Apixaban
- Product NDC
- 33342-338
- 11-digit product format
- 333420338
- Labeler code
- 33342
- Product ID
- 33342-338_396912c0-9f68-47ed-ba3f-8d9ace755a48
- Type
- HUMAN PRESCRIPTION DRUG
- Nonproprietary name
- Apixaban
- Dosage form
- TABLET, FILM COATED
- Route
- ORAL
- Labeler
- Macleods Pharmaceuticals Limited
- Application
- ANDA210067
- Marketing category
- ANDA
- Marketing start
- 2025-02-27
- Substance
- APIXABAN
- Active strength
- 5 mg/1
- Pharmacologic classes
- Factor Xa Inhibitor [EPC], Factor Xa 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
- Apixaban
- Listing expiration
- 2026-12-31
Active Ingredients#
Ingredient, Strength table| Ingredient | Strength |
|---|
| APIXABAN | 5 mg/1 |
Harmonized Identifiers#
Field, Values table| Field | Values |
|---|
| Unii | 3Z9Y7UWC1J |
| Rxcui | 1364435, 1364445 |
DailyMed Product Concepts#
DailyMed Package Descriptions#
Package NDC, Product, Description table| Package NDC | Product | Description | Form | Quantity | Strength | SPL version |
|---|
| 33342-338-09 | Apixaban | 60 in 1 BOTTLE | TABLET, FILM COATED | 60 | | 1 |
| 33342-338-12 | Apixaban | 10 in 1 CARTON | TABLET, FILM COATED | 10 | | 1 |
| 33342-338-12 | Apixaban | 10 in 1 BLISTER PACK | TABLET, FILM COATED | 10 | | 1 |
| 33342-338-15 | Apixaban | 500 in 1 BOTTLE | TABLET, FILM COATED | 500 | | 1 |
DailyMed Dashboard NDC Coverage#
NDC, Dashboard title, SPL version table| NDC | Dashboard title | SPL version | Validation | Dashboard ZIP |
|---|
| 33342-338 | APIXABAN TABLET, FILM COATED [MACLEODS PHARMACEUTICALS LIMITED] | 1 | Current NDC, 4 package rows | 20250427_396912c0-9f68-47ed-ba3f-8d9ace755a48.zip |
DailyMed RxNorm Mappings#
Packages#
Package NDC, 11-digit format, Description table| Package NDC | 11-digit format | Description | Units | Marketing start | Sample | Exclude flag | Status |
|---|
| 33342-338-09 | 33342033809 | 60 TABLET, FILM COATED in 1 BOTTLE (33342-338-09) | | 2025-02-27 | No | No | Current |
| 33342-338-12 | 33342033812 | 10 BLISTER PACK in 1 CARTON (33342-338-12) / 10 TABLET, FILM COATED in 1 BLISTER PACK | 10 blister pack | 2025-02-27 | No | No | Current |
| 33342-338-15 | 33342033815 | 500 TABLET, FILM COATED in 1 BOTTLE (33342-338-15) | | 2025-02-27 | No | No | Current |