modafinil

Generic: modafinil

Labeler: viona pharmaceuticals inc
NDC Directory HUMAN PRESCRIPTION DRUG ANDA Inactive Finished

Drug Facts

Product Profile

Brand Name modafinil
Generic Name modafinil
Labeler viona pharmaceuticals inc
Dosage Form TABLET
Routes
ORAL
Active Ingredients

modafinil 200 mg/1

Manufacturer
Viona Pharmaceuticals Inc

Identifiers & Regulatory

Product NDC 72578-006
Product ID 72578-006_452d2687-49ff-4734-8799-a4a5264cc584
Product Type HUMAN PRESCRIPTION DRUG
Marketing Category ANDA
Application Number ANDA209966
DEA Schedule civ
Listing Expiration 2026-12-31
Marketing Start 2019-02-15

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 72578006
Hyphenated Format 72578-006

Supplemental Identifiers

RxCUI
205324 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 modafinil (source: ndc)
Generic Name modafinil (source: ndc)
Application Number ANDA209966 (source: ndc)
Routes
ORAL
source: ndc

Resolved Composition

Strengths
  • 200 mg/1
source: ndc
Packaging
  • 100 TABLET in 1 BOTTLE (72578-006-01)
  • 30 TABLET in 1 BOTTLE (72578-006-06)
  • 90 TABLET in 1 BOTTLE (72578-006-16)
source: ndc

Packages (3)

72578-006-01 100 TABLET in 1 BOTTLE (72578-006-01) 72578-006-06 30 TABLET in 1 BOTTLE (72578-006-06) 72578-006-16 90 TABLET in 1 BOTTLE (72578-006-16)

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": "452d2687-49ff-4734-8799-a4a5264cc584", "openfda": {"nui": ["N0000175729", "N0000175651", "N0000175769"], "unii": ["R3UK8X3U3D"], "rxcui": ["205324", "260218"], "spl_set_id": ["15739a31-2433-49b5-90ea-b974214f73be"], "pharm_class_pe": ["Central Nervous System Stimulation [PE]", "Increased Sympathetic Activity [PE]"], "pharm_class_epc": ["Sympathomimetic-like Agent [EPC]"], "manufacturer_name": ["Viona Pharmaceuticals Inc"], "is_original_packager": [true]}, "finished": true, "packaging": [{"sample": false, "description": "100 TABLET in 1 BOTTLE (72578-006-01)", "package_ndc": "72578-006-01", "marketing_start_date": "20190215"}, {"sample": false, "description": "30 TABLET in 1 BOTTLE (72578-006-06)", "package_ndc": "72578-006-06", "marketing_start_date": "20190215"}, {"sample": false, "description": "90 TABLET in 1 BOTTLE (72578-006-16)", "package_ndc": "72578-006-16", "marketing_start_date": "20190215"}], "brand_name": "Modafinil", "product_id": "72578-006_452d2687-49ff-4734-8799-a4a5264cc584", "dosage_form": "TABLET", "pharm_class": ["Central Nervous System Stimulation [PE]", "Increased Sympathetic Activity [PE]", "Sympathomimetic-like Agent [EPC]"], "product_ndc": "72578-006", "dea_schedule": "CIV", "generic_name": "Modafinil", "labeler_name": "Viona Pharmaceuticals Inc", "product_type": "HUMAN PRESCRIPTION DRUG", "brand_name_base": "Modafinil", "active_ingredients": [{"name": "MODAFINIL", "strength": "200 mg/1"}], "application_number": "ANDA209966", "marketing_category": "ANDA", "marketing_start_date": "20190215", "listing_expiration_date": "20261231"}