Home NDC 52544-082 Fioricet with Codeine
Product NDC 52544-082
11-digit product format 525440082
Labeler code 52544
Product ID 52544-082_c5c3390f-a64b-49cb-8fcb-5762dc8ee74a
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
Marketing end 2026-09-30
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
Current FDA listing Yes Additional Listing Data#
Finished product Yes
Brand name base Fioricet with Codeine 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, 1433802
DailyMed Product Concepts# DailyMed Package Descriptions# Package NDC, Product, Description table Package NDC Product Description Form Quantity Strength SPL version 52544-082-01 Fioricet with Codeine 100 in 1 BOTTLE, PLASTIC CAPSULE 100 11
DailyMed Socrata Ingredients# Ingredient, Type, UNII table Ingredient Type UNII DailyMed label SPL version Uploaded ACETAMINOPHEN ACTIVE INGREDIENT 362O9ITL9D FIORICET WITH CODEINE (BUTALBITAL, ACETAMINOPHEN, CAFFEINE, AND CODEINE PHOSPHATE) CAPSULE [WATSON PHARMA, INC.] 3 BUTALBITAL ACTIVE INGREDIENT KHS0AZ4JVK FIORICET WITH CODEINE (BUTALBITAL, ACETAMINOPHEN, CAFFEINE, AND CODEINE PHOSPHATE) CAPSULE [WATSON PHARMA, INC.] 3 CAFFEINE ACTIVE INGREDIENT 3G6A5W338E FIORICET WITH CODEINE (BUTALBITAL, ACETAMINOPHEN, CAFFEINE, AND CODEINE PHOSPHATE) CAPSULE [WATSON PHARMA, INC.] 3 CODEINE PHOSPHATE ACTIVE INGREDIENT GSL05Y1MN6 FIORICET WITH CODEINE (BUTALBITAL, ACETAMINOPHEN, CAFFEINE, AND CODEINE PHOSPHATE) CAPSULE [WATSON PHARMA, INC.] 3 ACETAMINOPHEN ACTIVE MOIETY 362O9ITL9D FIORICET WITH CODEINE (BUTALBITAL, ACETAMINOPHEN, CAFFEINE, AND CODEINE PHOSPHATE) CAPSULE [WATSON PHARMA, INC.] 3 BUTALBITAL ACTIVE MOIETY KHS0AZ4JVK FIORICET WITH CODEINE (BUTALBITAL, ACETAMINOPHEN, CAFFEINE, AND CODEINE PHOSPHATE) CAPSULE [WATSON PHARMA, INC.] 3 CAFFEINE ACTIVE MOIETY 3G6A5W338E FIORICET WITH CODEINE (BUTALBITAL, ACETAMINOPHEN, CAFFEINE, AND CODEINE PHOSPHATE) CAPSULE [WATSON PHARMA, INC.] 3 CODEINE ANHYDROUS ACTIVE MOIETY UX6OWY2V7J FIORICET WITH CODEINE (BUTALBITAL, ACETAMINOPHEN, CAFFEINE, AND CODEINE PHOSPHATE) CAPSULE [WATSON PHARMA, INC.] 3 CELLULOSE, MICROCRYSTALLINE INACTIVE INGREDIENT OP1R32D61U FIORICET WITH CODEINE (BUTALBITAL, ACETAMINOPHEN, CAFFEINE, AND CODEINE PHOSPHATE) CAPSULE [WATSON PHARMA, INC.] 3 D&C YELLOW NO. 10 INACTIVE INGREDIENT 35SW5USQ3G FIORICET WITH CODEINE (BUTALBITAL, ACETAMINOPHEN, CAFFEINE, AND CODEINE PHOSPHATE) CAPSULE [WATSON PHARMA, INC.] 3 FD&C BLUE NO. 1 INACTIVE INGREDIENT H3R47K3TBD FIORICET WITH CODEINE (BUTALBITAL, ACETAMINOPHEN, CAFFEINE, AND CODEINE PHOSPHATE) CAPSULE [WATSON PHARMA, INC.] 3 FD&C RED NO. 40 INACTIVE INGREDIENT WZB9127XOA FIORICET WITH CODEINE (BUTALBITAL, ACETAMINOPHEN, CAFFEINE, AND CODEINE PHOSPHATE) CAPSULE [WATSON PHARMA, INC.] 3 FD&C YELLOW NO. 6 INACTIVE INGREDIENT H77VEI93A8 FIORICET WITH CODEINE (BUTALBITAL, ACETAMINOPHEN, CAFFEINE, AND CODEINE PHOSPHATE) CAPSULE [WATSON PHARMA, INC.] 3 GELATIN INACTIVE INGREDIENT 2G86QN327L FIORICET WITH CODEINE (BUTALBITAL, ACETAMINOPHEN, CAFFEINE, AND CODEINE PHOSPHATE) CAPSULE [WATSON PHARMA, INC.] 3 SODIUM LAURYL SULFATE INACTIVE INGREDIENT 368GB5141J FIORICET WITH CODEINE (BUTALBITAL, ACETAMINOPHEN, CAFFEINE, AND CODEINE PHOSPHATE) CAPSULE [WATSON PHARMA, INC.] 3 STEARIC ACID INACTIVE INGREDIENT 4ELV7Z65AP FIORICET WITH CODEINE (BUTALBITAL, ACETAMINOPHEN, CAFFEINE, AND CODEINE PHOSPHATE) CAPSULE [WATSON PHARMA, INC.] 3 TALC INACTIVE INGREDIENT 7SEV7J4R1U FIORICET WITH CODEINE (BUTALBITAL, ACETAMINOPHEN, CAFFEINE, AND CODEINE PHOSPHATE) CAPSULE [WATSON PHARMA, INC.] 3
DailyMed Dashboard NDC Coverage# NDC, Dashboard title, SPL version table NDC Dashboard title SPL version Validation Dashboard ZIP 52544-082 FIORICET WITH CODEINE (BUTALBITAL, ACETAMINOPHEN, CAFFEINE, AND CODEINE PHOSPHATE) CAPSULE [ACTAVIS PHARMA, INC.] 8 Current NDC, Legacy NDC, 1 package rows 20210414_df9801fc-03fe-41da-a6b3-0f76788217c9.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 52544-082-01 52544008201 100 CAPSULE in 1 BOTTLE, PLASTIC (52544-082-01) 100 capsule 2013-07-29 2026-09-30 No No Current