Home NDC 43547-686 BUTALBITAL, ACETAMINOPHEN AND CAFFEINE
Product NDC 43547-686
11-digit product format 435470686
Labeler code 43547
Product ID 43547-686_f0520093-dfda-4a04-85c4-9ef3c23a8b60
Type HUMAN PRESCRIPTION DRUG
Nonproprietary name butalbital, acetaminophen and caffeine
Dosage form CAPSULE
Route ORAL
Labeler SOLCO HEALTHCARE US, LLC
Application ANDA214087
Marketing category ANDA
Marketing start 2023-12-05
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 43547-686-10 BUTALBITAL, ACETAMINOPHEN AND CAFFEINE 100 in 1 BOTTLE CAPSULE 100 2
DailyMed Dashboard NDC Coverage# NDC, Dashboard title, SPL version table NDC Dashboard title SPL version Validation Dashboard ZIP 43547-686 BUTALBITAL, ACETAMINOPHEN AND CAFFEINE CAPSULE [SOLCO HEALTHCARE US, LLC] 2 Current NDC, 1 package rows 20240911_5c9c3407-212a-4ae9-a574-2b0c53f3c5eb.zip
DailyMed RxNorm Mappings# Packages# Package NDC, 11-digit format, Description table Package NDC 11-digit format Description Units Marketing start Sample Exclude flag Status 43547-686-10 43547068610 100 CAPSULE in 1 BOTTLE (43547-686-10) 100 capsule 2023-12-05 No No Historical