Naproxen Sodium
- Product NDC
- 81522-045
- 11-digit product format
- 815220045
- Labeler code
- 81522
- Product ID
- 81522-045_37cb3db7-1ced-fafb-e063-6394a90a8f39
- Type
- HUMAN OTC DRUG
- Nonproprietary name
- NAPROXEN SODIUM
- Dosage form
- TABLET, COATED
- Route
- ORAL
- Labeler
- FSA STORE INC.
- Application
- ANDA079096
- Marketing category
- ANDA
- Marketing start
- 2023-05-02
- Substance
- NAPROXEN SODIUM
- Active strength
- 220 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 Sodium
- Listing expiration
- 2026-12-31
Active Ingredients#
Ingredient, Strength table| Ingredient | Strength |
|---|
| NAPROXEN SODIUM | 220 mg/1 |
Harmonized Identifiers#
Field, Values table| Field | Values |
|---|
| Unii | 9TN87S3A3C |
| Rxcui | 849574 |
DailyMed Product Concepts#
DailyMed Package Descriptions#
Package NDC, Product, Description table| Package NDC | Product | Description | Form | Quantity | Strength | SPL version |
|---|
| 81522-045-05 | Naproxen Sodium | 1 in 1 CARTON | TABLET, COATED | 1 | | 3 |
| 81522-045-05 | Naproxen Sodium | 200 in 1 BOTTLE, PLASTIC | TABLET, COATED | 200 | | 3 |
DailyMed Dashboard NDC Coverage#
NDC, Dashboard title, SPL version table| NDC | Dashboard title | SPL version | Validation | Dashboard ZIP |
|---|
| 81522-045 | NAPROXEN SODIUM TABLET, COATED [FSA STORE INC.] | 2 | Current NDC, 2 package rows | 20230504_f4326f99-142b-0b70-e053-2995a90ac951.zip |
DailyMed RxNorm Mappings#
Packages#
Package NDC, 11-digit format, Description table| Package NDC | 11-digit format | Description | Marketing start | Sample | Exclude flag | Status |
|---|
| 81522-045-05 | 81522004505 | 1 BOTTLE, PLASTIC in 1 CARTON (81522-045-05) / 200 TABLET, COATED in 1 BOTTLE, PLASTIC | 2023-05-02 | No | No | Current |