Abacavir
- Product NDC
- 68084-021
- 11-digit product format
- 680840021
- Labeler code
- 68084
- Product ID
- 68084-021_1ea3a366-c7c0-2e89-e063-6294a90a2419
- Type
- HUMAN PRESCRIPTION DRUG
- Nonproprietary name
- Abacavir
- Dosage form
- TABLET, FILM COATED
- Route
- ORAL
- Labeler
- American Health Packaging
- Application
- ANDA077844
- Marketing category
- ANDA
- Marketing start
- 2013-02-04
- Substance
- ABACAVIR SULFATE
- Active strength
- 300 mg/1
- Pharmacologic classes
- Cytochrome P450 1A1 Inhibitors [MoA], Human Immunodeficiency Virus Nucleoside Analog Reverse Transcriptase Inhibitor [EPC], 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
- Listing expiration
- 2026-12-31
Active Ingredients#
Ingredient, Strength table| Ingredient | Strength |
|---|
| ABACAVIR SULFATE | 300 mg/1 |
Harmonized Identifiers#
Field, Values table| Field | Values |
|---|
| Unii | J220T4J9Q2 |
| Rxcui | 242679 |
DailyMed Product Concepts#
DailyMed Package Descriptions#
Package NDC, Product, Description table| Package NDC | Product | Description | Form | Quantity | Strength | SPL version |
|---|
| 68084-021-11 | Abacavir | 1 in 1 BLISTER PACK | TABLET, FILM COATED | 1 | | 7 |
| 68084-021-21 | Abacavir | 30 in 1 BOX, UNIT-DOSE | TABLET, FILM COATED | 30 | | 7 |
DailyMed Socrata Ingredients#
Ingredient, Type, UNII table| Ingredient | Type | UNII | DailyMed label | SPL version | Uploaded |
|---|
| ABACAVIR SULFATE | ACTIVE INGREDIENT | J220T4J9Q2 | ABACAVIR (ABACAVIR SULFATE) TABLET, FILM COATED [AMERICAN HEALTH PACKAGING] | 2 | |
| ABACAVIR | ACTIVE MOIETY | WR2TIP26VS | ABACAVIR (ABACAVIR SULFATE) TABLET, FILM COATED [AMERICAN HEALTH PACKAGING] | 2 | |
| CELLULOSE, MICROCRYSTALLINE | INACTIVE INGREDIENT | OP1R32D61U | ABACAVIR (ABACAVIR SULFATE) TABLET, FILM COATED [AMERICAN HEALTH PACKAGING] | 2 | |
| FERRIC OXIDE YELLOW | INACTIVE INGREDIENT | EX438O2MRT | ABACAVIR (ABACAVIR SULFATE) TABLET, FILM COATED [AMERICAN HEALTH PACKAGING] | 2 | |
| HYPROMELLOSES | INACTIVE INGREDIENT | 3NXW29V3WO | ABACAVIR (ABACAVIR SULFATE) TABLET, FILM COATED [AMERICAN HEALTH PACKAGING] | 2 | |
| MAGNESIUM STEARATE | INACTIVE INGREDIENT | 70097M6I30 | ABACAVIR (ABACAVIR SULFATE) TABLET, FILM COATED [AMERICAN HEALTH PACKAGING] | 2 | |
| POLYSORBATE 80 | INACTIVE INGREDIENT | 6OZP39ZG8H | ABACAVIR (ABACAVIR SULFATE) TABLET, FILM COATED [AMERICAN HEALTH PACKAGING] | 2 | |
| SILICON DIOXIDE | INACTIVE INGREDIENT | ETJ7Z6XBU4 | ABACAVIR (ABACAVIR SULFATE) TABLET, FILM COATED [AMERICAN HEALTH PACKAGING] | 2 | |
| SODIUM STARCH GLYCOLATE TYPE A POTATO | INACTIVE INGREDIENT | 5856J3G2A2 | ABACAVIR (ABACAVIR SULFATE) TABLET, FILM COATED [AMERICAN HEALTH PACKAGING] | 2 | |
| TITANIUM DIOXIDE | INACTIVE INGREDIENT | 15FIX9V2JP | ABACAVIR (ABACAVIR SULFATE) TABLET, FILM COATED [AMERICAN HEALTH PACKAGING] | 2 | |
| TRIACETIN | INACTIVE INGREDIENT | XHX3C3X673 | ABACAVIR (ABACAVIR SULFATE) TABLET, FILM COATED [AMERICAN HEALTH PACKAGING] | 2 | |
DailyMed Dashboard NDC Coverage#
NDC, Dashboard title, SPL version table| NDC | Dashboard title | SPL version | Validation | Dashboard ZIP |
|---|
| 68084-021 | ABACAVIR TABLET, FILM COATED [AMERICAN HEALTH PACKAGING] | 7 | Current NDC, Legacy NDC, 2 package rows | 20240802_01e46f58-8bda-4ff3-ab21-57d5b540d440.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 |
|---|
| 68084-021-11 | 68084002111 | 1 in 1 BLISTER PACK | | | | | | Historical |
| 68084-021-21 | 68084002121 | 30 BLISTER PACK in 1 BOX, UNIT-DOSE (68084-021-21) / 1 TABLET, FILM COATED in 1 BLISTER PACK (68084-021-11) | 30 blister pack | 2013-02-04 | 0000-00-00 | No | No | Current |