modafinil

Generic: modafinil

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

Drug Facts

Product Profile

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

modafinil 100 mg/1

Manufacturer
Bionpharma Inc.

Identifiers & Regulatory

Product NDC 69452-342
Product ID 69452-342_45322b3a-fdbe-466f-a2d3-b64e12b36efe
Product Type HUMAN PRESCRIPTION DRUG
Marketing Category ANDA
Application Number ANDA078963
DEA Schedule civ
Listing Expiration 2026-12-31
Marketing Start 2022-02-28

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 69452342
Hyphenated Format 69452-342

Supplemental Identifiers

RxCUI
205324 260218
UPC
0369452343135 0369452342138
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 ANDA078963 (source: ndc)
Routes
ORAL
source: ndc

Resolved Composition

Strengths
  • 100 mg/1
source: ndc
Packaging
  • 30 TABLET in 1 BOTTLE, PLASTIC (69452-342-13)
  • 90 TABLET in 1 BOTTLE, PLASTIC (69452-342-19)
  • 100 TABLET in 1 BOTTLE, PLASTIC (69452-342-20)
source: ndc

Packages (3)

69452-342-13 30 TABLET in 1 BOTTLE, PLASTIC (69452-342-13) 69452-342-19 90 TABLET in 1 BOTTLE, PLASTIC (69452-342-19) 69452-342-20 100 TABLET in 1 BOTTLE, PLASTIC (69452-342-20)

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": "45322b3a-fdbe-466f-a2d3-b64e12b36efe", "openfda": {"nui": ["N0000175729", "N0000175651", "N0000175769"], "upc": ["0369452343135", "0369452342138"], "unii": ["R3UK8X3U3D"], "rxcui": ["205324", "260218"], "spl_set_id": ["63604fef-0b80-40ce-8dbf-3384f1aee395"], "pharm_class_pe": ["Central Nervous System Stimulation [PE]", "Increased Sympathetic Activity [PE]"], "pharm_class_epc": ["Sympathomimetic-like Agent [EPC]"], "manufacturer_name": ["Bionpharma Inc."], "is_original_packager": [true]}, "finished": true, "packaging": [{"sample": false, "description": "30 TABLET in 1 BOTTLE, PLASTIC (69452-342-13)", "package_ndc": "69452-342-13", "marketing_start_date": "20220228"}, {"sample": false, "description": "90 TABLET in 1 BOTTLE, PLASTIC (69452-342-19)", "package_ndc": "69452-342-19", "marketing_start_date": "20220228"}, {"sample": false, "description": "100 TABLET in 1 BOTTLE, PLASTIC (69452-342-20)", "package_ndc": "69452-342-20", "marketing_start_date": "20220228"}], "brand_name": "Modafinil", "product_id": "69452-342_45322b3a-fdbe-466f-a2d3-b64e12b36efe", "dosage_form": "TABLET", "pharm_class": ["Central Nervous System Stimulation [PE]", "Increased Sympathetic Activity [PE]", "Sympathomimetic-like Agent [EPC]"], "product_ndc": "69452-342", "dea_schedule": "CIV", "generic_name": "Modafinil", "labeler_name": "Bionpharma Inc.", "product_type": "HUMAN PRESCRIPTION DRUG", "brand_name_base": "Modafinil", "active_ingredients": [{"name": "MODAFINIL", "strength": "100 mg/1"}], "application_number": "ANDA078963", "marketing_category": "ANDA", "marketing_start_date": "20220228", "listing_expiration_date": "20261231"}