Home NDC 0904-6938 Butalbital, Acetaminophen, and Caffeine
Product NDC 0904-6938
11-digit product format 009046938
Labeler code 0904
Product ID 0904-6938_32566e32-634f-4d28-b269-a65e97a1d258
Type HUMAN PRESCRIPTION DRUG
Nonproprietary name Butalbital, Acetaminophen, and Caffeine
Dosage form TABLET
Route ORAL
Labeler Major Pharmaceuticals
Application ANDA200243
Marketing category ANDA
Marketing start 2012-09-13
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 2027-12-31
Current FDA listing Yes Additional Listing Data#
Finished product Yes
Brand name base Butalbital, Acetaminophen, and Caffeine
Listing expiration 2027-12-31 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 0904-6938-06 Butalbital, Acetaminophen, and Caffeine 50 in 1 CARTON TABLET 50 7 0904-6938-06 Butalbital, Acetaminophen, and Caffeine 1 in 1 BLISTER PACK TABLET 1 7
DailyMed Dashboard NDC Coverage# NDC, Dashboard title, SPL version table NDC Dashboard title SPL version Validation Dashboard ZIP 0904-6938 BUTALBITAL, ACETAMINOPHEN, AND CAFFEINE TABLET [MAJOR PHARMACEUTICALS] 5 Current NDC, Legacy NDC, 2 package rows 20250212_0ca49c3c-f2cb-40e3-a7d5-5f48eca59016.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 0904-6938-06 00904693806 50 BLISTER PACK in 1 CARTON (0904-6938-06) / 1 TABLET in 1 BLISTER PACK 50 blister pack 2012-09-13 0000-00-00 No No Current