Home NDC 62135-751 BUTALBITAL, ACETAMINOPHEN AND CAFFEINE
Product NDC 62135-751
11-digit product format 621350751
Labeler code 62135
Product ID 62135-751_458c0456-32bb-ff23-e063-6394a90aceea
Type HUMAN PRESCRIPTION DRUG
Nonproprietary name BUTALBITAL, ACETAMINOPHEN AND CAFFEINE
Dosage form TABLET
Route ORAL
Labeler Chartwell RX, LLC
Application ANDA089175
Marketing category ANDA
Marketing start 1987-01-21
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 62135-751-01 BUTALBITAL, ACETAMINOPHEN AND CAFFEINE 100 in 1 BOTTLE TABLET 100 3
DailyMed Dashboard NDC Coverage# NDC, Dashboard title, SPL version table NDC Dashboard title SPL version Validation Dashboard ZIP 62135-751 BUTALBITAL, ACETAMINOPHEN AND CAFFEINE TABLET [CHARTWELL RX, LLC] 2 Current NDC, 1 package rows 20241016_77776146-c6e6-478c-b30e-2b729e758400.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 62135-751-01 62135075101 100 TABLET in 1 BOTTLE (62135-751-01) 100 tablet 2023-08-25 No No Current