Home NDC 42858-055 Dextroamphetamine Saccharate, Amphetamine Aspartate Monohydrate, Dextroamphetamine Sulfate, and Amphetamine Sulfate Extended-Release
Product NDC 42858-055
11-digit product format 428580055
Labeler code 42858
Product ID 42858-055_fc3523da-50f2-4962-8fdc-eee17997dcd1
Type HUMAN PRESCRIPTION DRUG
Nonproprietary name DEXTROAMPHETAMINE SACCHARATE, AMPHETAMINE ASPARTATE MONOHYDRATE, DEXTROAMPHETAMINE SULFATE, and AMPHETAMINE SULFATE
Dosage form CAPSULE, EXTENDED RELEASE
Route ORAL
Labeler Rhodes Pharmaceuticals LLC
Application ANDA210651
Marketing category ANDA
Marketing start 2019-08-22
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 Extended-Release
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 42858-055-01 Dextroamphetamine Saccharate, Amphetamine Aspartate Monohydrate, Dextroamphetamine Sulfate, and Amphetamine Sulfate Extended-Release 100 in 1 BOTTLE, PLASTIC CAPSULE, EXTENDED RELEASE 100 8
DailyMed Dashboard NDC Coverage# NDC, Dashboard title, SPL version table NDC Dashboard title SPL version Validation Dashboard ZIP 42858-055 DEXTROAMPHETAMINE SACCHARATE, AMPHETAMINE ASPARTATE MONOHYDRATE, DEXTROAMPHETAMINE SULFATE, AND AMPHETAMINE SULFATE EXTENDED-RELEASE (DEXTROAMPHETAMINE SACCHARATE, AMPHETAMINE ASPARTATE MONOHYDRATE, DEXTROAMPHETAMINE SULFATE, AND AMPHETAMINE SULFATE) CAPSULE, EXTENDED RELEASE [RHODES PHARMACEUTICALS L.P.] 6 Current NDC, Legacy NDC, 1 package rows 20231109_690e1ef4-caf7-4c48-a4ae-d2a0ab684e82.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 690e1ef4-caf7-4c48-a4ae-d2a0ab684e82 8 861221 dextroamphetamine saccharate 2.5 MG / amphetamine aspartate 2.5 MG / dextroamphetamine sulfate 2.5 MG / amphetamine sulfate 2.5 MG 24HR Extended Release Oral Capsule PSN 690e1ef4-caf7-4c48-a4ae-d2a0ab684e82 8 861223 dextroamphetamine saccharate 3.75 MG / amphetamine aspartate 3.75 MG / dextroamphetamine sulfate 3.75 MG / amphetamine sulfate 3.75 MG 24HR Extended Release Oral Capsule PSN 690e1ef4-caf7-4c48-a4ae-d2a0ab684e82 8 861225 dextroamphetamine saccharate 5 MG / amphetamine aspartate 5 MG / dextroamphetamine sulfate 5 MG / amphetamine sulfate 5 MG 24HR Extended Release Oral Capsule PSN 690e1ef4-caf7-4c48-a4ae-d2a0ab684e82 8 861227 dextroamphetamine saccharate 6.25 MG / amphetamine aspartate 6.25 MG / dextroamphetamine sulfate 6.25 MG / amphetamine sulfate 6.25 MG 24HR Extended Release Oral Capsule PSN 690e1ef4-caf7-4c48-a4ae-d2a0ab684e82 8 861232 dextroamphetamine saccharate 7.5 MG / amphetamine aspartate 7.5 MG / dextroamphetamine sulfate 7.5 MG / amphetamine sulfate 7.5 MG 24HR Extended Release Oral Capsule PSN 690e1ef4-caf7-4c48-a4ae-d2a0ab684e82 8 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 690e1ef4-caf7-4c48-a4ae-d2a0ab684e82 8 861221 24 HR amphetamine aspartate 2.5 MG / amphetamine sulfate 2.5 MG / dextroamphetamine saccharate 2.5 MG / dextroamphetamine sulfate 2.5 MG Extended Release Oral Capsule SCD 690e1ef4-caf7-4c48-a4ae-d2a0ab684e82 8 861223 24 HR amphetamine aspartate 3.75 MG / amphetamine sulfate 3.75 MG / dextroamphetamine saccharate 3.75 MG / dextroamphetamine sulfate 3.75 MG Extended Release Oral Capsule SCD 690e1ef4-caf7-4c48-a4ae-d2a0ab684e82 8 861225 24 HR amphetamine aspartate 5 MG / amphetamine sulfate 5 MG / dextroamphetamine saccharate 5 MG / dextroamphetamine sulfate 5 MG Extended Release Oral Capsule SCD 690e1ef4-caf7-4c48-a4ae-d2a0ab684e82 8 861227 24 HR amphetamine aspartate 6.25 MG / amphetamine sulfate 6.25 MG / dextroamphetamine saccharate 6.25 MG / dextroamphetamine sulfate 6.25 MG Extended Release Oral Capsule SCD 690e1ef4-caf7-4c48-a4ae-d2a0ab684e82 8 861232 24 HR amphetamine aspartate 7.5 MG / amphetamine sulfate 7.5 MG / dextroamphetamine saccharate 7.5 MG / dextroamphetamine sulfate 7.5 MG Extended Release Oral Capsule SCD 690e1ef4-caf7-4c48-a4ae-d2a0ab684e82 8 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 690e1ef4-caf7-4c48-a4ae-d2a0ab684e82 8 861221 amphetamine aspartate 2.5 MG / amphetamine sulfate 2.5 MG / dextroamphetamine saccharate 2.5 MG / dextroamphetamine sulfate 2.5 MG 24 HR Extended Release Oral Capsule SY 690e1ef4-caf7-4c48-a4ae-d2a0ab684e82 8 861223 amphetamine aspartate 3.75 MG / amphetamine sulfate 3.75 MG / dextroamphetamine saccharate 3.75 MG / dextroamphetamine sulfate 3.75 MG 24 HR Extended Release Oral Capsule SY 690e1ef4-caf7-4c48-a4ae-d2a0ab684e82 8 861225 amphetamine aspartate 5 MG / amphetamine sulfate 5 MG / dextroamphetamine saccharate 5 MG / dextroamphetamine sulfate 5 MG 24 HR Extended Release Oral Capsule SY 690e1ef4-caf7-4c48-a4ae-d2a0ab684e82 8 861227 amphetamine aspartate 6.25 MG / amphetamine sulfate 6.25 MG / dextroamphetamine saccharate 6.25 MG / dextroamphetamine sulfate 6.25 MG 24 HR Extended Release Oral Capsule SY 690e1ef4-caf7-4c48-a4ae-d2a0ab684e82 8 861232 amphetamine aspartate 7.5 MG / amphetamine sulfate 7.5 MG / dextroamphetamine saccharate 7.5 MG / dextroamphetamine sulfate 7.5 MG 24 HR Extended Release Oral Capsule SY 690e1ef4-caf7-4c48-a4ae-d2a0ab684e82 8
Packages# Package NDC, 11-digit format, Description table Package NDC 11-digit format Description Marketing start Marketing end Sample Exclude flag Status 42858-055-01 42858005501 100 CAPSULE, EXTENDED RELEASE in 1 BOTTLE, PLASTIC (42858-055-01) 2019-08-22 0000-00-00 No No Current