modafinil

Generic: modafinil

Labeler: bryant ranch prepack
NDC Directory HUMAN PRESCRIPTION DRUG ANDA Inactive Finished

Drug Facts

Product Profile

Brand Name modafinil
Generic Name modafinil
Labeler bryant ranch prepack
Dosage Form TABLET
Routes
ORAL
Active Ingredients

modafinil 100 mg/1

Manufacturer
Bryant Ranch Prepack

Identifiers & Regulatory

Product NDC 71335-1122
Product ID 71335-1122_0c6f0c70-8e9e-4d04-bd7d-88bc33255611
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 713351122
Hyphenated Format 71335-1122

Supplemental Identifiers

RxCUI
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
  • 30 TABLET in 1 BOTTLE (71335-1122-1)
  • 60 TABLET in 1 BOTTLE (71335-1122-2)
  • 28 TABLET in 1 BOTTLE (71335-1122-3)
  • 90 TABLET in 1 BOTTLE (71335-1122-4)
  • 45 TABLET in 1 BOTTLE (71335-1122-5)
  • 180 TABLET in 1 BOTTLE (71335-1122-6)
  • 100 TABLET in 1 BOTTLE (71335-1122-7)
source: ndc

Packages (7)

71335-1122-1 30 TABLET in 1 BOTTLE (71335-1122-1) 71335-1122-2 60 TABLET in 1 BOTTLE (71335-1122-2) 71335-1122-3 28 TABLET in 1 BOTTLE (71335-1122-3) 71335-1122-4 90 TABLET in 1 BOTTLE (71335-1122-4) 71335-1122-5 45 TABLET in 1 BOTTLE (71335-1122-5) 71335-1122-6 180 TABLET in 1 BOTTLE (71335-1122-6) 71335-1122-7 100 TABLET in 1 BOTTLE (71335-1122-7)

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": "0c6f0c70-8e9e-4d04-bd7d-88bc33255611", "openfda": {"nui": ["N0000175729", "N0000175651", "N0000175769"], "unii": ["R3UK8X3U3D"], "rxcui": ["260218"], "spl_set_id": ["f1ff7c6d-df04-48dd-a971-454d38e7d997"], "pharm_class_pe": ["Central Nervous System Stimulation [PE]", "Increased Sympathetic Activity [PE]"], "pharm_class_epc": ["Sympathomimetic-like Agent [EPC]"], "manufacturer_name": ["Bryant Ranch Prepack"]}, "finished": true, "packaging": [{"sample": false, "description": "30 TABLET in 1 BOTTLE (71335-1122-1)", "package_ndc": "71335-1122-1", "marketing_start_date": "20190226"}, {"sample": false, "description": "60 TABLET in 1 BOTTLE (71335-1122-2)", "package_ndc": "71335-1122-2", "marketing_start_date": "20190314"}, {"sample": false, "description": "28 TABLET in 1 BOTTLE (71335-1122-3)", "package_ndc": "71335-1122-3", "marketing_start_date": "20190314"}, {"sample": false, "description": "90 TABLET in 1 BOTTLE (71335-1122-4)", "package_ndc": "71335-1122-4", "marketing_start_date": "20190314"}, {"sample": false, "description": "45 TABLET in 1 BOTTLE (71335-1122-5)", "package_ndc": "71335-1122-5", "marketing_start_date": "20240709"}, {"sample": false, "description": "180 TABLET in 1 BOTTLE (71335-1122-6)", "package_ndc": "71335-1122-6", "marketing_start_date": "20240709"}, {"sample": false, "description": "100 TABLET in 1 BOTTLE (71335-1122-7)", "package_ndc": "71335-1122-7", "marketing_start_date": "20221212"}], "brand_name": "Modafinil", "product_id": "71335-1122_0c6f0c70-8e9e-4d04-bd7d-88bc33255611", "dosage_form": "TABLET", "pharm_class": ["Central Nervous System Stimulation [PE]", "Increased Sympathetic Activity [PE]", "Sympathomimetic-like Agent [EPC]"], "product_ndc": "71335-1122", "dea_schedule": "CIV", "generic_name": "Modafinil", "labeler_name": "Bryant Ranch Prepack", "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"}