Home NDC 10702-253 Butalbital, Acetaminophen and Caffeine
Product NDC 10702-253
11-digit product format 107020253
Labeler code 10702
Product ID 10702-253_11879952-bfdc-4f90-e063-6394a90aae40
Type HUMAN PRESCRIPTION DRUG
Nonproprietary name Butalbital, Acetaminophen and Caffeine
Dosage form TABLET
Route ORAL
Labeler KVK-Tech, Inc.
Application ANDA211106
Marketing category ANDA
Marketing start 2018-09-26
Substance ACETAMINOPHEN; BUTALBITAL; CAFFEINE
Active strength 325; 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 325 mg/1 BUTALBITAL 50 mg/1 CAFFEINE 40 mg/1
Harmonized Identifiers# Field, Values table Field Values Unii 362O9ITL9D, KHS0AZ4JVK, 3G6A5W338E Rxcui 238154
DailyMed Product Concepts# FDA-Initiated Inactive NDC Indexing# NDC, Effective, Action table NDC Effective Action Document Indexing SPL Related label 10702-253-01 2024-02-16 C162847 48780-1 1030e365-259b-111a-e063-dadaa90a10e2 Butalbital, Acetaminophen and Caffeine Tablets, USP 50 mg/325 mg/40 mg Rx Only 10702-253-50 2024-02-16 C162847 48780-1 1030e365-259b-111a-e063-dadaa90a10e2 Butalbital, Acetaminophen and Caffeine Tablets, USP 50 mg/325 mg/40 mg Rx Only 10702-253-01 2024-01-30 C162847 48780-1 1030e365-259b-111a-e063-dadaa90a10e2 Butalbital, Acetaminophen and Caffeine Tablets, USP 50 mg/325 mg/40 mg Rx Only 10702-253-50 2024-01-30 C162847 48780-1 1030e365-259b-111a-e063-dadaa90a10e2 Butalbital, Acetaminophen and Caffeine Tablets, USP 50 mg/325 mg/40 mg Rx Only
DailyMed Package Descriptions# Package NDC, Product, Description table Package NDC Product Description Form Quantity Strength SPL version 10702-253-01 Butalbital, Acetaminophen and Caffeine 100 in 1 BOTTLE TABLET 100 6 10702-253-50 Butalbital, Acetaminophen and Caffeine 500 in 1 BOTTLE TABLET 500 6
DailyMed Dashboard NDC Coverage# NDC, Dashboard title, SPL version table NDC Dashboard title SPL version Validation Dashboard ZIP 10702-253 BUTALBITAL, ACETAMINOPHEN AND CAFFEINE TABLET [KVK-TECH, INC.] 6 Current NDC, Legacy NDC, 2 package rows 20240217_7f9c4668-4f4a-453b-b2fa-a6fed903ddfa.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 10702-253-01 10702025301 100 TABLET in 1 BOTTLE (10702-253-01) 100 tablet 2018-09-26 0000-00-00 No No Current 10702-253-50 10702025350 500 TABLET in 1 BOTTLE (10702-253-50) 500 tablet 2018-11-29 0000-00-00 No No Current