Home NDC 42195-955 Butalbital, Acetaminophen and Caffeine
Product NDC 42195-955
11-digit product format 421950955
Labeler code 42195
Product ID 42195-955_ec7c3ac0-9be8-4f4b-8ca8-2790eaaec326
Type HUMAN PRESCRIPTION DRUG
Nonproprietary name Butalbital, Acetaminophen and Caffeine
Dosage form CAPSULE
Route ORAL
Labeler Xspire Pharma, LLC
Application ANDA206615
Marketing category ANDA
Marketing start 2017-08-04
Marketing end 0000-00-00
Substance ACETAMINOPHEN; BUTALBITAL; CAFFEINE
Active strength 300 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 2023-12-31
Current FDA listing Historical FDA.report record DailyMed Product Concepts# FDA-Initiated Inactive NDC Indexing# DailyMed Dashboard NDC Coverage# NDC, Dashboard title, SPL version table NDC Dashboard title SPL version Validation Dashboard ZIP 42195-955 BUTALBITAL, ACETAMINOPHEN AND CAFFEINE CAPSULE [XSPIRE PHARMA, LLC] 11 Legacy NDC 20220119_56d6c70e-b2c0-0276-e054-00144ff88e88.zip
Packages# Package NDC, 11-digit format, Description table Package NDC 11-digit format Description Units Marketing start Marketing end Sample Exclude flag Status 42195-955-10 42195095510 100 CAPSULE in 1 BOTTLE (42195-955-10) 100 capsule 2017-08-04 0000-00-00 No No Current