Naproxen Sodium
- Product NDC
- 63868-465
- 11-digit product format
- 638680465
- Labeler code
- 63868
- Product ID
- 63868-465_459ae61b-c6b3-bb0c-e063-6294a90af809
- Type
- HUMAN OTC DRUG
- Nonproprietary name
- NAPROXEN SODIUM
- Dosage form
- TABLET, COATED
- Route
- ORAL
- Labeler
- Chain Drug Marketing Association
- Application
- ANDA079096
- Marketing category
- ANDA
- Marketing start
- 2009-09-03
- Marketing end
- 2027-12-31
- 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
- Current FDA listing
- Yes
Additional Listing Data#
- Finished product
- Yes
- Brand name base
- Naproxen Sodium
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 |
|---|
| 63868-465-01 | Naproxen Sodium | 1 in 1 CARTON | TABLET, COATED | 1 | | 4 |
| 63868-465-01 | Naproxen Sodium | 100 in 1 BOTTLE, PLASTIC | TABLET, COATED | 100 | | 4 |
| 63868-465-50 | Naproxen Sodium | 50 in 1 BOTTLE, PLASTIC | TABLET, COATED | 50 | | 4 |
| 63868-465-50 | Naproxen Sodium | 1 in 1 CARTON | TABLET, COATED | 1 | | 4 |
DailyMed Socrata Ingredients#
Ingredient, Type, UNII table| Ingredient | Type | UNII | DailyMed label | SPL version | Uploaded |
|---|
| NAPROXEN SODIUM | ACTIVE INGREDIENT | 9TN87S3A3C | NAPROXEN SODIUM TABLET, COATED [CHAIN DRUG MARKETING ASSOCIATION] | 1 | |
| NAPROXEN | ACTIVE MOIETY | 57Y76R9ATQ | NAPROXEN SODIUM TABLET, COATED [CHAIN DRUG MARKETING ASSOCIATION] | 1 | |
| CROSCARMELLOSE SODIUM | INACTIVE INGREDIENT | M28OL1HH48 | NAPROXEN SODIUM TABLET, COATED [CHAIN DRUG MARKETING ASSOCIATION] | 1 | |
| FD&C BLUE NO. 2 | INACTIVE INGREDIENT | L06K8R7DQK | NAPROXEN SODIUM TABLET, COATED [CHAIN DRUG MARKETING ASSOCIATION] | 1 | |
| MAGNESIUM STEARATE | INACTIVE INGREDIENT | 70097M6I30 | NAPROXEN SODIUM TABLET, COATED [CHAIN DRUG MARKETING ASSOCIATION] | 1 | |
| POLYETHYLENE GLYCOLS | INACTIVE INGREDIENT | 3WJQ0SDW1A | NAPROXEN SODIUM TABLET, COATED [CHAIN DRUG MARKETING ASSOCIATION] | 1 | |
| POLYVINYL ALCOHOL | INACTIVE INGREDIENT | 532B59J990 | NAPROXEN SODIUM TABLET, COATED [CHAIN DRUG MARKETING ASSOCIATION] | 1 | |
| POVIDONES | INACTIVE INGREDIENT | FZ989GH94E | NAPROXEN SODIUM TABLET, COATED [CHAIN DRUG MARKETING ASSOCIATION] | 1 | |
| STARCH, CORN | INACTIVE INGREDIENT | O8232NY3SJ | NAPROXEN SODIUM TABLET, COATED [CHAIN DRUG MARKETING ASSOCIATION] | 1 | |
| TALC | INACTIVE INGREDIENT | 7SEV7J4R1U | NAPROXEN SODIUM TABLET, COATED [CHAIN DRUG MARKETING ASSOCIATION] | 1 | |
| TITANIUM DIOXIDE | INACTIVE INGREDIENT | 15FIX9V2JP | NAPROXEN SODIUM TABLET, COATED [CHAIN DRUG MARKETING ASSOCIATION] | 1 | |
DailyMed Dashboard NDC Coverage#
NDC, Dashboard title, SPL version table| NDC | Dashboard title | SPL version | Validation | Dashboard ZIP |
|---|
| 63868-465 | NAPROXEN SODIUM TABLET, COATED [CHAIN DRUG MARKETING ASSOCIATION] | 3 | Current NDC, Legacy NDC, 4 package rows | 20241208_d9e72c3f-addc-4391-a7a4-2680a3e7f5c4.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 |
|---|
| 63868-465-01 | 63868046501 | 1 BOTTLE, PLASTIC in 1 CARTON (63868-465-01) / 100 TABLET, COATED in 1 BOTTLE, PLASTIC | 2009-09-03 | 2027-12-31 | No | No | Current |
| 63868-465-50 | 63868046550 | 1 BOTTLE, PLASTIC in 1 CARTON (63868-465-50) / 50 TABLET, COATED in 1 BOTTLE, PLASTIC | 2009-09-03 | 2027-12-31 | No | No | Current |