naproxen sodium

Generic: naproxen sodium

Labeler: aurohealth llc
NDC Directory HUMAN OTC DRUG ANDA Inactive Finished

Drug Facts

Product Profile

Brand Name naproxen sodium
Generic Name naproxen sodium
Labeler aurohealth llc
Dosage Form TABLET, FILM COATED
Routes
ORAL
Active Ingredients

naproxen sodium 220 mg/1

Manufacturer
Aurohealth LLC

Identifiers & Regulatory

Product NDC 58602-819
Product ID 58602-819_915208d0-ee3a-4b1f-9c3c-76d9cb8362c9
Product Type HUMAN OTC DRUG
Marketing Category ANDA
Application Number ANDA205497
Listing Expiration 2026-12-31
Marketing Start 2017-12-11

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 58602819
Hyphenated Format 58602-819

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 (source: ndc)
Generic Name naproxen sodium (source: ndc)
Application Number ANDA205497 (source: ndc)
Routes
ORAL
source: ndc

Resolved Composition

Strengths
  • 220 mg/1
source: ndc
Packaging
  • 1 BOTTLE in 1 CARTON (58602-819-07) / 24 TABLET, FILM COATED in 1 BOTTLE
  • 1 BOTTLE in 1 CARTON (58602-819-14) / 50 TABLET, FILM COATED in 1 BOTTLE
  • 1 BOTTLE in 1 CARTON (58602-819-19) / 90 TABLET, FILM COATED in 1 BOTTLE
  • 1 BOTTLE in 1 CARTON (58602-819-21) / 100 TABLET, FILM COATED in 1 BOTTLE
  • 1 BOTTLE in 1 CARTON (58602-819-29) / 150 TABLET, FILM COATED in 1 BOTTLE
  • 1 BOTTLE in 1 CARTON (58602-819-38) / 300 TABLET, FILM COATED in 1 BOTTLE
  • 1 BOTTLE in 1 CARTON (58602-819-40) / 500 TABLET, FILM COATED in 1 BOTTLE
source: ndc

Packages (7)

58602-819-07 1 BOTTLE in 1 CARTON (58602-819-07) / 24 TABLET, FILM COATED in 1 BOTTLE 58602-819-14 1 BOTTLE in 1 CARTON (58602-819-14) / 50 TABLET, FILM COATED in 1 BOTTLE 58602-819-19 1 BOTTLE in 1 CARTON (58602-819-19) / 90 TABLET, FILM COATED in 1 BOTTLE 58602-819-21 1 BOTTLE in 1 CARTON (58602-819-21) / 100 TABLET, FILM COATED in 1 BOTTLE 58602-819-29 1 BOTTLE in 1 CARTON (58602-819-29) / 150 TABLET, FILM COATED in 1 BOTTLE 58602-819-38 1 BOTTLE in 1 CARTON (58602-819-38) / 300 TABLET, FILM COATED in 1 BOTTLE 58602-819-40 1 BOTTLE in 1 CARTON (58602-819-40) / 500 TABLET, FILM COATED in 1 BOTTLE

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": "915208d0-ee3a-4b1f-9c3c-76d9cb8362c9", "openfda": {"unii": ["9TN87S3A3C"], "rxcui": ["849574"], "spl_set_id": ["46a15412-25d6-454d-86db-70321d19a2c9"], "manufacturer_name": ["Aurohealth LLC"], "is_original_packager": [true]}, "finished": true, "packaging": [{"sample": false, "description": "1 BOTTLE in 1 CARTON (58602-819-07)  / 24 TABLET, FILM COATED in 1 BOTTLE", "package_ndc": "58602-819-07", "marketing_start_date": "20211025"}, {"sample": false, "description": "1 BOTTLE in 1 CARTON (58602-819-14)  / 50 TABLET, FILM COATED in 1 BOTTLE", "package_ndc": "58602-819-14", "marketing_start_date": "20171211"}, {"sample": false, "description": "1 BOTTLE in 1 CARTON (58602-819-19)  / 90 TABLET, FILM COATED in 1 BOTTLE", "package_ndc": "58602-819-19", "marketing_start_date": "20230921"}, {"sample": false, "description": "1 BOTTLE in 1 CARTON (58602-819-21)  / 100 TABLET, FILM COATED in 1 BOTTLE", "package_ndc": "58602-819-21", "marketing_start_date": "20171211"}, {"sample": false, "description": "1 BOTTLE in 1 CARTON (58602-819-29)  / 150 TABLET, FILM COATED in 1 BOTTLE", "package_ndc": "58602-819-29", "marketing_start_date": "20211025"}, {"sample": false, "description": "1 BOTTLE in 1 CARTON (58602-819-38)  / 300 TABLET, FILM COATED in 1 BOTTLE", "package_ndc": "58602-819-38", "marketing_start_date": "20211025"}, {"sample": false, "description": "1 BOTTLE in 1 CARTON (58602-819-40)  / 500 TABLET, FILM COATED in 1 BOTTLE", "package_ndc": "58602-819-40", "marketing_start_date": "20211025"}], "brand_name": "Naproxen Sodium", "product_id": "58602-819_915208d0-ee3a-4b1f-9c3c-76d9cb8362c9", "dosage_form": "TABLET, FILM COATED", "pharm_class": ["Anti-Inflammatory Agents", "Non-Steroidal [CS]", "Cyclooxygenase Inhibitors [MoA]", "Nonsteroidal Anti-inflammatory Drug [EPC]"], "product_ndc": "58602-819", "generic_name": "Naproxen Sodium", "labeler_name": "Aurohealth LLC", "product_type": "HUMAN OTC DRUG", "brand_name_base": "Naproxen Sodium", "active_ingredients": [{"name": "NAPROXEN SODIUM", "strength": "220 mg/1"}], "application_number": "ANDA205497", "marketing_category": "ANDA", "marketing_start_date": "20171211", "listing_expiration_date": "20261231"}