NAPROXEN SODIUM
- Product NDC
- 51013-137
- 11-digit product format
- 510130137
- Labeler code
- 51013
- Product ID
- 51013-137_9a223804-f229-442b-85a9-7f0f8fd74ba1
- Type
- HUMAN OTC DRUG
- Nonproprietary name
- Naproxen Sodium
- Dosage form
- CAPSULE, LIQUID FILLED
- Route
- ORAL
- Labeler
- PuraCap Pharmaceutical LLC
- Application
- ANDA208363
- Marketing category
- ANDA
- Marketing start
- 2018-03-20
- Substance
- NAPROXEN SODIUM
- Active strength
- 220 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
- 2026-12-31
- Current FDA listing
- Yes
Additional Listing Data#
- Finished product
- Yes
- Brand name base
- NAPROXEN SODIUM
- Listing expiration
- 2026-12-31
Active Ingredients#
Ingredient, Strength table| Ingredient | Strength |
|---|
| NAPROXEN SODIUM | 220 mg/1 |
Harmonized Identifiers#
Field, Values table| Field | Values |
|---|
| Unii | 9TN87S3A3C |
| Rxcui | 1112231 |
DailyMed Product Concepts#
DailyMed Package Descriptions#
Package NDC, Product, Description table| Package NDC | Product | Description | Form | Quantity | Strength | SPL version |
|---|
| 51013-137-15 | NAPROXEN SODIUM | 1 in 1 CARTON | CAPSULE, LIQUID FILLED | 1 | | 4 |
| 51013-137-15 | NAPROXEN SODIUM | 20 in 1 BOTTLE | CAPSULE, LIQUID FILLED | 20 | | 4 |
| 51013-137-28 | NAPROXEN SODIUM | 1 in 1 CARTON | CAPSULE, LIQUID FILLED | 1 | | 4 |
| 51013-137-28 | NAPROXEN SODIUM | 160 in 1 BOTTLE | CAPSULE, LIQUID FILLED | 160 | | 4 |
| 51013-137-60 | NAPROXEN SODIUM | 160 in 1 BOTTLE | CAPSULE, LIQUID FILLED | 160 | | 4 |
DailyMed Dashboard NDC Coverage#
NDC, Dashboard title, SPL version table| NDC | Dashboard title | SPL version | Validation | Dashboard ZIP |
|---|
| 51013-137 | NAPROXEN SODIUM CAPSULE, LIQUID FILLED [PURACAP PHARMACEUTICAL LLC] | 4 | Current NDC, Legacy NDC, 5 package rows | 20191211_fc865e81-164c-48e9-8fb9-6fc27d1c33cf.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 |
|---|
| 51013-137-15 | 51013013715 | 1 BOTTLE in 1 CARTON (51013-137-15) / 20 CAPSULE, LIQUID FILLED in 1 BOTTLE | 1 bottle | 2018-03-20 | 0000-00-00 | No | No | Current |
| 51013-137-28 | 51013013728 | 1 BOTTLE in 1 CARTON (51013-137-28) / 160 CAPSULE, LIQUID FILLED in 1 BOTTLE | 1 bottle | 2018-03-20 | 0000-00-00 | No | No | Current |
| 51013-137-60 | 51013013760 | 160 CAPSULE, LIQUID FILLED in 1 BOTTLE (51013-137-60) | | 2018-03-20 | 0000-00-00 | No | No | Current |