Naproxen Sodium 220mg
- Product NDC
- 53185-394
- 11-digit product format
- 531850394
- Labeler code
- 53185
- Product ID
- 53185-394_aa5989d3-2bbf-448d-b90f-ec90849011c1
- Type
- HUMAN OTC DRUG
- Nonproprietary name
- Naproxen Sodium 220mg
- Dosage form
- TABLET, COATED
- Route
- ORAL
- Labeler
- Athlete's Needs, Inc.
- Application
- ANDA090545
- Marketing category
- ANDA
- Marketing start
- 2014-12-23
- 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 220mg
- 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 |
|---|
| 53185-394-50 | Naproxen Sodium 220mg | 50 in 1 BOTTLE | TABLET, COATED | 50 | | 4 |
DailyMed Dashboard NDC Coverage#
NDC, Dashboard title, SPL version table| NDC | Dashboard title | SPL version | Validation | Dashboard ZIP |
|---|
| 53185-394 | NAPROXEN SODIUM 220MG TABLET, COATED [ATHLETE'S NEEDS, INC.] | 4 | Current NDC, Legacy NDC, 1 package rows | 20210422_84445187-8e57-4c0e-83c0-16b105a1cdd2.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 |
|---|
| 53185-394-50 | 53185039450 | 50 TABLET, COATED in 1 BOTTLE (53185-394-50) | 2014-12-23 | 0000-00-00 | No | No | Current |