54123-114 : Zubsolv Sublingual Tablet, Orally Disintegrating


NDC54123-114
Labeler: Orexo Us, Inc.
Product Type: Human Prescription Drug
Drug Name:  Zubsolv
Dosage Form: Sublingual Tablet, Orally Disintegrating
Application #: NDA204242
Rev. Date: 
CSA Schedule: CIII (US) [1]


[1] Schedule III / IIIN Controlled Substance: Has a potential for abuse less than substances in Schedules I or II and abuse may lead to moderate or low physical dependence or high psychological dependence. (i.e. Products containing not more than 90 milligrams of Codeine per dosage unit [such as Tylenol with Codeine], other narcotics such as Buprenorphine (Suboxone), and Schedule IIIN non-narcotics such as Didrex, Ketamine, Phendimetrazine, and Anabolic Steroids). More Details: US Dept of Justice Controlled Substance Schedules.

Appearance:


Markings: 11;4
Shapes:  Oval
Colors:  White
Size (mm): 7
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:

  • 54123-114-30: 3 BLISTER PACK IN 1 CARTON (54123‑114‑30) > 10 TABLET, ORALLY DISINTEGRATING IN 1 BLISTER PACK

Active Ingredients:

  • Buprenorphine Hydrochloride
  • Naloxone Hydrochloride

Dosage Strength:

  • 11.4 mg
  • 2.9 mg

Inactive Ingredients:

  • Mannitol
  • Anhydrous Citric Acid
  • Trisodium Citrate Dihydrate
  • Cellulose, Microcrystalline
  • Croscarmellose Sodium
  • Sucralose
  • Menthol, Unspecified Form
  • Silicon Dioxide
  • Sodium Stearyl Fumarate

Pharmaceutical Classes:

  • Partial Opioid Agonists [MoA]
  • Partial Opioid Agonist [EPC]
  • Opioid Antagonist [EPC]
  • Opioid Antagonists [MoA]

Related Products:

Based on records with the same trade name.
  • 54123-907 Zubsolv Sublingual Tablet, Orally Disintegrating by Orexo Us, Inc.
  • 54123-914 Zubsolv 1.4/0.36 Sublingual Tablet by Orexo Us, Inc.
  • 54123-929 Zubsolv Sublingual Tablet, Orally Disintegrating by Orexo Us, Inc.
  • 54123-957 Zubsolv 5.7/1.4 Sublingual Tablet by Orexo Us, Inc.
  • 54123-986 Zubsolv Sublingual Tablet, Orally Disintegrating by Orexo Us, Inc.

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.