naproxen sodium

Generic: naproxen sodium

Labeler: chain drug marketing association, inc.
NDC Directory HUMAN OTC DRUG ANDA Inactive Finished

Drug Facts

Product Profile

Brand Name naproxen sodium
Generic Name naproxen sodium
Labeler chain drug marketing association, inc.
Dosage Form TABLET, COATED
Routes
ORAL
Active Ingredients

naproxen sodium 220 mg/1

Manufacturer
CHAIN DRUG MARKETING ASSOCIATION, INC.

Identifiers & Regulatory

Product NDC 83324-109
Product ID 83324-109_3806291c-fce8-bcac-e063-6294a90ae162
Product Type HUMAN OTC DRUG
Marketing Category ANDA
Application Number ANDA079096
Listing Expiration 2026-12-31
Marketing Start 2025-05-20

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 83324109
Hyphenated Format 83324-109

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 ANDA079096 (source: ndc)
Routes
ORAL
source: ndc

Resolved Composition

Strengths
  • 220 mg/1
source: ndc
Packaging
  • 1 BOTTLE, PLASTIC in 1 PACKAGE (83324-109-01) / 100 TABLET, COATED in 1 BOTTLE, PLASTIC
  • 1 BOTTLE, PLASTIC in 1 CARTON (83324-109-50) / 50 TABLET, COATED in 1 BOTTLE, PLASTIC
source: ndc

Packages (2)

83324-109-01 1 BOTTLE, PLASTIC in 1 PACKAGE (83324-109-01) / 100 TABLET, COATED in 1 BOTTLE, PLASTIC 83324-109-50 1 BOTTLE, PLASTIC in 1 CARTON (83324-109-50) / 50 TABLET, COATED in 1 BOTTLE, PLASTIC

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": "3806291c-fce8-bcac-e063-6294a90ae162", "openfda": {"unii": ["9TN87S3A3C"], "rxcui": ["849574"], "spl_set_id": ["84b9e9a4-b805-420e-83be-ebe98776d1ee"], "manufacturer_name": ["CHAIN DRUG MARKETING ASSOCIATION, INC."], "is_original_packager": [true]}, "finished": true, "packaging": [{"sample": false, "description": "1 BOTTLE, PLASTIC in 1 PACKAGE (83324-109-01)  / 100 TABLET, COATED in 1 BOTTLE, PLASTIC", "package_ndc": "83324-109-01", "marketing_start_date": "20250520"}, {"sample": false, "description": "1 BOTTLE, PLASTIC in 1 CARTON (83324-109-50)  / 50 TABLET, COATED in 1 BOTTLE, PLASTIC", "package_ndc": "83324-109-50", "marketing_start_date": "20250520"}], "brand_name": "Naproxen Sodium", "product_id": "83324-109_3806291c-fce8-bcac-e063-6294a90ae162", "dosage_form": "TABLET, COATED", "pharm_class": ["Anti-Inflammatory Agents", "Non-Steroidal [CS]", "Cyclooxygenase Inhibitors [MoA]", "Nonsteroidal Anti-inflammatory Drug [EPC]"], "product_ndc": "83324-109", "generic_name": "NAPROXEN SODIUM", "labeler_name": "CHAIN DRUG MARKETING ASSOCIATION, INC.", "product_type": "HUMAN OTC DRUG", "brand_name_base": "Naproxen Sodium", "active_ingredients": [{"name": "NAPROXEN SODIUM", "strength": "220 mg/1"}], "application_number": "ANDA079096", "marketing_category": "ANDA", "marketing_start_date": "20250520", "listing_expiration_date": "20261231"}