naproxen

Generic: naproxen

Labeler: glenmark pharmaceuticals inc., usa
NDC Directory HUMAN PRESCRIPTION DRUG ANDA Inactive Finished

Drug Facts

Product Profile

Brand Name naproxen
Generic Name naproxen
Labeler glenmark pharmaceuticals inc., usa
Dosage Form TABLET
Routes
ORAL
Active Ingredients

naproxen 375 mg/1

Manufacturer
Glenmark Pharmaceuticals Inc., USA

Identifiers & Regulatory

Product NDC 68462-189
Product ID 68462-189_16372549-a419-4920-a200-5128017570ed
Product Type HUMAN PRESCRIPTION DRUG
Marketing Category ANDA
Application Number ANDA078250
Listing Expiration 2026-12-31
Marketing Start 2007-07-01

Pharmacologic Class

Established (EPC)
nonsteroidal anti-inflammatory drug [epc]
Mechanism of Action
cyclooxygenase inhibitors [moa]
Chemical Structure
anti-inflammatory agents, non-steroidal [cs]

Normalized Code Variants

Searchable formats for this product NDC code

Digits Only 68462189
Hyphenated Format 68462-189

Supplemental Identifiers

RxCUI
198012 198013 198014 849398 849431
UPC
0368462189016 0368462178010 0368462179017 0368462188019 0368462190012
UNII
57Y76R9ATQ 9TN87S3A3C
NUI
N0000000160 M0001335 N0000175722

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 (source: ndc)
Application Number ANDA078250 (source: ndc)
Routes
ORAL
source: ndc

Resolved Composition

Strengths
  • 375 mg/1
source: ndc
Packaging
  • 100 TABLET in 1 BOTTLE (68462-189-01)
  • 500 TABLET in 1 BOTTLE (68462-189-05)
source: ndc

Packages (2)

68462-189-01 100 TABLET in 1 BOTTLE (68462-189-01) 68462-189-05 500 TABLET in 1 BOTTLE (68462-189-05)

Ingredients (1)

naproxen (375 mg/1)

Linked Drug Pages (1)

Naproxen Sodium, Naproxen ndc-match (0.9)

Raw FDA Data

View complete raw FDA NDC JSON payload 
{"route": ["ORAL"], "spl_id": "16372549-a419-4920-a200-5128017570ed", "openfda": {"nui": ["N0000000160", "M0001335", "N0000175722"], "upc": ["0368462189016", "0368462178010", "0368462179017", "0368462188019", "0368462190012"], "unii": ["57Y76R9ATQ", "9TN87S3A3C"], "rxcui": ["198012", "198013", "198014", "849398", "849431"], "spl_set_id": ["6c5bb008-e66f-4ef0-bf84-aca7eb5983e9"], "pharm_class_cs": ["Anti-Inflammatory Agents, Non-Steroidal [CS]"], "pharm_class_epc": ["Nonsteroidal Anti-inflammatory Drug [EPC]"], "pharm_class_moa": ["Cyclooxygenase Inhibitors [MoA]"], "manufacturer_name": ["Glenmark Pharmaceuticals Inc., USA"], "is_original_packager": [true]}, "finished": true, "packaging": [{"sample": false, "description": "100 TABLET in 1 BOTTLE (68462-189-01)", "package_ndc": "68462-189-01", "marketing_start_date": "20070701"}, {"sample": false, "description": "500 TABLET in 1 BOTTLE (68462-189-05)", "package_ndc": "68462-189-05", "marketing_start_date": "20070701"}], "brand_name": "Naproxen", "product_id": "68462-189_16372549-a419-4920-a200-5128017570ed", "dosage_form": "TABLET", "pharm_class": ["Anti-Inflammatory Agents", "Non-Steroidal [CS]", "Cyclooxygenase Inhibitors [MoA]", "Nonsteroidal Anti-inflammatory Drug [EPC]"], "product_ndc": "68462-189", "generic_name": "Naproxen", "labeler_name": "Glenmark Pharmaceuticals Inc., USA", "product_type": "HUMAN PRESCRIPTION DRUG", "brand_name_base": "Naproxen", "active_ingredients": [{"name": "NAPROXEN", "strength": "375 mg/1"}], "application_number": "ANDA078250", "marketing_category": "ANDA", "marketing_start_date": "20070701", "listing_expiration_date": "20261231"}