Naproxen
- Product NDC
- 85509-1436
- 11-digit product format
- 855091436
- Labeler code
- 85509
- Product ID
- 85509-1436_439125a3-e443-f439-e063-6394a90abe0d
- Type
- HUMAN PRESCRIPTION DRUG
- Nonproprietary name
- Naproxen
- Dosage form
- TABLET
- Route
- ORAL
- Labeler
- PHOENIX RX LLC
- Application
- ANDA212517
- Marketing category
- ANDA
- Marketing start
- 2020-03-01
- Substance
- NAPROXEN
- Active strength
- 500 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 | 500 mg/1 |
Harmonized Identifiers#
Field, Values table| Field | Values |
|---|
| Unii | 57Y76R9ATQ |
| Rxcui | 198014 |
DailyMed Product Concepts#
DailyMed Package Descriptions#
Package NDC, Product, Description table| Package NDC | Product | Description | Form | Quantity | Strength | SPL version |
|---|
| 85509-1436-3 | Naproxen | 30 in 1 BOTTLE | TABLET | 30 | | 1 |
| 85509-1436-6 | Naproxen | 60 in 1 BOTTLE | TABLET | 60 | | 1 |
| 85509-1436-9 | Naproxen | 90 in 1 BOTTLE | TABLET | 90 | | 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 |
|---|
| 85509-1436-3 | 85509143603 | 30 TABLET in 1 BOTTLE (85509-1436-3) | 30 tablet | 2025-11-14 | No | No | Current |
| 85509-1436-6 | 85509143606 | 60 TABLET in 1 BOTTLE (85509-1436-6) | 60 tablet | 2025-11-14 | No | No | Current |
| 85509-1436-9 | 85509143609 | 90 TABLET in 1 BOTTLE (85509-1436-9) | 90 tablet | 2025-11-14 | No | No | Current |