naproxen sodium (nsaid) fever reducer/ pain reliever

Generic: naproxen sodium

Labeler: amneal pharmaceuticals of new york llc
NDC Directory HUMAN OTC DRUG ANDA Inactive Finished

Drug Facts

Product Profile

Brand Name naproxen sodium (nsaid) fever reducer/ pain reliever
Generic Name naproxen sodium
Labeler amneal pharmaceuticals of new york llc
Dosage Form TABLET
Routes
ORAL
Active Ingredients

naproxen sodium 220 mg/1

Manufacturer
Amneal Pharmaceuticals of New York LLC

Identifiers & Regulatory

Product NDC 53746-191
Product ID 53746-191_9cc39ab5-450a-4e0b-948d-fdebd66c0f6f
Product Type HUMAN OTC DRUG
Marketing Category ANDA
Application Number ANDA079096
Listing Expiration 2026-12-31
Marketing Start 2009-11-25

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 53746191
Hyphenated Format 53746-191

Supplemental Identifiers

RxCUI
849574
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 (nsaid) fever reducer/ pain reliever (source: ndc)
Generic Name naproxen sodium (source: ndc)
Application Number ANDA079096 (source: ndc)
Routes
ORAL
source: ndc

Resolved Composition

Strengths
  • 220 mg/1
source: ndc
Packaging
  • 500 TABLET in 1 BOTTLE (53746-191-05)
  • 8 TABLET in 1 VIAL (53746-191-08)
  • 24 TABLET in 1 BOTTLE (53746-191-24)
source: ndc

Packages (3)

53746-191-05 500 TABLET in 1 BOTTLE (53746-191-05) 53746-191-08 8 TABLET in 1 VIAL (53746-191-08) 53746-191-24 24 TABLET in 1 BOTTLE (53746-191-24)

Ingredients (1)

naproxen sodium (220 mg/1)

Linked Drug Pages (1)

Naproxen Sodium (NSAID) Fever Reducer/ Pain Reliever ndc-match (0.9)

Raw FDA Data

View complete raw FDA NDC JSON payload 
{"route": ["ORAL"], "spl_id": "9cc39ab5-450a-4e0b-948d-fdebd66c0f6f", "openfda": {"unii": ["9TN87S3A3C"], "rxcui": ["849574"], "spl_set_id": ["0bb41b8c-6031-4e96-95e1-31adab811837"], "manufacturer_name": ["Amneal Pharmaceuticals of New York LLC"], "is_original_packager": [true]}, "finished": true, "packaging": [{"sample": false, "description": "500 TABLET in 1 BOTTLE (53746-191-05)", "package_ndc": "53746-191-05", "marketing_start_date": "20091125"}, {"sample": false, "description": "8 TABLET in 1 VIAL (53746-191-08)", "package_ndc": "53746-191-08", "marketing_start_date": "20091125"}, {"sample": false, "description": "24 TABLET in 1 BOTTLE (53746-191-24)", "package_ndc": "53746-191-24", "marketing_start_date": "20091125"}], "brand_name": "Naproxen Sodium (NSAID) Fever Reducer/ Pain Reliever", "product_id": "53746-191_9cc39ab5-450a-4e0b-948d-fdebd66c0f6f", "dosage_form": "TABLET", "pharm_class": ["Anti-Inflammatory Agents", "Non-Steroidal [CS]", "Cyclooxygenase Inhibitors [MoA]", "Nonsteroidal Anti-inflammatory Drug [EPC]"], "product_ndc": "53746-191", "generic_name": "Naproxen Sodium", "labeler_name": "Amneal Pharmaceuticals of New York LLC", "product_type": "HUMAN OTC DRUG", "brand_name_base": "Naproxen Sodium (NSAID)", "brand_name_suffix": "Fever Reducer/ Pain Reliever", "active_ingredients": [{"name": "NAPROXEN SODIUM", "strength": "220 mg/1"}], "application_number": "ANDA079096", "marketing_category": "ANDA", "marketing_start_date": "20091125", "listing_expiration_date": "20261231"}