC.] | 1 | |
| SODIUM STARCH GLYCOLATE TYPE A POTATO | INACTIVE INGREDIENT | 5856J3G2A2 | LAMIVUDINE AND ZIDOVUDINE TABLET, FILM COATED [CAMBER PHARMACEUTICALS, INC.] | 1 | |
| TITANIUM DIOXIDE | INACTIVE INGREDIENT | 15FIX9V2JP | LAMIVUDINE AND ZIDOVUDINE TABLET, FILM COATED [CAMBER PHARMACEUTICALS, INC.] | 1 | |
DailyMed Dashboard NDC Coverage#
NDC, Dashboard title, SPL version table| NDC | Dashboard title | SPL version | Validation | Dashboard ZIP |
|---|
| 31722-739 | LAMIVUDINE AND ZIDOVUDINE (LAMIVUDINE AND ZIDOVUDINE) TABLET, FILM COATED [CAMBER PHARMACEUTICALS, INC.] | 6 | Current NDC, Legacy NDC, 3 package rows | 20240510_e816e8f5-1e50-4f49-8bea-92da0121d26e.zip |
DailyMed RxNorm Mappings#
Packages#
Package NDC, 11-digit format, Description table| Package NDC | 11-digit format | Description | Marketing start | Marketing end | Sample | Exclude flag | Status |
|---|
| 31722-739-05 | 31722073905 | 500 TABLET, FILM COATED in 1 BOTTLE (31722-739-05) | 2014-02-06 | 0000-00-00 | No | No | Current |
| 31722-739-31 | 31722073931 | 100 TABLET, FILM COATED in 1 BLISTER PACK (31722-739-31) | 2014-02-06 | 0000-00-00 | No | No | Current |
| 31722-739-60 | 31722073960 | 60 TABLET, FILM COATED in 1 BOTTLE (31722-739-60) | 2014-02-06 | 0000-00-00 | No | No | Current |