Naproxen
- Product NDC
- 11534-211
- 11-digit product format
- 115340211
- Labeler code
- 11534
- Product ID
- 11534-211_502c7695-7f9d-4893-b151-65111de2e2a7
- Type
- HUMAN PRESCRIPTION DRUG
- Nonproprietary name
- Naproxen
- Dosage form
- TABLET, DELAYED RELEASE
- Route
- ORAL
- Labeler
- Sunrise Pharmaceutical, Inc.
- Application
- ANDA091432
- Marketing category
- ANDA
- Marketing start
- 2025-12-09
- Substance
- NAPROXEN
- Active strength
- 375 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
- Listing expiration
- 2026-12-31
Active Ingredients#
Ingredient, Strength table| Ingredient | Strength |
|---|
| NAPROXEN | 375 mg/1 |
Harmonized Identifiers#
Field, Values table| Field | Values |
|---|
| Unii | 57Y76R9ATQ |
| Rxcui | 311915, 603103 |
DailyMed Product Concepts#
DailyMed Package Descriptions#
Package NDC, Product, Description table| Package NDC | Product | Description | Form | Quantity | Strength | SPL version |
|---|
| 11534-211-01 | Naproxen | 100 in 1 BOTTLE, PLASTIC | TABLET, DELAYED RELEASE | 100 | | 2 |
DailyMed RxNorm Mappings#
Packages#
Package NDC, 11-digit format, Description table| Package NDC | 11-digit format | Description | Marketing start | Sample | Exclude flag | Status |
|---|
| 11534-211-01 | 11534021101 | 100 TABLET, DELAYED RELEASE in 1 BOTTLE, PLASTIC (11534-211-01) | 2025-12-09 | No | No | Current |