Naproxen
- Product NDC
- 51655-363
- 11-digit product format
- 516550363
- Labeler code
- 51655
- Product ID
- 51655-363_4b3480bd-bd54-1325-e063-6394a90ad76c
- Type
- HUMAN PRESCRIPTION DRUG
- Nonproprietary name
- Naproxen
- Dosage form
- TABLET
- Route
- ORAL
- Labeler
- Northwind Health Company, LLC
- Application
- ANDA075927
- Marketing category
- ANDA
- Marketing start
- 2020-05-28
- 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
- 2027-12-31
- Current FDA listing
- Yes
Additional Listing Data#
- Finished product
- Yes
- Brand name base
- Naproxen
- Listing expiration
- 2027-12-31
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 |
|---|
| 51655-363-20 | Naproxen | 20 in 1 BOTTLE, PLASTIC | TABLET | 20 | | 6 |
| 51655-363-25 | Naproxen | 60 in 1 BOTTLE, PLASTIC | TABLET | 60 | | 6 |
| 51655-363-26 | Naproxen | 90 in 1 BOTTLE, PLASTIC | TABLET | 90 | | 6 |
| 51655-363-52 | Naproxen | 30 in 1 BOTTLE, PLASTIC | TABLET | 30 | | 6 |
DailyMed Dashboard NDC Coverage#
NDC, Dashboard title, SPL version table| NDC | Dashboard title | SPL version | Validation | Dashboard ZIP |
|---|
| 51655-363 | NAPROXEN TABLET [NORTHWIND PHARMACEUTICALS, LLC] | 5 | Current NDC, Legacy NDC, 4 package rows | 20240720_ab6ec2c9-5df9-346c-e053-2a95a90ac81d.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 |
|---|
| 51655-363-20 | 51655036320 | 20 TABLET in 1 BOTTLE, PLASTIC (51655-363-20) | 20 tablet | 2023-10-23 | | No | No | Historical |
| 51655-363-25 | 51655036325 | 60 TABLET in 1 BOTTLE, PLASTIC (51655-363-25) | 60 tablet | 2023-08-30 | | No | No | Historical |
| 51655-363-26 | 51655036326 | 90 TABLET in 1 BOTTLE, PLASTIC (51655-363-26) | 90 tablet | 2020-05-28 | 0000-00-00 | No | No | Current |
| 51655-363-52 | 51655036352 | 30 TABLET in 1 BOTTLE, PLASTIC (51655-363-52) | 30 tablet | 2023-08-17 | | No | No | Historical |