0054-0189 : Buprenorphine Hydrochloride and Naloxone Hydrochloride Dihydrate Sublingual Tablet


NDC0054-0189
Labeler: Roxane Laboratories, Inc.
Product Type: Human Prescription Drug
Drug Name: Buprenorphine Hydrochloride and Naloxone Hydrochloride Dihydrate
Dosage Form: Sublingual Tablet
Application #: ANDA203326
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: 54;375
Shapes:  Round
Colors:  Orange
Size (mm): 10
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:

  • 0054-0189-13: 30 TABLET IN 1 BOTTLE (0054‑0189‑13)

Active Ingredients:

  • Buprenorphine Hydrochloride
  • Naloxone Hydrochloride Dihydrate

Dosage Strength:

  • 8 mg
  • 2 mg

Inactive Ingredients:

  • Anhydrous Citric Acid
  • Starch, Corn
  • Fd&c Yellow No. 6
  • Lactose Monohydrate
  • Magnesium Stearate
  • Mannitol
  • Povidones
  • Sodium Citrate
  • Sucralose

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.
  • 0054-0188 Buprenorphine Hydrochloride and Naloxone Hydrochloride Dihydrate Sublingual Tablet by Roxane Laboratories, Inc.
  • 0228-3154 Buprenorphine 2 mg / Naloxone 0.5 mg Sublingual Tablet by Actavis Elizabeth LLC
  • 0228-3155 Buprenorphine 8 mg / Naloxone 2 mg Sublingual Tablet by Actavis Elizabeth LLC
  • 0406-8005 Buprenorphine Hydrochloride and Naloxone Hydrochloride Dihydrate Sublingual Tablet by Specgx LLC
  • 0406-8020 Buprenorphine Hydrochloride and Naloxone Hydrochloride Dihydrate Sublingual Tablet by Specgx LLC
  • 69189-0591 Buprenorphine Hydrochloride and Naloxone Hydrochloride Dihydrate Sublingual Tablet by Avera Mckennan Hospital

NDC QR Code

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