Home NDC 0054-3000 Butalbital, Acetaminophen, Caffeine and Codeine Phosphate
Product NDC 0054-3000
11-digit product format 000543000
Labeler code 0054
Product ID 0054-3000_3477a730-97ec-460b-9e7f-0fd5e84c4404
Type HUMAN PRESCRIPTION DRUG
Nonproprietary name Butalbital, Acetaminophen, Caffeine and Codeine Phosphate
Dosage form CAPSULE
Route ORAL
Labeler Hikma Pharmaceuticals USA Inc.
Application ANDA215138
Marketing category ANDA
Marketing start 2022-05-09
Substance ACETAMINOPHEN; BUTALBITAL; CAFFEINE; CODEINE PHOSPHATE
Active strength 325; 50; 40; 30 mg/1; mg/1; mg/1; mg/1
Pharmacologic classes Barbiturate [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 schedule CIII
NDC exclude flag No
Listing certified through 2027-12-31
Current FDA listing Yes Additional Listing Data#
Finished product Yes
Brand name base Butalbital, Acetaminophen, Caffeine and Codeine Phosphate
Listing expiration 2027-12-31 Active Ingredients# Ingredient, Strength table Ingredient Strength ACETAMINOPHEN 325 mg/1 BUTALBITAL 50 mg/1 CAFFEINE 40 mg/1 CODEINE PHOSPHATE 30 mg/1
Harmonized Identifiers# Field, Values table Field Values Unii KHS0AZ4JVK, 3G6A5W338E, GSL05Y1MN6, 362O9ITL9D Rxcui 993943, 1431286
DailyMed Product Concepts# DailyMed Package Descriptions# Package NDC, Product, Description table Package NDC Product Description Form Quantity Strength SPL version 0054-3000-01 Butalbital, Acetaminophen, Caffeine and Codeine Phosphate 100 in 1 BOTTLE CAPSULE 100 6
DailyMed Dashboard NDC Coverage# NDC, Dashboard title, SPL version table NDC Dashboard title SPL version Validation Dashboard ZIP 0054-3000 BUTALBITAL, ACETAMINOPHEN, CAFFEINE AND CODEINE PHOSPHATE CAPSULE [HIKMA PHARMACEUTICALS USA INC.] 5 Current NDC, Legacy NDC, 1 package rows 20250316_6e0e8abc-512b-42f7-8323-434c589edecf.zip
DailyMed RxNorm Mappings# Packages# Package NDC, 11-digit format, Description table Package NDC 11-digit format Description Units Marketing start Marketing end Sample Exclude flag Status 0054-3000-01 00054300001 100 CAPSULE in 1 BOTTLE (0054-3000-01) 100 capsule 2022-05-09 0000-00-00 No No Current