Home NDC 51672-4222 Butalbital, Acetaminophen and Caffeine
Product NDC 51672-4222
11-digit product format 516724222
Labeler code 51672
Product ID 51672-4222_2035de72-f010-bc60-e063-6394a90a24f9
Type HUMAN PRESCRIPTION DRUG
Nonproprietary name butalbital, acetaminophen, and caffeine
Dosage form CAPSULE
Route ORAL
Labeler Taro Pharmaceuticals U.S.A., Inc.
Application ANDA213046
Marketing category ANDA
Marketing start 2020-07-01
Substance ACETAMINOPHEN; BUTALBITAL; CAFFEINE
Active strength 300; 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 300 mg/1 BUTALBITAL 50 mg/1 CAFFEINE 40 mg/1
Harmonized Identifiers# Field, Values table Field Values Unii 362O9ITL9D, KHS0AZ4JVK, 3G6A5W338E Rxcui 889520
DailyMed Product Concepts# FDA-Initiated Inactive NDC Indexing# NDC, Effective, Action table NDC Effective Action Document Indexing SPL Related label 51672-4222-1 2024-08-21 C162847 48780-1 f386c64a-0b7d-0266-e053-dadaa90a7c1a Butalbital, Acetaminophen5234032-0922-00, and Caffeine Capsules, USP 50 mg, 300 mg and 40 mg 51672-4222-1 2024-01-30 C162847 48780-1 f386c64a-0b7d-0266-e053-dadaa90a7c1a Butalbital, Acetaminophen5234032-0922-00, and Caffeine Capsules, USP 50 mg, 300 mg and 40 mg 51672-4222-1 2023-02-03 C162847 48780-1 f386c64a-0b7d-0266-e053-dadaa90a7c1a Butalbital, Acetaminophen5234032-0922-00, and Caffeine Capsules, USP 50 mg, 300 mg and 40 mg 51672-4222-1 2023-01-30 C162847 48780-1 f386c64a-0b7d-0266-e053-dadaa90a7c1a Butalbital, Acetaminophen5234032-0922-00, and Caffeine Capsules, USP 50 mg, 300 mg and 40 mg
DailyMed Package Descriptions# Package NDC, Product, Description table Package NDC Product Description Form Quantity Strength SPL version 51672-4222-1 Butalbital, Acetaminophen and Caffeine 100 in 1 BOTTLE CAPSULE 100 4
DailyMed Dashboard NDC Coverage# NDC, Dashboard title, SPL version table NDC Dashboard title SPL version Validation Dashboard ZIP 51672-4222 BUTALBITAL, ACETAMINOPHEN AND CAFFEINE (BUTALBITAL, ACETAMINOPHEN, AND CAFFEINE) CAPSULE [TARO PHARMACEUTICALS U.S.A., INC.] 4 Current NDC, Legacy NDC, 1 package rows 20240823_a68de112-f5af-49ba-a8a8-3adbaa7df36e.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 51672-4222-1 51672422201 100 CAPSULE in 1 BOTTLE (51672-4222-1) 100 capsule 2020-07-01 0000-00-00 No No Current