NDC 0228-3059

Dextroamphetamine saccharate, amphetamine aspartate monohydrate, dextroamphetamine sulfate, amphetamine sulfate

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

Dextroamphetamine saccharate, amphetamine aspartate monohydrate, dextroamphetamine sulfate, amphetamine sulfate is a Oral Capsule, Extended Release in the Human Prescription Drug category. It is labeled and distributed by Actavis Pharma, Inc.. The primary component is Amphetamine Aspartate Monohydrate; Amphetamine Sulfate; Dextroamphetamine Saccharate; Dextroamphetamine Sulfate.

Product ID	0228-3059_227465ee-0fce-4491-b0c2-9506d64df743
NDC	0228-3059
Product Type	Human Prescription Drug
Proprietary Name	Dextroamphetamine saccharate, amphetamine aspartate monohydrate, dextroamphetamine sulfate, amphetamine sulfate
Generic Name	Dextroamphetamine Saccharate, Amphetamine Aspartate Monohydrate, Dextroamphetamine Sulfate, Amphetamine Sulfate
Dosage Form	Capsule, Extended Release
Route of Administration	ORAL
Marketing Start Date	2012-06-22
Marketing Category	ANDA / ANDA
Application Number	ANDA077302
Labeler Name	Actavis Pharma, Inc.
Substance Name	AMPHETAMINE ASPARTATE MONOHYDRATE; AMPHETAMINE SULFATE; DEXTROAMPHETAMINE SACCHARATE; DEXTROAMPHETAMINE SULFATE
Active Ingredient Strength	3 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 0228-3059-11

100 CAPSULE, EXTENDED RELEASE in 1 BOTTLE (0228-3059-11)

Marketing Start Date	2012-06-22
NDC Exclude Flag	N
Sample Package?	N

NDC SPL Data Element Entries

NDC 0228-3059-11 [00228305911]

Dextroamphetamine saccharate, amphetamine aspartate monohydrate, dextroamphetamine sulfate, amphetamine sulfate CAPSULE, EXTENDED RELEASE

Marketing Category	ANDA
Application Number	ANDA077302
Product Type	HUMAN PRESCRIPTION DRUG
Billing Unit	EA
Marketing Start Date	2012-06-22

Drug Details

Active Ingredients

Ingredient	Strength
DEXTROAMPHETAMINE SACCHARATE	2.5 mg/1

OpenFDA Data

SPL SET ID:	c5c2d060-452c-4f76-ad93-2e41fd8f06c2
Manufacturer	Actavis Pharma, Inc.
UNII	6DPV8NK46S G83415V073 O1ZPV620O4 JJ768O327N
RxNorm Concept Unique ID - RxCUI	861232 861237 861227 861225 861223 861221
UPC Code	0302283060116 0302283063117 0302283059110 0302283062110 0302283061113 0302283064114

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]
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, amphetamine sulfate" or generic name "Dextroamphetamine Saccharate, Amphetamine Aspartate Monohydrate, Dextroamphetamine Sulfate, Amphetamine Sulfate"