febuxostat
- Product NDC
- 70518-4626
- 11-digit product format
- 705184626
- Labeler code
- 70518
- Product ID
- 70518-4626_50715053-7e60-460b-e063-6394a90a877c
- Type
- HUMAN PRESCRIPTION DRUG
- Nonproprietary name
- febuxostat
- Dosage form
- TABLET
- Route
- ORAL
- Labeler
- REMEDYREPACK INC.
- Application
- ANDA205443
- Marketing category
- ANDA
- Marketing start
- 2026-04-24
- Substance
- FEBUXOSTAT
- Active strength
- 40 mg/1
- Pharmacologic classes
- Xanthine Oxidase Inhibitor [EPC], Xanthine Oxidase 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
- febuxostat
- Listing expiration
- 2027-12-31
Active Ingredients#
Ingredient, Strength table| Ingredient | Strength |
|---|
| FEBUXOSTAT | 40 mg/1 |
Harmonized Identifiers#
Field, Values table| Field | Values |
|---|
| Unii | 101V0R1N2E |
| Rxcui | 834235 |
DailyMed Product Concepts#
DailyMed Package Descriptions#
Package NDC, Product, Description table| Package NDC | Product | Description | Form | Quantity | Strength | SPL version |
|---|
| 70518-4626-0 | febuxostat | 50 in 1 BOX | TABLET | 50 | | 1 |
| 70518-4626-1 | febuxostat | 1 in 1 POUCH | TABLET | 1 | | 1 |
DailyMed RxNorm Mappings#
Packages#
Package NDC, 11-digit format, Description table| Package NDC | 11-digit format | Description | Units | Marketing start | Sample | Exclude flag | Status |
|---|
| 70518-4626-0 | 70518462600 | 50 POUCH in 1 BOX (70518-4626-0) / 1 TABLET in 1 POUCH (70518-4626-1) | 50 pouch | 2026-04-24 | No | No | Historical |
| 70518-4626-1 | 70518462601 | 1 in 1 POUCH | | | | | Historical |