NDC 68308-554

Zebutal

Butalbital, Acetaminophen And Caffeine

Zebutal is a Oral Capsule in the Human Prescription Drug category. It is labeled and distributed by Mayne Pharma Inc.. The primary component is Butalbital; Acetaminophen; Caffeine.

Product ID68308-554_7b193956-c805-5998-e053-2a91aa0a61eb
NDC68308-554
Product TypeHuman Prescription Drug
Proprietary NameZebutal
Generic NameButalbital, Acetaminophen And Caffeine
Dosage FormCapsule
Route of AdministrationORAL
Marketing Start Date2013-12-26
Marketing CategoryANDA / ANDA
Application NumberANDA089007
Labeler NameMayne Pharma Inc.
Substance NameBUTALBITAL; ACETAMINOPHEN; CAFFEINE
Active Ingredient Strength50 mg/1; mg/1; mg/1
Pharm ClassesBarbiturates [CS],Barbiturate [EPC],Central Nervous System Stimulant [EPC],Methylxanthine [EPC],Xanthines [CS],Central Nervous System Stimulation [PE]
NDC Exclude FlagN
Listing Certified Through2019-12-31

Packaging

NDC 68308-554-10

100 CAPSULE in 1 BOTTLE, PLASTIC (68308-554-10)
Marketing Start Date2013-12-26
NDC Exclude FlagN
Sample Package?N

NDC SPL Data Element Entries

NDC 68308-554-10 [68308055410]

Zebutal CAPSULE
Marketing CategoryANDA
Application NumberANDA089007
Product TypeHUMAN PRESCRIPTION DRUG
Billing UnitEA
Marketing Start Date2013-12-26

Drug Details

Active Ingredients

IngredientStrength
BUTALBITAL50 mg/1

OpenFDA Data

SPL SET ID:ac7e8ce7-088f-4d9c-ad52-2af60436d836
Manufacturer
UNII
RxNorm Concept Unique ID - RxCUI
  • 238153
  • 1487251
    • UPC Code
  • 0368308554107

    • Pharmacological Class

    • Barbiturates [CS]
    • Barbiturate [EPC]
    • Central Nervous System Stimulant [EPC]
    • Methylxanthine [EPC]
    • Xanthines [CS]
    • Central Nervous System Stimulation [PE]

    Medicade Reported Pricing

    68308055410 ZEBUTAL 50-325-40 MG CAPSULE

    Pricing Unit: EA | Drug Type:

    NDC Crossover Matching brand name "Zebutal" or generic name "Butalbital, Acetaminophen And Caffeine"

    NDCBrand NameGeneric Name
    68308-554ZebutalZebutal
    0143-1787Butalbital, Acetaminophen and CaffeineButalbital, Acetaminophen and Caffeine
    0527-4094butalbital, acetaminophen and caffeinebutalbital, acetaminophen and caffeine
    0904-6538Butalbital, Acetaminophen and CaffeineButalbital, Acetaminophen and Caffeine
    10135-628Butalbital, Acetaminophen and CaffeineButalbital, Acetaminophen and Caffeine
    10702-253Butalbital, Acetaminophen and CaffeineButalbital, Acetaminophen and Caffeine
    11534-187BUTALBITAL, ACETAMINOPHEN AND CAFFEINEbutalbital, acetaminophen and caffeine
    13107-075Butalbital, Acetaminophen and CaffeineButalbital, Acetaminophen and Caffeine
    13925-535BUTALBITAL, ACETAMINOPHEN AND CAFFEINEbutalbital, acetaminophen and caffeine
    13925-536BUTALBITAL, ACETAMINOPHEN AND CAFFEINEbutalbital, acetaminophen and caffeine
    17856-1787Butalbital, Acetaminophen and CaffeineButalbital, Acetaminophen and Caffeine
    21695-257Butalbital, Acetaminophen and CaffeineButalbital, Acetaminophen and Caffeine
    21695-843Butalbital, Acetaminophen and CaffeineButalbital, Acetaminophen and Caffeine
    42195-955Butalbital, Acetaminophen and CaffeineButalbital, Acetaminophen and Caffeine
    42543-094Butalbital, Acetaminophen and CaffeineButalbital, Acetaminophen and Caffeine
    43063-369Butalbital, Acetaminophen and CaffeineButalbital, Acetaminophen and Caffeine
    46672-053butalbital, acetaminophen and caffeinebutalbital, acetaminophen and caffeine
    46672-633butalbital, acetaminophen and caffeinebutalbital, acetaminophen and caffeine
    50090-2105Butalbital, Acetaminophen and CaffeineButalbital, Acetaminophen and Caffeine
    50268-139Butalbital, Acetaminophen and CaffeineButalbital, Acetaminophen and Caffeine
    50436-4856butalbital, acetaminophen and caffeinebutalbital, acetaminophen and caffeine
    51407-200BUTALBITAL, ACETAMINOPHEN AND CAFFEINEbutalbital, acetaminophen and caffeine
    51407-556Butalbital, Acetaminophen and CaffeineButalbital, Acetaminophen and Caffeine
    51862-179butalbital, acetaminophen and caffeinebutalbital, acetaminophen and caffeine
    51862-540butalbital, acetaminophen and caffeinebutalbital, acetaminophen and caffeine
    51862-542butalbital, acetaminophen and caffeinebutalbital, acetaminophen and caffeine

    Trademark Results [Zebutal]

    Mark Image

    Registration | Serial
    Company
    Trademark
    Application Date
    ZEBUTAL
    ZEBUTAL
    77517336 3564608 Dead/Cancelled
    METRICS, INC
    2008-07-08
    ZEBUTAL
    ZEBUTAL
    75581231 2416322 Live/Registered
    MAYNE PHARMA, INC.
    1998-11-02
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