modafinil

Generic: modafinil

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

Drug Facts

Product Profile

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

modafinil 100 mg/1

Manufacturer
NuCare Pharmaceuticals,Inc.

Identifiers & Regulatory

Product NDC 68071-5121
Product ID 68071-5121_1b547633-2137-67d7-e063-6294a90a1b5a
Product Type HUMAN PRESCRIPTION DRUG
Marketing Category ANDA
Application Number ANDA202566
DEA Schedule civ
Listing Expiration 2026-12-31
Marketing Start 2012-09-27

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 680715121
Hyphenated Format 68071-5121

Supplemental Identifiers

RxCUI
260218
UPC
0368071512137
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
  • 30 TABLET in 1 BOTTLE (68071-5121-3)
source: ndc

Packages (1)

68071-5121-3 30 TABLET in 1 BOTTLE (68071-5121-3)

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": "1b547633-2137-67d7-e063-6294a90a1b5a", "openfda": {"nui": ["N0000175729", "N0000175651", "N0000175769"], "upc": ["0368071512137"], "unii": ["R3UK8X3U3D"], "rxcui": ["260218"], "spl_set_id": ["98e54b10-8ae0-7c43-e053-2a95a90ae8bb"], "pharm_class_pe": ["Central Nervous System Stimulation [PE]", "Increased Sympathetic Activity [PE]"], "pharm_class_epc": ["Sympathomimetic-like Agent [EPC]"], "manufacturer_name": ["NuCare Pharmaceuticals,Inc."]}, "finished": true, "packaging": [{"sample": false, "description": "30 TABLET in 1 BOTTLE (68071-5121-3)", "package_ndc": "68071-5121-3", "marketing_start_date": "20191204"}], "brand_name": "Modafinil", "product_id": "68071-5121_1b547633-2137-67d7-e063-6294a90a1b5a", "dosage_form": "TABLET", "pharm_class": ["Central Nervous System Stimulation [PE]", "Increased Sympathetic Activity [PE]", "Sympathomimetic-like Agent [EPC]"], "product_ndc": "68071-5121", "dea_schedule": "CIV", "generic_name": "Modafinil", "labeler_name": "NuCare Pharmaceuticals,Inc.", "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": "20120927", "listing_expiration_date": "20261231"}