NDC 0054-3000

Butalbital, Acetaminophen, Caffeine and Codeine Phosphate

Butalbital, Acetaminophen, Caffeine And Codeine Phosphate

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

Product ID0054-3000_674ad8d3-2800-420b-8001-c5b84cd5086b
NDC0054-3000
Product TypeHuman Prescription Drug
Proprietary NameButalbital, Acetaminophen, Caffeine and Codeine Phosphate
Generic NameButalbital, Acetaminophen, Caffeine And Codeine Phosphate
Dosage FormCapsule
Route of AdministrationORAL
Marketing Start Date2022-05-09
Marketing CategoryANDA /
Application NumberANDA215138
Labeler NameHikma Pharmaceuticals USA Inc.
Substance NameACETAMINOPHEN; BUTALBITAL; CAFFEINE; CODEINE PHOSPHATE
Active Ingredient Strength325 mg/1; mg/1; mg/1; mg/1
Pharm ClassesBarbiturate [EPC], Barbiturates [CS], Central Nervous System Stimulant [EPC], Central Nervous System Stimulation [PE], Full Opioid Agonists [MoA], Methylxanthine [EPC], Opioid Agonist [EPC], Xanthines [CS]
DEA ScheduleCIII
NDC Exclude FlagN
Listing Certified Through2023-12-31

Packaging

NDC 0054-3000-01

100 CAPSULE in 1 BOTTLE (0054-3000-01)
Marketing Start Date2022-05-09
NDC Exclude FlagN
Sample Package?N

Drug Details

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

NDCBrand NameGeneric Name
0054-0650Butalbital, Acetaminophen, Caffeine and Codeine PhosphateButalbital, Acetaminophen, Caffeine and Codeine Phosphate
0054-3000Butalbital, Acetaminophen, Caffeine and Codeine PhosphateButalbital, Acetaminophen, Caffeine and Codeine Phosphate
51991-073Butalbital, Acetaminophen, Caffeine and Codeine PhosphateButalbital, Acetaminophen, Caffeine and Codeine Phosphate
68258-2012Butalbital, Acetaminophen, Caffeine and Codeine PhosphateButalbital, Acetaminophen, Caffeine and Codeine Phosphate
71335-0194Butalbital, Acetaminophen, Caffeine and Codeine PhosphateButalbital, Acetaminophen, Caffeine and Codeine Phosphate

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