Home NDC 13925-535 BUTALBITAL, ACETAMINOPHEN AND CAFFEINE
Product NDC 13925-535
11-digit product format 139250535
Labeler code 13925
Product ID 13925-535_5b7dfab1-0311-4748-9dc0-9e7e33c3eac4
Type HUMAN PRESCRIPTION DRUG
Nonproprietary name butalbital, acetaminophen and caffeine
Dosage form CAPSULE
Route ORAL
Labeler Seton Pharmaceuticals LLC
Application ANDA214087
Marketing category ANDA
Marketing start 2022-03-02
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 KHS0AZ4JVK, 3G6A5W338E, 362O9ITL9D Rxcui 238153, 889520
DailyMed Product Concepts# DailyMed Package Descriptions# Package NDC, Product, Description table Package NDC Product Description Form Quantity Strength SPL version 13925-535-01 BUTALBITAL, ACETAMINOPHEN AND CAFFEINE 100 in 1 BOTTLE CAPSULE 100 3
DailyMed Dashboard NDC Coverage# NDC, Dashboard title, SPL version table NDC Dashboard title SPL version Validation Dashboard ZIP 13925-535 BUTALBITAL, ACETAMINOPHEN AND CAFFEINE CAPSULE [SETON PHARMACEUTICALS LLC] 3 Current NDC, Legacy NDC, 1 package rows 20240131_3c5cefe3-c84e-4380-97f3-78e3fe92543a.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 13925-535-01 13925053501 100 CAPSULE in 1 BOTTLE (13925-535-01) 100 capsule 2022-03-02 0000-00-00 No No Current