naproxen sodium

Generic: naproxen sodium

Labeler: granules india ltd
NDC Directory HUMAN OTC DRUG ANDA Inactive Finished

Drug Facts

Product Profile

Brand Name naproxen sodium
Generic Name naproxen sodium
Labeler granules india ltd
Dosage Form TABLET, FILM COATED
Routes
ORAL
Active Ingredients

naproxen sodium 220 mg/1

Manufacturer
Granules India Ltd

Identifiers & Regulatory

Product NDC 62207-762
Product ID 62207-762_f4026a0a-c9cd-3850-e053-2995a90a459c
Product Type HUMAN OTC DRUG
Marketing Category ANDA
Application Number ANDA091353
Listing Expiration 2026-12-31
Marketing Start 2011-09-30

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 62207762
Hyphenated Format 62207-762

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
  • 50 TABLET, FILM COATED in 1 BOTTLE (62207-762-42)
  • 100 TABLET, FILM COATED in 1 BOTTLE (62207-762-43)
  • 500 TABLET, FILM COATED in 1 BOTTLE (62207-762-47)
  • 1000 TABLET, FILM COATED in 1 BOTTLE (62207-762-49)
source: ndc

Packages (4)

62207-762-42 50 TABLET, FILM COATED in 1 BOTTLE (62207-762-42) 62207-762-43 100 TABLET, FILM COATED in 1 BOTTLE (62207-762-43) 62207-762-47 500 TABLET, FILM COATED in 1 BOTTLE (62207-762-47) 62207-762-49 1000 TABLET, FILM COATED in 1 BOTTLE (62207-762-49)

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": "f4026a0a-c9cd-3850-e053-2995a90a459c", "openfda": {"unii": ["9TN87S3A3C"], "rxcui": ["849574"], "spl_set_id": ["95ba1722-60ed-4a83-9f26-50c4de8cf180"], "manufacturer_name": ["Granules India Ltd"], "is_original_packager": [true]}, "finished": true, "packaging": [{"sample": false, "description": "50 TABLET, FILM COATED in 1 BOTTLE (62207-762-42)", "package_ndc": "62207-762-42", "marketing_start_date": "20110930"}, {"sample": false, "description": "100 TABLET, FILM COATED in 1 BOTTLE (62207-762-43)", "package_ndc": "62207-762-43", "marketing_start_date": "20110930"}, {"sample": false, "description": "500 TABLET, FILM COATED in 1 BOTTLE (62207-762-47)", "package_ndc": "62207-762-47", "marketing_start_date": "20110930"}, {"sample": false, "description": "1000 TABLET, FILM COATED in 1 BOTTLE (62207-762-49)", "package_ndc": "62207-762-49", "marketing_start_date": "20110930"}], "brand_name": "Naproxen Sodium", "product_id": "62207-762_f4026a0a-c9cd-3850-e053-2995a90a459c", "dosage_form": "TABLET, FILM COATED", "pharm_class": ["Anti-Inflammatory Agents", "Non-Steroidal [CS]", "Cyclooxygenase Inhibitors [MoA]", "Nonsteroidal Anti-inflammatory Drug [EPC]"], "product_ndc": "62207-762", "generic_name": "Naproxen Sodium", "labeler_name": "Granules India Ltd", "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": "20110930", "listing_expiration_date": "20261231"}