Naproxen
- Product NDC
- 72789-003
- 11-digit product format
- 727890003
- Labeler code
- 72789
- Product ID
- 72789-003_4030dd59-8cd7-cfbe-e063-6294a90aad75
- Type
- HUMAN PRESCRIPTION DRUG
- Nonproprietary name
- Naproxen
- Dosage form
- TABLET, DELAYED RELEASE
- Route
- ORAL
- Labeler
- PD-Rx Pharmaceuticals, Inc.
- Application
- ANDA091432
- Marketing category
- ANDA
- Marketing start
- 2016-07-05
- 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 | 311915 |
DailyMed Product Concepts#
DailyMed Package Descriptions#
Package NDC, Product, Description table| Package NDC | Product | Description | Form | Quantity | Strength | SPL version |
|---|
| 72789-003-60 | Naproxen | 60 in 1 BOTTLE, PLASTIC | TABLET, DELAYED RELEASE | 60 | | 10 |
DailyMed Dashboard NDC Coverage#
NDC, Dashboard title, SPL version table| NDC | Dashboard title | SPL version | Validation | Dashboard ZIP |
|---|
| 72789-003 | NAPROXEN TABLET, DELAYED RELEASE [PD-RX PHARMACEUTICALS, INC.] | 9 | Current NDC, Legacy NDC, 1 package rows | 20241010_2d01e583-670a-46f4-b5f2-3fad46d0376f.zip |
DailyMed RxNorm Mappings#
Packages#
Package NDC, 11-digit format, Description table| Package NDC | 11-digit format | Description | Marketing start | Marketing end | Sample | Exclude flag | Status |
|---|
| 72789-003-60 | 72789000360 | 60 TABLET, DELAYED RELEASE in 1 BOTTLE, PLASTIC (72789-003-60) | 2019-08-20 | 0000-00-00 | No | No | Current |