Home NDC 0591-2641 Butalbital, Acetaminophen, Caffeine, and Codeine Phosphate
Product NDC 0591-2641
11-digit product format 005912641
Labeler code 0591
Product ID 0591-2641_423a1275-8347-42e4-82b9-bd4f193c03e6
Type HUMAN PRESCRIPTION DRUG
Nonproprietary name Butalbital, Acetaminophen, Caffeine, and Codeine Phosphate
Dosage form CAPSULE
Route ORAL
Labeler Actavis Pharma, Inc.
Application ANDA076560
Marketing category ANDA
Marketing start 2013-07-29
Substance ACETAMINOPHEN; BUTALBITAL; CAFFEINE; CODEINE PHOSPHATE
Active strength 300; 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 2026-12-31
Current FDA listing Yes Additional Listing Data#
Finished product Yes
Brand name base Butalbital, Acetaminophen, Caffeine, and Codeine Phosphate
Listing expiration 2026-12-31 Active Ingredients# Ingredient, Strength table Ingredient Strength ACETAMINOPHEN 300 mg/1 BUTALBITAL 50 mg/1 CAFFEINE 40 mg/1 CODEINE PHOSPHATE 30 mg/1
Harmonized Identifiers# Field, Values table Field Values Unii 362O9ITL9D, KHS0AZ4JVK, 3G6A5W338E, GSL05Y1MN6 Rxcui 1431286
DailyMed Product Concepts# DailyMed Package Descriptions# Package NDC, Product, Description table Package NDC Product Description Form Quantity Strength SPL version 0591-2641-01 Butalbital, Acetaminophen, Caffeine, and Codeine Phosphate 100 in 1 BOTTLE, PLASTIC CAPSULE 100 10
DailyMed Socrata Ingredients# Ingredient, Type, UNII table Ingredient Type UNII DailyMed label SPL version Uploaded ACETAMINOPHEN ACTIVE INGREDIENT 362O9ITL9D BUTALBITAL, ACETAMINOPHEN, CAFFEINE, AND CODEINE PHOSPHATE CAPSULE [ACTAVIS PHARMA, INC.] 3 BUTALBITAL ACTIVE INGREDIENT KHS0AZ4JVK BUTALBITAL, ACETAMINOPHEN, CAFFEINE, AND CODEINE PHOSPHATE CAPSULE [ACTAVIS PHARMA, INC.] 3 CAFFEINE ACTIVE INGREDIENT 3G6A5W338E BUTALBITAL, ACETAMINOPHEN, CAFFEINE, AND CODEINE PHOSPHATE CAPSULE [ACTAVIS PHARMA, INC.] 3 CODEINE PHOSPHATE ACTIVE INGREDIENT GSL05Y1MN6 BUTALBITAL, ACETAMINOPHEN, CAFFEINE, AND CODEINE PHOSPHATE CAPSULE [ACTAVIS PHARMA, INC.] 3 ACETAMINOPHEN ACTIVE MOIETY 362O9ITL9D BUTALBITAL, ACETAMINOPHEN, CAFFEINE, AND CODEINE PHOSPHATE CAPSULE [ACTAVIS PHARMA, INC.] 3 BUTALBITAL ACTIVE MOIETY KHS0AZ4JVK BUTALBITAL, ACETAMINOPHEN, CAFFEINE, AND CODEINE PHOSPHATE CAPSULE [ACTAVIS PHARMA, INC.] 3 CAFFEINE ACTIVE MOIETY 3G6A5W338E BUTALBITAL, ACETAMINOPHEN, CAFFEINE, AND CODEINE PHOSPHATE CAPSULE [ACTAVIS PHARMA, INC.] 3 CODEINE ANHYDROUS ACTIVE MOIETY UX6OWY2V7J BUTALBITAL, ACETAMINOPHEN, CAFFEINE, AND CODEINE PHOSPHATE CAPSULE [ACTAVIS PHARMA, INC.] 3 CELLULOSE, MICROCRYSTALLINE INACTIVE INGREDIENT OP1R32D61U BUTALBITAL, ACETAMINOPHEN, CAFFEINE, AND CODEINE PHOSPHATE CAPSULE [ACTAVIS PHARMA, INC.] 3 D&C YELLOW NO. 10 INACTIVE INGREDIENT 35SW5USQ3G BUTALBITAL, ACETAMINOPHEN, CAFFEINE, AND CODEINE PHOSPHATE CAPSULE [ACTAVIS PHARMA, INC.] 3 FD&C BLUE NO. 1 INACTIVE INGREDIENT H3R47K3TBD BUTALBITAL, ACETAMINOPHEN, CAFFEINE, AND CODEINE PHOSPHATE CAPSULE [ACTAVIS PHARMA, INC.] 3 FD&C RED NO. 40 INACTIVE INGREDIENT WZB9127XOA BUTALBITAL, ACETAMINOPHEN, CAFFEINE, AND CODEINE PHOSPHATE CAPSULE [ACTAVIS PHARMA, INC.] 3 FD&C YELLOW NO. 6 INACTIVE INGREDIENT H77VEI93A8 BUTALBITAL, ACETAMINOPHEN, CAFFEINE, AND CODEINE PHOSPHATE CAPSULE [ACTAVIS PHARMA, INC.] 3 GELATIN INACTIVE INGREDIENT 2G86QN327L BUTALBITAL, ACETAMINOPHEN, CAFFEINE, AND CODEINE PHOSPHATE CAPSULE [ACTAVIS PHARMA, INC.] 3 SODIUM LAURYL SULFATE INACTIVE INGREDIENT 368GB5141J BUTALBITAL, ACETAMINOPHEN, CAFFEINE, AND CODEINE PHOSPHATE CAPSULE [ACTAVIS PHARMA, INC.] 3 STEARIC ACID INACTIVE INGREDIENT 4ELV7Z65AP BUTALBITAL, ACETAMINOPHEN, CAFFEINE, AND CODEINE PHOSPHATE CAPSULE [ACTAVIS PHARMA, INC.] 3 TALC INACTIVE INGREDIENT 7SEV7J4R1U BUTALBITAL, ACETAMINOPHEN, CAFFEINE, AND CODEINE PHOSPHATE CAPSULE [ACTAVIS PHARMA, INC.] 3
DailyMed Dashboard NDC Coverage# NDC, Dashboard title, SPL version table NDC Dashboard title SPL version Validation Dashboard ZIP 0591-2641 BUTALBITAL, ACETAMINOPHEN, CAFFEINE, AND CODEINE PHOSPHATE CAPSULE [ACTAVIS PHARMA, INC.] 9 Current NDC, Legacy NDC, 1 package rows 20210424_52321fe5-c001-4e2d-8149-3197ddc13764.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 0591-2641-01 00591264101 100 CAPSULE in 1 BOTTLE, PLASTIC (0591-2641-01) 100 capsule 2013-07-29 0000-00-00 No No Current