Nabumetone
- Product NDC
- 70518-3835
- 11-digit product format
- 705183835
- Labeler code
- 70518
- Product ID
- 70518-3835_3f68d0c6-26a6-df70-e063-6294a90a1f75
- Type
- HUMAN PRESCRIPTION DRUG
- Nonproprietary name
- Nabumetone
- Dosage form
- TABLET
- Route
- ORAL
- Labeler
- REMEDYREPACK INC.
- Application
- ANDA078420
- Marketing category
- ANDA
- Marketing start
- 2023-08-18
- Substance
- NABUMETONE
- Active strength
- 500 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 | 500 mg/1 |
Harmonized Identifiers#
Field, Values table| Field | Values |
|---|
| Unii | LW0TIW155Z |
DailyMed Product Concepts#
DailyMed Package Descriptions#
Package NDC, Product, Description table| Package NDC | Product | Description | Form | Quantity | Strength | SPL version |
|---|
| 70518-3835-0 | Nabumetone | 14 in 1 BOTTLE, PLASTIC | TABLET | 14 | | 3 |
| 70518-3835-1 | Nabumetone | 60 in 1 BOTTLE, PLASTIC | TABLET | 60 | | 3 |
DailyMed Dashboard NDC Coverage#
NDC, Dashboard title, SPL version table| NDC | Dashboard title | SPL version | Validation | Dashboard ZIP |
|---|
| 70518-3835 | NABUMETONE TABLET [REMEDYREPACK INC.] | 2 | Current NDC, 2 package rows | 20240314_311ae656-55d2-4116-a1bd-6f4a4ce70185.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 |
|---|
| 70518-3835-0 | 70518383500 | 14 TABLET in 1 BOTTLE, PLASTIC (70518-3835-0) | 14 tablet | 2023-08-18 | No | No | Current |
| 70518-3835-1 | 70518383501 | 60 TABLET in 1 BOTTLE, PLASTIC (70518-3835-1) | 60 tablet | 2024-03-12 | No | No | Current |