Home NDC 42291-181 Butalbital, Acetaminophen, and Caffeine
Product NDC 42291-181
11-digit product format 422910181
Labeler code 42291
Product ID 42291-181_43545fa6-9313-8af9-e063-6294a90af617
Type HUMAN PRESCRIPTION DRUG
Nonproprietary name Butalbital, Acetaminophen, and Caffeine
Dosage form CAPSULE
Route ORAL
Labeler AvKARE
Application ANDA040885
Marketing category ANDA
Marketing start 2014-11-24
Substance ACETAMINOPHEN; BUTALBITAL; CAFFEINE
Active strength 300; 50; 40 mg/1; mg/1; mg/1
Pharmacologic classes Barbiturate [EPC], Barbiturates [CS], Central Nervous System Stimulant [EPC], Central Nervous System Stimulation [PE], Methylxanthine [EPC], Xanthines [CS]
DEA schedule CIII
NDC exclude flag No
Listing certified through 2026-12-31
Current FDA listing Yes Additional Listing Data#
Finished product Yes
Brand name base Butalbital, Acetaminophen, and Caffeine
Listing expiration 2026-12-31 Active Ingredients# Ingredient, Strength table Ingredient Strength ACETAMINOPHEN 300 mg/1 BUTALBITAL 50 mg/1 CAFFEINE 40 mg/1
Harmonized Identifiers# Field, Values table Field Values Unii 362O9ITL9D, KHS0AZ4JVK, 3G6A5W338E Rxcui 889520
DailyMed Product Concepts# DailyMed Package Descriptions# Package NDC, Product, Description table Package NDC Product Description Form Quantity Strength SPL version 42291-181-01 Butalbital, Acetaminophen, and Caffeine 100 in 1 BOTTLE CAPSULE 100 10
DailyMed Socrata Ingredients# Ingredient, Type, UNII table Ingredient Type UNII DailyMed label SPL version Uploaded ACETAMINOPHEN ACTIVE INGREDIENT 362O9ITL9D BUTALBITAL, ACETAMINOPHEN, AND CAFFEINE (BUTALBITAL, ACETAMINOPHEN, AND CAFFEINE) CAPSULE [AVKARE, INC.] 2 BUTALBITAL ACTIVE INGREDIENT KHS0AZ4JVK BUTALBITAL, ACETAMINOPHEN, AND CAFFEINE (BUTALBITAL, ACETAMINOPHEN, AND CAFFEINE) CAPSULE [AVKARE, INC.] 2 CAFFEINE ACTIVE INGREDIENT 3G6A5W338E BUTALBITAL, ACETAMINOPHEN, AND CAFFEINE (BUTALBITAL, ACETAMINOPHEN, AND CAFFEINE) CAPSULE [AVKARE, INC.] 2 ACETAMINOPHEN ACTIVE MOIETY 362O9ITL9D BUTALBITAL, ACETAMINOPHEN, AND CAFFEINE (BUTALBITAL, ACETAMINOPHEN, AND CAFFEINE) CAPSULE [AVKARE, INC.] 2 BUTALBITAL ACTIVE MOIETY KHS0AZ4JVK BUTALBITAL, ACETAMINOPHEN, AND CAFFEINE (BUTALBITAL, ACETAMINOPHEN, AND CAFFEINE) CAPSULE [AVKARE, INC.] 2 CAFFEINE ACTIVE MOIETY 3G6A5W338E BUTALBITAL, ACETAMINOPHEN, AND CAFFEINE (BUTALBITAL, ACETAMINOPHEN, AND CAFFEINE) CAPSULE [AVKARE, INC.] 2
DailyMed Dashboard NDC Coverage# NDC, Dashboard title, SPL version table NDC Dashboard title SPL version Validation Dashboard ZIP 42291-181 BUTALBITAL, ACETAMINOPHEN, AND CAFFEINE CAPSULE [AVKARE] 9 Current NDC, Legacy NDC, 1 package rows 20240110_f5bbad36-6a0e-3518-3f12-138ae9f63980.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 42291-181-01 42291018101 100 CAPSULE in 1 BOTTLE (42291-181-01) 100 capsule 2014-11-24 0000-00-00 No No Current