Home NDC 0591-3369 Butalbital, Acetaminophen, and Caffeine
Product NDC 0591-3369
11-digit product format 005913369
Labeler code 0591
Product ID 0591-3369_4f43a8e6-42b9-4743-9ffa-3783e1b5e15b
Type HUMAN PRESCRIPTION DRUG
Nonproprietary name Butalbital, Acetaminophen, and Caffeine
Dosage form TABLET
Route ORAL
Labeler Actavis Pharma, Inc.
Application ANDA088616
Marketing category ANDA
Marketing start 2007-12-13
Substance ACETAMINOPHEN; BUTALBITAL; CAFFEINE
Active strength 325; 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 2027-12-31
Current FDA listing Yes Additional Listing Data#
Finished product Yes
Brand name base Butalbital, Acetaminophen, and Caffeine
Listing expiration 2027-12-31 Active Ingredients# Ingredient, Strength table Ingredient Strength ACETAMINOPHEN 325 mg/1 BUTALBITAL 50 mg/1 CAFFEINE 40 mg/1
Harmonized Identifiers# Field, Values table Field Values Unii 362O9ITL9D, KHS0AZ4JVK, 3G6A5W338E Rxcui 238154
DailyMed Product Concepts# DailyMed Package Descriptions# Package NDC, Product, Description table Package NDC Product Description Form Quantity Strength SPL version 0591-3369-01 Butalbital, Acetaminophen, and Caffeine 100 in 1 BOTTLE TABLET 100 17 0591-3369-05 Butalbital, Acetaminophen, and Caffeine 500 in 1 BOTTLE TABLET 500 17
DailyMed Socrata Ingredients# Ingredient, Type, UNII table Ingredient Type UNII DailyMed label SPL version Uploaded ACETAMINOPHEN ACTIVE INGREDIENT 362O9ITL9D BUTALBITAL, ACETAMINOPHEN, AND CAFFEINE TABLET [ACTAVIS PHARMA, INC.] 12 BUTALBITAL ACTIVE INGREDIENT KHS0AZ4JVK BUTALBITAL, ACETAMINOPHEN, AND CAFFEINE TABLET [ACTAVIS PHARMA, INC.] 12 CAFFEINE ACTIVE INGREDIENT 3G6A5W338E BUTALBITAL, ACETAMINOPHEN, AND CAFFEINE TABLET [ACTAVIS PHARMA, INC.] 12 ACETAMINOPHEN ACTIVE MOIETY 362O9ITL9D BUTALBITAL, ACETAMINOPHEN, AND CAFFEINE TABLET [ACTAVIS PHARMA, INC.] 12 BUTALBITAL ACTIVE MOIETY KHS0AZ4JVK BUTALBITAL, ACETAMINOPHEN, AND CAFFEINE TABLET [ACTAVIS PHARMA, INC.] 12 CAFFEINE ACTIVE MOIETY 3G6A5W338E BUTALBITAL, ACETAMINOPHEN, AND CAFFEINE TABLET [ACTAVIS PHARMA, INC.] 12 CELLULOSE, MICROCRYSTALLINE INACTIVE INGREDIENT OP1R32D61U BUTALBITAL, ACETAMINOPHEN, AND CAFFEINE TABLET [ACTAVIS PHARMA, INC.] 12 CROSPOVIDONE (15 MPA.S AT 5%) INACTIVE INGREDIENT 68401960MK BUTALBITAL, ACETAMINOPHEN, AND CAFFEINE TABLET [ACTAVIS PHARMA, INC.] 12 MAGNESIUM STEARATE INACTIVE INGREDIENT 70097M6I30 BUTALBITAL, ACETAMINOPHEN, AND CAFFEINE TABLET [ACTAVIS PHARMA, INC.] 12 POVIDONES INACTIVE INGREDIENT FZ989GH94E BUTALBITAL, ACETAMINOPHEN, AND CAFFEINE TABLET [ACTAVIS PHARMA, INC.] 12 STARCH, CORN INACTIVE INGREDIENT O8232NY3SJ BUTALBITAL, ACETAMINOPHEN, AND CAFFEINE TABLET [ACTAVIS PHARMA, INC.] 12 STEARIC ACID INACTIVE INGREDIENT 4ELV7Z65AP BUTALBITAL, ACETAMINOPHEN, AND CAFFEINE TABLET [ACTAVIS PHARMA, INC.] 12 ACETAMINOPHEN ACTIVE INGREDIENT 362O9ITL9D BUTALBITAL, ACETAMINOPHEN, AND CAFFEINE TABLET [A-S MEDICATION SOLUTIONS LLC] 2 BUTALBITAL ACTIVE INGREDIENT KHS0AZ4JVK BUTALBITAL, ACETAMINOPHEN, AND CAFFEINE TABLET [A-S MEDICATION SOLUTIONS LLC] 2 CAFFEINE ACTIVE INGREDIENT 3G6A5W338E BUTALBITAL, ACETAMINOPHEN, AND CAFFEINE TABLET [A-S MEDICATION SOLUTIONS LLC] 2 ACETAMINOPHEN ACTIVE MOIETY 362O9ITL9D BUTALBITAL, ACETAMINOPHEN, AND CAFFEINE TABLET [A-S MEDICATION SOLUTIONS LLC] 2 BUTALBITAL ACTIVE MOIETY KHS0AZ4JVK BUTALBITAL, ACETAMINOPHEN, AND CAFFEINE TABLET [A-S MEDICATION SOLUTIONS LLC] 2 CAFFEINE ACTIVE MOIETY 3G6A5W338E BUTALBITAL, ACETAMINOPHEN, AND CAFFEINE TABLET [A-S MEDICATION SOLUTIONS LLC] 2 CELLULOSE, MICROCRYSTALLINE INACTIVE INGREDIENT OP1R32D61U BUTALBITAL, ACETAMINOPHEN, AND CAFFEINE TABLET [A-S MEDICATION SOLUTIONS LLC] 2 CROSPOVIDONE INACTIVE INGREDIENT 68401960MK BUTALBITAL, ACETAMINOPHEN, AND CAFFEINE TABLET [A-S MEDICATION SOLUTIONS LLC] 2 MAGNESIUM STEARATE INACTIVE INGREDIENT 70097M6I30 BUTALBITAL, ACETAMINOPHEN, AND CAFFEINE TABLET [A-S MEDICATION SOLUTIONS LLC] 2 POVIDONES INACTIVE INGREDIENT FZ989GH94E BUTALBITAL, ACETAMINOPHEN, AND CAFFEINE TABLET [A-S MEDICATION SOLUTIONS LLC] 2 STARCH, CORN INACTIVE INGREDIENT O8232NY3SJ BUTALBITAL, ACETAMINOPHEN, AND CAFFEINE TABLET [A-S MEDICATION SOLUTIONS LLC] 2 STEARIC ACID INACTIVE INGREDIENT 4ELV7Z65AP BUTALBITAL, ACETAMINOPHEN, AND CAFFEINE TABLET [A-S MEDICATION SOLUTIONS LLC] 2 ACETAMINOPHEN ACTIVE INGREDIENT 362O9ITL9D BUTALBITAL, ACETAMINOPHEN, AND CAFFEINE TABLET [PREFERRED PHARMACEUTICALS INC.] 1 BUTALBITAL ACTIVE INGREDIENT KHS0AZ4JVK BUTALBITAL, ACETAMINOPHEN, AND CAFFEINE TABLET [PREFERRED PHARMACEUTICALS INC.] 1 CAFFEINE ACTIVE INGREDIENT 3G6A5W338E BUTALBITAL, ACETAMINOPHEN, AND CAFFEINE TABLET [PREFERRED PHARMACEUTICALS INC.] 1 ACETAMINOPHEN ACTIVE MOIETY 362O9ITL9D BUTALBITAL, ACETAMINOPHEN, AND CAFFEINE TABLET [PREFERRED PHARMACEUTICALS INC.] 1 BUTALBITAL ACTIVE MOIETY KHS0AZ4JVK BUTALBITAL, ACETAMINOPHEN, AND CAFFEINE TABLET [PREFERRED PHARMACEUTICALS INC.] 1 CAFFEINE ACTIVE MOIETY 3G6A5W338E BUTALBITAL, ACETAMINOPHEN, AND CAFFEINE TABLET [PREFERRED PHARMACEUTICALS INC.] 1 CELLULOSE, MICROCRYSTALLINE INACTIVE INGREDIENT OP1R32D61U BUTALBITAL, ACETAMINOPHEN, AND CAFFEINE TABLET [PREFERRED PHARMACEUTICALS INC.] 1 CROSPOVIDONE INACTIVE INGREDIENT 68401960MK BUTALBITAL, ACETAMINOPHEN, AND CAFFEINE TABLET [PREFERRED PHARMACEUTICALS INC.] 1 MAGNESIUM STEARATE INACTIVE INGREDIENT 70097M6I30 BUTALBITAL, ACETAMINOPHEN, AND CAFFEINE TABLET [PREFERRED PHARMACEUTICALS INC.] 1 POVIDONES INACTIVE INGREDIENT FZ989GH94E BUTALBITAL, ACETAMINOPHEN, AND CAFFEINE TABLET [PREFERRED PHARMACEUTICALS INC.] 1 STARCH, CORN INACTIVE INGREDIENT O8232NY3SJ BUTALBITAL, ACETAMINOPHEN, AND CAFFEINE TABLET [PREFERRED PHARMACEUTICALS INC.] 1 STEARIC ACID INACTIVE INGREDIENT 4ELV7Z65AP BUTALBITAL, ACETAMINOPHEN, AND CAFFEINE TABLET [PREFERRED PHARMACEUTICALS INC.] 1
DailyMed Dashboard NDC Coverage# NDC, Dashboard title, SPL version table NDC Dashboard title SPL version Validation Dashboard ZIP 0591-3369 BUTALBITAL, ACETAMINOPHEN, AND CAFFEINE TABLET [ACTAVIS PHARMA, INC.] 16 Current NDC, Legacy NDC, 2 package rows 20241114_a6cbc17f-5c60-489c-8029-84b0add556d8.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 0591-3369-01 00591336901 100 TABLET in 1 BOTTLE (0591-3369-01) 100 tablet 2007-12-13 0000-00-00 No No Current 0591-3369-05 00591336905 500 TABLET in 1 BOTTLE (0591-3369-05) 500 tablet 2007-12-13 0000-00-00 No No Current