Home NDC 0591-2640 Butalbital, Acetaminophen, and Caffeine
Product NDC 0591-2640
11-digit product format 005912640
Labeler code 0591
Product ID 0591-2640_62e81b0e-5abd-49ef-9131-10ebdd923c1f
Type HUMAN PRESCRIPTION DRUG
Nonproprietary name Butalbital, Acetaminophen, and Caffeine
Dosage form CAPSULE
Route ORAL
Labeler Actavis Pharma, Inc.
Application ANDA040885
Marketing category ANDA
Marketing start 2013-07-29
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]
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 0591-2640-01 Butalbital, Acetaminophen, and Caffeine 100 in 1 BOTTLE CAPSULE 100 11 0591-2640-05 Butalbital, Acetaminophen, and Caffeine 500 in 1 BOTTLE CAPSULE 500 11
DailyMed Socrata Ingredients# Ingredient, Type, UNII table Ingredient Type UNII DailyMed label SPL version Uploaded ACETAMINOPHEN ACTIVE INGREDIENT 362O9ITL9D BUTALBITAL, ACETAMINOPHEN, AND CAFFEINE CAPSULE [ACTAVIS PHARMA, INC.] 4 BUTALBITAL ACTIVE INGREDIENT KHS0AZ4JVK BUTALBITAL, ACETAMINOPHEN, AND CAFFEINE CAPSULE [ACTAVIS PHARMA, INC.] 4 CAFFEINE ACTIVE INGREDIENT 3G6A5W338E BUTALBITAL, ACETAMINOPHEN, AND CAFFEINE CAPSULE [ACTAVIS PHARMA, INC.] 4 ACETAMINOPHEN ACTIVE MOIETY 362O9ITL9D BUTALBITAL, ACETAMINOPHEN, AND CAFFEINE CAPSULE [ACTAVIS PHARMA, INC.] 4 BUTALBITAL ACTIVE MOIETY KHS0AZ4JVK BUTALBITAL, ACETAMINOPHEN, AND CAFFEINE CAPSULE [ACTAVIS PHARMA, INC.] 4 CAFFEINE ACTIVE MOIETY 3G6A5W338E BUTALBITAL, ACETAMINOPHEN, AND CAFFEINE CAPSULE [ACTAVIS PHARMA, INC.] 4 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 0591-2640 BUTALBITAL, ACETAMINOPHEN, AND CAFFEINE CAPSULE [ACTAVIS PHARMA, INC.] 10 Current NDC, Legacy NDC, 2 package rows 20221124_ea5b9ffe-3cda-405e-8f75-3fd4a64c9a35.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 0591-2640-01 00591264001 100 CAPSULE in 1 BOTTLE (0591-2640-01) 100 capsule 2013-07-29 0000-00-00 No No Current 0591-2640-05 00591264005 500 CAPSULE in 1 BOTTLE (0591-2640-05) 500 capsule 2013-07-29 0000-00-00 No No Current