Naproxen Sodium
- Product NDC
- 72789-389
- 11-digit product format
- 727890389
- Labeler code
- 72789
- Product ID
- 72789-389_47a9b7b5-2b1d-7a8e-e063-6294a90a1f63
- Type
- HUMAN PRESCRIPTION DRUG
- Nonproprietary name
- Naproxen Sodium
- Dosage form
- TABLET
- Route
- ORAL
- Labeler
- PD-Rx Pharmaceuticals, Inc.
- Application
- ANDA212199
- Marketing category
- ANDA
- Marketing start
- 2019-10-30
- Substance
- NAPROXEN SODIUM
- Active strength
- 550 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
- 2027-12-31
- Current FDA listing
- Yes
Additional Listing Data#
- Finished product
- Yes
- Brand name base
- Naproxen Sodium
- Listing expiration
- 2027-12-31
Active Ingredients#
Ingredient, Strength table| Ingredient | Strength |
|---|
| NAPROXEN SODIUM | 550 mg/1 |
Harmonized Identifiers#
Field, Values table| Field | Values |
|---|
| Unii | 9TN87S3A3C |
| Rxcui | 849431 |
DailyMed Product Concepts#
DailyMed Package Descriptions#
Package NDC, Product, Description table| Package NDC | Product | Description | Form | Quantity | Strength | SPL version |
|---|
| 72789-389-60 | Naproxen Sodium | 60 in 1 BOTTLE, PLASTIC | TABLET | 60 | | 6 |
DailyMed Dashboard NDC Coverage#
NDC, Dashboard title, SPL version table| NDC | Dashboard title | SPL version | Validation | Dashboard ZIP |
|---|
| 72789-389 | NAPROXEN SODIUM TABLET [PD-RX PHARMACEUTICALS, INC.] | 4 | Current NDC, 1 package rows | 20240402_145cdcc0-9bd5-4a0e-81fc-11a24d181980.zip |
DailyMed RxNorm Mappings#
Packages#
Package NDC, 11-digit format, Description table| Package NDC | 11-digit format | Description | Units | Marketing start | Sample | Exclude flag | Status |
|---|
| 72789-389-60 | 72789038960 | 60 TABLET in 1 BOTTLE, PLASTIC (72789-389-60) | 60 tablet | 2024-04-01 | No | No | Current |