RELAFEN DS
- Product NDC
- 15370-170
- 11-digit product format
- 153700170
- Labeler code
- 15370
- Product ID
- 15370-170_48aa3640-1dd2-4693-9b0d-a99595b97a0e
- Type
- HUMAN PRESCRIPTION DRUG
- Nonproprietary name
- NABUMETONE
- Dosage form
- TABLET
- Route
- ORAL
- Labeler
- Carwin Pharmaceutical Associates, LLC
- Application
- ANDA203166
- Marketing category
- ANDA
- Marketing start
- 2019-09-20
- Substance
- NABUMETONE
- Active strength
- 1000 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
- RELAFEN DS
- Listing expiration
- 2026-12-31
Active Ingredients#
Ingredient, Strength table| Ingredient | Strength |
|---|
| NABUMETONE | 1000 mg/1 |
Harmonized Identifiers#
Field, Values table| Field | Values |
|---|
| Unii | LW0TIW155Z |
| Rxcui | 427726, 2200291 |
DailyMed Product Concepts#
DailyMed Package Descriptions#
Package NDC, Product, Description table| Package NDC | Product | Description | Form | Quantity | Strength | SPL version |
|---|
| 15370-170-10 | RELAFEN DS | 100 in 1 BOTTLE, PLASTIC | TABLET | 100 | | 5 |
| 15370-170-30 | RELAFEN DS | 30 in 1 BOTTLE, PLASTIC | TABLET | 30 | | 5 |
| 15370-170-60 | RELAFEN DS | 60 in 1 BOTTLE, PLASTIC | TABLET | 60 | | 5 |
| 15370-170-99 | RELAFEN DS | 1 in 1 CARTON | TABLET | 1 | | 5 |
| 15370-170-99 | RELAFEN DS | 2 in 1 BLISTER PACK | TABLET | 2 | | 5 |
DailyMed Dashboard NDC Coverage#
NDC, Dashboard title, SPL version table| NDC | Dashboard title | SPL version | Validation | Dashboard ZIP |
|---|
| 15370-170 | RELAFEN DS (NABUMETONE) TABLET [CARWIN PHARMACEUTICAL ASSOCIATES, LLC] | 5 | Current NDC, Legacy NDC, 5 package rows | 20240110_a9a0af85-6c43-4a2d-ba75-0be4ca64c931.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 |
|---|
| 15370-170-10 | 15370017010 | 100 TABLET in 1 BOTTLE, PLASTIC (15370-170-10) | 100 tablet | 2022-05-12 | 0000-00-00 | No | No | Current |
| 15370-170-30 | 15370017030 | 30 TABLET in 1 BOTTLE, PLASTIC (15370-170-30) | 30 tablet | 2019-09-20 | 0000-00-00 | No | No | Current |
| 15370-170-60 | 15370017060 | 60 TABLET in 1 BOTTLE, PLASTIC (15370-170-60) | 60 tablet | 2020-02-28 | 0000-00-00 | No | No | Current |
| 15370-170-99 | 15370017099 | 1 BLISTER PACK in 1 CARTON (15370-170-99) / 2 TABLET in 1 BLISTER PACK | 1 blister pack | 2020-02-28 | 0000-00-00 | Yes | No | Current |