naproxen sodium

Generic: naproxen sodium

Labeler: bryant ranch prepack
NDC Directory HUMAN PRESCRIPTION DRUG ANDA Inactive Finished

Drug Facts

Product Profile

Brand Name naproxen sodium
Generic Name naproxen sodium
Labeler bryant ranch prepack
Dosage Form TABLET
Routes
ORAL
Active Ingredients

naproxen sodium 550 mg/1

Manufacturer
Bryant Ranch Prepack

Identifiers & Regulatory

Product NDC 63629-8516
Product ID 63629-8516_92a76ca5-8c83-4a3a-94e4-c0d9d26c366b
Product Type HUMAN PRESCRIPTION DRUG
Marketing Category ANDA
Application Number ANDA212199
Listing Expiration 2026-12-31
Marketing Start 2019-10-30

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 636298516
Hyphenated Format 63629-8516

Supplemental Identifiers

RxCUI
849431
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 ANDA212199 (source: ndc)
Routes
ORAL
source: ndc

Resolved Composition

Strengths
  • 550 mg/1
source: ndc
Packaging
  • 500 TABLET in 1 BOTTLE (63629-8516-1)
source: ndc

Packages (1)

63629-8516-1 500 TABLET in 1 BOTTLE (63629-8516-1)

Ingredients (1)

naproxen sodium (550 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": "92a76ca5-8c83-4a3a-94e4-c0d9d26c366b", "openfda": {"unii": ["9TN87S3A3C"], "rxcui": ["849431"], "spl_set_id": ["bee7b482-8ba5-411d-90ee-de00df50d2b7"], "manufacturer_name": ["Bryant Ranch Prepack"]}, "finished": true, "packaging": [{"sample": false, "description": "500 TABLET in 1 BOTTLE (63629-8516-1)", "package_ndc": "63629-8516-1", "marketing_start_date": "20191030"}], "brand_name": "Naproxen Sodium", "product_id": "63629-8516_92a76ca5-8c83-4a3a-94e4-c0d9d26c366b", "dosage_form": "TABLET", "pharm_class": ["Anti-Inflammatory Agents", "Non-Steroidal [CS]", "Cyclooxygenase Inhibitors [MoA]", "Nonsteroidal Anti-inflammatory Drug [EPC]"], "product_ndc": "63629-8516", "generic_name": "Naproxen Sodium", "labeler_name": "Bryant Ranch Prepack", "product_type": "HUMAN PRESCRIPTION DRUG", "brand_name_base": "Naproxen Sodium", "active_ingredients": [{"name": "NAPROXEN SODIUM", "strength": "550 mg/1"}], "application_number": "ANDA212199", "marketing_category": "ANDA", "marketing_start_date": "20191030", "listing_expiration_date": "20261231"}