naproxen sodium

Generic: naproxen sodium

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

Drug Facts

Product Profile

Brand Name naproxen sodium
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 50844-417
Product ID 50844-417_89d3ed35-e75c-41d8-aa99-57cc1fd866d2
Product Type HUMAN OTC DRUG
Marketing Category ANDA
Application Number ANDA204872
Listing Expiration 2027-12-31
Marketing Start 2017-02-01

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 50844417
Hyphenated Format 50844-417

Supplemental Identifiers

RxCUI
849574
UPC
0050844604063 0050844417168
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 ANDA204872 (source: ndc)
Routes
ORAL
source: ndc

Resolved Composition

Strengths
  • 220 mg/1
source: ndc
Packaging
  • 60 POUCH in 1 CARTON (50844-417-11) / 1 TABLET, FILM COATED in 1 POUCH (50844-417-43)
  • 500 TABLET, FILM COATED in 1 BOTTLE, PLASTIC (50844-417-14)
  • 1000 TABLET, FILM COATED in 1 BOTTLE, PLASTIC (50844-417-16)
  • 1 BOTTLE, PLASTIC in 1 CARTON (50844-417-19) / 8 TABLET, FILM COATED in 1 BOTTLE, PLASTIC
  • 48 POUCH in 1 CARTON (50844-417-22) / 1 TABLET, FILM COATED in 1 POUCH (50844-417-43)
  • 25 TABLET, FILM COATED in 1 BOTTLE, PLASTIC (50844-417-56)
  • 8 TABLET, FILM COATED in 1 BOTTLE, PLASTIC (50844-417-98)
  • 8 TABLET, FILM COATED in 1 BOTTLE, PLASTIC (50844-417-99)
source: ndc

Packages (8)

50844-417-11 60 POUCH in 1 CARTON (50844-417-11) / 1 TABLET, FILM COATED in 1 POUCH (50844-417-43) 50844-417-14 500 TABLET, FILM COATED in 1 BOTTLE, PLASTIC (50844-417-14) 50844-417-16 1000 TABLET, FILM COATED in 1 BOTTLE, PLASTIC (50844-417-16) 50844-417-19 1 BOTTLE, PLASTIC in 1 CARTON (50844-417-19) / 8 TABLET, FILM COATED in 1 BOTTLE, PLASTIC 50844-417-22 48 POUCH in 1 CARTON (50844-417-22) / 1 TABLET, FILM COATED in 1 POUCH (50844-417-43) 50844-417-56 25 TABLET, FILM COATED in 1 BOTTLE, PLASTIC (50844-417-56) 50844-417-98 8 TABLET, FILM COATED in 1 BOTTLE, PLASTIC (50844-417-98) 50844-417-99 8 TABLET, FILM COATED in 1 BOTTLE, PLASTIC (50844-417-99)

Ingredients (1)

naproxen sodium (220 mg/1)

Linked Drug Pages (1)

Naproxen Sodium ndc-match (0.9)

Raw FDA Data

View complete raw FDA NDC JSON payload 
{"route": ["ORAL"], "spl_id": "89d3ed35-e75c-41d8-aa99-57cc1fd866d2", "openfda": {"upc": ["0050844604063", "0050844417168"], "unii": ["9TN87S3A3C"], "rxcui": ["849574"], "spl_set_id": ["717518e4-2537-4229-b765-c6acfe963d4b"], "manufacturer_name": ["L.N.K. International, Inc."], "is_original_packager": [true]}, "finished": true, "packaging": [{"sample": false, "description": "60 POUCH in 1 CARTON (50844-417-11)  / 1 TABLET, FILM COATED in 1 POUCH (50844-417-43)", "package_ndc": "50844-417-11", "marketing_start_date": "20170201"}, {"sample": false, "description": "500 TABLET, FILM COATED in 1 BOTTLE, PLASTIC (50844-417-14)", "package_ndc": "50844-417-14", "marketing_start_date": "20170201"}, {"sample": false, "description": "1000 TABLET, FILM COATED in 1 BOTTLE, PLASTIC (50844-417-16)", "package_ndc": "50844-417-16", "marketing_start_date": "20170201"}, {"sample": false, "description": "1 BOTTLE, PLASTIC in 1 CARTON (50844-417-19)  / 8 TABLET, FILM COATED in 1 BOTTLE, PLASTIC", "package_ndc": "50844-417-19", "marketing_start_date": "20170201"}, {"sample": false, "description": "48 POUCH in 1 CARTON (50844-417-22)  / 1 TABLET, FILM COATED in 1 POUCH (50844-417-43)", "package_ndc": "50844-417-22", "marketing_start_date": "20170201"}, {"sample": false, "description": "25 TABLET, FILM COATED in 1 BOTTLE, PLASTIC (50844-417-56)", "package_ndc": "50844-417-56", "marketing_start_date": "20170201"}, {"sample": false, "description": "8 TABLET, FILM COATED in 1 BOTTLE, PLASTIC (50844-417-98)", "package_ndc": "50844-417-98", "marketing_start_date": "20170201"}, {"sample": false, "description": "8 TABLET, FILM COATED in 1 BOTTLE, PLASTIC (50844-417-99)", "package_ndc": "50844-417-99", "marketing_start_date": "20170201"}], "brand_name": "Naproxen Sodium", "product_id": "50844-417_89d3ed35-e75c-41d8-aa99-57cc1fd866d2", "dosage_form": "TABLET, FILM COATED", "pharm_class": ["Anti-Inflammatory Agents", "Non-Steroidal [CS]", "Cyclooxygenase Inhibitors [MoA]", "Nonsteroidal Anti-inflammatory Drug [EPC]"], "product_ndc": "50844-417", "generic_name": "Naproxen Sodium", "labeler_name": "L.N.K. International, Inc.", "product_type": "HUMAN OTC DRUG", "brand_name_base": "Naproxen Sodium", "active_ingredients": [{"name": "NAPROXEN SODIUM", "strength": "220 mg/1"}], "application_number": "ANDA204872", "marketing_category": "ANDA", "marketing_start_date": "20170201", "listing_expiration_date": "20271231"}