24510-140 : Xtampza 36 mg Oral Capsule, Extended Release


NDC24510-140
Labeler: Collegium Pharmaceutical, Inc.
Product Type: Human Prescription Drug
Drug Name:  Xtampza ER
Dosage Form: Oral Capsule, Extended Release
Application #: NDA208090
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: XTAMPZA;ER;36;mg
Shapes:  Capsule
Colors:  Pink / White
Size (mm): 23
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:

  • 24510-140-10: 100 CAPSULE, EXTENDED RELEASE IN 1 BOTTLE, PLASTIC (24510‑140‑10)
  • 24510-140-20: 20 CAPSULE, EXTENDED RELEASE IN 1 BLISTER PACK (24510‑140‑20)

Active Ingredients:

  • Oxycodone

Dosage Strength:

  • 36 mg

Inactive Ingredients:

  • Myristic Acid
  • Yellow Wax
  • Carnauba Wax
  • Peg-32 Stearate
  • Magnesium Stearate
  • Silicon Dioxide
  • Hypromellose, Unspecified
  • Titanium Dioxide
  • Water
  • Ferric Oxide Red

Pharmaceutical Classes:

  • Full Opioid Agonists [MoA]
  • Opioid Agonist [EPC]

Related Products:

Based on records with the same trade name.
  • 24510-110 Xtampza 9 mg Oral Capsule, Extended Release by Collegium Pharmaceutical, Inc.
  • 24510-115 Xtampza 13.5 mg Oral Capsule, Extended Release by Collegium Pharmaceutical, Inc.
  • 24510-120 Xtampza 18 mg Oral Capsule, Extended Release by Collegium Pharmaceutical, Inc.
  • 24510-130 Xtampza 27 mg Oral Capsule, Extended Release by Collegium Pharmaceutical, Inc.
  • 55700-557 Xtampza 13.5 mg Oral Capsule, Extended Release by Lake Erie Medical Dba Quality Care Products LLC

NDC QR Code

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NDC 24510-140 QR Code

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