Home NDC 63629-2380 DEXTROAMPHETAMINE SACCHARATE, AMPHETAMINE ASPARTATE, DEXTROAMPHETAMINE SULFATE AND AMPHETAMINE SULFATE
Product NDC 63629-2380
11-digit product format 636292380
Labeler code 63629
Product ID 63629-2380_01b755c0-e17e-4c0f-a62d-12eb858bc888
Type HUMAN PRESCRIPTION DRUG
Nonproprietary name dextroamphetamine saccharate, amphetamine aspartate, dextroamphetamine sulfate and amphetamine sulfate
Dosage form TABLET
Route ORAL
Labeler Bryant Ranch Prepack
Application ANDA209799
Marketing category ANDA
Marketing start 2018-07-04
Substance AMPHETAMINE ASPARTATE MONOHYDRATE; AMPHETAMINE SULFATE; DEXTROAMPHETAMINE SACCHARATE; DEXTROAMPHETAMINE SULFATE
Active strength 2.5; 2.5; 2.5; 2.5 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 2026-12-31
Current FDA listing Yes Additional Listing Data#
Finished product Yes
Brand name base DEXTROAMPHETAMINE SACCHARATE, AMPHETAMINE ASPARTATE, DEXTROAMPHETAMINE SULFATE AND AMPHETAMINE SULFATE
Listing expiration 2026-12-31 Active Ingredients# Ingredient, Strength table Ingredient Strength AMPHETAMINE ASPARTATE MONOHYDRATE 2.5 mg/1 AMPHETAMINE SULFATE 2.5 mg/1 DEXTROAMPHETAMINE SACCHARATE 2.5 mg/1 DEXTROAMPHETAMINE SULFATE 2.5 mg/1
Harmonized Identifiers# Field, Values table Field Values Unii O1ZPV620O4, 6DPV8NK46S, G83415V073, JJ768O327N Rxcui 541892
DailyMed Product Concepts# DailyMed Package Descriptions# Package NDC, Product, Description table Package NDC Product Description Form Quantity Strength SPL version 63629-2380-1 DEXTROAMPHETAMINE SACCHARATE, AMPHETAMINE ASPARTATE, DEXTROAMPHETAMINE SULFATE AND AMPHETAMINE SULFATE 100 in 1 BOTTLE TABLET 100 103
DailyMed Dashboard NDC Coverage# NDC, Dashboard title, SPL version table NDC Dashboard title SPL version Validation Dashboard ZIP 63629-2380 DEXTROAMPHETAMINE SACCHARATE, AMPHETAMINE ASPARTATE, DEXTROAMPHETAMINE SULFATE AND AMPHETAMINE SULFATE TABLET [BRYANT RANCH PREPACK] 103 Current NDC, Legacy NDC, 1 package rows 20231209_f897046a-8034-48d7-8b10-d57885868ba2.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 63629-2380-1 63629238001 100 TABLET in 1 BOTTLE (63629-2380-1) 100 tablet 2021-02-24 0000-00-00 No No Current