Home NDC 16714-170 Butalbital, Acetaminophen, and Caffeine
Product NDC 16714-170
11-digit product format 167140170
Labeler code 16714
Product ID 16714-170_c884344b-2520-4874-866c-bf9798b506d3
Type HUMAN PRESCRIPTION DRUG
Nonproprietary name Butalbital, Acetaminophen, and Caffeine
Dosage form CAPSULE
Route ORAL
Labeler NORTHSTAR RX LLC
Application ANDA213046
Marketing category ANDA
Marketing start 2020-07-01
Substance ACETAMINOPHEN; BUTALBITAL; CAFFEINE
Active strength 300; 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 300 mg/1 BUTALBITAL 50 mg/1 CAFFEINE 40 mg/1
Harmonized Identifiers# Field, Values table Field Values Unii 362O9ITL9D, KHS0AZ4JVK, 3G6A5W338E Rxcui 889520
DailyMed Product Concepts# DailyMed Package Descriptions# Package NDC, Product, Description table Package NDC Product Description Form Quantity Strength SPL version 16714-170-01 Butalbital, Acetaminophen, and Caffeine 100 in 1 BOTTLE CAPSULE 100 1
DailyMed Dashboard NDC Coverage# NDC, Dashboard title, SPL version table NDC Dashboard title SPL version Validation Dashboard ZIP 16714-170 BUTALBITAL, ACETAMINOPHEN, AND CAFFEINE CAPSULE [NORTHSTAR RX LLC] 1 Current NDC, Legacy NDC, 1 package rows 20201006_83a63e9b-0a97-4725-bcbb-906fb678ba42.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 16714-170-01 16714017001 100 CAPSULE in 1 BOTTLE (16714-170-01) 100 capsule 2020-09-23 0000-00-00 No No Current