naproxen sodium

Generic: naproxen sodium

Labeler: athlete's needs inc
NDC Directory HUMAN OTC DRUG ANDA Inactive Finished

Drug Facts

Product Profile

Brand Name naproxen sodium
Generic Name naproxen sodium
Labeler athlete's needs inc
Dosage Form TABLET, FILM COATED
Routes
ORAL
Active Ingredients

naproxen sodium 220 mg/1

Manufacturer
Athlete's Needs Inc

Identifiers & Regulatory

Product NDC 53185-604
Product ID 53185-604_b5125434-5aab-4cbd-afba-c6ca1381b2a9
Product Type HUMAN OTC DRUG
Marketing Category ANDA
Application Number ANDA204872
Listing Expiration 2026-12-31
Marketing Start 2022-03-11

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 53185604
Hyphenated Format 53185-604

Supplemental Identifiers

RxCUI
849574
UPC
0092617374506
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
  • 100 TABLET, FILM COATED in 1 BOTTLE, PLASTIC (53185-604-12)
  • 50 TABLET, FILM COATED in 1 BOTTLE, PLASTIC (53185-604-15)
source: ndc

Packages (2)

53185-604-12 100 TABLET, FILM COATED in 1 BOTTLE, PLASTIC (53185-604-12) 53185-604-15 50 TABLET, FILM COATED in 1 BOTTLE, PLASTIC (53185-604-15)

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": "b5125434-5aab-4cbd-afba-c6ca1381b2a9", "openfda": {"upc": ["0092617374506"], "unii": ["9TN87S3A3C"], "rxcui": ["849574"], "spl_set_id": ["d5984c9d-3941-45d6-8392-87564b2faae0"], "manufacturer_name": ["Athlete's Needs Inc"], "is_original_packager": [true]}, "finished": true, "packaging": [{"sample": false, "description": "100 TABLET, FILM COATED in 1 BOTTLE, PLASTIC (53185-604-12)", "package_ndc": "53185-604-12", "marketing_start_date": "20220311"}, {"sample": false, "description": "50 TABLET, FILM COATED in 1 BOTTLE, PLASTIC (53185-604-15)", "package_ndc": "53185-604-15", "marketing_start_date": "20220311"}], "brand_name": "Naproxen Sodium", "product_id": "53185-604_b5125434-5aab-4cbd-afba-c6ca1381b2a9", "dosage_form": "TABLET, FILM COATED", "pharm_class": ["Anti-Inflammatory Agents", "Non-Steroidal [CS]", "Cyclooxygenase Inhibitors [MoA]", "Nonsteroidal Anti-inflammatory Drug [EPC]"], "product_ndc": "53185-604", "generic_name": "Naproxen Sodium", "labeler_name": "Athlete's Needs 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": "20220311", "listing_expiration_date": "20261231"}