naproxen sodium

Generic: naproxen sodium

Labeler: sa3, llc
NDC Directory HUMAN PRESCRIPTION DRUG NDA AUTHORIZED GENERIC Inactive Finished

Drug Facts

Product Profile

Brand Name naproxen sodium
Generic Name naproxen sodium
Labeler sa3, llc
Dosage Form TABLET, FILM COATED, EXTENDED RELEASE
Routes
ORAL
Active Ingredients

naproxen sodium 375 mg/1

Manufacturer
SA3, LLC

Identifiers & Regulatory

Product NDC 69420-1375
Product ID 69420-1375_f34d9d85-4a82-43b6-bf5b-3b2893c6b009
Product Type HUMAN PRESCRIPTION DRUG
Marketing Category NDA AUTHORIZED GENERIC
Application Number NDA020353
Listing Expiration 2026-12-31
Marketing Start 2019-05-01

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 694201375
Hyphenated Format 69420-1375

Supplemental Identifiers

RxCUI
1116320
UPC
0369420137513
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 NDA020353 (source: ndc)
Routes
ORAL
source: ndc

Resolved Composition

Strengths
  • 375 mg/1
source: ndc
Packaging
  • 100 TABLET, FILM COATED, EXTENDED RELEASE in 1 BOTTLE (69420-1375-1)
source: ndc

Packages (1)

69420-1375-1 100 TABLET, FILM COATED, EXTENDED RELEASE in 1 BOTTLE (69420-1375-1)

Ingredients (1)

naproxen sodium (375 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": "f34d9d85-4a82-43b6-bf5b-3b2893c6b009", "openfda": {"upc": ["0369420137513"], "unii": ["9TN87S3A3C"], "rxcui": ["1116320"], "spl_set_id": ["313dd447-4b9f-4e5b-8ca9-4a2a5a1a53d9"], "manufacturer_name": ["SA3, LLC"], "is_original_packager": [true]}, "finished": true, "packaging": [{"sample": false, "description": "100 TABLET, FILM COATED, EXTENDED RELEASE in 1 BOTTLE (69420-1375-1)", "package_ndc": "69420-1375-1", "marketing_start_date": "20190501"}], "brand_name": "Naproxen Sodium", "product_id": "69420-1375_f34d9d85-4a82-43b6-bf5b-3b2893c6b009", "dosage_form": "TABLET, FILM COATED, EXTENDED RELEASE", "pharm_class": ["Anti-Inflammatory Agents", "Non-Steroidal [CS]", "Cyclooxygenase Inhibitors [MoA]", "Nonsteroidal Anti-inflammatory Drug [EPC]"], "product_ndc": "69420-1375", "generic_name": "Naproxen Sodium", "labeler_name": "SA3, LLC", "product_type": "HUMAN PRESCRIPTION DRUG", "brand_name_base": "Naproxen Sodium", "active_ingredients": [{"name": "NAPROXEN SODIUM", "strength": "375 mg/1"}], "application_number": "NDA020353", "marketing_category": "NDA AUTHORIZED GENERIC", "marketing_start_date": "20190501", "listing_expiration_date": "20261231"}