Naproxen
- Product NDC
- 70010-137
- 11-digit product format
- 700100137
- Labeler code
- 70010
- Product ID
- 70010-137_451b46b7-e6fb-8436-e063-6294a90adcf1
- Type
- HUMAN PRESCRIPTION DRUG
- Nonproprietary name
- Naproxen
- Dosage form
- TABLET
- Route
- ORAL
- Labeler
- Granules Pharmaceuticals Inc.
- Application
- ANDA074140
- Marketing category
- ANDA
- Marketing start
- 2021-04-15
- Substance
- NAPROXEN
- Active strength
- 250 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
- Naproxen
- Listing expiration
- 2026-12-31
Active Ingredients#
Ingredient, Strength table| Ingredient | Strength |
|---|
| NAPROXEN | 250 mg/1 |
Harmonized Identifiers#
Field, Values table| Field | Values |
|---|
| Unii | 57Y76R9ATQ |
| Rxcui | 198012, 198013, 198014 |
DailyMed Product Concepts#
DailyMed Package Descriptions#
Package NDC, Product, Description table| Package NDC | Product | Description | Form | Quantity | Strength | SPL version |
|---|
| 70010-137-01 | Naproxen | 100 in 1 BOTTLE | TABLET | 100 | | 11 |
| 70010-137-05 | Naproxen | 500 in 1 BOTTLE | TABLET | 500 | | 11 |
| 70010-137-10 | Naproxen | 1000 in 1 BOTTLE | TABLET | 1000 | | 11 |
DailyMed Dashboard NDC Coverage#
NDC, Dashboard title, SPL version table| NDC | Dashboard title | SPL version | Validation | Dashboard ZIP |
|---|
| 70010-137 | NAPROXEN TABLET [GRANULES PHARMACEUTICALS INC.] | 10 | Current NDC, Legacy NDC, 3 package rows | 20241222_c1cb9bb9-fbae-5e5c-e053-2995a90a0d21.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 |
|---|
| 70010-137-01 | 70010013701 | 100 TABLET in 1 BOTTLE (70010-137-01) | 100 tablet | 2021-04-15 | 0000-00-00 | No | No | Current |
| 70010-137-05 | 70010013705 | 500 TABLET in 1 BOTTLE (70010-137-05) | 500 tablet | 2021-04-15 | 0000-00-00 | No | No | Current |
| 70010-137-10 | 70010013710 | 1000 TABLET in 1 BOTTLE (70010-137-10) | 1000 tablet | 2021-04-15 | 0000-00-00 | No | No | Current |