NDC 51862-544

butalbital and acetaminophen

Butalbital And Acetaminophen

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

Product ID51862-544_59320c11-d7c0-402e-8871-924a9e498d71
NDC51862-544
Product TypeHuman Prescription Drug
Proprietary Namebutalbital and acetaminophen
Generic NameButalbital And Acetaminophen
Dosage FormCapsule
Route of AdministrationORAL
Marketing Start Date2018-07-30
Marketing CategoryANDA / ANDA
Application NumberANDA207313
Labeler NameMayne Pharma
Substance NameBUTALBITAL; ACETAMINOPHEN
Active Ingredient Strength50 mg/1; mg/1
Pharm ClassesBarbiturates [CS],Barbiturate [EPC]
NDC Exclude FlagN
Listing Certified Through2019-12-31

Packaging

NDC 51862-544-01

100 CAPSULE in 1 BOTTLE (51862-544-01)
Marketing Start Date2018-07-30
NDC Exclude FlagN
Sample Package?N

NDC SPL Data Element Entries

NDC 51862-544-05 [51862054405]

butalbital and acetaminophen CAPSULE
Marketing CategoryANDA
Application NumberANDA207313
Product TypeHUMAN PRESCRIPTION DRUG
Marketing Start Date2018-07-30

NDC 51862-544-01 [51862054401]

butalbital and acetaminophen CAPSULE
Marketing CategoryANDA
Application NumberANDA207313
Product TypeHUMAN PRESCRIPTION DRUG
Billing UnitEA
Marketing Start Date2018-07-30

Drug Details

Active Ingredients

IngredientStrength
BUTALBITAL50 mg/1

OpenFDA Data

SPL SET ID:c45b797e-62b2-4944-989e-c17b4204ffdb
Manufacturer
UNII
RxNorm Concept Unique ID - RxCUI
  • 1995136
    • UPC Code
  • 0351862544011

    • Pharmacological Class

    • Barbiturates [CS]
    • Barbiturate [EPC]

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

    NDCBrand NameGeneric Name
    0603-2540butalbital and acetaminophenbutalbital and acetaminophen
    0722-7075Butalbital and AcetaminophenButalbital and Acetaminophen
    35573-455BUTALBITAL AND ACETAMINOPHENbutalbital and acetaminophen
    35573-456BUTALBITAL AND ACETAMINOPHENbutalbital and acetaminophen
    46672-856butalbital and acetaminophenbutalbital and acetaminophen
    47781-534butalbital and acetaminophenbutalbital and acetaminophen
    47781-535Butalbital and AcetaminophenButalbital and Acetaminophen
    47781-628Butalbital and AcetaminophenButalbital and Acetaminophen
    47781-644butalbital and acetaminophenbutalbital and acetaminophen
    51862-538butalbital and acetaminophenbutalbital and acetaminophen
    51862-544butalbital and acetaminophenbutalbital and acetaminophen
    54879-026Butalbital And Acetaminophenbutalbital and acetaminophen
    68047-721Butalbital And Acetaminophenbutalbital and acetaminophen
    68047-722butalbital and acetaminophenbutalbital and acetaminophen
    68682-306Butalbital and AcetaminophenButalbital and Acetaminophen
    69499-342Butalbital and AcetaminophenButalbital and Acetaminophen
    70010-054butalbital and acetaminophenbutalbital and acetaminophen
    71993-301Butalbital and AcetaminophenButalbital and Acetaminophen
    79739-7075Butalbital and AcetaminophenButalbital and Acetaminophen
    68047-752Allzitalbutalbital and acetaminophen
    46672-099Butapapbutalbital and acetaminophen
    11584-0030Tenconbutalbital and acetaminophen
    © 2024 FDA.report
    This site is not affiliated with or endorsed by the FDA.