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 50090-1585
Product ID 50090-1585_e24486ae-36f5-4052-8fc3-b0d579a20b59
Product Type HUMAN PRESCRIPTION DRUG
Marketing Category ANDA
Application Number ANDA078250
Listing Expiration 2027-12-31
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 500901585
Hyphenated Format 50090-1585

Supplemental Identifiers

RxCUI
198012 198014 849431
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 ANDA078250 (source: ndc)
Routes
ORAL
source: ndc

Resolved Composition

Strengths
  • 375 mg/1
source: ndc
Packaging
  • 20 TABLET in 1 BOTTLE (50090-1585-0)
source: ndc

Packages (1)

50090-1585-0 20 TABLET in 1 BOTTLE (50090-1585-0)

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": "e24486ae-36f5-4052-8fc3-b0d579a20b59", "openfda": {"nui": ["N0000000160", "M0001335", "N0000175722"], "unii": ["57Y76R9ATQ"], "rxcui": ["198012", "198014", "849431"], "spl_set_id": ["9d28422f-6f25-4f14-9272-e0907c971f33"], "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": "20 TABLET in 1 BOTTLE (50090-1585-0)", "package_ndc": "50090-1585-0", "marketing_start_date": "20141229"}], "brand_name": "Naproxen", "product_id": "50090-1585_e24486ae-36f5-4052-8fc3-b0d579a20b59", "dosage_form": "TABLET", "pharm_class": ["Anti-Inflammatory Agents", "Non-Steroidal [CS]", "Cyclooxygenase Inhibitors [MoA]", "Nonsteroidal Anti-inflammatory Drug [EPC]"], "product_ndc": "50090-1585", "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": "ANDA078250", "marketing_category": "ANDA", "marketing_start_date": "20070701", "listing_expiration_date": "20271231"}