naproxen

Generic: naproxen

Labeler: sciegen pharmaceuticals, inc.
NDC Directory HUMAN PRESCRIPTION DRUG ANDA Inactive Finished

Drug Facts

Product Profile

Brand Name naproxen
Generic Name naproxen
Labeler sciegen pharmaceuticals, inc.
Dosage Form TABLET
Routes
ORAL
Active Ingredients

naproxen 250 mg/1

Manufacturer
ScieGen Pharmaceuticals, Inc.

Identifiers & Regulatory

Product NDC 50228-434
Product ID 50228-434_4279d204-4d40-971c-e063-6394a90a2f60
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 50228434
Hyphenated Format 50228-434

Supplemental Identifiers

RxCUI
198012 198013 198014
UPC
0350228436106 0350228435017 0350228434010 0350228436014 0350228434058 0350228435055 0350228436052
UNII
57Y76R9ATQ
NUI
N0000000160 M0001335 N0000175722

Packaging Origin

Original Packager
true

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
  • 100 TABLET in 1 BOTTLE (50228-434-01)
  • 500 TABLET in 1 BOTTLE (50228-434-05)
  • 1000 TABLET in 1 BOTTLE (50228-434-10)
  • 30 TABLET in 1 BOTTLE (50228-434-30)
source: ndc

Packages (4)

50228-434-01 100 TABLET in 1 BOTTLE (50228-434-01) 50228-434-05 500 TABLET in 1 BOTTLE (50228-434-05) 50228-434-10 1000 TABLET in 1 BOTTLE (50228-434-10) 50228-434-30 30 TABLET in 1 BOTTLE (50228-434-30)

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": "4279d204-4d40-971c-e063-6394a90a2f60", "openfda": {"nui": ["N0000000160", "M0001335", "N0000175722"], "upc": ["0350228436106", "0350228435017", "0350228434010", "0350228436014", "0350228434058", "0350228435055", "0350228436052"], "unii": ["57Y76R9ATQ"], "rxcui": ["198012", "198013", "198014"], "spl_set_id": ["81e22c1f-f94d-46e9-8b7d-72dc2518319e"], "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": ["ScieGen Pharmaceuticals, Inc."], "is_original_packager": [true]}, "finished": true, "packaging": [{"sample": false, "description": "100 TABLET in 1 BOTTLE (50228-434-01)", "package_ndc": "50228-434-01", "marketing_start_date": "20200301"}, {"sample": false, "description": "500 TABLET in 1 BOTTLE (50228-434-05)", "package_ndc": "50228-434-05", "marketing_start_date": "20200301"}, {"sample": false, "description": "1000 TABLET in 1 BOTTLE (50228-434-10)", "package_ndc": "50228-434-10", "marketing_start_date": "20200301"}, {"sample": false, "description": "30 TABLET in 1 BOTTLE (50228-434-30)", "package_ndc": "50228-434-30", "marketing_start_date": "20200301"}], "brand_name": "Naproxen", "product_id": "50228-434_4279d204-4d40-971c-e063-6394a90a2f60", "dosage_form": "TABLET", "pharm_class": ["Anti-Inflammatory Agents", "Non-Steroidal [CS]", "Cyclooxygenase Inhibitors [MoA]", "Nonsteroidal Anti-inflammatory Drug [EPC]"], "product_ndc": "50228-434", "generic_name": "Naproxen", "labeler_name": "ScieGen Pharmaceuticals, Inc.", "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"}