naproxen

Generic: naproxen

Labeler: a-s medication solutions
NDC Directory HUMAN PRESCRIPTION DRUG ANDA Inactive Finished

Drug Facts

Product Profile

Brand Name naproxen
Generic Name naproxen
Labeler a-s medication solutions
Dosage Form TABLET
Routes
ORAL
Active Ingredients

naproxen 375 mg/1

Manufacturer
A-S Medication Solutions

Identifiers & Regulatory

Product NDC 50090-4638
Product ID 50090-4638_d2e46eff-5ef3-4315-a690-ed09438c0258
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 500904638
Hyphenated Format 50090-4638

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 ANDA075927 (source: ndc)
Routes
ORAL
source: ndc

Resolved Composition

Strengths
  • 375 mg/1
source: ndc
Packaging
  • 10 TABLET in 1 BOTTLE (50090-4638-0)
  • 21 TABLET in 1 BOTTLE (50090-4638-1)
  • 30 TABLET in 1 BOTTLE (50090-4638-2)
  • 14 TABLET in 1 BOTTLE (50090-4638-3)
  • 20 TABLET in 1 BOTTLE (50090-4638-4)
  • 15 TABLET in 1 BOTTLE (50090-4638-5)
  • 45 TABLET in 1 BOTTLE (50090-4638-6)
  • 40 TABLET in 1 BOTTLE (50090-4638-7)
  • 100 TABLET in 1 BOTTLE (50090-4638-8)
  • 42 TABLET in 1 BOTTLE (50090-4638-9)
source: ndc

Packages (10)

50090-4638-0 10 TABLET in 1 BOTTLE (50090-4638-0) 50090-4638-1 21 TABLET in 1 BOTTLE (50090-4638-1) 50090-4638-2 30 TABLET in 1 BOTTLE (50090-4638-2) 50090-4638-3 14 TABLET in 1 BOTTLE (50090-4638-3) 50090-4638-4 20 TABLET in 1 BOTTLE (50090-4638-4) 50090-4638-5 15 TABLET in 1 BOTTLE (50090-4638-5) 50090-4638-6 45 TABLET in 1 BOTTLE (50090-4638-6) 50090-4638-7 40 TABLET in 1 BOTTLE (50090-4638-7) 50090-4638-8 100 TABLET in 1 BOTTLE (50090-4638-8) 50090-4638-9 42 TABLET in 1 BOTTLE (50090-4638-9)

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": "d2e46eff-5ef3-4315-a690-ed09438c0258", "openfda": {"nui": ["N0000000160", "M0001335", "N0000175722"], "unii": ["57Y76R9ATQ"], "rxcui": ["198012"], "spl_set_id": ["c5c8b6fd-f3f5-4fed-823c-9a80386b27b1"], "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": ["A-S Medication Solutions"]}, "finished": true, "packaging": [{"sample": false, "description": "10 TABLET in 1 BOTTLE (50090-4638-0)", "package_ndc": "50090-4638-0", "marketing_start_date": "20191022"}, {"sample": false, "description": "21 TABLET in 1 BOTTLE (50090-4638-1)", "package_ndc": "50090-4638-1", "marketing_start_date": "20191022"}, {"sample": false, "description": "30 TABLET in 1 BOTTLE (50090-4638-2)", "package_ndc": "50090-4638-2", "marketing_start_date": "20191022"}, {"sample": false, "description": "14 TABLET in 1 BOTTLE (50090-4638-3)", "package_ndc": "50090-4638-3", "marketing_start_date": "20191022"}, {"sample": false, "description": "20 TABLET in 1 BOTTLE (50090-4638-4)", "package_ndc": "50090-4638-4", "marketing_start_date": "20191022"}, {"sample": false, "description": "15 TABLET in 1 BOTTLE (50090-4638-5)", "package_ndc": "50090-4638-5", "marketing_start_date": "20191022"}, {"sample": false, "description": "45 TABLET in 1 BOTTLE (50090-4638-6)", "package_ndc": "50090-4638-6", "marketing_start_date": "20191022"}, {"sample": false, "description": "40 TABLET in 1 BOTTLE (50090-4638-7)", "package_ndc": "50090-4638-7", "marketing_start_date": "20191022"}, {"sample": false, "description": "100 TABLET in 1 BOTTLE (50090-4638-8)", "package_ndc": "50090-4638-8", "marketing_start_date": "20191022"}, {"sample": false, "description": "42 TABLET in 1 BOTTLE (50090-4638-9)", "package_ndc": "50090-4638-9", "marketing_start_date": "20191022"}], "brand_name": "Naproxen", "product_id": "50090-4638_d2e46eff-5ef3-4315-a690-ed09438c0258", "dosage_form": "TABLET", "pharm_class": ["Anti-Inflammatory Agents", "Non-Steroidal [CS]", "Cyclooxygenase Inhibitors [MoA]", "Nonsteroidal Anti-inflammatory Drug [EPC]"], "product_ndc": "50090-4638", "generic_name": "Naproxen", "labeler_name": "A-S Medication Solutions", "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"}