Warfarin Sodium
- Product NDC
- 43353-053
- 11-digit product format
- 433530053
- Labeler code
- 43353
- Product ID
- 43353-053_49001c15-cda7-00e5-e063-6394a90a0853
- Type
- HUMAN PRESCRIPTION DRUG
- Nonproprietary name
- Warfarin
- Dosage form
- TABLET
- Route
- ORAL
- Labeler
- Aphena Pharma Solutions - Tennessee, LLC
- Application
- ANDA090935
- Marketing category
- ANDA
- Marketing start
- 2015-04-08
- Substance
- WARFARIN SODIUM
- Active strength
- 7.5 mg/1
- Pharmacologic classes
- Vitamin K Antagonist [EPC], Vitamin K 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
- Warfarin Sodium
- Listing expiration
- 2027-12-31
Active Ingredients#
Ingredient, Strength table| Ingredient | Strength |
|---|
| WARFARIN SODIUM | 7.5 mg/1 |
Harmonized Identifiers#
Field, Values table| Field | Values |
|---|
| Unii | 6153CWM0CL |
| Rxcui | 855288, 855296, 855302, 855312, 855318, 855324, 855332, 855344 |
DailyMed Product Concepts#
DailyMed Package Descriptions#
Package NDC, Product, Description table| Package NDC | Product | Description | Form | Quantity | Strength | SPL version |
|---|
| 43353-053-30 | Warfarin Sodium | 30 in 1 BOTTLE | TABLET | 30 | | 3 |
DailyMed Dashboard NDC Coverage#
NDC, Dashboard title, SPL version table| NDC | Dashboard title | SPL version | Validation | Dashboard ZIP |
|---|
| 43353-053 | WARFARIN SODIUM (WARFARIN) TABLET [APHENA PHARMA SOLUTIONS - TENNESSEE, LLC] | 2 | Current NDC, Legacy NDC, 1 package rows | 20170711_4f276251-49b7-438f-9c47-f1cdfc47e519.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 |
|---|
| 43353-053-30 | 43353005330 | 30 TABLET in 1 BOTTLE (43353-053-30) | 30 tablet | 2015-05-24 | 0000-00-00 | No | No | Current |