Naproxen Sodium
- Product NDC
- 53746-193
- 11-digit product format
- 537460193
- Labeler code
- 53746
- Product ID
- 53746-193_58c84756-9886-4cfa-937c-f8894064c606
- Type
- HUMAN PRESCRIPTION DRUG
- Nonproprietary name
- Naproxen Sodium
- Dosage form
- TABLET
- Route
- ORAL
- Labeler
- Amneal Pharmaceuticals of New York LLC
- Application
- ANDA078432
- Marketing category
- ANDA
- Marketing start
- 2007-04-26
- Marketing end
- 0000-00-00
- Substance
- NAPROXEN SODIUM
- Active strength
- 275 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
- 2023-12-31
- Current FDA listing
- Historical FDA.report record
DailyMed Product Concepts#
FDA-Initiated Inactive NDC Indexing#
DailyMed Socrata Ingredients#
Ingredient, Type, UNII table| Ingredient | Type | UNII | DailyMed label | SPL version | Uploaded |
|---|
| NAPROXEN SODIUM | ACTIVE INGREDIENT | 9TN87S3A3C | NAPROXEN SODIUM TABLET [AMNEAL PHARMACEUTICALS OF NEW YORK, LLC] | 9 | |
| NAPROXEN | ACTIVE MOIETY | 57Y76R9ATQ | NAPROXEN SODIUM TABLET [AMNEAL PHARMACEUTICALS OF NEW YORK, LLC] | 9 | |
| CROSCARMELLOSE SODIUM | INACTIVE INGREDIENT | M28OL1HH48 | NAPROXEN SODIUM TABLET [AMNEAL PHARMACEUTICALS OF NEW YORK, LLC] | 9 | |
| FD&C BLUE NO. 2 | INACTIVE INGREDIENT | L06K8R7DQK | NAPROXEN SODIUM TABLET [AMNEAL PHARMACEUTICALS OF NEW YORK, LLC] | 9 | |
| MAGNESIUM STEARATE | INACTIVE INGREDIENT | 70097M6I30 | NAPROXEN SODIUM TABLET [AMNEAL PHARMACEUTICALS OF NEW YORK, LLC] | 9 | |
| POLYETHYLENE GLYCOLS | INACTIVE INGREDIENT | 3WJQ0SDW1A | NAPROXEN SODIUM TABLET [AMNEAL PHARMACEUTICALS OF NEW YORK, LLC] | 9 | |
| POLYVINYL ALCOHOL | INACTIVE INGREDIENT | 532B59J990 | NAPROXEN SODIUM TABLET [AMNEAL PHARMACEUTICALS OF NEW YORK, LLC] | 9 | |
| POVIDONES | INACTIVE INGREDIENT | FZ989GH94E | NAPROXEN SODIUM TABLET [AMNEAL PHARMACEUTICALS OF NEW YORK, LLC] | 9 | |
| TALC | INACTIVE INGREDIENT | 7SEV7J4R1U | NAPROXEN SODIUM TABLET [AMNEAL PHARMACEUTICALS OF NEW YORK, LLC] | 9 | |
| TITANIUM DIOXIDE | INACTIVE INGREDIENT | 15FIX9V2JP | NAPROXEN SODIUM TABLET [AMNEAL PHARMACEUTICALS OF NEW YORK, LLC] | 9 | |
| NAPROXEN SODIUM | ACTIVE INGREDIENT | 9TN87S3A3C | NAPROXEN SODIUM TABLET [BLENHEIM PHARMACAL, INC.] | 1 | |
| NAPROXEN SODIUM | ACTIVE INGREDIENT | 9TN87S3A3C | NAPROXEN SODIUM TABLET [AIDAREX PHARMACEUTICALS LLC] | 1 | |
| NAPROXEN | ACTIVE MOIETY | 57Y76R9ATQ | NAPROXEN SODIUM TABLET [BLENHEIM PHARMACAL, INC.] | 1 | |
| NAPROXEN | ACTIVE MOIETY | 57Y76R9ATQ | NAPROXEN SODIUM TABLET [AIDAREX PHARMACEUTICALS LLC] | 1 | |
| CROSCARMELLOSE SODIUM | INACTIVE INGREDIENT | M28OL1HH48 | NAPROXEN SODIUM TABLET [BLENHEIM PHARMACAL, INC.] | 1 | |
| CROSCARMELLOSE SODIUM | INACTIVE INGREDIENT | M28OL1HH48 | NAPROXEN SODIUM TABLET [AIDAREX PHARMACEUTICALS LLC] | 1 | |
| FD&C BLUE NO. 2 | INACTIVE INGREDIENT | L06K8R7DQK | NAPROXEN SODIUM TABLET [AIDAREX PHARMACEUTICALS LLC] | 1 | |
| FD&C BLUE NO. 2 | INACTIVE INGREDIENT | L06K8R7DQK | NAPROXEN SODIUM TABLET [BLENHEIM PHARMACAL, INC.] | 1 | |
| MAGNESIUM STEARATE | INACTIVE INGREDIENT | 70097M6I30 | NAPROXEN SODIUM TABLET [AIDAREX PHARMACEUTICALS LLC] | 1 | |
| MAGNESIUM STEARATE | INACTIVE INGREDIENT | 70097M6I30 | NAPROXEN SODIUM TABLET [BLENHEIM PHARMACAL, INC.] | 1 | |
| POLYVINYL ALCOHOL | INACTIVE INGREDIENT | 532B59J990 | NAPROXEN SODIUM TABLET [AIDAREX PHARMACEUTICALS LLC] | 1 | |
| POLYVINYL ALCOHOL | INACTIVE INGREDIENT | 532B59J990 | NAPROXEN SODIUM TABLET [BLENHEIM PHARMACAL, INC.] | 1 | |
| POVIDONE | INACTIVE INGREDIENT | FZ989GH94E | NAPROXEN SODIUM TABLET [BLENHEIM PHARMACAL, INC.] | 1 | |
| POVIDONES | INACTIVE INGREDIENT | FZ989GH94E | NAPROXEN SODIUM TABLET [AIDAREX PHARMACEUTICALS LLC] | 1 | |
| TALC | INACTIVE INGREDIENT | 7SEV7J4R1U | NAPROXEN SODIUM TABLET [AIDAREX PHARMACEUTICALS LLC] | 1 | |
| TALC | INACTIVE INGREDIENT | 7SEV7J4R1U | NAPROXEN SODIUM TABLET [BLENHEIM PHARMACAL, INC.] | 1 | |
| TITANIUM DIOXIDE | INACTIVE INGREDIENT | 15FIX9V2JP | NAPROXEN SODIUM TABLET [AIDAREX PHARMACEUTICALS LLC] | 1 | |
| TITANIUM DIOXIDE | INACTIVE INGREDIENT | 15FIX9V2JP | NAPROXEN SODIUM TABLET [BLENHEIM PHARMACAL, INC.] | 1 | |
DailyMed Dashboard NDC Coverage#
NDC, Dashboard title, SPL version table| NDC | Dashboard title | SPL version | Validation | Dashboard ZIP |
|---|
| 53746-193 | NAPROXEN SODIUM TABLET [AMNEAL PHARMACEUTICALS OF NEW YORK LLC] | 26 | Legacy NDC | 20241218_3c55594c-7801-4f59-8f4f-e85a03f3776b.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 |
|---|
| 53746-193-01 | 53746019301 | 100 TABLET in 1 BOTTLE (53746-193-01) | 100 tablet | 2007-04-26 | 0000-00-00 | No | No | Current |
| 53746-193-05 | 53746019305 | 500 TABLET in 1 BOTTLE (53746-193-05) | 500 tablet | 2007-04-26 | 0000-00-00 | No | No | Current |