Abacavir Sulfate
- Product NDC
- 48433-001
- 11-digit product format
- 484330001
- Labeler code
- 48433
- Product ID
- 48433-001_4c48242c-1749-1a49-e063-6294a90ac81d
- Type
- HUMAN PRESCRIPTION DRUG
- Nonproprietary name
- abacavir sulfate
- Dosage form
- TABLET, FILM COATED
- Route
- ORAL
- Labeler
- Safecor Health, LLC
- Application
- ANDA091294
- Marketing category
- ANDA
- Marketing start
- 2026-02-23
- 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
- 2027-12-31
- Current FDA listing
- Yes
Additional Listing Data#
- Finished product
- Yes
- Brand name base
- Abacavir Sulfate
- Listing expiration
- 2027-12-31
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 |
|---|
| 48433-001-01 | Abacavir Sulfate | 1 in 1 BLISTER PACK | TABLET, FILM COATED | 1 | | 2 |
| 48433-001-06 | Abacavir Sulfate | 50 in 1 CARTON | TABLET, FILM COATED | 50 | | 2 |
DailyMed RxNorm Mappings#
Packages#
Package NDC, 11-digit format, Description table| Package NDC | 11-digit format | Description | Units | Marketing start | Sample | Exclude flag | Status |
|---|
| 48433-001-01 | 48433000101 | 1 in 1 BLISTER PACK | | | | | Historical |
| 48433-001-06 | 48433000106 | 50 BLISTER PACK in 1 CARTON (48433-001-06) / 1 TABLET, FILM COATED in 1 BLISTER PACK (48433-001-01) | 50 blister pack | 2026-02-23 | No | No | Current |