Home NDC 68071-2365 Butalbital, Acetaminophen, Caffeine
Product NDC 68071-2365
11-digit product format 680712365
Labeler code 68071
Product ID 68071-2365_de1f2d42-17ec-34a4-e053-2995a90a3023
Type HUMAN PRESCRIPTION DRUG
Nonproprietary name Butalbital, Acetaminophen, and Caffeine
Dosage form TABLET, COATED
Route ORAL
Labeler NuCare 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 DailyMed Product Concepts# FDA-Initiated Inactive NDC Indexing# NDC, Effective, Action table NDC Effective Action Document Indexing SPL Related label 68071-2365-3 2025-01-30 C162847 48780-1 2cef2736-9cbd-d83d-e063-dadaa90ab31f BUTALBITAL, ACETAMINOPHEN AND CAFFEINE TABLETS, USP 50 mg/325 mg/40 mg 68071-2365-6 2025-01-30 C162847 48780-1 2cef2736-9cbd-d83d-e063-dadaa90ab31f BUTALBITAL, ACETAMINOPHEN AND CAFFEINE TABLETS, USP 50 mg/325 mg/40 mg 68071-2365-8 2025-01-30 C162847 48780-1 2cef2736-9cbd-d83d-e063-dadaa90ab31f BUTALBITAL, ACETAMINOPHEN AND CAFFEINE TABLETS, USP 50 mg/325 mg/40 mg 68071-2365-9 2025-01-30 C162847 48780-1 2cef2736-9cbd-d83d-e063-dadaa90ab31f BUTALBITAL, ACETAMINOPHEN AND CAFFEINE TABLETS, USP 50 mg/325 mg/40 mg
DailyMed Package Descriptions# Package NDC, Product, Description table Package NDC Product Description Form Quantity Strength SPL version 68071-2365-3 Butalbital, Acetaminophen, Caffeine 30 in 1 BOTTLE TABLET, COATED 30 3 68071-2365-6 Butalbital, Acetaminophen, Caffeine 60 in 1 BOTTLE TABLET, COATED 60 3 68071-2365-8 Butalbital, Acetaminophen, Caffeine 180 in 1 BOTTLE TABLET, COATED 180 3 68071-2365-9 Butalbital, Acetaminophen, Caffeine 90 in 1 BOTTLE TABLET, COATED 90 3
DailyMed Dashboard NDC Coverage# NDC, Dashboard title, SPL version table NDC Dashboard title SPL version Validation Dashboard ZIP 68071-2365 BUTALBITAL, ACETAMINOPHEN, CAFFEINE (BUTALBITAL, ACETAMINOPHEN, AND CAFFEINE) TABLET, COATED [NUCARE PHARMACEUTICALS,INC.] 3 Legacy NDC, 4 package rows 20220824_bd5d031e-e5e2-1671-e053-2995a90a5d5a.zip
DailyMed RxNorm Mappings# Packages# Package NDC, 11-digit format, Description table Package NDC 11-digit format Description Marketing start Marketing end Sample Exclude flag Status 68071-2365-3 68071236503 30 TABLET, COATED in 1 BOTTLE (68071-2365-3) 2021-03-12 0000-00-00 No No Current 68071-2365-6 68071236506 60 TABLET, COATED in 1 BOTTLE (68071-2365-6) 2021-03-12 0000-00-00 No No Current 68071-2365-8 68071236508 180 TABLET, COATED in 1 BOTTLE (68071-2365-8) 2021-03-12 0000-00-00 No No Current 68071-2365-9 68071236509 90 TABLET, COATED in 1 BOTTLE (68071-2365-9) 2021-03-12 0000-00-00 No No Current