NDC 47781-644

butalbital and acetaminophen

Butalbital And Acetaminophen

butalbital and acetaminophen is a Oral Tablet in the Human Prescription Drug category. It is labeled and distributed by Alvogen Inc.. The primary component is Butalbital; Acetaminophen.

Product ID47781-644_6aa67243-32c5-1aef-5cd3-11400c5713cc
NDC47781-644
Product TypeHuman Prescription Drug
Proprietary Namebutalbital and acetaminophen
Generic NameButalbital And Acetaminophen
Dosage FormTablet
Route of AdministrationORAL
Marketing Start Date2019-12-03
Marketing CategoryANDA / ANDA
Application NumberANDA207635
Labeler NameAlvogen Inc.
Substance NameBUTALBITAL; ACETAMINOPHEN
Active Ingredient Strength50 mg/1; mg/1
Pharm ClassesBarbiturates [CS],Barbiturate [EPC]
NDC Exclude FlagN
Listing Certified Through2020-12-31

Packaging

NDC 47781-644-01

100 TABLET in 1 BOTTLE (47781-644-01)
Marketing Start Date2019-12-03
NDC Exclude FlagN
Sample Package?N

NDC SPL Data Element Entries

NDC 47781-644-01 [47781064401]

butalbital and acetaminophen TABLET
Marketing CategoryANDA
Application NumberANDA207635
Product TypeHUMAN PRESCRIPTION DRUG
Billing UnitEA
Marketing Start Date2019-12-03

Drug Details

Active Ingredients

IngredientStrength
BUTALBITAL50 mg/1

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.