Naproxen
- Product NDC
- 53217-405
- 11-digit product format
- 532170405
- Labeler code
- 53217
- Product ID
- 53217-405_d8a7ed12-2361-443a-929f-bced6ca97bca
- Type
- HUMAN PRESCRIPTION DRUG
- Nonproprietary name
- Naproxen
- Dosage form
- TABLET, DELAYED RELEASE
- Route
- ORAL
- Labeler
- Aidarex Pharmaceuticals LLC
- Application
- ANDA091432
- Marketing category
- ANDA
- Marketing start
- 2018-08-10
- Marketing end
- 0000-00-00
- Substance
- NAPROXEN
- Active strength
- 500 mg/1
- Pharmacologic classes
- Cyclooxygenase Inhibitors [MoA],Anti-Inflammatory Agents, Non-Steroidal [CS],Nonsteroidal Anti-inflammatory Drug [EPC]
- NDC exclude flag
- No
- Listing certified through
- 2019-12-31
- Current FDA listing
- Historical FDA.report record
DailyMed Product Concepts#
FDA-Initiated Inactive NDC Indexing#
DailyMed Package Descriptions#
Package NDC, Product, Description table| Package NDC | Product | Description | Form | Quantity | Strength | SPL version |
|---|
| 53217-405-30 | Naproxen | 30 in 1 BOTTLE | TABLET, DELAYED RELEASE | 30 | | 1 |
DailyMed Dashboard NDC Coverage#
NDC, Dashboard title, SPL version table| NDC | Dashboard title | SPL version | Validation | Dashboard ZIP |
|---|
| 53217-405 | NAPROXEN TABLET, DELAYED RELEASE [AIDAREX PHARMACEUTICALS LLC] | 1 | Legacy NDC, 1 package rows | 20180825_c89df567-5228-4073-a139-71ee22cf359b.zip |
DailyMed RxNorm Mappings#
Packages#
Package NDC, 11-digit format, Description table| Package NDC | 11-digit format | Description | Status |
|---|
| 53217-405-30 | 53217040530 | 30 in 1 BOTTLE | Historical |