Lamivudine and Zidovudine
- Product NDC
- 71335-1916
- 11-digit product format
- 713351916
- Labeler code
- 71335
- Product ID
- 71335-1916_ae1913db-ec19-4f19-9ca8-0c524410de4c
- Type
- HUMAN PRESCRIPTION DRUG
- Nonproprietary name
- Lamivudine and Zidovudine
- Dosage form
- TABLET
- Route
- ORAL
- Labeler
- Bryant Ranch Prepack
- Application
- ANDA090679
- Marketing category
- ANDA
- Marketing start
- 2018-08-30
- 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 |
|---|
| 71335-1916-1 | Lamivudine and Zidovudine | 6 in 1 BOTTLE | TABLET | 6 | | 102 |
| 71335-1916-2 | Lamivudine and Zidovudine | 60 in 1 BOTTLE | TABLET | 60 | | 102 |
| 71335-1916-3 | Lamivudine and Zidovudine | 4 in 1 BOTTLE | TABLET | 4 | | 102 |
DailyMed Dashboard NDC Coverage#
NDC, Dashboard title, SPL version table| NDC | Dashboard title | SPL version | Validation | Dashboard ZIP |
|---|
| 71335-1916 | LAMIVUDINE AND ZIDOVUDINE TABLET [BRYANT RANCH PREPACK] | 102 | Current NDC, Legacy NDC, 3 package rows | 20240415_61d14a88-9fdf-4373-8360-44ec9e1cd350.zip |
DailyMed RxNorm Mappings#
Packages#
Package NDC, 11-digit format, Description table| Package NDC | 11-digit format | Description | Units | Marketing start | Marketing end | Sample | Exclude flag | Status |
|---|
| 71335-1916-1 | 71335191601 | 6 TABLET in 1 BOTTLE (71335-1916-1) | 6 tablet | 2021-07-15 | 0000-00-00 | No | No | Current |
| 71335-1916-2 | 71335191602 | 60 TABLET in 1 BOTTLE (71335-1916-2) | 60 tablet | 2024-04-05 | 0000-00-00 | No | No | Current |
| 71335-1916-3 | 71335191603 | 4 TABLET in 1 BOTTLE (71335-1916-3) | 4 tablet | 2024-04-05 | 0000-00-00 | No | No | Current |