Home NDC 63629-2372 BUTALBITAL, ACETAMINOPHEN AND CAFFEINE
Product NDC 63629-2372
11-digit product format 636292372
Labeler code 63629
Product ID 63629-2372_1c4a130a-f8e5-4115-934e-7df2165d8853
Type HUMAN PRESCRIPTION DRUG
Nonproprietary name butalbital, acetaminophen and caffeine
Dosage form CAPSULE
Route ORAL
Labeler Bryant Ranch Prepack
Application ANDA207118
Marketing category ANDA
Marketing start 2017-01-10
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]
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 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 63629-2372-1 BUTALBITAL, ACETAMINOPHEN AND CAFFEINE 100 in 1 BOTTLE CAPSULE 100 104
DailyMed Dashboard NDC Coverage# NDC, Dashboard title, SPL version table NDC Dashboard title SPL version Validation Dashboard ZIP 63629-2372 BUTALBITAL, ACETAMINOPHEN AND CAFFEINE CAPSULE [BRYANT RANCH PREPACK] 104 Current NDC, Legacy NDC, 1 package rows 20250323_03475828-eae2-49ed-a1c0-8074f35c712d.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 63629-2372-1 63629237201 100 CAPSULE in 1 BOTTLE (63629-2372-1) 100 capsule 2021-02-22 0000-00-00 No No Current