Abacavir Sulfate
- Product NDC
- 51079-204
- 11-digit product format
- 510790204
- Labeler code
- 51079
- Product ID
- 51079-204_3a22f5ef-d757-6414-e063-6294a90af7de
- Type
- HUMAN PRESCRIPTION DRUG
- Nonproprietary name
- abacavir sulfate
- Dosage form
- TABLET, FILM COATED
- Route
- ORAL
- Labeler
- Mylan Institutional Inc.
- Application
- ANDA091294
- Marketing category
- ANDA
- Marketing start
- 2012-08-01
- 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 Sulfate
- 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 |
|---|
| 51079-204-01 | Abacavir Sulfate | 1 in 1 BLISTER PACK | TABLET, FILM COATED | 1 | | 13 |
| 51079-204-06 | Abacavir Sulfate | 50 in 1 CARTON | TABLET, FILM COATED | 50 | | 13 |
DailyMed Socrata Ingredients#
Ingredient, Type, UNII table| Ingredient | Type | UNII | DailyMed label | SPL version | Uploaded |
|---|
| ABACAVIR SULFATE | ACTIVE INGREDIENT | J220T4J9Q2 | ABACAVIR SULFATE TABLET, FILM COATED [MYLAN INSTITUTIONAL INC.] | 3 | |
| ABACAVIR | ACTIVE MOIETY | WR2TIP26VS | ABACAVIR SULFATE TABLET, FILM COATED [MYLAN INSTITUTIONAL INC.] | 3 | |
| CELLULOSE, MICROCRYSTALLINE | INACTIVE INGREDIENT | OP1R32D61U | ABACAVIR SULFATE TABLET, FILM COATED [MYLAN INSTITUTIONAL INC.] | 3 | |
| FERRIC OXIDE RED | INACTIVE INGREDIENT | 1K09F3G675 | ABACAVIR SULFATE TABLET, FILM COATED [MYLAN INSTITUTIONAL INC.] | 3 | |
| FERRIC OXIDE YELLOW | INACTIVE INGREDIENT | EX438O2MRT | ABACAVIR SULFATE TABLET, FILM COATED [MYLAN INSTITUTIONAL INC.] | 3 | |
| HYPROMELLOSES | INACTIVE INGREDIENT | 3NXW29V3WO | ABACAVIR SULFATE TABLET, FILM COATED [MYLAN INSTITUTIONAL INC.] | 3 | |
| MAGNESIUM STEARATE | INACTIVE INGREDIENT | 70097M6I30 | ABACAVIR SULFATE TABLET, FILM COATED [MYLAN INSTITUTIONAL INC.] | 3 | |
| POLYETHYLENE GLYCOLS | INACTIVE INGREDIENT | 3WJQ0SDW1A | ABACAVIR SULFATE TABLET, FILM COATED [MYLAN INSTITUTIONAL INC.] | 3 | |
| SILICON DIOXIDE | INACTIVE INGREDIENT | ETJ7Z6XBU4 | ABACAVIR SULFATE TABLET, FILM COATED [MYLAN INSTITUTIONAL INC.] | 3 | |
| SODIUM STARCH GLYCOLATE TYPE A POTATO | INACTIVE INGREDIENT | 5856J3G2A2 | ABACAVIR SULFATE TABLET, FILM COATED [MYLAN INSTITUTIONAL INC.] | 3 | |
| TITANIUM DIOXIDE | INACTIVE INGREDIENT | 15FIX9V2JP | ABACAVIR SULFATE TABLET, FILM COATED [MYLAN INSTITUTIONAL INC.] | 3 | |
DailyMed Dashboard NDC Coverage#
NDC, Dashboard title, SPL version table| NDC | Dashboard title | SPL version | Validation | Dashboard ZIP |
|---|
| 51079-204 | ABACAVIR SULFATE TABLET, FILM COATED [MYLAN INSTITUTIONAL INC.] | 12 | Current NDC, Legacy NDC, 2 package rows | 20220706_80c1702a-973c-436a-90f8-69b29674dca0.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 |
|---|
| 51079-204-01 | 51079020401 | 1 in 1 BLISTER PACK | | | | | | Historical |
| 51079-204-06 | 51079020406 | 50 BLISTER PACK in 1 CARTON (51079-204-06) / 1 TABLET, FILM COATED in 1 BLISTER PACK (51079-204-01) | 50 blister pack | 2012-08-01 | 0000-00-00 | No | No | Current |