Naproxen Sodium
- Product NDC
- 55289-367
- 11-digit product format
- 552890367
- Labeler code
- 55289
- Product ID
- 55289-367_dee8dec8-0c62-83bc-e053-2995a90ab743
- Type
- HUMAN PRESCRIPTION DRUG
- Nonproprietary name
- Naproxen Sodium
- Dosage form
- TABLET
- Route
- ORAL
- Labeler
- PD-Rx Pharmaceuticals, Inc.
- Application
- ANDA078432
- Marketing category
- ANDA
- Marketing start
- 2007-04-26
- Marketing end
- 0000-00-00
- Substance
- NAPROXEN SODIUM
- Active strength
- 550 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
- 2023-12-31
- Current FDA listing
- Historical FDA.report record
DailyMed Product Concepts#
DailyMed Socrata Ingredients#
Ingredient, Type, UNII table| Ingredient | Type | UNII | DailyMed label | SPL version | Uploaded |
|---|
| NAPROXEN SODIUM | ACTIVE INGREDIENT | 9TN87S3A3C | NAPROXEN SODIUM TABLET [PD-RX PHARMACEUTICALS, INC.] | 2 | |
| NAPROXEN | ACTIVE MOIETY | 57Y76R9ATQ | NAPROXEN SODIUM TABLET [PD-RX PHARMACEUTICALS, INC.] | 2 | |
| CROSCARMELLOSE SODIUM | INACTIVE INGREDIENT | M28OL1HH48 | NAPROXEN SODIUM TABLET [PD-RX PHARMACEUTICALS, INC.] | 2 | |
| FD&C BLUE NO. 2 | INACTIVE INGREDIENT | L06K8R7DQK | NAPROXEN SODIUM TABLET [PD-RX PHARMACEUTICALS, INC.] | 2 | |
| MAGNESIUM STEARATE | INACTIVE INGREDIENT | 70097M6I30 | NAPROXEN SODIUM TABLET [PD-RX PHARMACEUTICALS, INC.] | 2 | |
| POLYVINYL ALCOHOL | INACTIVE INGREDIENT | 532B59J990 | NAPROXEN SODIUM TABLET [PD-RX PHARMACEUTICALS, INC.] | 2 | |
| POVIDONE | INACTIVE INGREDIENT | FZ989GH94E | NAPROXEN SODIUM TABLET [PD-RX PHARMACEUTICALS, INC.] | 2 | |
| TALC | INACTIVE INGREDIENT | 7SEV7J4R1U | NAPROXEN SODIUM TABLET [PD-RX PHARMACEUTICALS, INC.] | 2 | |
| TITANIUM DIOXIDE | INACTIVE INGREDIENT | 15FIX9V2JP | NAPROXEN SODIUM TABLET [PD-RX PHARMACEUTICALS, INC.] | 2 | |
DailyMed Dashboard NDC Coverage#
NDC, Dashboard title, SPL version table| NDC | Dashboard title | SPL version | Validation | Dashboard ZIP |
|---|
| 55289-367 | NAPROXEN SODIUM TABLET [PD-RX PHARMACEUTICALS, INC.] | 27 | Legacy NDC | 20250322_58caec51-74aa-44b8-9638-f7cca096a54a.zip |
Packages#
Package NDC, 11-digit format, Description table| Package NDC | 11-digit format | Description | Units | Marketing start | Marketing end | Sample | Exclude flag | Status |
|---|
| 55289-367-06 | 55289036706 | 6 TABLET in 1 BOTTLE, PLASTIC (55289-367-06) | 6 tablet | 2010-09-22 | 0000-00-00 | No | No | Current |
| 55289-367-10 | 55289036710 | 10 TABLET in 1 BOTTLE, PLASTIC (55289-367-10) | 10 tablet | 2010-09-22 | 0000-00-00 | No | No | Current |
| 55289-367-14 | 55289036714 | 14 TABLET in 1 BOTTLE, PLASTIC (55289-367-14) | 14 tablet | 2010-09-22 | 0000-00-00 | No | No | Current |
| 55289-367-15 | 55289036715 | 15 TABLET in 1 BOTTLE, PLASTIC (55289-367-15) | 15 tablet | 2021-05-20 | 0000-00-00 | No | No | Current |
| 55289-367-20 | 55289036720 | 20 TABLET in 1 BOTTLE, PLASTIC (55289-367-20) | 20 tablet | 2010-09-22 | 0000-00-00 | No | No | Current |
| 55289-367-28 | 55289036728 | 28 TABLET in 1 BOTTLE, PLASTIC (55289-367-28) | 28 tablet | 2010-09-22 | 0000-00-00 | No | No | Current |
| 55289-367-30 | 55289036730 | 30 TABLET in 1 BOTTLE, PLASTIC (55289-367-30) | 30 tablet | 2010-09-22 | 0000-00-00 | No | No | Current |
| 55289-367-42 | 55289036742 | 42 TABLET in 1 BOTTLE, PLASTIC (55289-367-42) | 42 tablet | 2010-09-22 | 0000-00-00 | No | No | Current |
| 55289-367-60 | 55289036760 | 60 TABLET in 1 BOTTLE, PLASTIC (55289-367-60) | 60 tablet | 2010-09-22 | 0000-00-00 | No | No | Current |