Naproxen
- Product NDC
- 59651-528
- 11-digit product format
- 596510528
- Labeler code
- 59651
- Product ID
- 59651-528_570974d4-0d5b-4df2-b307-37380511835d
- Type
- HUMAN PRESCRIPTION DRUG
- Nonproprietary name
- Naproxen
- Dosage form
- SUSPENSION
- Route
- ORAL
- Labeler
- Aurobindo Pharma Limited
- Application
- ANDA216504
- Marketing category
- ANDA
- Marketing start
- 2025-10-03
- 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 |
|---|
| 59651-528-47 | Naproxen | 473 mL in 1 BOTTLE | SUSPENSION | 473 | | 1 |
| 59651-528-47 | Naproxen | 1 in 1 CARTON | SUSPENSION | 1 | | 1 |
DailyMed RxNorm Mappings#
Packages#
Package NDC, 11-digit format, Description table| Package NDC | 11-digit format | Description | Units | Marketing start | Sample | Exclude flag | Status |
|---|
| 59651-528-47 | 59651052847 | 1 BOTTLE in 1 CARTON (59651-528-47) / 473 mL in 1 BOTTLE | 1 bottle | 2025-10-03 | No | No | Current |