Naproxen
- Product NDC
- 31722-341
- 11-digit product format
- 317220341
- Labeler code
- 31722
- Product ID
- 31722-341_3466d710-2b9c-402a-9a88-a15411c974ed
- Type
- HUMAN PRESCRIPTION DRUG
- Nonproprietary name
- Naproxen
- Dosage form
- TABLET
- Route
- ORAL
- Labeler
- Camber Pharmaceuticals
- Application
- ANDA091305
- Marketing category
- ANDA
- Marketing start
- 2012-01-23
- Marketing end
- 0000-00-00
- Substance
- NAPROXEN
- Active strength
- 375 mg/1
- Pharmacologic classes
- Cyclooxygenase Inhibitors [MoA],Nonsteroidal Anti-inflammatory Compounds [Chemical/Ingredient],Nonsteroidal Anti-inflammatory Drug [EPC]
- NDC exclude flag
- E
- Listing certified through
- 2017-12-31
- Current FDA listing
- Historical FDA.report record
FDA-Initiated Inactive NDC Indexing#
| NDC | Effective | Action | Document | Indexing SPL | Related label |
|---|---|---|---|---|---|
| 31722-341-05 | 2025-09-05 | C162847 | 48780-1 | 97449f38-b531-f6ea-e053-dbdaa90aa703 | 8dd7fade-d750-49ce-b798-a1d3615e57b7 |
| 31722-341-50 | 2025-09-05 | C162847 | 48780-1 | 97449f38-b531-f6ea-e053-dbdaa90aa703 | 8dd7fade-d750-49ce-b798-a1d3615e57b7 |
| 31722-341-05 | 2019-11-13 | C162847 | 48780-1 | 97449f38-b531-f6ea-e053-dbdaa90aa703 | 8dd7fade-d750-49ce-b798-a1d3615e57b7 |
| 31722-341-50 | 2019-11-13 | C162847 | 48780-1 | 97449f38-b531-f6ea-e053-dbdaa90aa703 | 8dd7fade-d750-49ce-b798-a1d3615e57b7 |
DailyMed Billing Units#
| Package NDC | Billing unit | Product NDC | DailyMed indexing SPL | SPL version | Effective |
|---|---|---|---|---|---|
| 31722-341-01 | EA - Each | 31722-341 | 63b4f6d3-ac77-44dc-968a-b2227779ca6c | 1 | 2012-07-24 |
| 31722-341-05 | EA - Each | 31722-341 | a8f53f56-e3c1-48dd-b586-26588e68d297 | 1 | 2012-07-24 |
DailyMed Socrata Ingredients#
| Ingredient | Type | UNII | DailyMed label | SPL version | Uploaded |
|---|---|---|---|---|---|
| NAPROXEN | ACTIVE INGREDIENT | 57Y76R9ATQ | NAPROXEN TABLET [CAMBER PHARMACEUTICALS] | 1 | |
| NAPROXEN | ACTIVE MOIETY | 57Y76R9ATQ | NAPROXEN TABLET [CAMBER PHARMACEUTICALS] | 1 | |
| CROSCARMELLOSE SODIUM | INACTIVE INGREDIENT | M28OL1HH48 | NAPROXEN TABLET [CAMBER PHARMACEUTICALS] | 1 | |
| FERRIC OXIDE RED | INACTIVE INGREDIENT | 1K09F3G675 | NAPROXEN TABLET [CAMBER PHARMACEUTICALS] | 1 | |
| FERRIC OXIDE YELLOW | INACTIVE INGREDIENT | EX438O2MRT | NAPROXEN TABLET [CAMBER PHARMACEUTICALS] | 1 | |
| MAGNESIUM STEARATE | INACTIVE INGREDIENT | 70097M6I30 | NAPROXEN TABLET [CAMBER PHARMACEUTICALS] | 1 | |
| POVIDONE | INACTIVE INGREDIENT | FZ989GH94E | NAPROXEN TABLET [CAMBER PHARMACEUTICALS] | 1 | |
| SILICON DIOXIDE | INACTIVE INGREDIENT | ETJ7Z6XBU4 | NAPROXEN TABLET [CAMBER PHARMACEUTICALS] | 1 |