Naproxen Sodium
- Product NDC
- 72789-543
- 11-digit product format
- 727890543
- Labeler code
- 72789
- Product ID
- 72789-543_46b3a114-167a-d337-e063-6394a90a9a33
- Type
- HUMAN OTC DRUG
- Nonproprietary name
- Naproxen Sodium
- Dosage form
- TABLET, FILM COATED
- Route
- ORAL
- Labeler
- PD-Rx Pharmaceuticals, Inc.
- Application
- ANDA074661
- Marketing category
- ANDA
- Marketing start
- 2014-04-11
- 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 |
|---|
| 72789-543-14 | Naproxen Sodium | 14 in 1 BOTTLE, PLASTIC | TABLET, FILM COATED | 14 | | 2 |
| 72789-543-28 | Naproxen Sodium | 28 in 1 BOTTLE, PLASTIC | TABLET, FILM COATED | 28 | | 2 |
DailyMed RxNorm Mappings#
Packages#
Package NDC, 11-digit format, Description table| Package NDC | 11-digit format | Description | Marketing start | Sample | Exclude flag | Status |
|---|
| 72789-543-14 | 72789054314 | 14 TABLET, FILM COATED in 1 BOTTLE, PLASTIC (72789-543-14) | 2025-12-23 | No | No | Historical |
| 72789-543-28 | 72789054328 | 28 TABLET, FILM COATED in 1 BOTTLE, PLASTIC (72789-543-28) | 2025-12-23 | No | No | Historical |