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 250 mg/1

Manufacturer
Aphena Pharma Solutions - Tennessee, LLC

Identifiers & Regulatory

Product NDC 43353-216
Product ID 43353-216_68ef14c5-d88d-4c95-b6d4-65606f4c11fa
Product Type HUMAN PRESCRIPTION DRUG
Marketing Category ANDA
Application Number ANDA091305
Listing Expiration 2026-12-31
Marketing Start 2016-06-10

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 43353216
Hyphenated Format 43353-216

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 ANDA091305 (source: ndc)
Routes
ORAL
source: ndc

Resolved Composition

Strengths
  • 250 mg/1
source: ndc
Packaging
  • 90 TABLET in 1 BOTTLE (43353-216-60)
  • 120 TABLET in 1 BOTTLE (43353-216-70)
  • 180 TABLET in 1 BOTTLE (43353-216-80)
  • 360 TABLET in 1 BOTTLE (43353-216-94)
source: ndc

Packages (4)

43353-216-60 90 TABLET in 1 BOTTLE (43353-216-60) 43353-216-70 120 TABLET in 1 BOTTLE (43353-216-70) 43353-216-80 180 TABLET in 1 BOTTLE (43353-216-80) 43353-216-94 360 TABLET in 1 BOTTLE (43353-216-94)

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": "68ef14c5-d88d-4c95-b6d4-65606f4c11fa", "openfda": {"nui": ["N0000000160", "M0001335", "N0000175722"], "unii": ["57Y76R9ATQ"], "rxcui": ["198012", "198013", "198014"], "spl_set_id": ["e2347581-90da-429a-b17c-cffd0039fb86"], "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": "90 TABLET in 1 BOTTLE (43353-216-60)", "package_ndc": "43353-216-60", "marketing_start_date": "20160818"}, {"sample": false, "description": "120 TABLET in 1 BOTTLE (43353-216-70)", "package_ndc": "43353-216-70", "marketing_start_date": "20160818"}, {"sample": false, "description": "180 TABLET in 1 BOTTLE (43353-216-80)", "package_ndc": "43353-216-80", "marketing_start_date": "20160822"}, {"sample": false, "description": "360 TABLET in 1 BOTTLE (43353-216-94)", "package_ndc": "43353-216-94", "marketing_start_date": "20160822"}], "brand_name": "Naproxen", "product_id": "43353-216_68ef14c5-d88d-4c95-b6d4-65606f4c11fa", "dosage_form": "TABLET", "pharm_class": ["Anti-Inflammatory Agents", "Non-Steroidal [CS]", "Cyclooxygenase Inhibitors [MoA]", "Nonsteroidal Anti-inflammatory Drug [EPC]"], "product_ndc": "43353-216", "generic_name": "Naproxen", "labeler_name": "Aphena Pharma Solutions - Tennessee, LLC", "product_type": "HUMAN PRESCRIPTION DRUG", "brand_name_base": "Naproxen", "active_ingredients": [{"name": "NAPROXEN", "strength": "250 mg/1"}], "application_number": "ANDA091305", "marketing_category": "ANDA", "marketing_start_date": "20160610", "listing_expiration_date": "20261231"}