NDC 35573-456

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 Burel Pharmaceuticals, Llc. The primary component is Acetaminophen; Butalbital.

Product ID35573-456_877b0e9f-f7c3-40a9-905d-eb1c9eaec4e6
NDC35573-456
Product TypeHuman Prescription Drug
Proprietary NameBUTALBITAL AND ACETAMINOPHEN
Generic NameButalbital And Acetaminophen
Dosage FormTablet
Route of AdministrationORAL
Marketing Start Date2022-12-01
Marketing CategoryANDA /
Application NumberANDA214088
Labeler NameBurel Pharmaceuticals, LLC
Substance NameACETAMINOPHEN; BUTALBITAL
Active Ingredient Strength325 mg/1; mg/1
Pharm ClassesBarbiturate [EPC], Barbiturates [CS]
DEA ScheduleCIII
NDC Exclude FlagN
Listing Certified Through2023-12-31

Packaging

NDC 35573-456-02

100 TABLET in 1 BOTTLE (35573-456-02)
Marketing Start Date2022-12-01
NDC Exclude FlagN
Sample Package?N

Drug Details

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
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