Naproxen
- Product NDC
- 0054-3630
- 11-digit product format
- 000543630
- Labeler code
- 0054
- Product ID
- 0054-3630_ce07dc5c-441e-4f1c-a940-077306017c43
- Type
- HUMAN PRESCRIPTION DRUG
- Nonproprietary name
- Naproxen
- Dosage form
- SUSPENSION
- Route
- ORAL
- Labeler
- Hikma Pharmaceuticals USA Inc.
- Application
- ANDA074190
- Marketing category
- ANDA
- Marketing start
- 2021-02-24
- Substance
- NAPROXEN
- Active strength
- 125 mg/5mL
- 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
- Listing expiration
- 2026-12-31
Active Ingredients#
Ingredient, Strength table| Ingredient | Strength |
|---|
| NAPROXEN | 125 mg/5mL |
Harmonized Identifiers#
Field, Values table| Field | Values |
|---|
| Unii | 57Y76R9ATQ |
| Rxcui | 311913 |
DailyMed Product Concepts#
DailyMed Package Descriptions#
Package NDC, Product, Description table| Package NDC | Product | Description | Form | Quantity | Strength | SPL version |
|---|
| 0054-3630-63 | Naproxen | 500 mL in 1 BOTTLE, PLASTIC | SUSPENSION | 500 | | 11 |
DailyMed Dashboard NDC Coverage#
NDC, Dashboard title, SPL version table| NDC | Dashboard title | SPL version | Validation | Dashboard ZIP |
|---|
| 0054-3630 | NAPROXEN SUSPENSION [HIKMA PHARMACEUTICALS USA INC.] | 11 | Current NDC, Legacy NDC, 1 package rows | 20250221_a5757b1a-62c9-4421-9794-6fb121ce9b7e.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 |
|---|
| 0054-3630-63 | 00054363063 | 500 mL in 1 BOTTLE, PLASTIC (0054-3630-63) | 500 ml | 2021-02-24 | 0000-00-00 | No | No | Current |