naproxen

Generic: naproxen

Labeler: medsource pharmaceuticals
NDC Directory HUMAN PRESCRIPTION DRUG ANDA Inactive Finished

Drug Facts

Product Profile

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

naproxen 375 mg/1

Manufacturer
Medsource Pharmaceuticals

Identifiers & Regulatory

Product NDC 45865-238
Product ID 45865-238_12648511-1b01-aaf8-e063-6394a90a2297
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 45865238
Hyphenated Format 45865-238

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
  • 60 TABLET in 1 BOTTLE (45865-238-60)
source: ndc

Packages (1)

45865-238-60 60 TABLET in 1 BOTTLE (45865-238-60)

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": "12648511-1b01-aaf8-e063-6394a90a2297", "openfda": {"nui": ["N0000000160", "M0001335", "N0000175722"], "unii": ["57Y76R9ATQ"], "rxcui": ["198012"], "spl_set_id": ["12648efc-3be8-a915-e063-6394a90a3620"], "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": ["Medsource Pharmaceuticals"]}, "finished": true, "packaging": [{"sample": false, "description": "60 TABLET in 1 BOTTLE (45865-238-60)", "package_ndc": "45865-238-60", "marketing_start_date": "20200301"}], "brand_name": "Naproxen", "product_id": "45865-238_12648511-1b01-aaf8-e063-6394a90a2297", "dosage_form": "TABLET", "pharm_class": ["Anti-Inflammatory Agents", "Non-Steroidal [CS]", "Cyclooxygenase Inhibitors [MoA]", "Nonsteroidal Anti-inflammatory Drug [EPC]"], "product_ndc": "45865-238", "generic_name": "Naproxen", "labeler_name": "Medsource Pharmaceuticals", "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": "20200301", "listing_expiration_date": "20261231"}