Naproxen
- Product NDC
- 52817-380
- 11-digit product format
- 528170380
- Labeler code
- 52817
- Product ID
- 52817-380_28a0f21b-859f-0459-e063-6394a90a08e0
- Type
- HUMAN PRESCRIPTION DRUG
- Nonproprietary name
- Naproxen
- Dosage form
- TABLET, DELAYED RELEASE
- Route
- ORAL
- Labeler
- TruPharma LLC
- Application
- ANDA216908
- Marketing category
- ANDA
- Marketing start
- 2023-07-27
- 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 |
|---|
| 52817-380-10 | Naproxen | 100 in 1 BOTTLE, PLASTIC | TABLET, DELAYED RELEASE | 100 | | 3 |
DailyMed Dashboard NDC Coverage#
NDC, Dashboard title, SPL version table| NDC | Dashboard title | SPL version | Validation | Dashboard ZIP |
|---|
| 52817-380 | NAPROXEN TABLET, DELAYED RELEASE [TRUPHARMA LLC] | 3 | Current NDC, 1 package rows | 20241218_004bb832-29d5-add0-e063-6394a90a90f4.zip |
DailyMed RxNorm Mappings#
Packages#
Package NDC, 11-digit format, Description table| Package NDC | 11-digit format | Description | Marketing start | Sample | Exclude flag | Status |
|---|
| 52817-380-10 | 52817038010 | 100 TABLET, DELAYED RELEASE in 1 BOTTLE, PLASTIC (52817-380-10) | 2023-08-01 | No | No | Historical |