Home NDC 51862-179 butalbital, acetaminophen and caffeine
Product NDC 51862-179
11-digit product format 518620179
Labeler code 51862
Product ID 51862-179_2b358863-b03e-1f14-e063-6394a90a0fca
Type HUMAN PRESCRIPTION DRUG
Nonproprietary name butalbital, acetaminophen and caffeine
Dosage form CAPSULE
Route ORAL
Labeler Mayne Pharma
Application ANDA089007
Marketing category ANDA
Marketing start 2012-04-16
Marketing end 2026-09-19
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
Current FDA listing Yes Additional Listing Data#
Finished product Yes
Brand name base butalbital, acetaminophen and caffeine 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 51862-179-01 butalbital, acetaminophen and caffeine 100 in 1 BOTTLE, PLASTIC CAPSULE 100 10
DailyMed Socrata Ingredients# Ingredient, Type, UNII table Ingredient Type UNII DailyMed label SPL version Uploaded ACETAMINOPHEN ACTIVE INGREDIENT 362O9ITL9D BUTALBITAL, ACETAMINOPHEN AND CAFFEINE CAPSULE [MAYNE PHARMA INC.] 3 BUTALBITAL ACTIVE INGREDIENT KHS0AZ4JVK BUTALBITAL, ACETAMINOPHEN AND CAFFEINE CAPSULE [MAYNE PHARMA INC.] 3 CAFFEINE ACTIVE INGREDIENT 3G6A5W338E BUTALBITAL, ACETAMINOPHEN AND CAFFEINE CAPSULE [MAYNE PHARMA INC.] 3 ACETAMINOPHEN ACTIVE MOIETY 362O9ITL9D BUTALBITAL, ACETAMINOPHEN AND CAFFEINE CAPSULE [MAYNE PHARMA INC.] 3 BUTALBITAL ACTIVE MOIETY KHS0AZ4JVK BUTALBITAL, ACETAMINOPHEN AND CAFFEINE CAPSULE [MAYNE PHARMA INC.] 3 CAFFEINE ACTIVE MOIETY 3G6A5W338E BUTALBITAL, ACETAMINOPHEN AND CAFFEINE CAPSULE [MAYNE PHARMA INC.] 3 CELLULOSE, MICROCRYSTALLINE INACTIVE INGREDIENT OP1R32D61U BUTALBITAL, ACETAMINOPHEN AND CAFFEINE CAPSULE [MAYNE PHARMA INC.] 3 CROSCARMELLOSE SODIUM INACTIVE INGREDIENT M28OL1HH48 BUTALBITAL, ACETAMINOPHEN AND CAFFEINE CAPSULE [MAYNE PHARMA INC.] 3 GELATIN INACTIVE INGREDIENT 2G86QN327L BUTALBITAL, ACETAMINOPHEN AND CAFFEINE CAPSULE [MAYNE PHARMA INC.] 3 MAGNESIUM STEARATE INACTIVE INGREDIENT 70097M6I30 BUTALBITAL, ACETAMINOPHEN AND CAFFEINE CAPSULE [MAYNE PHARMA INC.] 3 SILICON DIOXIDE INACTIVE INGREDIENT ETJ7Z6XBU4 BUTALBITAL, ACETAMINOPHEN AND CAFFEINE CAPSULE [MAYNE PHARMA INC.] 3 TITANIUM DIOXIDE INACTIVE INGREDIENT 15FIX9V2JP BUTALBITAL, ACETAMINOPHEN AND CAFFEINE CAPSULE [MAYNE PHARMA INC.] 3
DailyMed Dashboard NDC Coverage# NDC, Dashboard title, SPL version table NDC Dashboard title SPL version Validation Dashboard ZIP 51862-179 BUTALBITAL, ACETAMINOPHEN AND CAFFEINE CAPSULE [MAYNE PHARMA] 10 Current NDC, Legacy NDC, 1 package rows 20250110_fa88f437-830b-48bc-a44c-fd142963a150.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 51862-179-01 51862017901 100 CAPSULE in 1 BOTTLE, PLASTIC (51862-179-01) 100 capsule 2012-04-16 2026-09-19 No No Current