Naproxen
- Product NDC
- 66267-807
- 11-digit product format
- 662670807
- Labeler code
- 66267
- Product ID
- 66267-807_1fa76f84-21fe-0e56-e063-6394a90a1a7a
- Type
- HUMAN PRESCRIPTION DRUG
- Nonproprietary name
- Naproxen
- Dosage form
- TABLET
- Route
- ORAL
- Labeler
- NuCare Pharmaceuticals, Inc.
- Application
- ANDA078250
- Marketing category
- ANDA
- Marketing start
- 2007-07-01
- Substance
- NAPROXEN
- 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
- Naproxen
- Listing expiration
- 2026-12-31
Active Ingredients#
Ingredient, Strength table| Ingredient | Strength |
|---|
| NAPROXEN | 500 mg/1 |
Harmonized Identifiers#
Field, Values table| Field | Values |
|---|
| Unii | 57Y76R9ATQ |
| Rxcui | 198014 |
DailyMed Product Concepts#
FDA-Initiated Inactive NDC Indexing#
NDC, Effective, Action table| NDC | Effective | Action | Document | Indexing SPL | Related label |
|---|
| 66267-807-04 | 2024-08-14 | C162847 | 48780-1 | f386c649-fc6f-0266-e053-dadaa90a7c1a | NAPROXEN Tablets, USP NAPROXEN SODIUM Tablets, USP |
| 66267-807-06 | 2024-08-14 | C162847 | 48780-1 | f386c649-fc6f-0266-e053-dadaa90a7c1a | NAPROXEN Tablets, USP NAPROXEN SODIUM Tablets, USP |
| 66267-807-04 | 2023-01-30 | C162847 | 48780-1 | f386c649-fc6f-0266-e053-dadaa90a7c1a | NAPROXEN Tablets, USP NAPROXEN SODIUM Tablets, USP |
| 66267-807-06 | 2023-01-30 | C162847 | 48780-1 | f386c649-fc6f-0266-e053-dadaa90a7c1a | NAPROXEN Tablets, USP NAPROXEN SODIUM Tablets, USP |
DailyMed Package Descriptions#
Package NDC, Product, Description table| Package NDC | Product | Description | Form | Quantity | Strength | SPL version |
|---|
| 66267-807-04 | Naproxen | 4 in 1 BOTTLE | TABLET | 4 | | 4 |
| 66267-807-06 | 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 |
|---|
| 66267-807 | NAPROXEN TABLET [NUCARE PHARMACEUTICALS, INC.] | 4 | Current NDC, Legacy NDC, 2 package rows | 20240815_46dd3908-6feb-4f50-e054-00144ff88e88.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 |
|---|
| 66267-807-04 | 66267080704 | 4 TABLET in 1 BOTTLE (66267-807-04) | 4 tablet | 2017-01-24 | 0000-00-00 | No | No | Current |
| 66267-807-06 | 66267080706 | 6 TABLET in 1 BOTTLE (66267-807-06) | 6 tablet | 2017-01-24 | 0000-00-00 | No | No | Current |