naproxen

Generic: naproxen

Labeler: direct_rx
NDC Directory HUMAN PRESCRIPTION DRUG ANDA Inactive Finished

Drug Facts

Product Profile

Brand Name naproxen
Generic Name naproxen
Labeler direct_rx
Dosage Form TABLET
Routes
ORAL
Active Ingredients

naproxen 375 mg/1

Manufacturer
Direct_Rx

Identifiers & Regulatory

Product NDC 72189-425
Product ID 72189-425_2c4d3694-d8da-9ffd-e063-6294a90a243d
Product Type HUMAN PRESCRIPTION DRUG
Marketing Category ANDA
Application Number ANDA212517
Listing Expiration 2026-12-31
Marketing Start 2023-02-13

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 72189425
Hyphenated Format 72189-425

Supplemental Identifiers

RxCUI
198012
UNII
57Y76R9ATQ
NUI
N0000000160 M0001335 N0000175722

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 ANDA212517 (source: ndc)
Routes
ORAL
source: ndc

Resolved Composition

Strengths
  • 375 mg/1
source: ndc
Packaging
  • 30 TABLET in 1 BOTTLE (72189-425-30)
  • 60 TABLET in 1 BOTTLE (72189-425-60)
source: ndc

Packages (2)

72189-425-30 30 TABLET in 1 BOTTLE (72189-425-30) 72189-425-60 60 TABLET in 1 BOTTLE (72189-425-60)

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": "2c4d3694-d8da-9ffd-e063-6294a90a243d", "openfda": {"nui": ["N0000000160", "M0001335", "N0000175722"], "unii": ["57Y76R9ATQ"], "rxcui": ["198012"], "spl_set_id": ["f499a207-02c8-a338-e053-2995a90accc0"], "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": ["Direct_Rx"]}, "finished": true, "packaging": [{"sample": false, "description": "30 TABLET in 1 BOTTLE (72189-425-30)", "package_ndc": "72189-425-30", "marketing_start_date": "20230213"}, {"sample": false, "description": "60 TABLET in 1 BOTTLE (72189-425-60)", "package_ndc": "72189-425-60", "marketing_start_date": "20230213"}], "brand_name": "Naproxen", "product_id": "72189-425_2c4d3694-d8da-9ffd-e063-6294a90a243d", "dosage_form": "TABLET", "pharm_class": ["Anti-Inflammatory Agents", "Non-Steroidal [CS]", "Cyclooxygenase Inhibitors [MoA]", "Nonsteroidal Anti-inflammatory Drug [EPC]"], "product_ndc": "72189-425", "generic_name": "Naproxen", "labeler_name": "Direct_Rx", "product_type": "HUMAN PRESCRIPTION DRUG", "brand_name_base": "Naproxen", "active_ingredients": [{"name": "NAPROXEN", "strength": "375 mg/1"}], "application_number": "ANDA212517", "marketing_category": "ANDA", "marketing_start_date": "20230213", "listing_expiration_date": "20261231"}