45963-303 : Dextroamphetamine Sulfate 5 mg Oral Capsule, Extended Release


NDC: 45963-303
Labeler: Actavis Pharma, Inc.
Product Type: Human Prescription Drug
Drug Name: Dextroamphetamine Sulfate
Dosage Form: Oral Capsule, Extended Release
Application #: ANDA203901
Rev. Date: 
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: 303
Shapes:  Capsule
Colors:  Brown
Size (mm): 14
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:

  • 45963-303-09: 90 CAPSULE, EXTENDED RELEASE IN 1 BOTTLE (45963‑303‑09)

Active Ingredients:

  • Dextroamphetamine Sulfate

Dosage Strength:

  • 5 mg

Inactive Ingredients:

  • Ammonia
  • Ferrosoferric Oxide
  • Ethylcelluloses
  • Gelatin
  • Hypromelloses
  • Hydroxypropyl Cellulose (Type H)
  • Medium-chain Triglycerides
  • Oleic Acid
  • Potassium Hydroxide
  • Propylene Glycol
  • Ferric Oxide Red
  • Shellac
  • Silicon Dioxide
  • Sodium Lauryl Sulfate
  • Sucrose
  • Starch, Corn
  • Talc
  • Titanium Dioxide
  • Ferric Oxide Yellow
  • Alcohol
  • Polyethylene Glycols
  • Butyl Alcohol
  • Isopropyl Alcohol
  • Water

Pharmaceutical Classes:

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

Related Products:

Based on records with the same trade name.
  • 45963-304 Dextroamphetamine Sulfate 10 mg Oral Capsule, Extended Release by Actavis Pharma, Inc.
  • 45963-305 Dextroamphetamine Sulfate 15 mg Oral Capsule, Extended Release by Actavis Pharma, 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.
  • More related products ...

NDC 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.