modafinil

Generic: modafinil

Labeler: proficient rx lp
NDC Directory HUMAN PRESCRIPTION DRUG ANDA Inactive Finished

Drug Facts

Product Profile

Brand Name modafinil
Generic Name modafinil
Labeler proficient rx lp
Dosage Form TABLET
Routes
ORAL
Active Ingredients

modafinil 200 mg/1

Manufacturer
Proficient Rx LP

Identifiers & Regulatory

Product NDC 82804-126
Product ID 82804-126_c332ea93-48d9-4c8a-a1ef-01c27a61350b
Product Type HUMAN PRESCRIPTION DRUG
Marketing Category ANDA
Application Number ANDA209966
DEA Schedule civ
Listing Expiration 2026-12-31
Marketing Start 2019-02-15

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 82804126
Hyphenated Format 82804-126

Supplemental Identifiers

RxCUI
205324
UPC
0382804126309
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 ANDA209966 (source: ndc)
Routes
ORAL
source: ndc

Resolved Composition

Strengths
  • 200 mg/1
source: ndc
Packaging
  • 30 TABLET in 1 BOTTLE (82804-126-30)
source: ndc

Packages (1)

82804-126-30 30 TABLET in 1 BOTTLE (82804-126-30)

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": "c332ea93-48d9-4c8a-a1ef-01c27a61350b", "openfda": {"nui": ["N0000175729", "N0000175651", "N0000175769"], "upc": ["0382804126309"], "unii": ["R3UK8X3U3D"], "rxcui": ["205324"], "spl_set_id": ["c332ea93-48d9-4c8a-a1ef-01c27a61350b"], "pharm_class_pe": ["Central Nervous System Stimulation [PE]", "Increased Sympathetic Activity [PE]"], "pharm_class_epc": ["Sympathomimetic-like Agent [EPC]"], "manufacturer_name": ["Proficient Rx LP"]}, "finished": true, "packaging": [{"sample": false, "description": "30 TABLET in 1 BOTTLE (82804-126-30)", "package_ndc": "82804-126-30", "marketing_start_date": "20240717"}], "brand_name": "Modafinil", "product_id": "82804-126_c332ea93-48d9-4c8a-a1ef-01c27a61350b", "dosage_form": "TABLET", "pharm_class": ["Central Nervous System Stimulation [PE]", "Increased Sympathetic Activity [PE]", "Sympathomimetic-like Agent [EPC]"], "product_ndc": "82804-126", "dea_schedule": "CIV", "generic_name": "Modafinil", "labeler_name": "Proficient Rx LP", "product_type": "HUMAN PRESCRIPTION DRUG", "brand_name_base": "Modafinil", "active_ingredients": [{"name": "MODAFINIL", "strength": "200 mg/1"}], "application_number": "ANDA209966", "marketing_category": "ANDA", "marketing_start_date": "20190215", "listing_expiration_date": "20261231"}