naproxen sodium

Generic: naproxen sodium

Labeler: aurobindo pharma limited
NDC Directory HUMAN PRESCRIPTION DRUG ANDA Inactive Finished

Drug Facts

Product Profile

Brand Name naproxen sodium
Generic Name naproxen sodium
Labeler aurobindo pharma limited
Dosage Form TABLET, FILM COATED
Routes
ORAL
Active Ingredients

naproxen sodium 550 mg/1

Manufacturer
Aurobindo Pharma Limited

Identifiers & Regulatory

Product NDC 65862-516
Product ID 65862-516_a4659cf5-a74b-42b3-968b-a8e4f14f94aa
Product Type HUMAN PRESCRIPTION DRUG
Marketing Category ANDA
Application Number ANDA200629
Listing Expiration 2026-12-31
Marketing Start 2011-10-31

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 65862516
Hyphenated Format 65862-516

Supplemental Identifiers

RxCUI
849398 849431
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 ANDA200629 (source: ndc)
Routes
ORAL
source: ndc

Resolved Composition

Strengths
  • 550 mg/1
source: ndc
Packaging
  • 100 TABLET, FILM COATED in 1 BOTTLE (65862-516-01)
  • 500 TABLET, FILM COATED in 1 BOTTLE (65862-516-05)
  • 2500 TABLET, FILM COATED in 1 BOTTLE (65862-516-26)
  • 30 TABLET, FILM COATED in 1 BOTTLE (65862-516-30)
source: ndc

Packages (4)

65862-516-01 100 TABLET, FILM COATED in 1 BOTTLE (65862-516-01) 65862-516-05 500 TABLET, FILM COATED in 1 BOTTLE (65862-516-05) 65862-516-26 2500 TABLET, FILM COATED in 1 BOTTLE (65862-516-26) 65862-516-30 30 TABLET, FILM COATED in 1 BOTTLE (65862-516-30)

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": "a4659cf5-a74b-42b3-968b-a8e4f14f94aa", "openfda": {"unii": ["9TN87S3A3C"], "rxcui": ["849398", "849431"], "spl_set_id": ["37b264f9-b46d-4635-8fab-246b1e08b653"], "manufacturer_name": ["Aurobindo Pharma Limited"], "is_original_packager": [true]}, "finished": true, "packaging": [{"sample": false, "description": "100 TABLET, FILM COATED in 1 BOTTLE (65862-516-01)", "package_ndc": "65862-516-01", "marketing_start_date": "20111031"}, {"sample": false, "description": "500 TABLET, FILM COATED in 1 BOTTLE (65862-516-05)", "package_ndc": "65862-516-05", "marketing_start_date": "20111031"}, {"sample": false, "description": "2500 TABLET, FILM COATED in 1 BOTTLE (65862-516-26)", "package_ndc": "65862-516-26", "marketing_start_date": "20111031"}, {"sample": false, "description": "30 TABLET, FILM COATED in 1 BOTTLE (65862-516-30)", "package_ndc": "65862-516-30", "marketing_start_date": "20111031"}], "brand_name": "Naproxen Sodium", "product_id": "65862-516_a4659cf5-a74b-42b3-968b-a8e4f14f94aa", "dosage_form": "TABLET, FILM COATED", "pharm_class": ["Anti-Inflammatory Agents", "Non-Steroidal [CS]", "Cyclooxygenase Inhibitors [MoA]", "Nonsteroidal Anti-inflammatory Drug [EPC]"], "product_ndc": "65862-516", "generic_name": "Naproxen Sodium", "labeler_name": "Aurobindo Pharma Limited", "product_type": "HUMAN PRESCRIPTION DRUG", "brand_name_base": "Naproxen Sodium", "active_ingredients": [{"name": "NAPROXEN SODIUM", "strength": "550 mg/1"}], "application_number": "ANDA200629", "marketing_category": "ANDA", "marketing_start_date": "20111031", "listing_expiration_date": "20261231"}