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 500 mg/1

Manufacturer
A-S Medication Solutions

Identifiers & Regulatory

Product NDC 50090-5645
Product ID 50090-5645_35a43392-eb57-4493-be32-5c7e74b2fdd7
Product Type HUMAN PRESCRIPTION DRUG
Marketing Category ANDA
Application Number ANDA212517
Listing Expiration 2026-12-31
Marketing Start 2020-03-01

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 500905645
Hyphenated Format 50090-5645

Supplemental Identifiers

RxCUI
198014
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
  • 500 mg/1
source: ndc
Packaging
  • 15 TABLET in 1 BOTTLE (50090-5645-0)
  • 20 TABLET in 1 BOTTLE (50090-5645-1)
  • 30 TABLET in 1 BOTTLE (50090-5645-2)
  • 14 TABLET in 1 BOTTLE (50090-5645-4)
  • 40 TABLET in 1 BOTTLE (50090-5645-5)
  • 100 TABLET in 1 BOTTLE (50090-5645-6)
  • 60 TABLET in 1 BOTTLE (50090-5645-7)
  • 6 TABLET in 1 BOTTLE (50090-5645-9)
source: ndc

Packages (8)

50090-5645-0 15 TABLET in 1 BOTTLE (50090-5645-0) 50090-5645-1 20 TABLET in 1 BOTTLE (50090-5645-1) 50090-5645-2 30 TABLET in 1 BOTTLE (50090-5645-2) 50090-5645-4 14 TABLET in 1 BOTTLE (50090-5645-4) 50090-5645-5 40 TABLET in 1 BOTTLE (50090-5645-5) 50090-5645-6 100 TABLET in 1 BOTTLE (50090-5645-6) 50090-5645-7 60 TABLET in 1 BOTTLE (50090-5645-7) 50090-5645-9 6 TABLET in 1 BOTTLE (50090-5645-9)

Ingredients (1)

naproxen (500 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": "35a43392-eb57-4493-be32-5c7e74b2fdd7", "openfda": {"nui": ["N0000000160", "M0001335", "N0000175722"], "unii": ["57Y76R9ATQ"], "rxcui": ["198014"], "spl_set_id": ["7fef9311-471b-472c-b4f2-c952a2b3a255"], "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": "15 TABLET in 1 BOTTLE (50090-5645-0)", "package_ndc": "50090-5645-0", "marketing_start_date": "20210913"}, {"sample": false, "description": "20 TABLET in 1 BOTTLE (50090-5645-1)", "package_ndc": "50090-5645-1", "marketing_start_date": "20210913"}, {"sample": false, "description": "30 TABLET in 1 BOTTLE (50090-5645-2)", "package_ndc": "50090-5645-2", "marketing_start_date": "20210913"}, {"sample": false, "description": "14 TABLET in 1 BOTTLE (50090-5645-4)", "package_ndc": "50090-5645-4", "marketing_start_date": "20210913"}, {"sample": false, "description": "40 TABLET in 1 BOTTLE (50090-5645-5)", "package_ndc": "50090-5645-5", "marketing_start_date": "20210913"}, {"sample": false, "description": "100 TABLET in 1 BOTTLE (50090-5645-6)", "package_ndc": "50090-5645-6", "marketing_start_date": "20210913"}, {"sample": false, "description": "60 TABLET in 1 BOTTLE (50090-5645-7)", "package_ndc": "50090-5645-7", "marketing_start_date": "20210913"}, {"sample": false, "description": "6 TABLET in 1 BOTTLE (50090-5645-9)", "package_ndc": "50090-5645-9", "marketing_start_date": "20210913"}], "brand_name": "Naproxen", "product_id": "50090-5645_35a43392-eb57-4493-be32-5c7e74b2fdd7", "dosage_form": "TABLET", "pharm_class": ["Anti-Inflammatory Agents", "Non-Steroidal [CS]", "Cyclooxygenase Inhibitors [MoA]", "Nonsteroidal Anti-inflammatory Drug [EPC]"], "product_ndc": "50090-5645", "generic_name": "Naproxen", "labeler_name": "A-S Medication Solutions", "product_type": "HUMAN PRESCRIPTION DRUG", "brand_name_base": "Naproxen", "active_ingredients": [{"name": "NAPROXEN", "strength": "500 mg/1"}], "application_number": "ANDA212517", "marketing_category": "ANDA", "marketing_start_date": "20200301", "listing_expiration_date": "20261231"}