Home NDC 79739-6670 Butalbital, Acetaminophen, Caffeine, and Codeine Phosphate
Product NDC 79739-6670
11-digit product format 797396670
Labeler code 79739
Product ID 79739-6670_20dc9c68-50ed-4c48-a516-d5b82b3654a6
Type HUMAN PRESCRIPTION DRUG
Nonproprietary name Butalbital, Acetaminophen, Caffeine, and Codeine Phosphate
Dosage form CAPSULE
Route ORAL
Labeler LGM PHARMA SOLUTIONS, LLC
Application ANDA076560
Marketing category ANDA
Marketing start 2004-06-10
Substance ACETAMINOPHEN; BUTALBITAL; CAFFEINE; CODEINE PHOSPHATE
Active strength 325; 50; 40; 30 mg/1; mg/1; mg/1; mg/1
Pharmacologic classes Barbiturate [EPC], Barbiturates [CS], Central Nervous System Stimulant [EPC], Central Nervous System Stimulation [PE], Full Opioid Agonists [MoA], Methylxanthine [EPC], Opioid Agonist [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, Caffeine, and Codeine Phosphate
Listing expiration 2026-12-31 Active Ingredients# Ingredient, Strength table Ingredient Strength ACETAMINOPHEN 325 mg/1 BUTALBITAL 50 mg/1 CAFFEINE 40 mg/1 CODEINE PHOSPHATE 30 mg/1
Harmonized Identifiers# Field, Values table Field Values Unii 362O9ITL9D, KHS0AZ4JVK, 3G6A5W338E, GSL05Y1MN6 Rxcui 993943
DailyMed Product Concepts# FDA-Initiated Inactive NDC Indexing# NDC, Effective, Action table NDC Effective Action Document Indexing SPL Related label 79739-6670-1 2024-04-23 C162847 48780-1 1030e365-49c7-111a-e063-dadaa90a10e2 These highlights do not include all the information needed to use Butalbital, Acetaminophen, Caffeine, and Codeine Phosphate Capsules safely and effectively. See full prescribing information for Butalbital, Acetaminophen, Caffeine, and Codeine Phosphate Capsules. Butalbital, Acetaminophen, Caffeine, and Codeine Phosphate Capsules for oral use, CIII Initial U.S. Approval: 1992 79739-6670-5 2024-04-23 C162847 48780-1 1030e365-49c7-111a-e063-dadaa90a10e2 These highlights do not include all the information needed to use Butalbital, Acetaminophen, Caffeine, and Codeine Phosphate Capsules safely and effectively. See full prescribing information for Butalbital, Acetaminophen, Caffeine, and Codeine Phosphate Capsules. Butalbital, Acetaminophen, Caffeine, and Codeine Phosphate Capsules for oral use, CIII Initial U.S. Approval: 1992 79739-6670-1 2024-01-30 C162847 48780-1 1030e365-49c7-111a-e063-dadaa90a10e2 These highlights do not include all the information needed to use Butalbital, Acetaminophen, Caffeine, and Codeine Phosphate Capsules safely and effectively. See full prescribing information for Butalbital, Acetaminophen, Caffeine, and Codeine Phosphate Capsules. Butalbital, Acetaminophen, Caffeine, and Codeine Phosphate Capsules for oral use, CIII Initial U.S. Approval: 1992 79739-6670-5 2024-01-30 C162847 48780-1 1030e365-49c7-111a-e063-dadaa90a10e2 These highlights do not include all the information needed to use Butalbital, Acetaminophen, Caffeine, and Codeine Phosphate Capsules safely and effectively. See full prescribing information for Butalbital, Acetaminophen, Caffeine, and Codeine Phosphate Capsules. Butalbital, Acetaminophen, Caffeine, and Codeine Phosphate Capsules for oral use, CIII Initial U.S. Approval: 1992
DailyMed Package Descriptions# Package NDC, Product, Description table Package NDC Product Description Form Quantity Strength SPL version 79739-6670-1 Butalbital, Acetaminophen, Caffeine, and Codeine Phosphate 100 in 1 BOTTLE, PLASTIC CAPSULE 100 4 79739-6670-5 Butalbital, Acetaminophen, Caffeine, and Codeine Phosphate 500 in 1 BOTTLE, PLASTIC CAPSULE 500 4
DailyMed Dashboard NDC Coverage# NDC, Dashboard title, SPL version table NDC Dashboard title SPL version Validation Dashboard ZIP 79739-6670 BUTALBITAL, ACETAMINOPHEN, CAFFEINE, AND CODEINE PHOSPHATE CAPSULE [LGM PHARMA SOLUTIONS, LLC] 4 Current NDC, Legacy NDC, 2 package rows 20240504_180d20a5-78a8-4faa-98ad-3196cdd5663a.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 79739-6670-1 79739667001 100 CAPSULE in 1 BOTTLE, PLASTIC (79739-6670-1) 100 capsule 2004-06-10 0000-00-00 No No Current 79739-6670-5 79739667005 500 CAPSULE in 1 BOTTLE, PLASTIC (79739-6670-5) 500 capsule 2004-06-10 0000-00-00 No No Current