Nabumetone
- Product NDC
- 70954-785
- 11-digit product format
- 709540785
- Labeler code
- 70954
- Product ID
- 70954-785_e87289f4-d4f9-4510-aaa5-51f8f8167658
- Type
- HUMAN PRESCRIPTION DRUG
- Nonproprietary name
- Nabumetone
- Dosage form
- TABLET, FILM COATED
- Route
- ORAL
- Labeler
- ANI Pharmaceuticals, Inc.
- Application
- ANDA219118
- Marketing category
- ANDA
- Marketing start
- 2025-01-07
- Substance
- NABUMETONE
- Active strength
- 750 mg/1
- Pharmacologic classes
- Anti-Inflammatory Agents, Non-Steroidal [CS], Cyclooxygenase Inhibitors [MoA], Nonsteroidal Anti-inflammatory Drug [EPC]
- NDC exclude flag
- No
- Listing certified through
- 2026-12-31
- Current FDA listing
- Yes
Additional Listing Data#
- Finished product
- Yes
- Brand name base
- Nabumetone
- Listing expiration
- 2027-12-31
Active Ingredients#
Ingredient, Strength table| Ingredient | Strength |
|---|
| NABUMETONE | 750 mg/1 |
Harmonized Identifiers#
Field, Values table| Field | Values |
|---|
| Unii | LW0TIW155Z |
| Rxcui | 311892, 311893 |
DailyMed Product Concepts#
DailyMed Package Descriptions#
Package NDC, Product, Description table| Package NDC | Product | Description | Form | Quantity | Strength | SPL version |
|---|
| 70954-785-10 | Nabumetone | 100 in 1 BOTTLE | TABLET, FILM COATED | 100 | | 1 |
| 70954-785-20 | Nabumetone | 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 |
|---|
| 70954-785 | NABUMETONE TABLET, FILM COATED [ANI PHARMACEUTICALS, INC.] | 1 | Current NDC, 2 package rows | 20250112_e87289f4-d4f9-4510-aaa5-51f8f8167658.zip |
DailyMed RxNorm Mappings#
Packages#
Package NDC, 11-digit format, Description table| Package NDC | 11-digit format | Description | Marketing start | Sample | Exclude flag | Status |
|---|
| 70954-785-10 | 70954078510 | 100 TABLET, FILM COATED in 1 BOTTLE (70954-785-10) | 2025-01-07 | No | No | Current |
| 70954-785-20 | 70954078520 | 500 TABLET, FILM COATED in 1 BOTTLE (70954-785-20) | 2025-01-07 | No | No | Current |