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
openFDA Listing Details
- Product ID
- 71335-1916_ae1913db-ec19-4f19-9ca8-0c524410de4c
- Product type
- HUMAN PRESCRIPTION DRUG
- Finished product
- Yes
- Brand name base
- Lamivudine and Zidovudine
- Generic name
- Lamivudine and Zidovudine
- Dosage form
- TABLET
- Route
- ORAL
- Marketing start
- 2018-08-30
- Marketing category
- ANDA
- Application number
- ANDA090679
- Pharmacologic classes
- Hepatitis B Virus Nucleoside Analog Reverse Transcriptase Inhibitor [EPC]; Human Immunodeficiency Virus Nucleoside Analog Reverse Transcriptase Inhibitor [EPC]; Nucleoside Reverse Transcriptase Inhibitors [MoA]
- Listing expiration
- 2026-12-31
openFDA Active Ingredients
| Ingredient | Strength |
|---|
| LAMIVUDINE | 150 mg/1 |
| ZIDOVUDINE | 300 mg/1 |
openFDA Harmonized Identifiers
| Field | Values |
|---|
| Unii | 2T8Q726O95, 4B9XT59T7S |
| Rxcui | 200082 |
| Spl Set Id | 61d14a88-9fdf-4373-8360-44ec9e1cd350 |
| Manufacturer Name | Bryant Ranch Prepack |
Related UNII Ingredients
| UNII | Preferred term | Registry number | Matched term |
|---|
| 2T8Q726O95 | LAMIVUDINE | 134678-17-4 | LAMIVUDINE |
| 4B9XT59T7S | ZIDOVUDINE | 30516-87-1 | ZIDOVUDINE |
Packages
| 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 |
Related DailyMed Labels
| Title | Manufacturer | Effective date | Type | Version |
|---|
| Lamivudine and Zidovudine | Bryant Ranch Prepack | 2024-04-05 | HUMAN PRESCRIPTION DRUG LABEL | 102 |