naproxen

Generic: naproxen

Labeler: amneal pharmaceuticals llc
NDC Directory HUMAN PRESCRIPTION DRUG ANDA Inactive Finished

Drug Facts

Product Profile

Brand Name naproxen
Generic Name naproxen
Labeler amneal pharmaceuticals llc
Dosage Form TABLET
Routes
ORAL
Active Ingredients

naproxen 375 mg/1

Manufacturer
Amneal Pharmaceuticals LLC

Identifiers & Regulatory

Product NDC 65162-189
Product ID 65162-189_691465d4-c26e-4118-9578-bec8d788f33b
Product Type HUMAN PRESCRIPTION DRUG
Marketing Category ANDA
Application Number ANDA075927
Listing Expiration 2026-12-31
Marketing Start 2010-02-18

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 65162189
Hyphenated Format 65162-189

Supplemental Identifiers

RxCUI
198012 198013 198014
UPC
0365162189100 0365162188103 0365162190106
UNII
57Y76R9ATQ
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 ANDA075927 (source: ndc)
Routes
ORAL
source: ndc

Resolved Composition

Strengths
  • 375 mg/1
source: ndc
Packaging
  • 100 TABLET in 1 BOTTLE (65162-189-10)
  • 1000 TABLET in 1 BOTTLE (65162-189-11)
  • 500 TABLET in 1 BOTTLE (65162-189-50)
source: ndc

Packages (3)

65162-189-10 100 TABLET in 1 BOTTLE (65162-189-10) 65162-189-11 1000 TABLET in 1 BOTTLE (65162-189-11) 65162-189-50 500 TABLET in 1 BOTTLE (65162-189-50)

Ingredients (1)

naproxen (375 mg/1)

Linked Drug Pages (1)

Naproxen ndc-match (0.9)

Raw FDA Data

View complete raw FDA NDC JSON payload 
{"route": ["ORAL"], "spl_id": "691465d4-c26e-4118-9578-bec8d788f33b", "openfda": {"nui": ["N0000000160", "M0001335", "N0000175722"], "upc": ["0365162189100", "0365162188103", "0365162190106"], "unii": ["57Y76R9ATQ"], "rxcui": ["198012", "198013", "198014"], "spl_set_id": ["c43a43e2-e867-448d-8f59-3efc7c077cbc"], "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": ["Amneal Pharmaceuticals LLC"], "is_original_packager": [true]}, "finished": true, "packaging": [{"sample": false, "description": "100 TABLET in 1 BOTTLE (65162-189-10)", "package_ndc": "65162-189-10", "marketing_start_date": "20100218"}, {"sample": false, "description": "1000 TABLET in 1 BOTTLE (65162-189-11)", "package_ndc": "65162-189-11", "marketing_start_date": "20100218"}, {"sample": false, "description": "500 TABLET in 1 BOTTLE (65162-189-50)", "package_ndc": "65162-189-50", "marketing_start_date": "20100218"}], "brand_name": "Naproxen", "product_id": "65162-189_691465d4-c26e-4118-9578-bec8d788f33b", "dosage_form": "TABLET", "pharm_class": ["Anti-Inflammatory Agents", "Non-Steroidal [CS]", "Cyclooxygenase Inhibitors [MoA]", "Nonsteroidal Anti-inflammatory Drug [EPC]"], "product_ndc": "65162-189", "generic_name": "Naproxen", "labeler_name": "Amneal Pharmaceuticals LLC", "product_type": "HUMAN PRESCRIPTION DRUG", "brand_name_base": "Naproxen", "active_ingredients": [{"name": "NAPROXEN", "strength": "375 mg/1"}], "application_number": "ANDA075927", "marketing_category": "ANDA", "marketing_start_date": "20100218", "listing_expiration_date": "20261231"}