Naproxen
- Product NDC
- 63629-8512
- 11-digit product format
- 636298512
- Labeler code
- 63629
- Product ID
- 63629-8512_be6dd8a5-6668-46d2-a6fd-993f3f72c666
- Type
- HUMAN PRESCRIPTION DRUG
- Nonproprietary name
- Naproxen
- Dosage form
- TABLET
- Route
- ORAL
- Labeler
- Bryant Ranch Prepack
- 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 |
DailyMed Product Concepts#
DailyMed Package Descriptions#
Package NDC, Product, Description table| Package NDC | Product | Description | Form | Quantity | Strength | SPL version |
|---|
| 63629-8512-1 | Naproxen | 500 in 1 BOTTLE | TABLET | 500 | | 106 |
DailyMed Dashboard NDC Coverage#
NDC, Dashboard title, SPL version table| NDC | Dashboard title | SPL version | Validation | Dashboard ZIP |
|---|
| 63629-8512 | NAPROXEN TABLET [BRYANT RANCH PREPACK] | 105 | Current NDC, Legacy NDC, 1 package rows | 20240602_852fed15-e78b-47a8-aeb4-623dfe1edad9.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 |
|---|
| 63629-8512-1 | 63629851201 | 500 TABLET in 1 BOTTLE (63629-8512-1) | 500 tablet | 2020-03-01 | 0000-00-00 | No | No | Current |