NDC 42858-930

Dextroamphetamine Saccharate, Amphetamine Aspartate Monohydrate, Dextroamphetamine Sulfate, and Amphetamine Sulfate Extended-Release

Dextroamphetamine Saccharate, Amphetamine Aspartate Monohydrate, Dextroamphetamine Sulfate, And Amphetamine Sulfate

Dextroamphetamine Saccharate, Amphetamine Aspartate Monohydrate, Dextroamphetamine Sulfate, and Amphetamine Sulfate Extended-Release is a Oral Capsule, Extended Release in the Human Prescription Drug category. It is labeled and distributed by Rhodes Pharmaceuticals L.p.. The primary component is Amphetamine Aspartate Monohydrate; Amphetamine Sulfate; Dextroamphetamine Saccharate; Dextroamphetamine Sulfate.

Product ID	42858-930_320bbddd-3880-4f4b-977e-9d0112c4075d
NDC	42858-930
Product Type	Human Prescription Drug
Proprietary Name	Dextroamphetamine Saccharate, Amphetamine Aspartate Monohydrate, Dextroamphetamine Sulfate, and Amphetamine Sulfate Extended-Release
Generic Name	Dextroamphetamine Saccharate, Amphetamine Aspartate Monohydrate, Dextroamphetamine Sulfate, And Amphetamine Sulfate
Dosage Form	Capsule, Extended Release
Route of Administration	ORAL
Marketing Start Date	2019-08-22
Marketing Category	ANDA / ANDA
Application Number	ANDA210651
Labeler Name	Rhodes Pharmaceuticals L.P.
Substance Name	AMPHETAMINE ASPARTATE MONOHYDRATE; AMPHETAMINE SULFATE; DEXTROAMPHETAMINE SACCHARATE; DEXTROAMPHETAMINE SULFATE
Active Ingredient Strength	8 mg/1; mg/1; mg/1; mg/1
Pharm 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	N
Listing Certified Through	2023-12-31

Packaging

NDC 42858-930-01

100 CAPSULE, EXTENDED RELEASE in 1 BOTTLE, PLASTIC (42858-930-01)

Marketing Start Date	2019-08-22
NDC Exclude Flag	N
Sample Package?	N

NDC SPL Data Element Entries

NDC 42858-930-01 [42858093001]

Dextroamphetamine Saccharate, Amphetamine Aspartate Monohydrate, Dextroamphetamine Sulfate, and Amphetamine Sulfate Extended-Release CAPSULE, EXTENDED RELEASE

Marketing Category	ANDA
Application Number	ANDA210651
Product Type	HUMAN PRESCRIPTION DRUG
Billing Unit	EA
Marketing Start Date	2019-08-22

Drug Details

Active Ingredients

Ingredient	Strength
DEXTROAMPHETAMINE SACCHARATE	7.5 mg/1

OpenFDA Data

SPL SET ID:	690e1ef4-caf7-4c48-a4ae-d2a0ab684e82
Manufacturer	Rhodes Pharmaceuticals L.P.
UNII	6DPV8NK46S G83415V073 O1ZPV620O4 JJ768O327N
RxNorm Concept Unique ID - RxCUI	861232 861237 861227 861225 861223 861221

Pharmacological Class

Central Nervous System Stimulant [EPC]
Central Nervous System Stimulation [PE]
Central Nervous System Stimulant [EPC]
Central Nervous System Stimulation [PE]
Central Nervous System Stimulant [EPC]
Central Nervous System Stimulation [PE]
Central Nervous System Stimulant [EPC]
Central Nervous System Stimulation [PE]
Central Nervous System Stimulant [EPC]
Central Nervous System Stimulation [PE]

NDC Crossover Matching brand name "Dextroamphetamine Saccharate, Amphetamine Aspartate Monohydrate, Dextroamphetamine Sulfate, and Amphetamine Sulfate Extended-Release" or generic name "Dextroamphetamine Saccharate, Amphetamine Aspartate Monohydrate, Dextroamphetamine Sulfate, And Amphetamine Sulfate"