Naproxen Sodium
- Product NDC
- 47781-155
- 11-digit product format
- 477810155
- Labeler code
- 47781
- Product ID
- 47781-155_0b8bae38-69cd-8602-a08e-e9e6fde9345c
- Type
- HUMAN PRESCRIPTION DRUG
- Nonproprietary name
- Naproxen Sodium
- Dosage form
- TABLET, FILM COATED, EXTENDED RELEASE
- Route
- ORAL
- Labeler
- Alvogen Inc.
- Application
- NDA020353
- Marketing category
- NDA AUTHORIZED GENERIC
- Marketing start
- 2015-03-11
- Marketing end
- 0000-00-00
- Substance
- NAPROXEN SODIUM
- Active strength
- 750 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
- 2023-12-31
- Current FDA listing
- Historical FDA.report record
DailyMed Product Concepts#
FDA-Initiated Inactive NDC Indexing#
DailyMed Package Descriptions#
Package NDC, Product, Description table| Package NDC | Product | Description | Form | Quantity | Strength | SPL version |
|---|
| 47781-155-30 | Naproxen Sodium | 30 in 1 BOTTLE | TABLET, FILM COATED, EXTENDED RE | 30 | | 11 |
DailyMed Socrata Ingredients#
Ingredient, Type, UNII table| Ingredient | Type | UNII | DailyMed label | SPL version | Uploaded |
|---|
| NAPROXEN SODIUM | ACTIVE INGREDIENT | 9TN87S3A3C | NAPROXEN SODIUM (NAPROXEN SODIUM) TABLET, FILM COATED, EXTENDED RELEASE [ALVOGEN INC.] | 1 | |
| NAPROXEN | ACTIVE MOIETY | 57Y76R9ATQ | NAPROXEN SODIUM (NAPROXEN SODIUM) TABLET, FILM COATED, EXTENDED RELEASE [ALVOGEN INC.] | 1 | |
| AMMONIO METHACRYLATE COPOLYMER TYPE A | INACTIVE INGREDIENT | 8GQS4E66YY | NAPROXEN SODIUM (NAPROXEN SODIUM) TABLET, FILM COATED, EXTENDED RELEASE [ALVOGEN INC.] | 1 | |
| AMMONIO METHACRYLATE COPOLYMER TYPE B | INACTIVE INGREDIENT | 161H3B14U2 | NAPROXEN SODIUM (NAPROXEN SODIUM) TABLET, FILM COATED, EXTENDED RELEASE [ALVOGEN INC.] | 1 | |
| CELLULOSE, MICROCRYSTALLINE | INACTIVE INGREDIENT | OP1R32D61U | NAPROXEN SODIUM (NAPROXEN SODIUM) TABLET, FILM COATED, EXTENDED RELEASE [ALVOGEN INC.] | 1 | |
| CITRIC ACID MONOHYDRATE | INACTIVE INGREDIENT | 2968PHW8QP | NAPROXEN SODIUM (NAPROXEN SODIUM) TABLET, FILM COATED, EXTENDED RELEASE [ALVOGEN INC.] | 1 | |
| CROSPOVIDONE | INACTIVE INGREDIENT | 68401960MK | NAPROXEN SODIUM (NAPROXEN SODIUM) TABLET, FILM COATED, EXTENDED RELEASE [ALVOGEN INC.] | 1 | |
| HYPROMELLOSES | INACTIVE INGREDIENT | 3NXW29V3WO | NAPROXEN SODIUM (NAPROXEN SODIUM) TABLET, FILM COATED, EXTENDED RELEASE [ALVOGEN INC.] | 1 | |
| MAGNESIUM STEARATE | INACTIVE INGREDIENT | 70097M6I30 | NAPROXEN SODIUM (NAPROXEN SODIUM) TABLET, FILM COATED, EXTENDED RELEASE [ALVOGEN INC.] | 1 | |
| METHACRYLIC ACID - METHYL METHACRYLATE COPOLYMER (1:1) | INACTIVE INGREDIENT | 74G4R6TH13 | NAPROXEN SODIUM (NAPROXEN SODIUM) TABLET, FILM COATED, EXTENDED RELEASE [ALVOGEN INC.] | 1 | |
| POLYETHYLENE GLYCOLS | INACTIVE INGREDIENT | 3WJQ0SDW1A | NAPROXEN SODIUM (NAPROXEN SODIUM) TABLET, FILM COATED, EXTENDED RELEASE [ALVOGEN INC.] | 1 | |
| POVIDONE | INACTIVE INGREDIENT | FZ989GH94E | NAPROXEN SODIUM (NAPROXEN SODIUM) TABLET, FILM COATED, EXTENDED RELEASE [ALVOGEN INC.] | 1 | |
| TALC | INACTIVE INGREDIENT | 7SEV7J4R1U | NAPROXEN SODIUM (NAPROXEN SODIUM) TABLET, FILM COATED, EXTENDED RELEASE [ALVOGEN INC.] | 1 | |
| TITANIUM DIOXIDE | INACTIVE INGREDIENT | 15FIX9V2JP | NAPROXEN SODIUM (NAPROXEN SODIUM) TABLET, FILM COATED, EXTENDED RELEASE [ALVOGEN INC.] | 1 | |
DailyMed Dashboard NDC Coverage#
NDC, Dashboard title, SPL version table| NDC | Dashboard title | SPL version | Validation | Dashboard ZIP |
|---|
| 47781-155 | NAPROXEN SODIUM TABLET, FILM COATED, EXTENDED RELEASE [ALVOGEN INC.] | 10 | Legacy NDC, 1 package rows | 20240723_9225acaa-209f-958b-2c51-9a46995dec33.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 |
|---|
| 47781-155-30 | 47781015530 | 30 TABLET, FILM COATED, EXTENDED RELEASE in 1 BOTTLE (47781-155-30) | 2015-03-11 | 0000-00-00 | No | No | Current |