ABACAVIR, LAMIVUDINE AND ZIDOVUDINE
- Product NDC
- 68180-286
- 11-digit product format
- 681800286
- Labeler code
- 68180
- Product ID
- 68180-286_e180b9ff-1e7c-422a-9fe7-afd39eee3e4e
- Type
- HUMAN PRESCRIPTION DRUG
- Nonproprietary name
- ABACAVIR , LAMIVUDINE AND ZIDOVUDINE
- Dosage form
- TABLET
- Route
- ORAL
- Labeler
- Lupin Pharmaceuticals, Inc.
- Application
- ANDA202912
- Marketing category
- ANDA
- Marketing start
- 2013-12-17
- Substance
- ABACAVIR SULFATE; LAMIVUDINE; ZIDOVUDINE
- Active strength
- 300; 150; 300 mg/1; 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], Human Immunodeficiency Virus Nucleoside Analog Reverse Transcriptase Inhibitor [EPC], Nucleoside Reverse Transcriptase Inhibitors [MoA], 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, LAMIVUDINE AND ZIDOVUDINE
- Listing expiration
- 2026-12-31
Active Ingredients#
Ingredient, Strength table| Ingredient | Strength |
|---|
| ABACAVIR SULFATE | 300 mg/1 |
| LAMIVUDINE | 150 mg/1 |
| ZIDOVUDINE | 300 mg/1 |
Harmonized Identifiers#
Field, Values table| Field | Values |
|---|
| Unii | J220T4J9Q2, 2T8Q726O95, 4B9XT59T7S |
| Rxcui | 307650 |
DailyMed Product Concepts#
DailyMed Package Descriptions#
Package NDC, Product, Description table| Package NDC | Product | Description | Form | Quantity | Strength | SPL version |
|---|
| 68180-286-01 | ABACAVIR, LAMIVUDINE AND ZIDOVUDINE | 1 in 1 CARTON | TABLET | 1 | | 16 |
| 68180-286-01 | ABACAVIR, LAMIVUDINE AND ZIDOVUDINE | 100 in 1 BOTTLE | TABLET | 100 | | 16 |
| 68180-286-02 | ABACAVIR, LAMIVUDINE AND ZIDOVUDINE | 500 in 1 BOTTLE | TABLET | 500 | | 16 |
| 68180-286-02 | ABACAVIR, LAMIVUDINE AND ZIDOVUDINE | 1 in 1 CARTON | TABLET | 1 | | 16 |
| 68180-286-07 | ABACAVIR, LAMIVUDINE AND ZIDOVUDINE | 1 in 1 CARTON | TABLET | 1 | | 16 |
| 68180-286-07 | ABACAVIR, LAMIVUDINE AND ZIDOVUDINE | 60 in 1 BOTTLE | TABLET | 60 | | 16 |
DailyMed Socrata Ingredients#
Ingredient, Type, UNII table| Ingredient | Type | UNII | DailyMed label | SPL version | Uploaded |
|---|
| ABACAVIR SULFATE | ACTIVE INGREDIENT | J220T4J9Q2 | ABACAVIR SULFATE, LAMIVUDINE AND ZIDOVUDINE TABLET [LUPIN PHARMACEUTICALS, INC.] | 5 | |
| LAMIVUDINE | ACTIVE INGREDIENT | 2T8Q726O95 | ABACAVIR SULFATE, LAMIVUDINE AND ZIDOVUDINE TABLET [LUPIN PHARMACEUTICALS, INC.] | 5 | |
| ZIDOVUDINE | ACTIVE INGREDIENT | 4B9XT59T7S | ABACAVIR SULFATE, LAMIVUDINE AND ZIDOVUDINE TABLET [LUPIN PHARMACEUTICALS, INC.] | 5 | |
| ABACAVIR | ACTIVE MOIETY | WR2TIP26VS | ABACAVIR SULFATE, LAMIVUDINE AND ZIDOVUDINE TABLET [LUPIN PHARMACEUTICALS, INC.] | 5 | |
| LAMIVUDINE | ACTIVE MOIETY | 2T8Q726O95 | ABACAVIR SULFATE, LAMIVUDINE AND ZIDOVUDINE TABLET [LUPIN PHARMACEUTICALS, INC.] | 5 | |
| ZIDOVUDINE | ACTIVE MOIETY | 4B9XT59T7S | ABACAVIR SULFATE, LAMIVUDINE AND ZIDOVUDINE TABLET [LUPIN PHARMACEUTICALS, INC.] | 5 | |
| CELLULOSE, MICROCRYSTALLINE | INACTIVE INGREDIENT | OP1R32D61U | ABACAVIR SULFATE, LAMIVUDINE AND ZIDOVUDINE TABLET [LUPIN PHARMACEUTICALS, INC.] | 5 | |
| CROSPOVIDONE | INACTIVE INGREDIENT | 68401960MK | ABACAVIR SULFATE, LAMIVUDINE AND ZIDOVUDINE TABLET [LUPIN PHARMACEUTICALS, INC.] | 5 | |
| FD&C BLUE NO. 2 | INACTIVE INGREDIENT | L06K8R7DQK | ABACAVIR SULFATE, LAMIVUDINE AND ZIDOVUDINE TABLET [LUPIN PHARMACEUTICALS, INC.] | 5 | |
| FERRIC OXIDE YELLOW | INACTIVE INGREDIENT | EX438O2MRT | ABACAVIR SULFATE, LAMIVUDINE AND ZIDOVUDINE TABLET [LUPIN PHARMACEUTICALS, INC.] | 5 | |
| MAGNESIUM STEARATE | INACTIVE INGREDIENT | 70097M6I30 | ABACAVIR SULFATE, LAMIVUDINE AND ZIDOVUDINE TABLET [LUPIN PHARMACEUTICALS, INC.] | 5 | |
| POLYETHYLENE GLYCOLS | INACTIVE INGREDIENT | 3WJQ0SDW1A | ABACAVIR SULFATE, LAMIVUDINE AND ZIDOVUDINE TABLET [LUPIN PHARMACEUTICALS, INC.] | 5 | |
| POLYVINYL ALCOHOL | INACTIVE INGREDIENT | 532B59J990 | ABACAVIR SULFATE, LAMIVUDINE AND ZIDOVUDINE TABLET [LUPIN PHARMACEUTICALS, INC.] | 5 | |
| POVIDONE | INACTIVE INGREDIENT | FZ989GH94E | ABACAVIR SULFATE, LAMIVUDINE AND ZIDOVUDINE TABLET [LUPIN PHARMACEUTICALS, INC.] | 5 | |
| TALC | INACTIVE INGREDIENT | 7SEV7J4R1U | ABACAVIR SULFATE, LAMIVUDINE AND ZIDOVUDINE TABLET [LUPIN PHARMACEUTICALS, INC.] | 5 | |
| TITANIUM DIOXIDE | INACTIVE INGREDIENT | 15FIX9V2JP | ABACAVIR SULFATE, LAMIVUDINE AND ZIDOVUDINE TABLET [LUPIN PHARMACEUTICALS, INC.] | 5 | |
DailyMed Dashboard NDC Coverage#
NDC, Dashboard title, SPL version table| NDC | Dashboard title | SPL version | Validation | Dashboard ZIP |
|---|
| 68180-286 | ABACAVIR, LAMIVUDINE AND ZIDOVUDINE (ABACAVIR , LAMIVUDINE AND ZIDOVUDINE) TABLET [LUPIN PHARMACEUTICALS, INC.] | 16 | Current NDC, Legacy NDC, 6 package rows | 20231102_f5f7c0d9-a247-4308-8269-32accc490ea6.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 |
|---|
| 68180-286-01 | 68180028601 | 1 BOTTLE in 1 CARTON (68180-286-01) > 100 TABLET in 1 BOTTLE | 1 bottle | 2013-12-17 | 0000-00-00 | No | No | Current |
| 68180-286-02 | 68180028602 | 1 BOTTLE in 1 CARTON (68180-286-02) > 500 TABLET in 1 BOTTLE | 1 bottle | 2013-12-17 | 0000-00-00 | No | No | Current |
| 68180-286-07 | 68180028607 | 1 BOTTLE in 1 CARTON (68180-286-07) > 60 TABLET in 1 BOTTLE | 1 bottle | 2013-12-17 | 0000-00-00 | No | No | Current |