Home NDC 51407-557 Dextroamphetamine Saccharate, Amphetamine Aspartate Monohydrate, Dextroamphetamine Sulfate and Amphetamine Sulfate
Product NDC 51407-557
11-digit product format 514070557
Labeler code 51407
Product ID 51407-557_52bb4c0f-7d36-f933-e063-6294a90ab549
Type HUMAN PRESCRIPTION DRUG
Nonproprietary name Dextroamphetamine Sulfate, Dextroamphetamine Saccharate, Amphetamine Sulfate and Amphetamine Aspartate
Dosage form CAPSULE, EXTENDED RELEASE
Route ORAL
Labeler Golden State Medical Supply, Inc.
Application ANDA214403
Marketing category ANDA
Marketing start 2021-11-26
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 6DPV8NK46S, G83415V073, O1ZPV620O4, JJ768O327N Rxcui 861221, 861223, 861225, 861227, 861232, 861237
DailyMed Product Concepts# DailyMed Package Descriptions# Package NDC, Product, Description table Package NDC Product Description Form Quantity Strength SPL version 51407-557-01 Dextroamphetamine Saccharate, Amphetamine Aspartate Monohydrate, Dextroamphetamine Sulfate and Amphetamine Sulfate 100 in 1 BOTTLE CAPSULE, EXTENDED RELEASE 100 6
DailyMed Dashboard NDC Coverage# NDC, Dashboard title, SPL version table NDC Dashboard title SPL version Validation Dashboard ZIP 51407-557 DEXTROAMPHETAMINE SACCHARATE, AMPHETAMINE ASPARTATE MONOHYDRATE, DEXTROAMPHETAMINE SULFATE AND AMPHETAMINE SULFATE (DEXTROAMPHETAMINE SULFATE, DEXTROAMPHETAMINE SACCHARATE, AMPHETAMINE SULFATE AND AMPHETAMINE ASPARTATE) CAPSULE, EXTENDED RELEASE [GOLDEN STATE MEDICAL SUPPLY, INC.] 3 Current NDC, 1 package rows 20231227_f6dfefdf-7a4a-e104-e053-6394a90a05bd.zip
Packages# Package NDC, 11-digit format, Description table Package NDC 11-digit format Description Marketing start Sample Exclude flag Status 51407-557-01 51407055701 100 CAPSULE, EXTENDED RELEASE in 1 BOTTLE (51407-557-01) 2023-02-21 No No Historical