naproxen sodium

Generic: naproxen sodium

Labeler: advanced rx of tennessee, llc
NDC Directory HUMAN PRESCRIPTION DRUG ANDA Inactive Finished

Drug Facts

Product Profile

Brand Name naproxen sodium
Generic Name naproxen sodium
Labeler advanced rx of tennessee, llc
Dosage Form TABLET
Routes
ORAL
Active Ingredients

naproxen sodium 550 mg/1

Manufacturer
Advanced Rx of Tennessee, LLC

Identifiers & Regulatory

Product NDC 80425-0574
Product ID 80425-0574_4a05c9b4-e04e-2ab1-e063-6294a90a34f6
Product Type HUMAN PRESCRIPTION DRUG
Marketing Category ANDA
Application Number ANDA212199
Listing Expiration 2027-12-31
Marketing Start 2026-02-04

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 804250574
Hyphenated Format 80425-0574

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
  • 30 TABLET in 1 BOTTLE (80425-0574-1)
  • 60 TABLET in 1 BOTTLE (80425-0574-2)
  • 90 TABLET in 1 BOTTLE (80425-0574-3)
source: ndc

Packages (3)

80425-0574-1 30 TABLET in 1 BOTTLE (80425-0574-1) 80425-0574-2 60 TABLET in 1 BOTTLE (80425-0574-2) 80425-0574-3 90 TABLET in 1 BOTTLE (80425-0574-3)

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": "4a05c9b4-e04e-2ab1-e063-6294a90a34f6", "openfda": {"unii": ["9TN87S3A3C"], "rxcui": ["849431"], "spl_set_id": ["4a05ca8c-1b03-fa86-e063-6394a90a4119"], "manufacturer_name": ["Advanced Rx of Tennessee, LLC"]}, "finished": true, "packaging": [{"sample": false, "description": "30 TABLET in 1 BOTTLE (80425-0574-1)", "package_ndc": "80425-0574-1", "marketing_start_date": "20260204"}, {"sample": false, "description": "60 TABLET in 1 BOTTLE (80425-0574-2)", "package_ndc": "80425-0574-2", "marketing_start_date": "20260204"}, {"sample": false, "description": "90 TABLET in 1 BOTTLE (80425-0574-3)", "package_ndc": "80425-0574-3", "marketing_start_date": "20260204"}], "brand_name": "Naproxen Sodium", "product_id": "80425-0574_4a05c9b4-e04e-2ab1-e063-6294a90a34f6", "dosage_form": "TABLET", "pharm_class": ["Anti-Inflammatory Agents", "Non-Steroidal [CS]", "Cyclooxygenase Inhibitors [MoA]", "Nonsteroidal Anti-inflammatory Drug [EPC]"], "product_ndc": "80425-0574", "generic_name": "Naproxen Sodium", "labeler_name": "Advanced Rx of Tennessee, LLC", "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": "20260204", "listing_expiration_date": "20271231"}