Lamivudine and Zidovudine
- Product NDC
- 76282-115
- 11-digit product format
- 762820115
- Labeler code
- 76282
- Product ID
- 76282-115_9d9239ba-eadd-45f3-a528-f9e2f7e2db04
- Type
- HUMAN PRESCRIPTION DRUG
- Nonproprietary name
- Lamivudine and Zidovudine
- Dosage form
- TABLET, FILM COATED
- Route
- ORAL
- Labeler
- Exelan Pharmaceuticals Inc.
- Application
- ANDA203259
- Marketing category
- ANDA
- Marketing start
- 2015-04-29
- 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 Analog [EXT], Nucleoside Analog [EXT], 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 |
|---|
| 76282-115-05 | Lamivudine and Zidovudine | 500 in 1 BOTTLE | TABLET, FILM COATED | 500 | | 2 |
| 76282-115-60 | Lamivudine and Zidovudine | 60 in 1 BOTTLE | TABLET, FILM COATED | 60 | | 2 |
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 [EXELAN PHARMACEUTICALS INC.] | 1 | |
| ZIDOVUDINE | ACTIVE INGREDIENT | 4B9XT59T7S | LAMIVUDINE AND ZIDOVUDINE TABLET, FILM COATED [EXELAN PHARMACEUTICALS INC.] | 1 | |
| LAMIVUDINE | ACTIVE MOIETY | 2T8Q726O95 | LAMIVUDINE AND ZIDOVUDINE TABLET, FILM COATED [EXELAN PHARMACEUTICALS INC.] | 1 | |
| ZIDOVUDINE | ACTIVE MOIETY | 4B9XT59T7S | LAMIVUDINE AND ZIDOVUDINE TABLET, FILM COATED [EXELAN PHARMACEUTICALS INC.] | 1 | |
| CELLULOSE, MICROCRYSTALLINE | INACTIVE INGREDIENT | OP1R32D61U | LAMIVUDINE AND ZIDOVUDINE TABLET, FILM COATED [EXELAN PHARMACEUTICALS INC.] | 1 | |
| HYPROMELLOSES | INACTIVE INGREDIENT | 3NXW29V3WO | LAMIVUDINE AND ZIDOVUDINE TABLET, FILM COATED [EXELAN PHARMACEUTICALS INC.] | 1 | |
| MAGNESIUM STEARATE | INACTIVE INGREDIENT | 70097M6I30 | LAMIVUDINE AND ZIDOVUDINE TABLET, FILM COATED [EXELAN PHARMACEUTICALS INC.] | 1 | |
| POLYETHYLENE GLYCOLS | INACTIVE INGREDIENT | 3WJQ0SDW1A | LAMIVUDINE AND ZIDOVUDINE TABLET, FILM COATED [EXELAN PHARMACEUTICALS INC.] | 1 | |
| POLYSORBATE 80 | INACTIVE INGREDIENT | 6OZP39ZG8H | LAMIVUDINE AND ZIDOVUDINE TABLET, FILM COATED [EXELAN PHARMACEUTICALS INC.] | 1 | |
| SODIUM STARCH GLYCOLATE TYPE A POTATO | INACTIVE INGREDIENT | 5856J3G2A2 | LAMIVUDINE AND ZIDOVUDINE TABLET, FILM COATED [EXELAN PHARMACEUTICALS INC.] | 1 | |
| TITANIUM DIOXIDE | INACTIVE INGREDIENT | 15FIX9V2JP | LAMIVUDINE AND ZIDOVUDINE TABLET, FILM COATED [EXELAN PHARMACEUTICALS INC.] | 1 | |
DailyMed Dashboard NDC Coverage#
NDC, Dashboard title, SPL version table| NDC | Dashboard title | SPL version | Validation | Dashboard ZIP |
|---|
| 76282-115 | LAMIVUDINE AND ZIDOVUDINE TABLET, FILM COATED [EXELAN PHARMACEUTICALS INC.] | 2 | Current NDC, Legacy NDC, 2 package rows | 20190103_4cf565c3-bdec-4c18-93c1-cc7fa8331c90.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 |
|---|
| 76282-115-05 | 76282011505 | 500 TABLET, FILM COATED in 1 BOTTLE (76282-115-05) | 2015-04-29 | 0000-00-00 | No | No | Current |
| 76282-115-60 | 76282011560 | 60 TABLET, FILM COATED in 1 BOTTLE (76282-115-60) | 2015-04-29 | 0000-00-00 | No | No | Current |