Naproxen Sodium
- Product NDC
- 36800-204
- 11-digit product format
- 368000204
- Labeler code
- 36800
- Product ID
- 36800-204_f0fce18a-cc1c-347f-e053-2a95a90ac3b9
- Type
- HUMAN OTC DRUG
- Nonproprietary name
- Naproxen Sodium
- Dosage form
- CAPSULE, LIQUID FILLED
- Route
- ORAL
- Labeler
- TOP CARE (Topco Associates LLC)
- Application
- NDA021920
- Marketing category
- NDA
- Marketing start
- 2021-07-02
- 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 | 1112231 |
DailyMed Product Concepts#
DailyMed Package Descriptions#
Package NDC, Product, Description table| Package NDC | Product | Description | Form | Quantity | Strength | SPL version |
|---|
| 36800-204-11 | Naproxen Sodium | 20 in 1 BOTTLE, PLASTIC | CAPSULE, LIQUID FILLED | 20 | | 2 |
| 36800-204-11 | Naproxen Sodium | 1 in 1 CARTON | CAPSULE, LIQUID FILLED | 1 | | 2 |
| 36800-204-16 | Naproxen Sodium | 1 in 1 CARTON | CAPSULE, LIQUID FILLED | 1 | | 2 |
| 36800-204-16 | Naproxen Sodium | 50 in 1 BOTTLE, PLASTIC | CAPSULE, LIQUID FILLED | 50 | | 2 |
| 36800-204-78 | Naproxen Sodium | 1 in 1 CARTON | CAPSULE, LIQUID FILLED | 1 | | 2 |
| 36800-204-78 | Naproxen Sodium | 80 in 1 BOTTLE, PLASTIC | CAPSULE, LIQUID FILLED | 80 | | 2 |
DailyMed Dashboard NDC Coverage#
NDC, Dashboard title, SPL version table| NDC | Dashboard title | SPL version | Validation | Dashboard ZIP |
|---|
| 36800-204 | NAPROXEN SODIUM CAPSULE, LIQUID FILLED [TOP CARE (TOPCO ASSOCIATES LLC)] | 2 | Current NDC, Legacy NDC, 6 package rows | 20221230_c62b7fa0-5ae9-276c-e053-2995a90ade25.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 |
|---|
| 36800-204-11 | 36800020411 | 1 BOTTLE, PLASTIC in 1 CARTON (36800-204-11) / 20 CAPSULE, LIQUID FILLED in 1 BOTTLE, PLASTIC | 2021-07-02 | 0000-00-00 | No | No | Current |
| 36800-204-16 | 36800020416 | 1 BOTTLE, PLASTIC in 1 CARTON (36800-204-16) / 50 CAPSULE, LIQUID FILLED in 1 BOTTLE, PLASTIC | 2021-07-02 | 0000-00-00 | No | No | Current |
| 36800-204-78 | 36800020478 | 1 BOTTLE, PLASTIC in 1 CARTON (36800-204-78) / 80 CAPSULE, LIQUID FILLED in 1 BOTTLE, PLASTIC | 2021-07-02 | 0000-00-00 | No | No | Current |