Home NDC 0527-4095 Butalbital, Acetaminophen, and Caffeine
Product NDC 0527-4095
11-digit product format 005274095
Labeler code 0527
Product ID 0527-4095_146b5639-6699-471c-ae28-1f576bbead9f
Type HUMAN PRESCRIPTION DRUG
Nonproprietary name Butalbital, Acetaminophen, and Caffeine Capsules
Dosage form CAPSULE
Route ORAL
Labeler Lannett Company, Inc.
Application ANDA212082
Marketing category ANDA
Marketing start 2019-12-17
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]
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 0527-4095-37 Butalbital, Acetaminophen, and Caffeine 100 in 1 BOTTLE CAPSULE 100 12
DailyMed Dashboard NDC Coverage# NDC, Dashboard title, SPL version table NDC Dashboard title SPL version Validation Dashboard ZIP 0527-4095 BUTALBITAL, ACETAMINOPHEN, AND CAFFEINE (BUTALBITAL, ACETAMINOPHEN, AND CAFFEINE CAPSULES) CAPSULE [LANNETT COMPANY, INC.] 12 Current NDC, Legacy NDC, 1 package rows 20231108_4d62259d-a582-4621-b62e-3d5640cadf7c.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 0527-4095-37 00527409537 100 CAPSULE in 1 BOTTLE (0527-4095-37) 100 capsule 2019-12-17 0000-00-00 No No Current