naproxen sodium

Generic: naproxen sodium

Labeler: pd-rx pharmaceuticals, inc.
NDC Directory HUMAN OTC DRUG ANDA Inactive Finished

Drug Facts

Product Profile

Brand Name naproxen sodium
Generic Name naproxen sodium
Labeler pd-rx pharmaceuticals, inc.
Dosage Form TABLET, FILM COATED
Routes
ORAL
Active Ingredients

naproxen sodium 220 mg/1

Manufacturer
PD-Rx Pharmaceuticals, Inc.

Identifiers & Regulatory

Product NDC 43063-909
Product ID 43063-909_302b48e9-e562-b7d7-e063-6394a90a3980
Product Type HUMAN OTC DRUG
Marketing Category ANDA
Application Number ANDA074661
Listing Expiration 2026-12-31
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 43063909
Hyphenated Format 43063-909

Supplemental Identifiers

RxCUI
849574
UNII
9TN87S3A3C

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
  • 20 TABLET, FILM COATED in 1 BOTTLE, PLASTIC (43063-909-20)
  • 30 TABLET, FILM COATED in 1 BOTTLE, PLASTIC (43063-909-30)
source: ndc

Packages (2)

43063-909-20 20 TABLET, FILM COATED in 1 BOTTLE, PLASTIC (43063-909-20) 43063-909-30 30 TABLET, FILM COATED in 1 BOTTLE, PLASTIC (43063-909-30)

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": "302b48e9-e562-b7d7-e063-6394a90a3980", "openfda": {"unii": ["9TN87S3A3C"], "rxcui": ["849574"], "spl_set_id": ["c5146d73-2f34-4dfe-ac29-97071279dc4d"], "manufacturer_name": ["PD-Rx Pharmaceuticals, Inc."]}, "finished": true, "packaging": [{"sample": false, "description": "20 TABLET, FILM COATED in 1 BOTTLE, PLASTIC (43063-909-20)", "package_ndc": "43063-909-20", "marketing_start_date": "20210327"}, {"sample": false, "description": "30 TABLET, FILM COATED in 1 BOTTLE, PLASTIC (43063-909-30)", "package_ndc": "43063-909-30", "marketing_start_date": "20210327"}], "brand_name": "Naproxen Sodium", "product_id": "43063-909_302b48e9-e562-b7d7-e063-6394a90a3980", "dosage_form": "TABLET, FILM COATED", "pharm_class": ["Anti-Inflammatory Agents", "Non-Steroidal [CS]", "Cyclooxygenase Inhibitors [MoA]", "Nonsteroidal Anti-inflammatory Drug [EPC]"], "product_ndc": "43063-909", "generic_name": "Naproxen Sodium", "labeler_name": "PD-Rx Pharmaceuticals, Inc.", "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": "20261231"}