NDC 10135-628

Butalbital, Acetaminophen and Caffeine

Butalbital, Acetaminophen And Caffeine

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

Product ID10135-628_09ec7682-a3a0-4ca1-a6e8-a55e201fcfb9
NDC10135-628
Product TypeHuman Prescription Drug
Proprietary NameButalbital, Acetaminophen and Caffeine
Generic NameButalbital, Acetaminophen And Caffeine
Dosage FormCapsule
Route of AdministrationORAL
Marketing Start Date2017-04-01
Marketing CategoryANDA / ANDA
Application NumberANDA207118
Labeler NameMarlex Pharmaceuticals Inc
Substance NameACETAMINOPHEN; CAFFEINE; BUTALBITAL
Active Ingredient Strength300 mg/1; mg/1; mg/1
Pharm ClassesCentral Nervous System Stimulant [EPC],Methylxanthine [EPC],Xanthines [CS],Central Nervous System Stimulation [PE],Barbiturates [CS],Barbiturate [EPC]
NDC Exclude FlagE
Listing Certified Through2018-12-31

Packaging

NDC 10135-628-01

100 CAPSULE in 1 BOTTLE (10135-628-01)
Marketing Start Date2017-04-01
NDC Exclude FlagN
Sample Package?N

NDC SPL Data Element Entries

NDC 10135-628-01 [10135062801]

Butalbital, Acetaminophen and Caffeine CAPSULE
Marketing CategoryANDA
Application NumberANDA207118
Product TypeHUMAN PRESCRIPTION DRUG
Billing UnitEA
Marketing Start Date2017-04-01
Inactivation Date2020-01-31

Drug Details

Active Ingredients

IngredientStrength
ACETAMINOPHEN300 mg/1

OpenFDA Data

SPL SET ID:5f6997ee-45d5-4ef9-a829-a284a35a4e72
Manufacturer
UNII
RxNorm Concept Unique ID - RxCUI
  • 889520
    • UPC Code
  • 0310135628018

    • Pharmacological Class

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

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

    NDCBrand NameGeneric Name
    0143-1787Butalbital, Acetaminophen and CaffeineButalbital, Acetaminophen and Caffeine
    0527-4094butalbital, acetaminophen and caffeinebutalbital, acetaminophen and caffeine
    0603-2544Butalbital, 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
    42254-323Butalbital, 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
    51672-4222Butalbital, Acetaminophen and Caffeinebutalbital, acetaminophen, and caffeine
    51862-179butalbital, acetaminophen and caffeinebutalbital, acetaminophen and caffeine
    68071-4657butalbital, acetaminophen and caffeinebutalbital, acetaminophen and caffeine
    68084-396BUTALBITAL, ACETAMINOPHEN AND CAFFEINEBUTALBITAL, ACETAMINOPHEN AND CAFFEINE
    68151-1313Butalbital, Acetaminophen and CaffeineButalbital, Acetaminophen and Caffeine
    68788-9025Butalbital, Acetaminophen and CaffeineButalbital, Acetaminophen and Caffeine
    68788-9711butalbital, acetaminophen and caffeinebutalbital, acetaminophen and caffeine
    71335-0347butalbital, acetaminophen and caffeinebutalbital, acetaminophen and caffeine
    71610-042butalbital, acetaminophen and caffeinebutalbital, acetaminophen and caffeine
    51862-540butalbital, acetaminophen and caffeinebutalbital, acetaminophen and caffeine
    52959-913Butalbital, Acetaminophen and CaffeineButalbital, Acetaminophen and Caffeine
    55289-879Butalbital, Acetaminophen and CaffeineButalbital, Acetaminophen and Caffeine
    55154-7147BUTALBITAL, ACETAMINOPHEN AND CAFFEINEBUTALBITAL, ACETAMINOPHEN AND CAFFEINE
    60429-589butalbital, acetaminophen and caffeinebutalbital, acetaminophen and caffeine
    61919-022BUTALBITAL, ACETAMINOPHEN AND CAFFEINEBUTALBITAL, ACETAMINOPHEN AND CAFFEINE
    63187-520butalbital, acetaminophen and caffeinebutalbital, acetaminophen and caffeine
    66267-039butalbital, acetaminophen and caffeinebutalbital, acetaminophen and caffeine
    67544-394Butalbital, Acetaminophen and CaffeineButalbital, Acetaminophen and Caffeine
    67296-0718Butalbital, Acetaminophen and CaffeineButalbital, Acetaminophen and Caffeine
    55154-7988Butalbital, Acetaminophen and CaffeineButalbital, Acetaminophen and Caffeine
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