naproxen

Generic: naproxen sodium

Labeler: l.n.k. international, inc.
NDC Directory HUMAN OTC DRUG ANDA Inactive Finished

Drug Facts

Product Profile

Brand Name naproxen
Generic Name naproxen sodium
Labeler l.n.k. international, inc.
Dosage Form TABLET, FILM COATED
Routes
ORAL
Active Ingredients

naproxen sodium 220 mg/1

Manufacturer
L.N.K. International, Inc.

Identifiers & Regulatory

Product NDC 50844-261
Product ID 50844-261_f5f6ef48-fa2a-4a62-9cde-0a685fe575b0
Product Type HUMAN OTC DRUG
Marketing Category ANDA
Application Number ANDA204872
Listing Expiration 2026-12-31
Marketing Start 2019-08-06

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 50844261
Hyphenated Format 50844-261

Supplemental Identifiers

RxCUI
849574
UPC
0052548689827
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 (source: ndc)
Generic Name naproxen sodium (source: ndc)
Application Number ANDA204872 (source: ndc)
Routes
ORAL
source: ndc

Resolved Composition

Strengths
  • 220 mg/1
source: ndc
Packaging
  • 1 BOTTLE, PLASTIC in 1 CARTON (50844-261-08) / 24 TABLET, FILM COATED in 1 BOTTLE, PLASTIC
source: ndc

Packages (1)

50844-261-08 1 BOTTLE, PLASTIC in 1 CARTON (50844-261-08) / 24 TABLET, FILM COATED in 1 BOTTLE, PLASTIC

Ingredients (1)

naproxen sodium (220 mg/1)

Linked Drug Pages (1)

Naproxen ndc-match (0.9)

Raw FDA Data

View complete raw FDA NDC JSON payload 
{"route": ["ORAL"], "spl_id": "f5f6ef48-fa2a-4a62-9cde-0a685fe575b0", "openfda": {"upc": ["0052548689827"], "unii": ["9TN87S3A3C"], "rxcui": ["849574"], "spl_set_id": ["82412133-c11a-4905-a119-965f44de10b7"], "manufacturer_name": ["L.N.K. International, Inc."], "is_original_packager": [true]}, "finished": true, "packaging": [{"sample": false, "description": "1 BOTTLE, PLASTIC in 1 CARTON (50844-261-08)  / 24 TABLET, FILM COATED in 1 BOTTLE, PLASTIC", "package_ndc": "50844-261-08", "marketing_start_date": "20190806"}], "brand_name": "Naproxen", "product_id": "50844-261_f5f6ef48-fa2a-4a62-9cde-0a685fe575b0", "dosage_form": "TABLET, FILM COATED", "pharm_class": ["Anti-Inflammatory Agents", "Non-Steroidal [CS]", "Cyclooxygenase Inhibitors [MoA]", "Nonsteroidal Anti-inflammatory Drug [EPC]"], "product_ndc": "50844-261", "generic_name": "Naproxen Sodium", "labeler_name": "L.N.K. International, Inc.", "product_type": "HUMAN OTC DRUG", "brand_name_base": "Naproxen", "active_ingredients": [{"name": "NAPROXEN SODIUM", "strength": "220 mg/1"}], "application_number": "ANDA204872", "marketing_category": "ANDA", "marketing_start_date": "20190806", "listing_expiration_date": "20261231"}