modafinil

Generic: modafinil

Labeler: avpak
NDC Directory HUMAN PRESCRIPTION DRUG ANDA Inactive Finished

Drug Facts

Product Profile

Brand Name modafinil
Generic Name modafinil
Labeler avpak
Dosage Form TABLET
Routes
ORAL
Active Ingredients

modafinil 100 mg/1

Manufacturer
AvPAK

Identifiers & Regulatory

Product NDC 50268-570
Product ID 50268-570_47e7afcc-7429-1e31-e063-6394a90ab335
Product Type HUMAN PRESCRIPTION DRUG
Marketing Category ANDA
Application Number ANDA202566
DEA Schedule civ
Listing Expiration 2027-12-31
Marketing Start 2016-08-01

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 50268570
Hyphenated Format 50268-570

Supplemental Identifiers

RxCUI
205324 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 ANDA202566 (source: ndc)
Routes
ORAL
source: ndc

Resolved Composition

Strengths
  • 100 mg/1
source: ndc
Packaging
  • 20 BLISTER PACK in 1 BOX (50268-570-12) / 1 TABLET in 1 BLISTER PACK (50268-570-11)
source: ndc

Packages (1)

50268-570-12 20 BLISTER PACK in 1 BOX (50268-570-12) / 1 TABLET in 1 BLISTER PACK (50268-570-11)

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": "47e7afcc-7429-1e31-e063-6394a90ab335", "openfda": {"nui": ["N0000175729", "N0000175651", "N0000175769"], "unii": ["R3UK8X3U3D"], "rxcui": ["205324", "260218"], "spl_set_id": ["4790bbe9-d753-1067-02ee-9536011650d9"], "pharm_class_pe": ["Central Nervous System Stimulation [PE]", "Increased Sympathetic Activity [PE]"], "pharm_class_epc": ["Sympathomimetic-like Agent [EPC]"], "manufacturer_name": ["AvPAK"]}, "finished": true, "packaging": [{"sample": false, "description": "20 BLISTER PACK in 1 BOX (50268-570-12)  / 1 TABLET in 1 BLISTER PACK (50268-570-11)", "package_ndc": "50268-570-12", "marketing_start_date": "20160801"}], "brand_name": "Modafinil", "product_id": "50268-570_47e7afcc-7429-1e31-e063-6394a90ab335", "dosage_form": "TABLET", "pharm_class": ["Central Nervous System Stimulation [PE]", "Increased Sympathetic Activity [PE]", "Sympathomimetic-like Agent [EPC]"], "product_ndc": "50268-570", "dea_schedule": "CIV", "generic_name": "Modafinil", "labeler_name": "AvPAK", "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": "20160801", "listing_expiration_date": "20271231"}