NAPROXEN
- Product NDC
- 68071-4510
- 11-digit product format
- 680714510
- Labeler code
- 68071
- Product ID
- 68071-4510_1a9069a4-cca5-c841-e063-6394a90ad4d2
- Type
- HUMAN PRESCRIPTION DRUG
- Nonproprietary name
- NAPROXEN
- Dosage form
- TABLET
- Route
- ORAL
- Labeler
- NuCare Pharmaceuticals,Inc.
- Application
- ANDA091416
- Marketing category
- ANDA
- Marketing start
- 2016-07-06
- 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 | 198013 |
DailyMed Product Concepts#
FDA-Initiated Inactive NDC Indexing#
DailyMed Package Descriptions#
Package NDC, Product, Description table| Package NDC | Product | Description | Form | Quantity | Strength | SPL version |
|---|
| 68071-4510-6 | NAPROXEN | 6 in 1 BOTTLE | TABLET | 6 | | 4 |
DailyMed Dashboard NDC Coverage#
NDC, Dashboard title, SPL version table| NDC | Dashboard title | SPL version | Validation | Dashboard ZIP |
|---|
| 68071-4510 | NAPROXEN TABLET [NUCARE PHARMACEUTICALS,INC.] | 4 | Current NDC, Legacy NDC, 1 package rows | 20240612_71d4a048-ca50-73db-e053-2a95a90ad465.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 |
|---|
| 68071-4510-6 | 68071451006 | 6 TABLET in 1 BOTTLE (68071-4510-6) | 6 tablet | 2018-07-25 | 0000-00-00 | No | No | Current |