LAMIVUDINE and ZIDOVUDINE
- Product NDC
- 31722-506
- 11-digit product format
- 317220506
- Labeler code
- 31722
- Product ID
- 31722-506_e8ca069d-b3f8-35bf-e053-2a95a90a0699
- Type
- HUMAN PRESCRIPTION DRUG
- Nonproprietary name
- LAMIVUDINE and ZIDOVUDINE
- Dosage form
- TABLET, FILM COATED
- Route
- ORAL
- Labeler
- Camber Pharmaceuticals, Inc.
- Application
- ANDA079124
- Marketing category
- ANDA
- Marketing start
- 2015-09-18
- 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
- 2026-12-31
- Current FDA listing
- Yes
Additional Listing Data#
- Finished product
- Yes
- Brand name base
- LAMIVUDINE and ZIDOVUDINE
- Listing expiration
- 2026-12-31
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#
DailyMed Package Descriptions#
Package NDC, Product, Description table| Package NDC | Product | Description | Form | Quantity | Strength | SPL version |
|---|
| 31722-506-05 | LAMIVUDINE and ZIDOVUDINE | 500 in 1 BOTTLE | TABLET, FILM COATED | 500 | | 7 |
| 31722-506-60 | 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 | |
| COLLOIDAL SILICON DIOXIDE | INACTIVE INGREDIENT | ETJ7Z6XBU4 | 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 |
|---|
| 31722-506 | LAMIVUDINE AND ZIDOVUDINE (LAMIVUDINE AND ZIDOVUDINE) TABLET, FILM COATED [CAMBER PHARMACEUTICALS, INC.] | 7 | Current NDC, Legacy NDC, 2 package rows | 20220919_f80bd0f3-47eb-4b82-a633-4536cf376cf6.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 |
|---|
| 31722-506-05 | 31722050605 | 500 TABLET, FILM COATED in 1 BOTTLE (31722-506-05) | 2015-09-18 | 0000-00-00 | No | No | Current |
| 31722-506-60 | 31722050660 | 60 TABLET, FILM COATED in 1 BOTTLE (31722-506-60) | 2015-09-18 | 0000-00-00 | No | No | Current |