NDC 51655-590

Butalbital Acetaminophen and Caffeine

Butalbital Acetaminophen And Caffeine

Butalbital Acetaminophen and Caffeine is a Oral Tablet in the Human Prescription Drug category. It is labeled and distributed by Northwind Pharmaceuticals. The primary component is Butalbital; Acetaminophen; Caffeine.

Product ID51655-590_ce2a7def-bab2-46e7-a055-9240f5c4ba1e
NDC51655-590
Product TypeHuman Prescription Drug
Proprietary NameButalbital Acetaminophen and Caffeine
Generic NameButalbital Acetaminophen And Caffeine
Dosage FormTablet
Route of AdministrationORAL
Marketing Start Date2015-05-13
Marketing CategoryANDA / ANDA
Application NumberANDA089175
Labeler NameNorthwind Pharmaceuticals
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 51655-590-50

60 TABLET in 1 BOTTLE, DISPENSING (51655-590-50)
Marketing Start Date2015-05-13
NDC Exclude FlagN
Sample Package?N

NDC SPL Data Element Entries

NDC 51655-590-29 [51655059029]

Butalbital Acetaminophen and Caffeine TABLET
Marketing CategoryANDA
Application NumberANDA089175
Product TypeHUMAN PRESCRIPTION DRUG
Marketing Start Date2015-05-13
Inactivation Date2020-01-31

NDC 51655-590-50 [51655059050]

Butalbital Acetaminophen and Caffeine TABLET
Marketing CategoryANDA
Application NumberANDA089175
Product TypeHUMAN PRESCRIPTION DRUG
Marketing Start Date2015-05-15
Inactivation Date2020-01-31

Drug Details

Active Ingredients

IngredientStrength
BUTALBITAL50 mg/1

OpenFDA Data

SPL SET ID:6bd940ca-bcc6-48e8-a98a-ddcea09a0e04
Manufacturer
UNII
RxNorm Concept Unique ID - RxCUI
  • 238154
  • Pharmacological Class

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

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

    NDCBrand NameGeneric Name
    49999-151Butalbital Acetaminophen and CaffeineButalbital Acetaminophen and Caffeine
    51655-590Butalbital Acetaminophen and CaffeineButalbital Acetaminophen and Caffeine

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