naproxen

Generic: naproxen sodium

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

Drug Facts

Product Profile

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

naproxen sodium 375 mg/1

Manufacturer
Granules India Ltd

Identifiers & Regulatory

Product NDC 62207-746
Product ID 62207-746_44e3cc97-267f-1e4a-e063-6294a90a74c4
Product Type HUMAN PRESCRIPTION DRUG
Marketing Category ANDA
Application Number ANDA074140
Listing Expiration 2026-12-31
Marketing Start 2021-04-15

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 62207746
Hyphenated Format 62207-746

Supplemental Identifiers

RxCUI
198012 198013 198014
UPC
0362207745437
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 (source: ndc)
Generic Name naproxen sodium (source: ndc)
Application Number ANDA074140 (source: ndc)
Routes
ORAL
source: ndc

Resolved Composition

Strengths
  • 375 mg/1
source: ndc
Packaging
  • 100 TABLET in 1 BOTTLE (62207-746-43)
  • 500 TABLET in 1 BOTTLE (62207-746-47)
  • 1000 TABLET in 1 BOTTLE (62207-746-49)
source: ndc

Packages (3)

Ingredients (1)

naproxen sodium (375 mg/1)

Linked Drug Pages (1)

Raw FDA Data

View complete raw FDA NDC JSON payload
{"route": ["ORAL"], "spl_id": "44e3cc97-267f-1e4a-e063-6294a90a74c4", "openfda": {"upc": ["0362207745437"], "unii": ["9TN87S3A3C"], "rxcui": ["198012", "198013", "198014"], "spl_set_id": ["1f8da545-bcfe-4c22-a9f1-d34108120aa0"], "manufacturer_name": ["Granules India Ltd"], "is_original_packager": [true]}, "finished": true, "packaging": [{"sample": false, "description": "100 TABLET in 1 BOTTLE (62207-746-43)", "package_ndc": "62207-746-43", "marketing_start_date": "20210415"}, {"sample": false, "description": "500 TABLET in 1 BOTTLE (62207-746-47)", "package_ndc": "62207-746-47", "marketing_start_date": "20210415"}, {"sample": false, "description": "1000 TABLET in 1 BOTTLE (62207-746-49)", "package_ndc": "62207-746-49", "marketing_start_date": "20210415"}], "brand_name": "Naproxen", "product_id": "62207-746_44e3cc97-267f-1e4a-e063-6294a90a74c4", "dosage_form": "TABLET", "pharm_class": ["Anti-Inflammatory Agents", "Non-Steroidal [CS]", "Cyclooxygenase Inhibitors [MoA]", "Nonsteroidal Anti-inflammatory Drug [EPC]"], "product_ndc": "62207-746", "generic_name": "Naproxen Sodium", "labeler_name": "Granules India Ltd", "product_type": "HUMAN PRESCRIPTION DRUG", "brand_name_base": "Naproxen", "active_ingredients": [{"name": "NAPROXEN SODIUM", "strength": "375 mg/1"}], "application_number": "ANDA074140", "marketing_category": "ANDA", "marketing_start_date": "20210415", "listing_expiration_date": "20261231"}