modafinil

Generic: modafinil

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

Drug Facts

Product Profile

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

modafinil 200 mg/1

Manufacturer
Alembic Pharmaceuticals Inc.

Identifiers & Regulatory

Product NDC 62332-386
Product ID 62332-386_7aa21a37-6c25-44ce-869c-c1b2309398bd
Product Type HUMAN PRESCRIPTION DRUG
Marketing Category ANDA
Application Number ANDA202700
DEA Schedule civ
Listing Expiration 2026-12-31
Marketing Start 2017-06-30

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 62332386
Hyphenated Format 62332-386

Supplemental Identifiers

RxCUI
205324 260218
UPC
0362332386307 0362332385300
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 ANDA202700 (source: ndc)
Routes
ORAL
source: ndc

Resolved Composition

Strengths
  • 200 mg/1
source: ndc
Packaging
  • 100 TABLET in 1 CARTON (62332-386-10)
  • 30 TABLET in 1 BOTTLE (62332-386-30)
  • 60 TABLET in 1 BOTTLE (62332-386-60)
  • 90 TABLET in 1 BOTTLE (62332-386-90)
  • 1000 TABLET in 1 BOTTLE (62332-386-91)
source: ndc

Packages (5)

62332-386-10 100 TABLET in 1 CARTON (62332-386-10) 62332-386-30 30 TABLET in 1 BOTTLE (62332-386-30) 62332-386-60 60 TABLET in 1 BOTTLE (62332-386-60) 62332-386-90 90 TABLET in 1 BOTTLE (62332-386-90) 62332-386-91 1000 TABLET in 1 BOTTLE (62332-386-91)

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": "7aa21a37-6c25-44ce-869c-c1b2309398bd", "openfda": {"nui": ["N0000175729", "N0000175651", "N0000175769"], "upc": ["0362332386307", "0362332385300"], "unii": ["R3UK8X3U3D"], "rxcui": ["205324", "260218"], "spl_set_id": ["41f9ddbd-5228-4f0c-b0aa-2056af79a21e"], "pharm_class_pe": ["Central Nervous System Stimulation [PE]", "Increased Sympathetic Activity [PE]"], "pharm_class_epc": ["Sympathomimetic-like Agent [EPC]"], "manufacturer_name": ["Alembic Pharmaceuticals Inc."], "is_original_packager": [true]}, "finished": true, "packaging": [{"sample": false, "description": "100 TABLET in 1 CARTON (62332-386-10)", "package_ndc": "62332-386-10", "marketing_start_date": "20170630"}, {"sample": false, "description": "30 TABLET in 1 BOTTLE (62332-386-30)", "package_ndc": "62332-386-30", "marketing_start_date": "20170630"}, {"sample": false, "description": "60 TABLET in 1 BOTTLE (62332-386-60)", "package_ndc": "62332-386-60", "marketing_start_date": "20170630"}, {"sample": false, "description": "90 TABLET in 1 BOTTLE (62332-386-90)", "package_ndc": "62332-386-90", "marketing_start_date": "20170630"}, {"sample": false, "description": "1000 TABLET in 1 BOTTLE (62332-386-91)", "package_ndc": "62332-386-91", "marketing_start_date": "20170630"}], "brand_name": "Modafinil", "product_id": "62332-386_7aa21a37-6c25-44ce-869c-c1b2309398bd", "dosage_form": "TABLET", "pharm_class": ["Central Nervous System Stimulation [PE]", "Increased Sympathetic Activity [PE]", "Sympathomimetic-like Agent [EPC]"], "product_ndc": "62332-386", "dea_schedule": "CIV", "generic_name": "Modafinil", "labeler_name": "Alembic Pharmaceuticals Inc.", "product_type": "HUMAN PRESCRIPTION DRUG", "brand_name_base": "Modafinil", "active_ingredients": [{"name": "MODAFINIL", "strength": "200 mg/1"}], "application_number": "ANDA202700", "marketing_category": "ANDA", "marketing_start_date": "20170630", "listing_expiration_date": "20261231"}