naproxen sodium

Generic: naproxen sodium

Labeler: teva pharmaceuticals, inc.
NDC Directory HUMAN PRESCRIPTION DRUG ANDA Inactive Finished

Drug Facts

Product Profile

Brand Name naproxen sodium
Generic Name naproxen sodium
Labeler teva pharmaceuticals, inc.
Dosage Form TABLET, FILM COATED, EXTENDED RELEASE
Routes
ORAL
Active Ingredients

naproxen sodium 375 mg/1

Manufacturer
Teva Pharmaceuticals, Inc.

Identifiers & Regulatory

Product NDC 0480-0951
Product ID 0480-0951_6d02cbbb-bfb4-4c68-8a7b-4207f6f9cfbb
Product Type HUMAN PRESCRIPTION DRUG
Marketing Category ANDA
Application Number ANDA075416
Listing Expiration 2026-12-31
Marketing Start 2022-11-01

Pharmacologic Class

Classes
anti-inflammatory agents non-steroidal [cs] cyclooxygenase inhibitors [moa] nonsteroidal anti-inflammatory drug [epc]

Normalized Code Variants

Searchable formats for this product NDC code

Digits Only 04800951
Hyphenated Format 0480-0951

Supplemental Identifiers

RxCUI
1116320 1116339 1116349
UPC
0304800953567 0304800952584 0304800951013
UNII
9TN87S3A3C

Packaging Origin

Original Packager
true

Resolved Product View

Precedence rule: structured NDC data is preferred, falling back to linked label metadata when unavailable. Source tags show the origin of each value.

Resolved Identity

Brand Name naproxen sodium (source: ndc)
Generic Name naproxen sodium (source: ndc)
Application Number ANDA075416 (source: ndc)
Routes
ORAL
source: ndc

Resolved Composition

Strengths
  • 375 mg/1
source: ndc
Packaging
  • 100 TABLET, FILM COATED, EXTENDED RELEASE in 1 BOTTLE (0480-0951-01)
source: ndc

Packages (1)

0480-0951-01 100 TABLET, FILM COATED, EXTENDED RELEASE in 1 BOTTLE (0480-0951-01)

Ingredients (1)

naproxen sodium (375 mg/1)

Linked Drug Pages (1)

Naproxen Sodium, Naproxen sodium ndc-match (0.9)

Raw FDA Data

View complete raw FDA NDC JSON payload 
{"route": ["ORAL"], "spl_id": "6d02cbbb-bfb4-4c68-8a7b-4207f6f9cfbb", "openfda": {"upc": ["0304800953567", "0304800952584", "0304800951013"], "unii": ["9TN87S3A3C"], "rxcui": ["1116320", "1116339", "1116349"], "spl_set_id": ["826fd9e3-22fe-408b-820c-f2b710189555"], "manufacturer_name": ["Teva Pharmaceuticals, Inc."], "is_original_packager": [true]}, "finished": true, "packaging": [{"sample": false, "description": "100 TABLET, FILM COATED, EXTENDED RELEASE in 1 BOTTLE (0480-0951-01)", "package_ndc": "0480-0951-01", "marketing_start_date": "20221101"}], "brand_name": "Naproxen Sodium", "product_id": "0480-0951_6d02cbbb-bfb4-4c68-8a7b-4207f6f9cfbb", "dosage_form": "TABLET, FILM COATED, EXTENDED RELEASE", "pharm_class": ["Anti-Inflammatory Agents", "Non-Steroidal [CS]", "Cyclooxygenase Inhibitors [MoA]", "Nonsteroidal Anti-inflammatory Drug [EPC]"], "product_ndc": "0480-0951", "generic_name": "naproxen sodium", "labeler_name": "Teva Pharmaceuticals, Inc.", "product_type": "HUMAN PRESCRIPTION DRUG", "brand_name_base": "Naproxen Sodium", "active_ingredients": [{"name": "NAPROXEN SODIUM", "strength": "375 mg/1"}], "application_number": "ANDA075416", "marketing_category": "ANDA", "marketing_start_date": "20221101", "listing_expiration_date": "20261231"}