57664-379 : Dexmethylphenidate Hydrochloride 10 mg Oral Tablet


NDC: 57664-379
Labeler: Sun Pharmaceutical Industries, Inc.
Product Type: Human Prescription Drug
Drug Name:  Dexmethylphenidate Hydrochloride
Dosage Form: Oral Tablet
Application #: ANDA201231
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: 379;S10
Shapes:  Round
Colors:  White
Size (mm): 6
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:

  • 57664-379-08: 100 TABLET IN 1 BOTTLE (57664‑379‑08)
  • 57664-379-13: 500 TABLET IN 1 BOTTLE (57664‑379‑13)
  • 57664-379-18: 1000 TABLET IN 1 BOTTLE (57664‑379‑18)
  • 57664-379-83: 30 TABLET IN 1 BOTTLE (57664‑379‑83)
  • 57664-379-88: 100 TABLET IN 1 BOTTLE (57664‑379‑88)

Active Ingredients:

  • Dexmethylphenidate Hydrochloride

Dosage Strength:

  • 10 mg

Inactive Ingredients:

  • Lactose Monohydrate
  • Sodium Starch Glycolate Type a Potato
  • Talc
  • Magnesium Stearate

Pharmaceutical Classes:

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

Related Products:

Based on records with the same trade name.
  • 57664-376 Dexmethylphenidate Hydrochloride 2.5 mg Oral Tablet by Sun Pharmaceutical Industries, Inc.
  • 57664-378 Dexmethylphenidate Hydrochloride 5 mg Oral Tablet by Sun Pharmaceutical Industries, Inc.
  • 57664-621 Dexmethylphenidate Hydrochloride 5 mg Oral Capsule, Extended Release by Sun Pharmaceutical Industries, Inc.
  • 57664-622 Dexmethylphenidate Hydrochloride 10 mg Oral Capsule, Extended Release by Sun Pharmaceutical Industries, Inc.
  • 57664-623 Dexmethylphenidate Hydrochloride 15 mg Oral Capsule, Extended Release by Sun Pharmaceutical Industries, Inc.
  • 57664-624 Dexmethylphenidate Hydrochloride 20 mg Oral Capsule, Extended Release by Sun Pharmaceutical Industries, Inc.
  • 57664-625 Dexmethylphenidate Hydrochloride 30 mg Oral Capsule, Extended Release by Sun Pharmaceutical Industries, Inc.
  • 57664-626 Dexmethylphenidate Hydrochloride 40 mg Oral Capsule, Extended Release by Sun Pharmaceutical Industries, Inc.
  • 57664-628 Dexmethylphenidate Hydrochloride 25 mg Oral Capsule, Extended Release by Sun Pharmaceutical Industries, Inc.
  • 57664-629 Dexmethylphenidate Hydrochloride 35 mg Oral Capsule, Extended Release by Sun Pharmaceutical Industries, Inc.
  • 0093-5045 Dexmethylphenidate Hydrochloride 25 mg Oral Capsule, Extended Release by Teva Pharmaceuticals USA, Inc.
  • 0093-5046 Dexmethylphenidate Hydrochloride 35 mg Oral Capsule, Extended Release by Teva Pharmaceuticals USA, Inc.
  • 0093-5275 Dexmethylphenidate Hydrochloride 2.5 mg Oral Tablet by Teva Pharmaceuticals USA Inc
  • 0093-5276 Dexmethylphenidate Hydrochloride 5 mg Oral Tablet by Teva Pharmaceuticals USA Inc
  • 0093-5277 Dexmethylphenidate Hydrochloride 10 mg Oral Tablet by Teva Pharmaceuticals USA Inc
  • 0093-5550 Dexmethylphenidate Hydrochloride 5 mg Oral Capsule, Extended Release by Teva Pharmaceuticals USA Inc
  • 0093-5551 Dexmethylphenidate Hydrochloride 10 mg Oral Capsule, Extended Release by Teva Pharmaceuticals USA Inc
  • 0093-5552 Dexmethylphenidate Hydrochloride 15 mg Oral Capsule, Extended Release by Teva Pharmaceuticals USA Inc
  • 0093-5553 Dexmethylphenidate Hydrochloride 20 mg Oral Capsule, Extended Release by Teva Pharmaceuticals USA Inc
  • 0093-5554 Dexmethylphenidate Hydrochloride 30 mg Oral Capsule, Extended Release by Teva Pharmaceuticals USA Inc
  • More related products ...

NDC QR Code

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NDC 57664-379 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.