Home NDC 0527-4094 butalbital, acetaminophen and caffeine
Product NDC 0527-4094
11-digit product format 005274094
Labeler code 0527
Product ID 0527-4094_e505b8df-b401-4967-b4d5-c0717a6a1d08
Type HUMAN PRESCRIPTION DRUG
Nonproprietary name butalbital, acetaminophen and caffeine
Dosage form CAPSULE
Route ORAL
Labeler Lannett Company, Inc.
Application ANDA212083
Marketing category ANDA
Marketing start 2019-12-17
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]
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 238153
DailyMed Product Concepts# DailyMed Package Descriptions# Package NDC, Product, Description table Package NDC Product Description Form Quantity Strength SPL version 0527-4094-37 butalbital, acetaminophen and caffeine 100 in 1 BOTTLE, PLASTIC CAPSULE 100 9
DailyMed Dashboard NDC Coverage# NDC, Dashboard title, SPL version table NDC Dashboard title SPL version Validation Dashboard ZIP 0527-4094 BUTALBITAL, ACETAMINOPHEN AND CAFFEINE CAPSULE [LANNETT COMPANY, INC.] 9 Current NDC, Legacy NDC, 1 package rows 20220826_c1107153-494b-4068-8500-96bc241187a5.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 0527-4094-37 00527409437 100 CAPSULE in 1 BOTTLE, PLASTIC (0527-4094-37) 100 capsule 2019-12-17 0000-00-00 No No Current