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 72789-543
Product ID 72789-543_46b3a114-167a-d337-e063-6394a90a9a33
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 72789543
Hyphenated Format 72789-543

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
  • 14 TABLET, FILM COATED in 1 BOTTLE, PLASTIC (72789-543-14)
  • 28 TABLET, FILM COATED in 1 BOTTLE, PLASTIC (72789-543-28)
source: ndc

Packages (2)

72789-543-14 14 TABLET, FILM COATED in 1 BOTTLE, PLASTIC (72789-543-14) 72789-543-28 28 TABLET, FILM COATED in 1 BOTTLE, PLASTIC (72789-543-28)

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": "46b3a114-167a-d337-e063-6394a90a9a33", "openfda": {"unii": ["9TN87S3A3C"], "rxcui": ["849574"], "spl_set_id": ["d2b1eedb-2be0-42af-ba0b-9da98560c91e"], "manufacturer_name": ["PD-Rx Pharmaceuticals, Inc."]}, "finished": true, "packaging": [{"sample": false, "description": "14 TABLET, FILM COATED in 1 BOTTLE, PLASTIC (72789-543-14)", "package_ndc": "72789-543-14", "marketing_start_date": "20251223"}, {"sample": false, "description": "28 TABLET, FILM COATED in 1 BOTTLE, PLASTIC (72789-543-28)", "package_ndc": "72789-543-28", "marketing_start_date": "20251223"}], "brand_name": "Naproxen Sodium", "product_id": "72789-543_46b3a114-167a-d337-e063-6394a90a9a33", "dosage_form": "TABLET, FILM COATED", "pharm_class": ["Anti-Inflammatory Agents", "Non-Steroidal [CS]", "Cyclooxygenase Inhibitors [MoA]", "Nonsteroidal Anti-inflammatory Drug [EPC]"], "product_ndc": "72789-543", "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"}