modafinil

Generic: modafinil

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

Drug Facts

Product Profile

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

modafinil 200 mg/1

Manufacturer
Aphena Pharma Solutions - Tennessee, LLC

Identifiers & Regulatory

Product NDC 43353-925
Product ID 43353-925_01f751d9-8907-4a54-b2e9-f57a8f150920
Product Type HUMAN PRESCRIPTION DRUG
Marketing Category NDA AUTHORIZED GENERIC
Application Number NDA020717
DEA Schedule civ
Listing Expiration 2026-12-31
Marketing Start 2012-03-29

Pharmacologic Class

Established (EPC)
sympathomimetic-like agent [epc]
Physiologic Effect
central nervous system stimulation [pe] increased sympathetic activity [pe]

Normalized Code Variants

Searchable formats for this product NDC code

Digits Only 43353925
Hyphenated Format 43353-925

Supplemental Identifiers

RxCUI
205324
UNII
R3UK8X3U3D
NUI
N0000175729 N0000175651 N0000175769

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 modafinil (source: ndc)
Generic Name modafinil (source: ndc)
Application Number NDA020717 (source: ndc)
Routes
ORAL
source: ndc

Resolved Composition

Strengths
  • 200 mg/1
source: ndc
Packaging
  • 30 TABLET in 1 BOTTLE, PLASTIC (43353-925-30)
  • 60 TABLET in 1 BOTTLE, PLASTIC (43353-925-53)
source: ndc

Packages (2)

43353-925-30 30 TABLET in 1 BOTTLE, PLASTIC (43353-925-30) 43353-925-53 60 TABLET in 1 BOTTLE, PLASTIC (43353-925-53)

Ingredients (1)

modafinil (200 mg/1)

Linked Drug Pages (1)

modafinil ndc-match (0.9)

Raw FDA Data

View complete raw FDA NDC JSON payload 
{"route": ["ORAL"], "spl_id": "01f751d9-8907-4a54-b2e9-f57a8f150920", "openfda": {"nui": ["N0000175729", "N0000175651", "N0000175769"], "unii": ["R3UK8X3U3D"], "rxcui": ["205324"], "spl_set_id": ["cad4201c-133c-4a61-9d93-3c5e51695430"], "pharm_class_pe": ["Central Nervous System Stimulation [PE]", "Increased Sympathetic Activity [PE]"], "pharm_class_epc": ["Sympathomimetic-like Agent [EPC]"], "manufacturer_name": ["Aphena Pharma Solutions - Tennessee, LLC"]}, "finished": true, "packaging": [{"sample": false, "description": "30 TABLET in 1 BOTTLE, PLASTIC (43353-925-30)", "package_ndc": "43353-925-30", "marketing_start_date": "20140417"}, {"sample": false, "description": "60 TABLET in 1 BOTTLE, PLASTIC (43353-925-53)", "package_ndc": "43353-925-53", "marketing_start_date": "20140417"}], "brand_name": "modafinil", "product_id": "43353-925_01f751d9-8907-4a54-b2e9-f57a8f150920", "dosage_form": "TABLET", "pharm_class": ["Central Nervous System Stimulation [PE]", "Increased Sympathetic Activity [PE]", "Sympathomimetic-like Agent [EPC]"], "product_ndc": "43353-925", "dea_schedule": "CIV", "generic_name": "modafinil", "labeler_name": "Aphena Pharma Solutions - Tennessee, LLC", "product_type": "HUMAN PRESCRIPTION DRUG", "brand_name_base": "modafinil", "active_ingredients": [{"name": "MODAFINIL", "strength": "200 mg/1"}], "application_number": "NDA020717", "marketing_category": "NDA AUTHORIZED GENERIC", "marketing_start_date": "20120329", "listing_expiration_date": "20261231"}