modafinil

Generic: modafinil

Labeler: aphena pharma solutions - tennessee, llc
NDC Directory HUMAN PRESCRIPTION DRUG ANDA 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 71610-685
Product ID 71610-685_e12198af-3556-407d-bac7-29b6ea6cc45f
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 71610685
Hyphenated Format 71610-685

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 ANDA077667 (source: ndc)
Routes
ORAL
source: ndc

Resolved Composition

Strengths
  • 200 mg/1
source: ndc
Packaging
  • 30 TABLET in 1 BOTTLE (71610-685-30)
  • 60 TABLET in 1 BOTTLE (71610-685-53)
source: ndc

Packages (2)

71610-685-30 30 TABLET in 1 BOTTLE (71610-685-30) 71610-685-53 60 TABLET in 1 BOTTLE (71610-685-53)

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": "e12198af-3556-407d-bac7-29b6ea6cc45f", "openfda": {"nui": ["N0000175729", "N0000175651", "N0000175769"], "unii": ["R3UK8X3U3D"], "rxcui": ["205324"], "spl_set_id": ["a4a27496-0f5a-4ea8-b48c-72fcb323dc8f"], "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 (71610-685-30)", "package_ndc": "71610-685-30", "marketing_start_date": "20230111"}, {"sample": false, "description": "60 TABLET in 1 BOTTLE (71610-685-53)", "package_ndc": "71610-685-53", "marketing_start_date": "20230111"}], "brand_name": "Modafinil", "product_id": "71610-685_e12198af-3556-407d-bac7-29b6ea6cc45f", "dosage_form": "TABLET", "pharm_class": ["Central Nervous System Stimulation [PE]", "Increased Sympathetic Activity [PE]", "Sympathomimetic-like Agent [EPC]"], "product_ndc": "71610-685", "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": "ANDA077667", "marketing_category": "ANDA", "marketing_start_date": "20140203", "listing_expiration_date": "20261231"}