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 100 mg/1

Manufacturer
Aphena Pharma Solutions - Tennessee, LLC

Identifiers & Regulatory

Product NDC 71610-976
Product ID 71610-976_463bbc40-763f-4ba5-e063-6394a90a1352
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 71610976
Hyphenated Format 71610-976

Supplemental Identifiers

RxCUI
260218
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 ANDA209966 (source: ndc)
Routes
ORAL
source: ndc

Resolved Composition

Strengths
  • 100 mg/1
source: ndc
Packaging
  • 30 TABLET in 1 BOTTLE (71610-976-30)
  • 60 TABLET in 1 BOTTLE (71610-976-53)
  • 90 TABLET in 1 BOTTLE (71610-976-60)
source: ndc

Packages (3)

71610-976-30 30 TABLET in 1 BOTTLE (71610-976-30) 71610-976-53 60 TABLET in 1 BOTTLE (71610-976-53) 71610-976-60 90 TABLET in 1 BOTTLE (71610-976-60)

Ingredients (1)

modafinil (100 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": "463bbc40-763f-4ba5-e063-6394a90a1352", "openfda": {"nui": ["N0000175729", "N0000175651", "N0000175769"], "unii": ["R3UK8X3U3D"], "rxcui": ["260218"], "spl_set_id": ["463bb960-a0b5-4ca4-e063-6294a90a683b"], "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 (71610-976-30)", "package_ndc": "71610-976-30", "marketing_start_date": "20251217"}, {"sample": false, "description": "60 TABLET in 1 BOTTLE (71610-976-53)", "package_ndc": "71610-976-53", "marketing_start_date": "20251217"}, {"sample": false, "description": "90 TABLET in 1 BOTTLE (71610-976-60)", "package_ndc": "71610-976-60", "marketing_start_date": "20251217"}], "brand_name": "Modafinil", "product_id": "71610-976_463bbc40-763f-4ba5-e063-6394a90a1352", "dosage_form": "TABLET", "pharm_class": ["Central Nervous System Stimulation [PE]", "Increased Sympathetic Activity [PE]", "Sympathomimetic-like Agent [EPC]"], "product_ndc": "71610-976", "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": "100 mg/1"}], "application_number": "ANDA209966", "marketing_category": "ANDA", "marketing_start_date": "20190215", "listing_expiration_date": "20261231"}