modafinil

Generic: modafinil

Labeler: apotex corp.
NDC Directory HUMAN PRESCRIPTION DRUG ANDA Inactive Finished

Drug Facts

Product Profile

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

modafinil 200 mg/1

Manufacturer
Apotex Corp.

Identifiers & Regulatory

Product NDC 60505-2527
Product ID 60505-2527_a15122ea-67a9-9fc1-51e2-a0b5b0052c91
Product Type HUMAN PRESCRIPTION DRUG
Marketing Category ANDA
Application Number ANDA077667
DEA Schedule civ
Listing Expiration 2026-12-31
Marketing Start 2014-02-03

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 605052527
Hyphenated Format 60505-2527

Supplemental Identifiers

RxCUI
205324 260218
UPC
0360505252633 0360505252732
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 modafinil (source: ndc)
Generic Name modafinil (source: ndc)
Application Number ANDA077667 (source: ndc)
Routes
ORAL
source: ndc

Resolved Composition

Strengths
  • 200 mg/1
source: ndc
Packaging
  • 100 TABLET in 1 BOTTLE (60505-2527-1)
  • 30 TABLET in 1 BOTTLE (60505-2527-3)
source: ndc

Packages (2)

60505-2527-1 100 TABLET in 1 BOTTLE (60505-2527-1) 60505-2527-3 30 TABLET in 1 BOTTLE (60505-2527-3)

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": "a15122ea-67a9-9fc1-51e2-a0b5b0052c91", "openfda": {"nui": ["N0000175729", "N0000175651", "N0000175769"], "upc": ["0360505252633", "0360505252732"], "unii": ["R3UK8X3U3D"], "rxcui": ["205324", "260218"], "spl_set_id": ["944daf47-49a6-93ca-e348-4a0f1b6d937e"], "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": "100 TABLET in 1 BOTTLE (60505-2527-1)", "package_ndc": "60505-2527-1", "marketing_start_date": "20210114"}, {"sample": false, "description": "30 TABLET in 1 BOTTLE (60505-2527-3)", "package_ndc": "60505-2527-3", "marketing_start_date": "20140203"}], "brand_name": "Modafinil", "product_id": "60505-2527_a15122ea-67a9-9fc1-51e2-a0b5b0052c91", "dosage_form": "TABLET", "pharm_class": ["Central Nervous System Stimulation [PE]", "Increased Sympathetic Activity [PE]", "Sympathomimetic-like Agent [EPC]"], "product_ndc": "60505-2527", "dea_schedule": "CIV", "generic_name": "modafinil", "labeler_name": "Apotex Corp.", "product_type": "HUMAN PRESCRIPTION DRUG", "brand_name_base": "Modafinil", "active_ingredients": [{"name": "MODAFINIL", "strength": "200 mg/1"}], "application_number": "ANDA077667", "marketing_category": "ANDA", "marketing_start_date": "20140203", "listing_expiration_date": "20261231"}