naproxen

Generic: naproxen

Labeler: sportpharm, inc. dba sportpharm
NDC Directory HUMAN PRESCRIPTION DRUG ANDA Inactive Finished

Drug Facts

Product Profile

Brand Name naproxen
Generic Name naproxen
Labeler sportpharm, inc. dba sportpharm
Dosage Form TABLET
Routes
ORAL
Active Ingredients

naproxen 250 mg/1

Manufacturer
Sportpharm, Inc. dba Sportpharm

Identifiers & Regulatory

Product NDC 85766-105
Product ID 85766-105_412ebc09-c6b9-ed79-e063-6294a90a73eb
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 85766105
Hyphenated Format 85766-105

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 ANDA212517 (source: ndc)
Routes
ORAL
source: ndc

Resolved Composition

Strengths
  • 250 mg/1
source: ndc
Packaging
  • 1000 TABLET in 1 BOTTLE (85766-105-00)
  • 100 TABLET in 1 BOTTLE (85766-105-01)
  • 500 TABLET in 1 BOTTLE (85766-105-05)
  • 10 TABLET in 1 BOTTLE (85766-105-10)
  • 14 TABLET in 1 BOTTLE (85766-105-14)
  • 20 TABLET in 1 BOTTLE (85766-105-20)
  • 30 TABLET in 1 BOTTLE (85766-105-30)
  • 60 TABLET in 1 BOTTLE (85766-105-60)
  • 90 TABLET in 1 BOTTLE (85766-105-90)
source: ndc

Packages (9)

85766-105-00 1000 TABLET in 1 BOTTLE (85766-105-00) 85766-105-01 100 TABLET in 1 BOTTLE (85766-105-01) 85766-105-05 500 TABLET in 1 BOTTLE (85766-105-05) 85766-105-10 10 TABLET in 1 BOTTLE (85766-105-10) 85766-105-14 14 TABLET in 1 BOTTLE (85766-105-14) 85766-105-20 20 TABLET in 1 BOTTLE (85766-105-20) 85766-105-30 30 TABLET in 1 BOTTLE (85766-105-30) 85766-105-60 60 TABLET in 1 BOTTLE (85766-105-60) 85766-105-90 90 TABLET in 1 BOTTLE (85766-105-90)

Ingredients (1)

naproxen (250 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": "412ebc09-c6b9-ed79-e063-6294a90a73eb", "openfda": {"nui": ["N0000000160", "M0001335", "N0000175722"], "unii": ["57Y76R9ATQ"], "rxcui": ["198012", "198013", "198014"], "spl_set_id": ["1c5b2bc1-26bb-4f88-bded-399263c82331"], "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": ["Sportpharm, Inc. dba Sportpharm"]}, "finished": true, "packaging": [{"sample": false, "description": "1000 TABLET in 1 BOTTLE (85766-105-00)", "package_ndc": "85766-105-00", "marketing_start_date": "20251015"}, {"sample": false, "description": "100 TABLET in 1 BOTTLE (85766-105-01)", "package_ndc": "85766-105-01", "marketing_start_date": "20251015"}, {"sample": false, "description": "500 TABLET in 1 BOTTLE (85766-105-05)", "package_ndc": "85766-105-05", "marketing_start_date": "20251015"}, {"sample": false, "description": "10 TABLET in 1 BOTTLE (85766-105-10)", "package_ndc": "85766-105-10", "marketing_start_date": "20251015"}, {"sample": false, "description": "14 TABLET in 1 BOTTLE (85766-105-14)", "package_ndc": "85766-105-14", "marketing_start_date": "20251015"}, {"sample": false, "description": "20 TABLET in 1 BOTTLE (85766-105-20)", "package_ndc": "85766-105-20", "marketing_start_date": "20251015"}, {"sample": false, "description": "30 TABLET in 1 BOTTLE (85766-105-30)", "package_ndc": "85766-105-30", "marketing_start_date": "20251015"}, {"sample": false, "description": "60 TABLET in 1 BOTTLE (85766-105-60)", "package_ndc": "85766-105-60", "marketing_start_date": "20251015"}, {"sample": false, "description": "90 TABLET in 1 BOTTLE (85766-105-90)", "package_ndc": "85766-105-90", "marketing_start_date": "20251015"}], "brand_name": "Naproxen", "product_id": "85766-105_412ebc09-c6b9-ed79-e063-6294a90a73eb", "dosage_form": "TABLET", "pharm_class": ["Anti-Inflammatory Agents", "Non-Steroidal [CS]", "Cyclooxygenase Inhibitors [MoA]", "Nonsteroidal Anti-inflammatory Drug [EPC]"], "product_ndc": "85766-105", "generic_name": "Naproxen", "labeler_name": "Sportpharm, Inc. dba Sportpharm", "product_type": "HUMAN PRESCRIPTION DRUG", "brand_name_base": "Naproxen", "active_ingredients": [{"name": "NAPROXEN", "strength": "250 mg/1"}], "application_number": "ANDA212517", "marketing_category": "ANDA", "marketing_start_date": "20200301", "listing_expiration_date": "20261231"}