59011-523 : Symproic .2 mg Oral Tablet


NDC: 59011-523
Labeler: Purdue Pharma Lp
Product Type: Human Prescription Drug
Drug Name:  Symproic
Dosage Form: Oral Tablet
Application #: NDA208854
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: 222;0;2
Shapes:  Round
Colors:  Yellow
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:

  • 59011-523-07: 1 BLISTER PACK IN 1 CAPSULE (59011‑523‑07) > 7 TABLET IN 1 BLISTER PACK
  • 59011-523-30: 30 TABLET IN 1 BOTTLE (59011‑523‑30)
  • 59011-523-90: 90 TABLET IN 1 BOTTLE (59011‑523‑90)

Active Ingredients:

  • Naldemedine Tosylate

Dosage Strength:

  • .2 mg

Inactive Ingredients:

  • Mannitol
  • Magnesium Stearate
  • Croscarmellose Sodium
  • Hypromellose, Unspecified
  • Talc
  • Ferric Oxide Yellow

Pharmaceutical Classes:

  • Opioid Antagonist [EPC]
  • Opioid Antagonists [MoA]

Related Products:

Based on records with the same trade name.
  • 59385-041 Symproic .2 mg Oral Tablet by Biodelivery Sciences International Inc
  • 59630-222 Symproic .2 mg Oral Tablet by Shionogi Inc.

NDC QR Code

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NDC 59011-523 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.