modafinil

Generic: modafinil

Labeler: heritage pharmaceuticals inc. d/b/a avet pharmaceuticals inc.
NDC Directory HUMAN PRESCRIPTION DRUG ANDA Inactive Finished

Drug Facts

Product Profile

Brand Name modafinil
Generic Name modafinil
Labeler heritage pharmaceuticals inc. d/b/a avet pharmaceuticals inc.
Dosage Form TABLET
Routes
ORAL
Active Ingredients

modafinil 100 mg/1

Manufacturer
Heritage Pharmaceuticals Inc. d/b/a Avet Pharmaceuticals Inc.

Identifiers & Regulatory

Product NDC 23155-604
Product ID 23155-604_d8fc4961-6cbc-44fc-be5f-63127fff98f8
Product Type HUMAN PRESCRIPTION DRUG
Marketing Category ANDA
Application Number ANDA207196
DEA Schedule civ
Listing Expiration 2026-12-31
Marketing Start 2021-02-18

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 23155604
Hyphenated Format 23155-604

Supplemental Identifiers

RxCUI
205324 260218
UPC
0323155605037 0323155862010 0323155862034 0323155604030 0323155862058 0323155604092 0323155605099 0323155862096
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 ANDA207196 (source: ndc)
Routes
ORAL
source: ndc

Resolved Composition

Strengths
  • 100 mg/1
source: ndc
Packaging
  • 100 TABLET in 1 BOTTLE, PLASTIC (23155-604-01)
  • 30 TABLET in 1 BOTTLE, PLASTIC (23155-604-03)
  • 500 TABLET in 1 BOTTLE, PLASTIC (23155-604-05)
  • 90 TABLET in 1 BOTTLE, PLASTIC (23155-604-09)
source: ndc

Packages (4)

23155-604-01 100 TABLET in 1 BOTTLE, PLASTIC (23155-604-01) 23155-604-03 30 TABLET in 1 BOTTLE, PLASTIC (23155-604-03) 23155-604-05 500 TABLET in 1 BOTTLE, PLASTIC (23155-604-05) 23155-604-09 90 TABLET in 1 BOTTLE, PLASTIC (23155-604-09)

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": "d8fc4961-6cbc-44fc-be5f-63127fff98f8", "openfda": {"nui": ["N0000175729", "N0000175651", "N0000175769"], "upc": ["0323155605037", "0323155862010", "0323155862034", "0323155604030", "0323155862058", "0323155604092", "0323155605099", "0323155862096"], "unii": ["R3UK8X3U3D"], "rxcui": ["205324", "260218"], "spl_set_id": ["1a309416-bd6a-45b1-982f-b689b097453d"], "pharm_class_pe": ["Central Nervous System Stimulation [PE]", "Increased Sympathetic Activity [PE]"], "pharm_class_epc": ["Sympathomimetic-like Agent [EPC]"], "manufacturer_name": ["Heritage Pharmaceuticals Inc. d/b/a Avet Pharmaceuticals Inc."], "is_original_packager": [true]}, "finished": true, "packaging": [{"sample": false, "description": "100 TABLET in 1 BOTTLE, PLASTIC (23155-604-01)", "package_ndc": "23155-604-01", "marketing_start_date": "20210218"}, {"sample": false, "description": "30 TABLET in 1 BOTTLE, PLASTIC (23155-604-03)", "package_ndc": "23155-604-03", "marketing_start_date": "20210218"}, {"sample": false, "description": "500 TABLET in 1 BOTTLE, PLASTIC (23155-604-05)", "package_ndc": "23155-604-05", "marketing_start_date": "20210218"}, {"sample": false, "description": "90 TABLET in 1 BOTTLE, PLASTIC (23155-604-09)", "package_ndc": "23155-604-09", "marketing_start_date": "20210218"}], "brand_name": "Modafinil", "product_id": "23155-604_d8fc4961-6cbc-44fc-be5f-63127fff98f8", "dosage_form": "TABLET", "pharm_class": ["Central Nervous System Stimulation [PE]", "Increased Sympathetic Activity [PE]", "Sympathomimetic-like Agent [EPC]"], "product_ndc": "23155-604", "dea_schedule": "CIV", "generic_name": "Modafinil", "labeler_name": "Heritage Pharmaceuticals Inc. d/b/a Avet Pharmaceuticals Inc.", "product_type": "HUMAN PRESCRIPTION DRUG", "brand_name_base": "Modafinil", "active_ingredients": [{"name": "MODAFINIL", "strength": "100 mg/1"}], "application_number": "ANDA207196", "marketing_category": "ANDA", "marketing_start_date": "20210218", "listing_expiration_date": "20261231"}