naproxen sodium

Generic: naproxen sodium

Labeler: granules usa, inc.
NDC Directory HUMAN OTC DRUG ANDA Inactive Finished

Drug Facts

Product Profile

Brand Name naproxen sodium
Generic Name naproxen sodium
Labeler granules usa, inc.
Dosage Form TABLET
Routes
ORAL
Active Ingredients

naproxen sodium 220 mg/1

Manufacturer
Granules USA, Inc.

Identifiers & Regulatory

Product NDC 69848-010
Product ID 69848-010_4690bf52-d225-e2ee-e063-6394a90ad8a9
Product Type HUMAN OTC DRUG
Marketing Category ANDA
Application Number ANDA091353
Listing Expiration 2026-12-31
Marketing Start 2019-07-01

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 69848010
Hyphenated Format 69848-010

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 ANDA091353 (source: ndc)
Routes
ORAL
source: ndc

Resolved Composition

Strengths
  • 220 mg/1
source: ndc
Packaging
  • 10 TABLET in 1 BOTTLE (69848-010-01)
  • 50 TABLET in 1 BOTTLE (69848-010-05)
  • 100 TABLET in 1 BOTTLE (69848-010-10)
source: ndc

Packages (3)

69848-010-01 10 TABLET in 1 BOTTLE (69848-010-01) 69848-010-05 50 TABLET in 1 BOTTLE (69848-010-05) 69848-010-10 100 TABLET in 1 BOTTLE (69848-010-10)

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": "4690bf52-d225-e2ee-e063-6394a90ad8a9", "openfda": {"unii": ["9TN87S3A3C"], "rxcui": ["849574"], "spl_set_id": ["8cb8030c-b281-315c-e053-2a95a90a36f0"], "manufacturer_name": ["Granules USA, Inc."], "is_original_packager": [true]}, "finished": true, "packaging": [{"sample": false, "description": "10 TABLET in 1 BOTTLE (69848-010-01)", "package_ndc": "69848-010-01", "marketing_start_date": "20190701"}, {"sample": false, "description": "50 TABLET in 1 BOTTLE (69848-010-05)", "package_ndc": "69848-010-05", "marketing_start_date": "20230301"}, {"sample": false, "description": "100 TABLET in 1 BOTTLE (69848-010-10)", "package_ndc": "69848-010-10", "marketing_start_date": "20230301"}], "brand_name": "Naproxen Sodium", "product_id": "69848-010_4690bf52-d225-e2ee-e063-6394a90ad8a9", "dosage_form": "TABLET", "pharm_class": ["Anti-Inflammatory Agents", "Non-Steroidal [CS]", "Cyclooxygenase Inhibitors [MoA]", "Nonsteroidal Anti-inflammatory Drug [EPC]"], "product_ndc": "69848-010", "generic_name": "Naproxen Sodium", "labeler_name": "Granules USA, Inc.", "product_type": "HUMAN OTC DRUG", "brand_name_base": "Naproxen Sodium", "active_ingredients": [{"name": "NAPROXEN SODIUM", "strength": "220 mg/1"}], "application_number": "ANDA091353", "marketing_category": "ANDA", "marketing_start_date": "20190701", "listing_expiration_date": "20261231"}