Home NDC 50090-7519 Butalbital, Acetaminophen and Caffeine
Product NDC 50090-7519
11-digit product format 500907519
Labeler code 50090
Product ID 50090-7519_fc8c3e9f-7122-4dd5-8252-07dc3307e6e6
Type HUMAN PRESCRIPTION DRUG
Nonproprietary name Butalbital, Acetaminophen and Caffeine
Dosage form TABLET
Route ORAL
Labeler A-S Medication Solutions
Application ANDA211106
Marketing category ANDA
Marketing start 2018-09-26
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 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 325 mg/1 BUTALBITAL 50 mg/1 CAFFEINE 40 mg/1
Harmonized Identifiers# Field, Values table Field Values Unii 362O9ITL9D, KHS0AZ4JVK, 3G6A5W338E Rxcui 238154
DailyMed Product Concepts# DailyMed Package Descriptions# Package NDC, Product, Description table Package NDC Product Description Form Quantity Strength SPL version 50090-7519-0 Butalbital, Acetaminophen and Caffeine 30 in 1 BOTTLE TABLET 30 2
DailyMed Dashboard NDC Coverage# NDC, Dashboard title, SPL version table NDC Dashboard title SPL version Validation Dashboard ZIP 50090-7519 BUTALBITAL, ACETAMINOPHEN AND CAFFEINE TABLET [A-S MEDICATION SOLUTIONS] 2 Current NDC, 1 package rows 20250326_21a148d1-b242-4414-82b2-cb78387d7d0f.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 50090-7519-0 50090751900 30 TABLET in 1 BOTTLE (50090-7519-0) 30 tablet 2025-03-17 No No Historical