naproxen sodium

Generic: naproxen sodium

Labeler: phoenix rx llc
NDC Directory HUMAN PRESCRIPTION DRUG ANDA Inactive Finished

Drug Facts

Product Profile

Brand Name naproxen sodium
Generic Name naproxen sodium
Labeler phoenix rx llc
Dosage Form TABLET, FILM COATED
Routes
ORAL
Active Ingredients

naproxen sodium 550 mg/1

Manufacturer
PHOENIX RX LLC

Identifiers & Regulatory

Product NDC 85509-1495
Product ID 85509-1495_4b97c5af-891e-98f4-e063-6394a90ab4ea
Product Type HUMAN PRESCRIPTION DRUG
Marketing Category ANDA
Application Number ANDA078486
Listing Expiration 2027-12-31
Marketing Start 2016-04-26

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 855091495
Hyphenated Format 85509-1495

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 ANDA078486 (source: ndc)
Routes
ORAL
source: ndc

Resolved Composition

Strengths
  • 550 mg/1
source: ndc
Packaging
  • 30 TABLET, FILM COATED in 1 BOTTLE (85509-1495-3)
  • 60 TABLET, FILM COATED in 1 BOTTLE (85509-1495-6)
  • 90 TABLET, FILM COATED in 1 BOTTLE (85509-1495-9)
source: ndc

Packages (3)

85509-1495-3 30 TABLET, FILM COATED in 1 BOTTLE (85509-1495-3) 85509-1495-6 60 TABLET, FILM COATED in 1 BOTTLE (85509-1495-6) 85509-1495-9 90 TABLET, FILM COATED in 1 BOTTLE (85509-1495-9)

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": "4b97c5af-891e-98f4-e063-6394a90ab4ea", "openfda": {"unii": ["9TN87S3A3C"], "rxcui": ["849431"], "spl_set_id": ["47d18804-d8d6-8248-e063-6394a90a48a9"], "manufacturer_name": ["PHOENIX RX LLC"]}, "finished": true, "packaging": [{"sample": false, "description": "30 TABLET, FILM COATED in 1 BOTTLE (85509-1495-3)", "package_ndc": "85509-1495-3", "marketing_start_date": "20260107"}, {"sample": false, "description": "60 TABLET, FILM COATED in 1 BOTTLE (85509-1495-6)", "package_ndc": "85509-1495-6", "marketing_start_date": "20260107"}, {"sample": false, "description": "90 TABLET, FILM COATED in 1 BOTTLE (85509-1495-9)", "package_ndc": "85509-1495-9", "marketing_start_date": "20260107"}], "brand_name": "Naproxen sodium", "product_id": "85509-1495_4b97c5af-891e-98f4-e063-6394a90ab4ea", "dosage_form": "TABLET, FILM COATED", "pharm_class": ["Anti-Inflammatory Agents", "Non-Steroidal [CS]", "Cyclooxygenase Inhibitors [MoA]", "Nonsteroidal Anti-inflammatory Drug [EPC]"], "product_ndc": "85509-1495", "generic_name": "Naproxen sodium", "labeler_name": "PHOENIX RX LLC", "product_type": "HUMAN PRESCRIPTION DRUG", "brand_name_base": "Naproxen sodium", "active_ingredients": [{"name": "NAPROXEN SODIUM", "strength": "550 mg/1"}], "application_number": "ANDA078486", "marketing_category": "ANDA", "marketing_start_date": "20160426", "listing_expiration_date": "20271231"}