Home NDC 63187-520 butalbital, acetaminophen and caffeine
Product NDC 63187-520
11-digit product format 631870520
Labeler code 63187
Product ID 63187-520_42b76389-6fa2-49a5-b435-672d3862c6f3
Type HUMAN PRESCRIPTION DRUG
Nonproprietary name butalbital, acetaminophen and caffeine
Dosage form TABLET
Route ORAL
Labeler Proficient Rx LP
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 63187-520-30 butalbital, acetaminophen and caffeine 30 in 1 BOTTLE, PLASTIC TABLET 30 3 63187-520-60 butalbital, acetaminophen and caffeine 60 in 1 BOTTLE, PLASTIC TABLET 60 3 63187-520-90 butalbital, acetaminophen and caffeine 90 in 1 BOTTLE, PLASTIC TABLET 90 3
DailyMed Socrata Ingredients# Ingredient, Type, UNII table Ingredient Type UNII DailyMed label SPL version Uploaded ACETAMINOPHEN ACTIVE INGREDIENT 362O9ITL9D BUTALBITAL, ACETAMINOPHEN AND CAFFEINE TABLET [PROFICIENT RX LP] 1 BUTALBITAL ACTIVE INGREDIENT KHS0AZ4JVK BUTALBITAL, ACETAMINOPHEN AND CAFFEINE TABLET [PROFICIENT RX LP] 1 CAFFEINE ACTIVE INGREDIENT 3G6A5W338E BUTALBITAL, ACETAMINOPHEN AND CAFFEINE TABLET [PROFICIENT RX LP] 1 ACETAMINOPHEN ACTIVE MOIETY 362O9ITL9D BUTALBITAL, ACETAMINOPHEN AND CAFFEINE TABLET [PROFICIENT RX LP] 1 BUTALBITAL ACTIVE MOIETY KHS0AZ4JVK BUTALBITAL, ACETAMINOPHEN AND CAFFEINE TABLET [PROFICIENT RX LP] 1 CAFFEINE ACTIVE MOIETY 3G6A5W338E BUTALBITAL, ACETAMINOPHEN AND CAFFEINE TABLET [PROFICIENT RX LP] 1 CELLULOSE, MICROCRYSTALLINE INACTIVE INGREDIENT OP1R32D61U BUTALBITAL, ACETAMINOPHEN AND CAFFEINE TABLET [PROFICIENT RX LP] 1 CROSCARMELLOSE SODIUM INACTIVE INGREDIENT M28OL1HH48 BUTALBITAL, ACETAMINOPHEN AND CAFFEINE TABLET [PROFICIENT RX LP] 1 CROSPOVIDONE INACTIVE INGREDIENT 68401960MK BUTALBITAL, ACETAMINOPHEN AND CAFFEINE TABLET [PROFICIENT RX LP] 1 POVIDONES INACTIVE INGREDIENT FZ989GH94E BUTALBITAL, ACETAMINOPHEN AND CAFFEINE TABLET [PROFICIENT RX LP] 1 SILICON DIOXIDE INACTIVE INGREDIENT ETJ7Z6XBU4 BUTALBITAL, ACETAMINOPHEN AND CAFFEINE TABLET [PROFICIENT RX LP] 1 STARCH, CORN INACTIVE INGREDIENT O8232NY3SJ BUTALBITAL, ACETAMINOPHEN AND CAFFEINE TABLET [PROFICIENT RX LP] 1 STEARIC ACID INACTIVE INGREDIENT 4ELV7Z65AP BUTALBITAL, ACETAMINOPHEN AND CAFFEINE TABLET [PROFICIENT RX LP] 1
DailyMed Dashboard NDC Coverage# NDC, Dashboard title, SPL version table NDC Dashboard title SPL version Validation Dashboard ZIP 63187-520 BUTALBITAL, ACETAMINOPHEN AND CAFFEINE TABLET [PROFICIENT RX LP] 3 Current NDC, Legacy NDC, 3 package rows 20210115_1bde13a5-cdd4-4bc2-8aeb-32e4dc157293.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 63187-520-30 63187052030 30 TABLET in 1 BOTTLE, PLASTIC (63187-520-30) 30 tablet 2018-12-01 0000-00-00 No No Current 63187-520-60 63187052060 60 TABLET in 1 BOTTLE, PLASTIC (63187-520-60) 60 tablet 2018-12-01 0000-00-00 No No Current 63187-520-90 63187052090 90 TABLET in 1 BOTTLE, PLASTIC (63187-520-90) 90 tablet 2018-12-01 0000-00-00 No No Current