provigil

Generic: modafinil

Labeler: apotex corp
NDC Directory HUMAN PRESCRIPTION DRUG NDA Inactive Finished

Drug Facts

Product Profile

Brand Name provigil
Generic Name modafinil
Labeler apotex corp
Dosage Form TABLET
Routes
ORAL
Active Ingredients

modafinil 100 mg/1

Manufacturer
Apotex Corp

Identifiers & Regulatory

Product NDC 60505-4851
Product ID 60505-4851_ff96d3ff-6a1c-2545-b939-f383e0262179
Product Type HUMAN PRESCRIPTION DRUG
Marketing Category NDA
Application Number NDA020717
DEA Schedule civ
Listing Expiration 2026-12-31
Marketing Start 2025-08-31

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 605054851
Hyphenated Format 60505-4851

Supplemental Identifiers

RxCUI
205324 213471 226426 260218
UNII
R3UK8X3U3D
NUI
N0000175729 N0000175651 N0000175769

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

Resolved Composition

Strengths
  • 100 mg/1
source: ndc
Packaging
  • 30 TABLET in 1 BOTTLE (60505-4851-3)
source: ndc

Packages (1)

60505-4851-3 30 TABLET in 1 BOTTLE (60505-4851-3)

Ingredients (1)

modafinil (100 mg/1)

Linked Drug Pages (1)

Provigil ndc-match (0.9)

Raw FDA Data

View complete raw FDA NDC JSON payload 
{"route": ["ORAL"], "spl_id": "ff96d3ff-6a1c-2545-b939-f383e0262179", "openfda": {"nui": ["N0000175729", "N0000175651", "N0000175769"], "unii": ["R3UK8X3U3D"], "rxcui": ["205324", "213471", "226426", "260218"], "spl_set_id": ["0391f182-1958-9fef-a944-53b229ce99e7"], "pharm_class_pe": ["Central Nervous System Stimulation [PE]", "Increased Sympathetic Activity [PE]"], "pharm_class_epc": ["Sympathomimetic-like Agent [EPC]"], "manufacturer_name": ["Apotex Corp"], "is_original_packager": [true]}, "finished": true, "packaging": [{"sample": false, "description": "30 TABLET in 1 BOTTLE (60505-4851-3)", "package_ndc": "60505-4851-3", "marketing_start_date": "20250831"}], "brand_name": "Provigil", "product_id": "60505-4851_ff96d3ff-6a1c-2545-b939-f383e0262179", "dosage_form": "TABLET", "pharm_class": ["Central Nervous System Stimulation [PE]", "Increased Sympathetic Activity [PE]", "Sympathomimetic-like Agent [EPC]"], "product_ndc": "60505-4851", "dea_schedule": "CIV", "generic_name": "Modafinil", "labeler_name": "Apotex Corp", "product_type": "HUMAN PRESCRIPTION DRUG", "brand_name_base": "Provigil", "active_ingredients": [{"name": "MODAFINIL", "strength": "100 mg/1"}], "application_number": "NDA020717", "marketing_category": "NDA", "marketing_start_date": "20250831", "listing_expiration_date": "20261231"}