Home NDC 72162-1377 Dextroamphetamine Saccharate, Amphetamine Aspartate Monohydrate, Dextroamphetamine Sulfate and Amphetamine Sulfate
Product NDC 72162-1377
11-digit product format 721621377
Labeler code 72162
Product ID 72162-1377_7f584b67-d1e0-4dcf-833e-60f651834cba
Type HUMAN PRESCRIPTION DRUG
Nonproprietary name Dextroamphetamine Saccharate, Amphetamine Aspartate Monohydrate, Dextroamphetamine Sulfate and Amphetamine Sulfate
Dosage form CAPSULE, EXTENDED RELEASE
Route ORAL
Labeler Bryant Ranch Prepack
Application ANDA205401
Marketing category ANDA
Marketing start 2020-03-16
Substance AMPHETAMINE ASPARTATE MONOHYDRATE; AMPHETAMINE SULFATE; DEXTROAMPHETAMINE SACCHARATE; DEXTROAMPHETAMINE SULFATE
Active strength 1.25; 1.25; 1.25; 1.25 mg/1; mg/1; mg/1; mg/1
Pharmacologic classes Central Nervous System Stimulant [EPC], Central Nervous System Stimulant [EPC], Central Nervous System Stimulant [EPC], Central Nervous System Stimulant [EPC], Central Nervous System Stimulation [PE], Central Nervous System Stimulation [PE], Central Nervous System Stimulation [PE], Central Nervous System Stimulation [PE]
DEA schedule CII
NDC exclude flag No
Listing certified through 2027-12-31
Current FDA listing Yes Additional Listing Data#
Finished product Yes
Brand name base Dextroamphetamine Saccharate, Amphetamine Aspartate Monohydrate, Dextroamphetamine Sulfate and Amphetamine Sulfate
Listing expiration 2027-12-31 Active Ingredients# Ingredient, Strength table Ingredient Strength AMPHETAMINE ASPARTATE MONOHYDRATE 1.25 mg/1 AMPHETAMINE SULFATE 1.25 mg/1 DEXTROAMPHETAMINE SACCHARATE 1.25 mg/1 DEXTROAMPHETAMINE SULFATE 1.25 mg/1
Harmonized Identifiers# Field, Values table Field Values Unii O1ZPV620O4, 6DPV8NK46S, G83415V073, JJ768O327N Rxcui 861237
DailyMed Product Concepts# DailyMed Package Descriptions# Package NDC, Product, Description table Package NDC Product Description Form Quantity Strength SPL version 72162-1377-1 Dextroamphetamine Saccharate, Amphetamine Aspartate Monohydrate, Dextroamphetamine Sulfate and Amphetamine Sulfate 100 in 1 BOTTLE CAPSULE, EXTENDED RELEASE 100 102
DailyMed Dashboard NDC Coverage# NDC, Dashboard title, SPL version table NDC Dashboard title SPL version Validation Dashboard ZIP 72162-1377 DEXTROAMPHETAMINE SACCHARATE, AMPHETAMINE ASPARTATE MONOHYDRATE, DEXTROAMPHETAMINE SULFATE AND AMPHETAMINE SULFATE CAPSULE, EXTENDED RELEASE [BRYANT RANCH PREPACK] 101 Current NDC, 1 package rows 20250403_23d5ce6b-7b59-402f-b32e-ed99231d9eb9.zip
DailyMed RxNorm Mappings# RxCUI, RxNorm string, TTY table RxCUI RxNorm string TTY DailyMed SPL version 861237 dextroamphetamine saccharate 1.25 MG / amphetamine aspartate 1.25 MG / dextroamphetamine sulfate 1.25 MG / amphetamine sulfate 1.25 MG 24HR Extended Release Oral Capsule PSN 23d5ce6b-7b59-402f-b32e-ed99231d9eb9 102 861237 24 HR amphetamine aspartate 1.25 MG / amphetamine sulfate 1.25 MG / dextroamphetamine saccharate 1.25 MG / dextroamphetamine sulfate 1.25 MG Extended Release Oral Capsule SCD 23d5ce6b-7b59-402f-b32e-ed99231d9eb9 102 861237 amphetamine aspartate 1.25 MG / amphetamine sulfate 1.25 MG / dextroamphetamine saccharate 1.25 MG / dextroamphetamine sulfate 1.25 MG 24 HR Extended Release Oral Capsule SY 23d5ce6b-7b59-402f-b32e-ed99231d9eb9 102
Packages# Package NDC, 11-digit format, Description table Package NDC 11-digit format Description Marketing start Sample Exclude flag Status 72162-1377-1 72162137701 100 CAPSULE, EXTENDED RELEASE in 1 BOTTLE (72162-1377-1) 2021-02-04 No No Historical