NAPROXEN SODIUM
- Product NDC
- 53345-042
- 11-digit product format
- 533450042
- Labeler code
- 53345
- Product ID
- 53345-042_1b92fe6c-7407-40e0-bcb2-27a62f4399a9
- Type
- HUMAN OTC DRUG
- Nonproprietary name
- Naproxen Sodium
- Dosage form
- CAPSULE, LIQUID FILLED
- Route
- ORAL
- Labeler
- Humanwell PuraCap Pharmaceuticals (Wuhan) Co., Ltd
- 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 |
|---|
| 53345-042-01 | NAPROXEN SODIUM | 1 in 1 BOX | CAPSULE, LIQUID FILLED | 1 | | 2 |
| 53345-042-01 | NAPROXEN SODIUM | 5000 in 1 BAG | CAPSULE, LIQUID FILLED | 5000 | | 2 |
DailyMed Dashboard NDC Coverage#
NDC, Dashboard title, SPL version table| NDC | Dashboard title | SPL version | Validation | Dashboard ZIP |
|---|
| 53345-042 | NAPROXEN SODIUM CAPSULE, LIQUID FILLED [HUMANWELL PURACAP PHARMACEUTICALS (WUHAN) CO., LTD] | 2 | Current NDC, Legacy NDC, 2 package rows | 20191109_1d5981dd-e3f5-48a3-a5f1-ce49689cdfac.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 |
|---|
| 53345-042-01 | 53345004201 | 1 BAG in 1 BOX (53345-042-01) / 5000 CAPSULE, LIQUID FILLED in 1 BAG | 1 bag | 2018-03-20 | 0000-00-00 | No | No | Current |