modafinil

Generic: modafinil

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

Drug Facts

Product Profile

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

modafinil 200 mg/1

Manufacturer
Preferred Pharmaceuticals Inc.

Identifiers & Regulatory

Product NDC 68788-8653
Product ID 68788-8653_7cd7e2ce-ecdf-4660-93e9-ee86e985d0a6
Product Type HUMAN PRESCRIPTION DRUG
Marketing Category ANDA
Application Number ANDA207196
DEA Schedule civ
Listing Expiration 2026-12-31
Marketing Start 2024-05-09

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 687888653
Hyphenated Format 68788-8653

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 ANDA207196 (source: ndc)
Routes
ORAL
source: ndc

Resolved Composition

Strengths
  • 200 mg/1
source: ndc
Packaging
  • 30 TABLET in 1 BOTTLE (68788-8653-3)
  • 60 TABLET in 1 BOTTLE (68788-8653-6)
  • 90 TABLET in 1 BOTTLE (68788-8653-9)
source: ndc

Packages (3)

68788-8653-3 30 TABLET in 1 BOTTLE (68788-8653-3) 68788-8653-6 60 TABLET in 1 BOTTLE (68788-8653-6) 68788-8653-9 90 TABLET in 1 BOTTLE (68788-8653-9)

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": "7cd7e2ce-ecdf-4660-93e9-ee86e985d0a6", "openfda": {"nui": ["N0000175729", "N0000175651", "N0000175769"], "unii": ["R3UK8X3U3D"], "rxcui": ["205324"], "spl_set_id": ["60ec6e2a-2576-498f-9a8c-fddc53d4a44c"], "pharm_class_pe": ["Central Nervous System Stimulation [PE]", "Increased Sympathetic Activity [PE]"], "pharm_class_epc": ["Sympathomimetic-like Agent [EPC]"], "manufacturer_name": ["Preferred Pharmaceuticals Inc."]}, "finished": true, "packaging": [{"sample": false, "description": "30 TABLET in 1 BOTTLE (68788-8653-3)", "package_ndc": "68788-8653-3", "marketing_start_date": "20240509"}, {"sample": false, "description": "60 TABLET in 1 BOTTLE (68788-8653-6)", "package_ndc": "68788-8653-6", "marketing_start_date": "20240509"}, {"sample": false, "description": "90 TABLET in 1 BOTTLE (68788-8653-9)", "package_ndc": "68788-8653-9", "marketing_start_date": "20240509"}], "brand_name": "Modafinil", "product_id": "68788-8653_7cd7e2ce-ecdf-4660-93e9-ee86e985d0a6", "dosage_form": "TABLET", "pharm_class": ["Central Nervous System Stimulation [PE]", "Increased Sympathetic Activity [PE]", "Sympathomimetic-like Agent [EPC]"], "product_ndc": "68788-8653", "dea_schedule": "CIV", "generic_name": "Modafinil", "labeler_name": "Preferred Pharmaceuticals Inc.", "product_type": "HUMAN PRESCRIPTION DRUG", "brand_name_base": "Modafinil", "active_ingredients": [{"name": "MODAFINIL", "strength": "200 mg/1"}], "application_number": "ANDA207196", "marketing_category": "ANDA", "marketing_start_date": "20240509", "listing_expiration_date": "20261231"}