Home NDC 52544-080 Fioricet
Product NDC 52544-080
11-digit product format 525440080
Labeler code 52544
Product ID 52544-080_b31b5178-c2d3-4d0c-9e68-95acc212a74a
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 Fioricet
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, 1432261
DailyMed Product Concepts# DailyMed Package Descriptions# Package NDC, Product, Description table Package NDC Product Description Form Quantity Strength SPL version 52544-080-01 Fioricet 100 in 1 BOTTLE CAPSULE 100 11
DailyMed Socrata Ingredients# Ingredient, Type, UNII table Ingredient Type UNII DailyMed label SPL version Uploaded ACETAMINOPHEN ACTIVE INGREDIENT 362O9ITL9D FIORICET (BUTALBITAL, ACETAMINOPHEN, AND CAFFEINE) CAPSULE [ACTAVIS PHARMA, INC.] 4 BUTALBITAL ACTIVE INGREDIENT KHS0AZ4JVK FIORICET (BUTALBITAL, ACETAMINOPHEN, AND CAFFEINE) CAPSULE [ACTAVIS PHARMA, INC.] 4 CAFFEINE ACTIVE INGREDIENT 3G6A5W338E FIORICET (BUTALBITAL, ACETAMINOPHEN, AND CAFFEINE) CAPSULE [ACTAVIS PHARMA, INC.] 4 ACETAMINOPHEN ACTIVE MOIETY 362O9ITL9D FIORICET (BUTALBITAL, ACETAMINOPHEN, AND CAFFEINE) CAPSULE [ACTAVIS PHARMA, INC.] 4 BUTALBITAL ACTIVE MOIETY KHS0AZ4JVK FIORICET (BUTALBITAL, ACETAMINOPHEN, AND CAFFEINE) CAPSULE [ACTAVIS PHARMA, INC.] 4 CAFFEINE ACTIVE MOIETY 3G6A5W338E FIORICET (BUTALBITAL, ACETAMINOPHEN, AND CAFFEINE) CAPSULE [ACTAVIS PHARMA, INC.] 4
DailyMed Dashboard NDC Coverage# NDC, Dashboard title, SPL version table NDC Dashboard title SPL version Validation Dashboard ZIP 52544-080 FIORICET (BUTALBITAL, ACETAMINOPHEN, AND CAFFEINE) CAPSULE [ACTAVIS PHARMA, INC.] 10 Current NDC, Legacy NDC, 1 package rows 20221124_c018be7d-f7b8-45e2-97b8-8e7a71740657.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 52544-080-01 52544008001 100 CAPSULE in 1 BOTTLE (52544-080-01) 100 capsule 2013-07-29 0000-00-00 No No Current