Abacavir and Lamivudine
- Product NDC
- 42385-962
- 11-digit product format
- 423850962
- Labeler code
- 42385
- Product ID
- 42385-962_e6dbfbf4-1917-4764-a6b2-e3da98aa5620
- Type
- HUMAN PRESCRIPTION DRUG
- Nonproprietary name
- Abacavir and Lamivudine
- Dosage form
- TABLET, FILM COATED
- Route
- ORAL
- Labeler
- Laurus Labs Limited
- Application
- ANDA216332
- Marketing category
- ANDA
- Marketing start
- 2022-07-25
- Substance
- ABACAVIR SULFATE; LAMIVUDINE
- Active strength
- 600; 300 mg/1; mg/1
- Pharmacologic classes
- Cytochrome P450 1A1 Inhibitors [MoA], 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
- Abacavir and Lamivudine
- Listing expiration
- 2027-12-31
Active Ingredients#
Ingredient, Strength table| Ingredient | Strength |
|---|
| ABACAVIR SULFATE | 600 mg/1 |
| LAMIVUDINE | 300 mg/1 |
Harmonized Identifiers#
Field, Values table| Field | Values |
|---|
| Unii | J220T4J9Q2, 2T8Q726O95 |
| Rxcui | 602393 |
DailyMed Product Concepts#
DailyMed Package Descriptions#
Package NDC, Product, Description table| Package NDC | Product | Description | Form | Quantity | Strength | SPL version |
|---|
| 42385-962-18 | Abacavir and Lamivudine | 180 in 1 BOTTLE | TABLET, FILM COATED | 180 | | 4 |
| 42385-962-30 | Abacavir and Lamivudine | 30 in 1 BOTTLE | TABLET, FILM COATED | 30 | | 4 |
| 42385-962-90 | Abacavir and Lamivudine | 90 in 1 BOTTLE | TABLET, FILM COATED | 90 | | 4 |
DailyMed Dashboard NDC Coverage#
NDC, Dashboard title, SPL version table| NDC | Dashboard title | SPL version | Validation | Dashboard ZIP |
|---|
| 42385-962 | ABACAVIR AND LAMIVUDINE TABLET, FILM COATED [LAURUS LABS LIMITED] | 3 | Current NDC, Legacy NDC, 3 package rows | 20241212_d12e80eb-906c-4932-bb03-b4060ba1d31c.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 |
|---|
| 42385-962-18 | 42385096218 | 180 TABLET, FILM COATED in 1 BOTTLE (42385-962-18) | 2022-07-25 | 0000-00-00 | No | No | Current |
| 42385-962-30 | 42385096230 | 30 TABLET, FILM COATED in 1 BOTTLE (42385-962-30) | 2022-07-25 | 0000-00-00 | No | No | Current |
| 42385-962-90 | 42385096290 | 90 TABLET, FILM COATED in 1 BOTTLE (42385-962-90) | 2022-07-25 | 0000-00-00 | No | No | Current |