Home NDC 69292-305 BUTALBITAL, ACETAMINOPHEN AND CAFFEINE
Product NDC 69292-305
11-digit product format 692920305
Labeler code 69292
Product ID 69292-305_b5af4a7c-13ee-4a3d-b305-853db330edaf
Type HUMAN PRESCRIPTION DRUG
Nonproprietary name butalbital, acetaminophen and caffeine
Dosage form CAPSULE
Route ORAL
Labeler Amici Pharma, Inc.
Application ANDA214087
Marketing category ANDA
Marketing start 2026-04-10
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]
DEA schedule CIII
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 238153
DailyMed Product Concepts# DailyMed Package Descriptions# Package NDC, Product, Description table Package NDC Product Description Form Quantity Strength SPL version 69292-305-01 BUTALBITAL, ACETAMINOPHEN AND CAFFEINE 100 in 1 BOTTLE CAPSULE 100 1
DailyMed RxNorm Mappings# Packages# Package NDC, 11-digit format, Description table Package NDC 11-digit format Description Units Marketing start Sample Exclude flag Status 69292-305-01 69292030501 100 CAPSULE in 1 BOTTLE (69292-305-01) 100 capsule 2026-04-10 No No Current