42858-325 : Dextroamphetamine Saccharate, Amphetamine Aspartate Monohydrate, Dextroamphetamine Sulfate, and Amphetamine Sulfate Extended-release Oral Capsule, Extended Release

NDC:	42858-325
Labeler:	Rhodes Pharmaceuticals L.p.
Product Type:	Human Prescription Drug
Drug Name:	Dextroamphetamine Saccharate, Amphetamine Aspartate Monohydrate, Dextroamphetamine Sulfate, and Amphetamine Sulfate Extended-release
Dosage Form:	Oral Capsule, Extended Release
Application #:	ANDA210651
Rev. Date:	Aug 22, 2019
CSA Schedule:	CII (US) ^[1]

^[1] Schedule II / IIN Controlled Substance: High potential for abuse which may lead to severe psychological or physical dependence. (i.e. Narcotics such as Dilaudid, Methadone, Demerol, Oxycodone, Percocet, Fentanyl, Morphine, Opium, Codeine, and Hydrocodone ... Schedule IIN stimulants include non-narcotic Amphetamines such as Dexedrine, Adderall, Desoxyn, Methylphenidate (Ritalin) ... Other Schedule II substances include Amobarbital, Glutethimide, and Pentobarbital. More Details: US Dept of Justice Controlled Substance Schedules.

Appearance:

Markings:	RP;725
Shapes:	Capsule
Colors:	White / Orange
Size (mm):	22
Segments: ^*	1
^* Segments = the number of equally sized pieces which the pill can be broken into. In this case, a value of 1 indicates a solid pill with no score lines.

NDC Package Codes:

42858-325-01: 100 CAPSULE, EXTENDED RELEASE IN 1 BOTTLE, PLASTIC (42858‑325‑01)

Active Ingredients:

Amphetamine Aspartate Monohydrate
Amphetamine Sulfate
Dextroamphetamine Saccharate
Dextroamphetamine Sulfate

Dosage Strength:

6.25 mg
6.25 mg
6.25 mg
6.25 mg

Inactive Ingredients:

Sucrose
Hypromellose, Unspecified
Talc
Triethyl Citrate
Methacrylic Acid - Ethyl Acrylate Copolymer (1:1) Type a
Water
Gelatin, Unspecified
Titanium Dioxide
Fd&c Blue No. 1
Fd&c Yellow No. 6
Shellac
Isopropyl Alcohol
Tert-butyl Alcohol
Propylene Glycol
Ammonia
Ferrosoferric Oxide
Potassium Hydroxide /

Pharmaceutical Classes:

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

NDC QR Code

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NDC 42858-325 QR Code

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Note: The RxChat NDC Database uses publicly available data from the FDA and the U.S. National Library of Medicine (NLM); The NLM is not responsible for the data presented and does not endorse or recommend this or any other product. While we make every effort to ensure that the information presented is accurate, you should assume that all results are unvalidated. To report any errors or inconsistencies please contact us.