naproxen

Generic: naproxen

Labeler: avpak
NDC Directory HUMAN PRESCRIPTION DRUG ANDA Inactive Finished

Drug Facts

Product Profile

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

naproxen 375 mg/1

Manufacturer
AvPAK

Identifiers & Regulatory

Product NDC 50268-595
Product ID 50268-595_446f7090-c715-3ee7-e063-6394a90ad6a2
Product Type HUMAN PRESCRIPTION DRUG
Marketing Category ANDA
Application Number ANDA075927
Listing Expiration 2026-12-31
Marketing Start 2015-02-11

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 50268595
Hyphenated Format 50268-595

Supplemental Identifiers

RxCUI
198012 198013 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 ANDA075927 (source: ndc)
Routes
ORAL
source: ndc

Resolved Composition

Strengths
  • 375 mg/1
source: ndc
Packaging
  • 50 BLISTER PACK in 1 BOX, UNIT-DOSE (50268-595-15) / 1 TABLET in 1 BLISTER PACK (50268-595-11)
source: ndc

Packages (1)

50268-595-15 50 BLISTER PACK in 1 BOX, UNIT-DOSE (50268-595-15) / 1 TABLET in 1 BLISTER PACK (50268-595-11)

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": "446f7090-c715-3ee7-e063-6394a90ad6a2", "openfda": {"nui": ["N0000000160", "M0001335", "N0000175722"], "unii": ["57Y76R9ATQ"], "rxcui": ["198012", "198013", "198014"], "spl_set_id": ["e6fbf8f1-b064-658d-17bb-e7d6320aa45f"], "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": ["AvPAK"]}, "finished": true, "packaging": [{"sample": false, "description": "50 BLISTER PACK in 1 BOX, UNIT-DOSE (50268-595-15)  / 1 TABLET in 1 BLISTER PACK (50268-595-11)", "package_ndc": "50268-595-15", "marketing_start_date": "20150211"}], "brand_name": "Naproxen", "product_id": "50268-595_446f7090-c715-3ee7-e063-6394a90ad6a2", "dosage_form": "TABLET", "pharm_class": ["Anti-Inflammatory Agents", "Non-Steroidal [CS]", "Cyclooxygenase Inhibitors [MoA]", "Nonsteroidal Anti-inflammatory Drug [EPC]"], "product_ndc": "50268-595", "generic_name": "Naproxen", "labeler_name": "AvPAK", "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": "20150211", "listing_expiration_date": "20261231"}