Abacavir and Lamivudine
- Product NDC
- 33342-440
- 11-digit product format
- 333420440
- Labeler code
- 33342
- Product ID
- 33342-440_42b22ad0-4838-43fd-9bf7-f22dafc7c352
- Type
- HUMAN PRESCRIPTION DRUG
- Nonproprietary name
- Abacavir and Lamivudine
- Dosage form
- TABLET, FILM COATED
- Route
- ORAL
- Labeler
- Macleods Pharmaceuticals Limited
- Application
- ANDA212663
- Marketing category
- ANDA
- Marketing start
- 2024-12-20
- 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
- 2026-12-31
- Current FDA listing
- Yes
Additional Listing Data#
- Finished product
- Yes
- Brand name base
- Abacavir and Lamivudine
- Listing expiration
- 2026-12-31
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 |
|---|
| 33342-440-02 | Abacavir and Lamivudine | 6 in 1 BLISTER PACK | TABLET, FILM COATED | 6 | | 2 |
| 33342-440-07 | Abacavir and Lamivudine | 30 in 1 BOTTLE | TABLET, FILM COATED | 30 | | 2 |
| 33342-440-14 | Abacavir and Lamivudine | 5 in 1 CARTON | TABLET, FILM COATED | 5 | | 2 |
| 33342-440-98 | Abacavir and Lamivudine | 10 in 1 CARTON | TABLET, FILM COATED | 10 | | 2 |
DailyMed Dashboard NDC Coverage#
NDC, Dashboard title, SPL version table| NDC | Dashboard title | SPL version | Validation | Dashboard ZIP |
|---|
| 33342-440 | ABACAVIR AND LAMIVUDINE TABLET, FILM COATED [MACLEODS PHARMACEUTICALS LIMITED] | 2 | Current NDC, 4 package rows | 20250305_d36624c8-d773-4f99-81fc-433fae17feb3.zip |
DailyMed RxNorm Mappings#
Packages#
Package NDC, 11-digit format, Description table| Package NDC | 11-digit format | Description | Units | Marketing start | Sample | Exclude flag | Status |
|---|
| 33342-440-02 | 33342044002 | 6 in 1 BLISTER PACK | | | | | Historical |
| 33342-440-07 | 33342044007 | 30 TABLET, FILM COATED in 1 BOTTLE (33342-440-07) | | 2024-12-20 | No | No | Current |
| 33342-440-14 | 33342044014 | 5 BLISTER PACK in 1 CARTON (33342-440-14) / 6 TABLET, FILM COATED in 1 BLISTER PACK (33342-440-02) | 5 blister pack | 2024-12-20 | No | No | Current |
| 33342-440-98 | 33342044098 | 10 BLISTER PACK in 1 CARTON (33342-440-98) / 6 TABLET, FILM COATED in 1 BLISTER PACK (33342-440-02) | 10 blister pack | 2024-12-20 | No | No | Current |