Naproxen Sodium
- Product NDC
- 53185-604
- 11-digit product format
- 531850604
- Labeler code
- 53185
- Product ID
- 53185-604_b5125434-5aab-4cbd-afba-c6ca1381b2a9
- Type
- HUMAN OTC DRUG
- Nonproprietary name
- Naproxen Sodium
- Dosage form
- TABLET, FILM COATED
- Route
- ORAL
- Labeler
- Athlete's Needs Inc
- Application
- ANDA204872
- Marketing category
- ANDA
- Marketing start
- 2022-03-11
- Substance
- NAPROXEN SODIUM
- Active strength
- 220 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 Sodium
- Listing expiration
- 2026-12-31
Active Ingredients#
Ingredient, Strength table| Ingredient | Strength |
|---|
| NAPROXEN SODIUM | 220 mg/1 |
Harmonized Identifiers#
Field, Values table| Field | Values |
|---|
| Unii | 9TN87S3A3C |
| Rxcui | 849574 |
DailyMed Product Concepts#
DailyMed Package Descriptions#
Package NDC, Product, Description table| Package NDC | Product | Description | Form | Quantity | Strength | SPL version |
|---|
| 53185-604-12 | Naproxen Sodium | 100 in 1 BOTTLE, PLASTIC | TABLET, FILM COATED | 100 | | 6 |
| 53185-604-15 | Naproxen Sodium | 50 in 1 BOTTLE, PLASTIC | TABLET, FILM COATED | 50 | | 6 |
DailyMed Dashboard NDC Coverage#
NDC, Dashboard title, SPL version table| NDC | Dashboard title | SPL version | Validation | Dashboard ZIP |
|---|
| 53185-604 | NAPROXEN SODIUM TABLET, FILM COATED [ATHLETE'S NEEDS INC] | 5 | Current NDC, Legacy NDC, 2 package rows | 20241108_d5984c9d-3941-45d6-8392-87564b2faae0.zip |
DailyMed RxNorm Mappings#
Packages#
Package NDC, 11-digit format, Description table| Package NDC | 11-digit format | Description | Marketing start | Marketing end | Sample | Exclude flag | Status |
|---|
| 53185-604-12 | 53185060412 | 100 TABLET, FILM COATED in 1 BOTTLE, PLASTIC (53185-604-12) | 2022-03-11 | 0000-00-00 | No | No | Current |
| 53185-604-15 | 53185060415 | 50 TABLET, FILM COATED in 1 BOTTLE, PLASTIC (53185-604-15) | 2022-03-11 | 0000-00-00 | No | No | Current |