Abacavir
- Product NDC
- 69097-514
- 11-digit product format
- 690970514
- Labeler code
- 69097
- Product ID
- 69097-514_cf84089d-b713-40b8-a815-b66f4119982e
- Type
- HUMAN PRESCRIPTION DRUG
- Nonproprietary name
- Abacavir
- Dosage form
- TABLET, FILM COATED
- Route
- ORAL
- Labeler
- Cipla USA Inc.
- Application
- ANDA078119
- Marketing category
- ANDA
- Marketing start
- 2017-11-21
- Substance
- ABACAVIR SULFATE
- Active strength
- 300 mg/1
- Pharmacologic classes
- Human Immunodeficiency Virus Nucleoside Analog Reverse Transcriptase Inhibitor [EPC], Nucleoside Analog [EXT], 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 |
|---|
| 69097-514-03 | Abacavir | 60 in 1 BOTTLE | TABLET, FILM COATED | 60 | | 9 |
DailyMed Dashboard NDC Coverage#
NDC, Dashboard title, SPL version table| NDC | Dashboard title | SPL version | Validation | Dashboard ZIP |
|---|
| 69097-514 | ABACAVIR TABLET, FILM COATED [CIPLA USA INC.] | 9 | Current NDC, Legacy NDC, 1 package rows | 20201231_0d791375-e311-41f9-87b8-940657e6318c.zip |
DailyMed RxNorm Mappings#
Packages#
Package NDC, 11-digit format, Description table| Package NDC | 11-digit format | Description | Marketing start | Marketing end | Sample | Exclude flag | Status |
|---|
| 69097-514-03 | 69097051403 | 60 TABLET, FILM COATED in 1 BOTTLE (69097-514-03) | 2017-11-21 | 0000-00-00 | No | No | Current |