naproxen

Generic: naproxen

Labeler: aphena pharma solutions - tennessee, llc
NDC Directory HUMAN PRESCRIPTION DRUG ANDA Inactive Finished

Drug Facts

Product Profile

Brand Name naproxen
Generic Name naproxen
Labeler aphena pharma solutions - tennessee, llc
Dosage Form TABLET
Routes
ORAL
Active Ingredients

naproxen 375 mg/1

Manufacturer
Aphena Pharma Solutions - Tennessee, LLC

Identifiers & Regulatory

Product NDC 71610-591
Product ID 71610-591_705546f2-9f9c-4b26-b5a6-f3d32bc92c60
Product Type HUMAN PRESCRIPTION DRUG
Marketing Category ANDA
Application Number ANDA212517
Listing Expiration 2026-12-31
Marketing Start 2021-06-04

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 71610591
Hyphenated Format 71610-591

Supplemental Identifiers

RxCUI
198012 198013
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 (71610-591-53)
  • 180 TABLET in 1 BOTTLE (71610-591-80)
source: ndc

Packages (2)

71610-591-53 60 TABLET in 1 BOTTLE (71610-591-53) 71610-591-80 180 TABLET in 1 BOTTLE (71610-591-80)

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": "705546f2-9f9c-4b26-b5a6-f3d32bc92c60", "openfda": {"nui": ["N0000000160", "M0001335", "N0000175722"], "unii": ["57Y76R9ATQ"], "rxcui": ["198012", "198013"], "spl_set_id": ["9c963e77-6e05-47d0-a8d3-e581777377b9"], "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": ["Aphena Pharma Solutions - Tennessee, LLC"]}, "finished": true, "packaging": [{"sample": false, "description": "60 TABLET in 1 BOTTLE (71610-591-53)", "package_ndc": "71610-591-53", "marketing_start_date": "20210809"}, {"sample": false, "description": "180 TABLET in 1 BOTTLE (71610-591-80)", "package_ndc": "71610-591-80", "marketing_start_date": "20210809"}], "brand_name": "Naproxen", "product_id": "71610-591_705546f2-9f9c-4b26-b5a6-f3d32bc92c60", "dosage_form": "TABLET", "pharm_class": ["Anti-Inflammatory Agents", "Non-Steroidal [CS]", "Cyclooxygenase Inhibitors [MoA]", "Nonsteroidal Anti-inflammatory Drug [EPC]"], "product_ndc": "71610-591", "generic_name": "Naproxen", "labeler_name": "Aphena Pharma Solutions - Tennessee, LLC", "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": "20210604", "listing_expiration_date": "20261231"}