0527-5513 : Dextroamphetamine Saccharate, Amphetamine Aspartate Monohydrate, Dextroamphetamine Sulfate, and Amphetamine Sulfate Oral Capsule, Extended Release


NDC: 0527-5513
Labeler: Lannett Company, Inc.
Product Type: Human Prescription Drug
Drug Name: Dextroamphetamine Saccharate, Amphetamine Aspartate Monohydrate, Dextroamphetamine Sulfate, and Amphetamine Sulfate
Dosage Form: Oral Capsule, Extended Release
Application #: ANDA212037
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: 20mg;ELI;513
Shapes:  Capsule
Colors:  White / Pink
Size (mm): 18
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:

  • 0527-5513-37: 100 CAPSULE, EXTENDED RELEASE IN 1 BOTTLE (0527‑5513‑37)

Active Ingredients:

  • Dextroamphetamine Saccharate
  • Dextroamphetamine Sulfate
  • Amphetamine Aspartate Monohydrate
  • Amphetamine Sulfate

Dosage Strength:

  • 5 mg
  • 5 mg
  • 5 mg
  • 5 mg

Inactive Ingredients:

  • Gelatin
  • Hypromellose 2910 (50 Mpa.s)
  • Methacrylic Acid - Ethyl Acrylate Copolymer (1:1) Type a
  • Ferric Oxide Red
  • Ferric Oxide Yellow
  • Hypromellose 2910 (3 Mpa.s)
  • Hypromellose 2910 (6 Mpa.s)
  • Polyethylene Glycol 400
  • Polysorbate 80
  • Titanium Dioxide
  • Sucrose
  • Talc
  • Triethyl Citrate
  • Fd&c Red No. 3
  • Fd&c Red No. 40
  • Fd&c Yellow No. 6
  • Propylene Glycol
  • Shellac
  • Fd&c Blue No. 1--aluminum Lake /

Pharmaceutical Classes:

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

Related Products:

Based on records with the same trade name.
  • 0527-0790 Dextroamphetamine Saccharate, Amphetamine Aspartate Monohydrate, Dextroamphetamine Sulfate and Amphetamine Sulfate Oral Capsule, Extended Release by Lannett Company, Inc.
  • 0527-0791 Dextroamphetamine Saccharate, Amphetamine Aspartate Monohydrate, Dextroamphetamine Sulfate and Amphetamine Sulfate Oral Capsule, Extended Release by Lannett Company, Inc.
  • 0527-0792 Dextroamphetamine Saccharate, Amphetamine Aspartate Monohydrate, Dextroamphetamine Sulfate and Amphetamine Sulfate Oral Capsule, Extended Release by Lannett Company, Inc.
  • 0527-0793 Dextroamphetamine Saccharate, Amphetamine Aspartate Monohydrate, Dextroamphetamine Sulfate and Amphetamine Sulfate Oral Capsule, Extended Release by Lannett Company, Inc.
  • 0527-0794 Dextroamphetamine Saccharate, Amphetamine Aspartate Monohydrate, Dextroamphetamine Sulfate and Amphetamine Sulfate Oral Capsule, Extended Release by Lannett Company, Inc.
  • 0527-0795 Dextroamphetamine Saccharate, Amphetamine Aspartate Monohydrate, Dextroamphetamine Sulfate and Amphetamine Sulfate Oral Capsule, Extended Release by Lannett Company, Inc.
  • 0527-5510 Dextroamphetamine Saccharate, Amphetamine Aspartate Monohydrate, Dextroamphetamine Sulfate, and Amphetamine Sulfate Oral Capsule, Extended Release by Lannett Company, Inc.
  • 0527-5511 Dextroamphetamine Saccharate, Amphetamine Aspartate Monohydrate, Dextroamphetamine Sulfate, and Amphetamine Sulfate Oral Capsule, Extended Release by Lannett Company, Inc.
  • 0527-5512 Dextroamphetamine Saccharate, Amphetamine Aspartate Monohydrate, Dextroamphetamine Sulfate, and Amphetamine Sulfate Oral Capsule, Extended Release by Lannett Company, Inc.
  • 0527-5514 Dextroamphetamine Saccharate, Amphetamine Aspartate Monohydrate, Dextroamphetamine Sulfate, and Amphetamine Sulfate Oral Capsule, Extended Release by Lannett Company, Inc.
  • 0527-5515 Dextroamphetamine Saccharate, Amphetamine Aspartate Monohydrate, Dextroamphetamine Sulfate, and Amphetamine Sulfate Oral Capsule, Extended Release by Lannett Company, Inc.
  • 0115-1486 Dextroamphetamine Saccharate, Amphetamine Aspartate Monohydrate, Dextroamphetamine Sulfate and Amphetamine Sulfate Oral Capsule by Impax Generics
  • 0115-1487 Dextroamphetamine Saccharate, Amphetamine Aspartate Monohydrate, Dextroamphetamine Sulfate and Amphetamine Sulfate Oral Capsule by Impax Generics
  • 0115-1488 Dextroamphetamine Saccharate, Amphetamine Aspartate Monohydrate, Dextroamphetamine Sulfate and Amphetamine Sulfate Oral Capsule by Impax Generics
  • 0115-1489 Dextroamphetamine Saccharate, Amphetamine Aspartate Monohydrate, Dextroamphetamine Sulfate and Amphetamine Sulfate Oral Capsule by Impax Generics
  • 0115-1490 Dextroamphetamine Saccharate, Amphetamine Aspartate Monohydrate, Dextroamphetamine Sulfate and Amphetamine Sulfate Oral Capsule by Impax Generics
  • 0115-1491 Dextroamphetamine Saccharate, Amphetamine Aspartate Monohydrate, Dextroamphetamine Sulfate and Amphetamine Sulfate Oral Capsule by Impax Generics
  • 0185-0831 Dextroamphetamine Saccharate, Amphetamine Aspartate Monohydrate, Dextroamphetamine Sulfate and Amphetamine Sulfate Oral Tablet by Eon Labs, Inc.
  • 0185-0842 Dextroamphetamine Saccharate, Amphetamine Aspartate Monohydrate, Dextroamphetamine Sulfate and Amphetamine Sulfate Oral Tablet by Eon Labs, Inc.
  • 0185-0853 Dextroamphetamine Saccharate, Amphetamine Aspartate Monohydrate, Dextroamphetamine Sulfate and Amphetamine Sulfate Oral Tablet by Eon Labs, Inc.
  • More related products ...

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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.