Last Updated: September 24, 2026

Details for New Drug Application (NDA): 040387


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NDA 040387 describes BUTALBITAL, ACETAMINOPHEN AND CAFFEINE, which is a drug marketed by Aurolife Pharma Llc, Dr Reddys Labs Sa, Gilbert Labs, Graham Dm, Granules, Hikma, Ingenus Pharms Llc, Key Therap, Lannett Co Inc, Lgm Pharma, Mallinckrodt, Nuvo Pharms Inc, Quagen, Senores Pharms, Taro, Genus, Abhai Llc, Able, Actavis Labs Ut Inc, Alvogen, Hikma Pharms, Mikart, Mirror Pharms Llc, Nesher Pharms, Specgx Llc, Strides Pharma, Strides Pharma Intl, Sun Pharm Industries, Vintage Pharms, and Watson Labs, and is included in forty-five NDAs. It is available from thirty-five suppliers. Additional details are available on the BUTALBITAL, ACETAMINOPHEN AND CAFFEINE profile page.

The generic ingredient in BUTALBITAL, ACETAMINOPHEN AND CAFFEINE is acetaminophen; butalbital; caffeine. There is one drug master file entry for this compound. Thirty-five suppliers are listed for this compound. Additional details are available on the acetaminophen; butalbital; caffeine profile page.
Summary for 040387
Tradename:BUTALBITAL, ACETAMINOPHEN AND CAFFEINE
Applicant:Genus
Ingredient:acetaminophen; butalbital; caffeine
Patents:0
Pharmacology for NDA: 040387
Physiological EffectCentral Nervous System Stimulation
Suppliers and Packaging for NDA: 040387
Tradename Generic Name Dosage NDA Application Type Supplier National Drug Code Package Code Package
BUTALBITAL, ACETAMINOPHEN AND CAFFEINE acetaminophen; butalbital; caffeine SOLUTION;ORAL 040387 ANDA Genus Lifesciences Inc. 64950-290 64950-290-16 473 mL in 1 BOTTLE (64950-290-16)

Profile for product number 001

Active Rx/OTC/Discontinued:RXDosage:SOLUTION;ORALStrength325MG/15ML;50MG/15ML;40MG/15ML
Approval Date:Jan 31, 2003TE:RLD:No

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Preferred Citation:

Friedman, Yali. "DrugPatentWatch" DrugPatentWatch, thinkBiotech, 2026, www.DrugPatentWatch.com.
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