naproxen sodium

Generic: naproxen sodium

Labeler: padagis israel pharmaceuticals ltd
NDC Directory HUMAN OTC DRUG ANDA Inactive Finished

Drug Facts

Product Profile

Brand Name naproxen sodium
Generic Name naproxen sodium
Labeler padagis israel pharmaceuticals ltd
Dosage Form TABLET, FILM COATED
Routes
ORAL
Active Ingredients

naproxen sodium 220 mg/1

Manufacturer
Padagis Israel Pharmaceuticals Ltd

Identifiers & Regulatory

Product NDC 45802-490
Product ID 45802-490_d92cd99a-ffdc-41e9-a7c3-8447910c3b92
Product Type HUMAN OTC DRUG
Marketing Category ANDA
Application Number ANDA074661
Listing Expiration 2027-12-31
Marketing Start 2014-04-11

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 45802490
Hyphenated Format 45802-490

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 ANDA074661 (source: ndc)
Routes
ORAL
source: ndc

Resolved Composition

Strengths
  • 220 mg/1
source: ndc
Packaging
  • 1 BOTTLE in 1 CARTON (45802-490-75) / 90 TABLET, FILM COATED in 1 BOTTLE
source: ndc

Packages (1)

45802-490-75 1 BOTTLE in 1 CARTON (45802-490-75) / 90 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": "d92cd99a-ffdc-41e9-a7c3-8447910c3b92", "openfda": {"unii": ["9TN87S3A3C"], "rxcui": ["849574"], "spl_set_id": ["cdb60f74-ce23-4015-90eb-b23a2275f6cb"], "manufacturer_name": ["Padagis Israel Pharmaceuticals Ltd"], "is_original_packager": [true]}, "finished": true, "packaging": [{"sample": false, "description": "1 BOTTLE in 1 CARTON (45802-490-75)  / 90 TABLET, FILM COATED in 1 BOTTLE", "package_ndc": "45802-490-75", "marketing_start_date": "20211202"}], "brand_name": "Naproxen Sodium", "product_id": "45802-490_d92cd99a-ffdc-41e9-a7c3-8447910c3b92", "dosage_form": "TABLET, FILM COATED", "pharm_class": ["Anti-Inflammatory Agents", "Non-Steroidal [CS]", "Cyclooxygenase Inhibitors [MoA]", "Nonsteroidal Anti-inflammatory Drug [EPC]"], "product_ndc": "45802-490", "generic_name": "Naproxen Sodium", "labeler_name": "Padagis Israel Pharmaceuticals Ltd", "product_type": "HUMAN OTC DRUG", "brand_name_base": "Naproxen Sodium", "active_ingredients": [{"name": "NAPROXEN SODIUM", "strength": "220 mg/1"}], "application_number": "ANDA074661", "marketing_category": "ANDA", "marketing_start_date": "20140411", "listing_expiration_date": "20271231"}