Naproxen
- Product NDC
- 50228-435
- 11-digit product format
- 502280435
- Labeler code
- 50228
- Product ID
- 50228-435_9af8c9f3-92e7-4301-b401-f40230af2eb7
- Type
- HUMAN PRESCRIPTION DRUG
- Nonproprietary name
- Naproxen
- Dosage form
- TABLET
- Route
- ORAL
- Labeler
- ScieGen Pharmaceuticals, Inc.
- Application
- ANDA212517
- Marketing category
- ANDA
- Marketing start
- 2020-03-01
- Substance
- NAPROXEN
- Active strength
- 375 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
- Listing expiration
- 2027-12-31
Active Ingredients#
Ingredient, Strength table| Ingredient | Strength |
|---|
| NAPROXEN | 375 mg/1 |
Harmonized Identifiers#
Field, Values table| Field | Values |
|---|
| Unii | 57Y76R9ATQ |
| Rxcui | 198012, 198013, 198014 |
DailyMed Product Concepts#
DailyMed Package Descriptions#
Package NDC, Product, Description table| Package NDC | Product | Description | Form | Quantity | Strength | SPL version |
|---|
| 50228-435-01 | Naproxen | 100 in 1 BOTTLE | TABLET | 100 | | 9 |
| 50228-435-05 | Naproxen | 500 in 1 BOTTLE | TABLET | 500 | | 9 |
| 50228-435-10 | Naproxen | 1000 in 1 BOTTLE | TABLET | 1000 | | 9 |
| 50228-435-30 | Naproxen | 30 in 1 BOTTLE | TABLET | 30 | | 9 |
DailyMed Dashboard NDC Coverage#
NDC, Dashboard title, SPL version table| NDC | Dashboard title | SPL version | Validation | Dashboard ZIP |
|---|
| 50228-435 | NAPROXEN TABLET [SCIEGEN PHARMACEUTICALS, INC.] | 7 | Current NDC, Legacy NDC, 4 package rows | 20231109_81e22c1f-f94d-46e9-8b7d-72dc2518319e.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 |
|---|
| 50228-435-01 | 50228043501 | 100 TABLET in 1 BOTTLE (50228-435-01) | 100 tablet | 2020-03-01 | 0000-00-00 | No | No | Current |
| 50228-435-05 | 50228043505 | 500 TABLET in 1 BOTTLE (50228-435-05) | 500 tablet | 2020-03-01 | 0000-00-00 | No | No | Current |
| 50228-435-10 | 50228043510 | 1000 TABLET in 1 BOTTLE (50228-435-10) | 1000 tablet | 2020-03-01 | 0000-00-00 | No | No | Current |
| 50228-435-30 | 50228043530 | 30 TABLET in 1 BOTTLE (50228-435-30) | 30 tablet | 2020-03-01 | 0000-00-00 | No | No | Current |