Home NDC 13107-075 Butalbital, Acetaminophen and Caffeine
Product NDC 13107-075
11-digit product format 131070075
Labeler code 13107
Product ID 13107-075_bc2de4b3-7c0d-48db-b6e1-ee41bfad08e5
Type HUMAN PRESCRIPTION DRUG
Nonproprietary name Butalbital, Acetaminophen and Caffeine
Dosage form CAPSULE
Route ORAL
Labeler Aurolife Pharma, LLC
Application ANDA204733
Marketing category ANDA
Marketing start 2017-04-26
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 238153
DailyMed Product Concepts# FDA-Initiated Inactive NDC Indexing# NDC, Effective, Action table NDC Effective Action Document Indexing SPL Related label 13107-075-01 2025-01-15 C162847 48780-1 f386c64a-3db7-0266-e053-dadaa90a7c1a Butalbital, Acetaminophen and Caffeine Capsules, USP 50 mg/325 mg/40 mg Rx Only 13107-075-05 2025-01-15 C162847 48780-1 f386c64a-3db7-0266-e053-dadaa90a7c1a Butalbital, Acetaminophen and Caffeine Capsules, USP 50 mg/325 mg/40 mg Rx Only 13107-075-30 2025-01-15 C162847 48780-1 f386c64a-3db7-0266-e053-dadaa90a7c1a Butalbital, Acetaminophen and Caffeine Capsules, USP 50 mg/325 mg/40 mg Rx Only 13107-075-01 2023-01-30 C162847 48780-1 f386c64a-3db7-0266-e053-dadaa90a7c1a Butalbital, Acetaminophen and Caffeine Capsules, USP 50 mg/325 mg/40 mg Rx Only 13107-075-05 2023-01-30 C162847 48780-1 f386c64a-3db7-0266-e053-dadaa90a7c1a Butalbital, Acetaminophen and Caffeine Capsules, USP 50 mg/325 mg/40 mg Rx Only 13107-075-30 2023-01-30 C162847 48780-1 f386c64a-3db7-0266-e053-dadaa90a7c1a Butalbital, Acetaminophen and Caffeine Capsules, USP 50 mg/325 mg/40 mg Rx Only
DailyMed Package Descriptions# Package NDC, Product, Description table Package NDC Product Description Form Quantity Strength SPL version 13107-075-01 Butalbital, Acetaminophen and Caffeine 100 in 1 BOTTLE CAPSULE 100 5 13107-075-05 Butalbital, Acetaminophen and Caffeine 500 in 1 BOTTLE CAPSULE 500 5 13107-075-30 Butalbital, Acetaminophen and Caffeine 30 in 1 BOTTLE CAPSULE 30 5
DailyMed Dashboard NDC Coverage# NDC, Dashboard title, SPL version table NDC Dashboard title SPL version Validation Dashboard ZIP 13107-075 BUTALBITAL, ACETAMINOPHEN AND CAFFEINE CAPSULE [AUROLIFE PHARMA, LLC] 5 Current NDC, Legacy NDC, 3 package rows 20250417_f9fde75d-7def-48fc-a2b0-727f677f6001.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 13107-075-01 13107007501 100 CAPSULE in 1 BOTTLE (13107-075-01) 100 capsule 2017-04-26 0000-00-00 No No Current 13107-075-05 13107007505 500 CAPSULE in 1 BOTTLE (13107-075-05) 500 capsule 2017-04-26 0000-00-00 No No Current 13107-075-30 13107007530 30 CAPSULE in 1 BOTTLE (13107-075-30) 30 capsule 2017-04-26 0000-00-00 No No Current