modafinil

Generic: modafinil

Labeler: aurobindo pharma limited
NDC Directory HUMAN PRESCRIPTION DRUG ANDA Inactive Finished

Drug Facts

Product Profile

Brand Name modafinil
Generic Name modafinil
Labeler aurobindo pharma limited
Dosage Form TABLET
Routes
ORAL
Active Ingredients

modafinil 100 mg/1

Manufacturer
Aurobindo Pharma Limited

Identifiers & Regulatory

Product NDC 65862-601
Product ID 65862-601_f2c9beee-f9fc-44c5-bbbd-0d617c04ab0d
Product Type HUMAN PRESCRIPTION DRUG
Marketing Category ANDA
Application Number ANDA202566
DEA Schedule civ
Listing Expiration 2026-12-31
Marketing Start 2012-09-27

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 65862601
Hyphenated Format 65862-601

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 ANDA202566 (source: ndc)
Routes
ORAL
source: ndc

Resolved Composition

Strengths
  • 100 mg/1
source: ndc
Packaging
  • 100 TABLET in 1 BOTTLE (65862-601-01)
  • 30 TABLET in 1 BOTTLE (65862-601-30)
  • 90 TABLET in 1 BOTTLE (65862-601-90)
  • 1000 TABLET in 1 BOTTLE (65862-601-99)
source: ndc

Packages (4)

65862-601-01 100 TABLET in 1 BOTTLE (65862-601-01) 65862-601-30 30 TABLET in 1 BOTTLE (65862-601-30) 65862-601-90 90 TABLET in 1 BOTTLE (65862-601-90) 65862-601-99 1000 TABLET in 1 BOTTLE (65862-601-99)

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": "f2c9beee-f9fc-44c5-bbbd-0d617c04ab0d", "openfda": {"nui": ["N0000175729", "N0000175651", "N0000175769"], "unii": ["R3UK8X3U3D"], "rxcui": ["205324", "260218"], "spl_set_id": ["f51ca007-3955-4540-a88a-0ddae8d8e8ab"], "pharm_class_pe": ["Central Nervous System Stimulation [PE]", "Increased Sympathetic Activity [PE]"], "pharm_class_epc": ["Sympathomimetic-like Agent [EPC]"], "manufacturer_name": ["Aurobindo Pharma Limited"], "is_original_packager": [true]}, "finished": true, "packaging": [{"sample": false, "description": "100 TABLET in 1 BOTTLE (65862-601-01)", "package_ndc": "65862-601-01", "marketing_start_date": "20120927"}, {"sample": false, "description": "30 TABLET in 1 BOTTLE (65862-601-30)", "package_ndc": "65862-601-30", "marketing_start_date": "20120927"}, {"sample": false, "description": "90 TABLET in 1 BOTTLE (65862-601-90)", "package_ndc": "65862-601-90", "marketing_start_date": "20120927"}, {"sample": false, "description": "1000 TABLET in 1 BOTTLE (65862-601-99)", "package_ndc": "65862-601-99", "marketing_start_date": "20120927"}], "brand_name": "Modafinil", "product_id": "65862-601_f2c9beee-f9fc-44c5-bbbd-0d617c04ab0d", "dosage_form": "TABLET", "pharm_class": ["Central Nervous System Stimulation [PE]", "Increased Sympathetic Activity [PE]", "Sympathomimetic-like Agent [EPC]"], "product_ndc": "65862-601", "dea_schedule": "CIV", "generic_name": "Modafinil", "labeler_name": "Aurobindo Pharma Limited", "product_type": "HUMAN PRESCRIPTION DRUG", "brand_name_base": "Modafinil", "active_ingredients": [{"name": "MODAFINIL", "strength": "100 mg/1"}], "application_number": "ANDA202566", "marketing_category": "ANDA", "marketing_start_date": "20120927", "listing_expiration_date": "20261231"}