Home NDC 53002-6031 Butalbital, Acetaminophen, Caffeine
Product NDC 53002-6031
11-digit product format 530026031
Labeler code 53002
Product ID 53002-6031_2f87defd-d0a8-4137-a063-70d1d6b7456a
Type HUMAN PRESCRIPTION DRUG
Nonproprietary name Butalbital, Acetaminophen, and Caffeine
Dosage form TABLET, COATED
Route ORAL
Labeler RPK Pharmaceuticals, Inc.
Application ANDA209587
Marketing category ANDA
Marketing start 2019-03-05
Marketing end 0000-00-00
Substance ACETAMINOPHEN; BUTALBITAL; CAFFEINE
Active strength 325 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 Packages# Package NDC, 11-digit format, Description table Package NDC 11-digit format Description Marketing start Marketing end Sample Exclude flag Status 53002-6031-1 53002603101 10 TABLET, COATED in 1 BOTTLE (53002-6031-1) 2022-04-01 0000-00-00 No No Current 53002-6031-2 53002603102 20 TABLET, COATED in 1 BOTTLE (53002-6031-2) 2022-04-01 0000-00-00 No No Current 53002-6031-3 53002603103 30 TABLET, COATED in 1 BOTTLE (53002-6031-3) 2022-04-01 0000-00-00 No No Current