11534-188 : Dextroamphetamine Sulfate 5 mg Oral Tablet

NDC:	11534-188
Labeler:	Sunrise Pharmaceutical, Inc.
Product Type:	Human Prescription Drug
Drug Name:	Dextroamphetamine Sulfate
Dosage Form:	Oral Tablet
Application #:	ANDA210059
Rev. Date:	Jul 4, 2018
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:	N27
Shapes:	Round
Colors:	Orange
Size (mm):	10
Segments: *	2
* Segments = the number of equally sized pieces which the pill can be broken into. In this case, a value of 2 indicates a scored pill which can be broken into 2 equal pieces.

NDC Package Codes:

• 11534-188-01: 100 TABLET IN 1 BOTTLE (11534‑188‑01)
• 11534-188-03: 1000 TABLET IN 1 BOTTLE (11534‑188‑03)

Active Ingredients:

• Dextroamphetamine Sulfate

Inactive Ingredients:

• Silicon Dioxide
• Cellulose, Microcrystalline
• Magnesium Stearate
• Starch, Corn
• D&c Yellow No. 10
• Fd&c Red No. 40 /

Pharmaceutical Classes:

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

Related Products:

Based on records with the same trade name.

• 11534-189 Dextroamphetamine Sulfate 10 mg Oral Tablet by Sunrise Pharmaceutical, Inc.
• 0378-1070 Dextroamphetamine Sulfate 5 mg Oral Capsule, Extended Release by Mylan Pharmaceuticals Inc.
• 0378-1071 Dextroamphetamine Sulfate 10 mg Oral Capsule, Extended Release by Mylan Pharmaceuticals Inc.
• 0378-1072 Dextroamphetamine Sulfate 15 mg Oral Capsule, Extended Release by Mylan Pharmaceuticals Inc.
• 0406-8958 Dextroamphetamine Sulfate 5 mg Oral Tablet by Mallinckrodt, Inc.
• 0406-8959 Dextroamphetamine Sulfate 10 mg Oral Tablet by Mallinckrodt, Inc.
• 0406-8960 Dextroamphetamine Sulfate 5 mg Extended Release Capsule by Mallinckrodt Inc.
• 0406-8961 Dextroamphetamine Sulfate 10 mg Extended Release Capsule by Mallinckrodt Inc.
• 0406-8962 Dextroamphetamine Sulfate 15 mg Extended Release Capsule by Mallinckrodt Inc.
• 0555-0952 Dextroamphetamine Sulfate 5 mg Oral Tablet by Barr Laboratories Inc.
• 0555-0953 Dextroamphetamine Sulfate 10 mg Oral Tablet by Barr Laboratories Inc.
• 0555-0954 Dextroamphetamine Sulfate 5 mg Extended Release Capsule by Barr Laboratories Inc.
• 0555-0955 Dextroamphetamine Sulfate 10 mg Extended Release Capsule by Barr Laboratories Inc.
• 0555-0956 Dextroamphetamine Sulfate 15 mg Extended Release Capsule by Barr Laboratories Inc.
• 0603-2674 Dextroamphetamine Sulfate 5 mg Oral Capsule, Extended Release by Par Pharmaceutical
• 0603-2675 Dextroamphetamine Sulfate 10 mg Oral Capsule, Extended Release by Par Pharmaceutical
• 0603-2676 Dextroamphetamine Sulfate 15 mg Oral Capsule, Extended Release by Par Pharmaceutical
• 10702-065 Dextroamphetamine Sulfate 5 mg Oral Tablet by Kvk-tech, Inc.
• 10702-066 Dextroamphetamine Sulfate 10 mg Oral Tablet by Kvk-tech, Inc.
• 13107-035 Dextroamphetamine Sulfate 5 mg Oral Tablet by Aurolife Pharma, LLC
• More related products ...

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