58118-8005 : Buprenorphine Hydrochloride and Naloxone Hydrochloride Dihydrate Sublingual Tablet


NDC58118-8005
Labeler: Clinical Solutions Wholesale, LLC
Product Type: Human Prescription Drug
Drug Name: Buprenorphine Hydrochloride and Naloxone Hydrochloride Dihydrate
Dosage Form: Sublingual Tablet
Application #: ANDA207000
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.

NDC Package Codes:

  • 58118-8005-8: 30 TABLET IN 1 BLISTER PACK (58118‑8005‑8)

Active Ingredients:

  • Buprenorphine Hydrochloride
  • Naloxone Hydrochloride Dihydrate

Dosage Strength:

  • 2 mg
  • .5 mg

Pharmaceutical Classes:

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

Related Products:

Based on records with the same trade name.
  • 58118-8020 Buprenorphine Hydrochloride and Naloxone Hydrochloride Dihydrate Sublingual Tablet by Clinical Solutions Wholesale, LLC
  • 0054-0188 Buprenorphine Hydrochloride and Naloxone Hydrochloride Dihydrate Sublingual Tablet by Roxane Laboratories, Inc.
  • 0054-0189 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
  • 0904-7009 Buprenorphine Hydrochloride and Naloxone Hydrochloride Dihydrate Sublingual Tablet by Major Pharmaceuticals
  • 0904-7010 Buprenorphine Hydrochloride and Naloxone Hydrochloride Dihydrate Sublingual Tablet by Major Pharmaceuticals
  • 16729-549 Buprenorphine Hydrochloride and Naloxone Hydrochloride Dihydrate Sublingual Tablet by Accord Healthcare, Inc
  • 16729-550 Buprenorphine Hydrochloride and Naloxone Hydrochloride Dihydrate Sublingual Tablet by Accord Healthcare, Inc
  • 24555-8005 Buprenorphine Hydrochloride and Naloxone Hydrochloride Dihydrate Sublingual Tablet by Correct Rx Pharmacy Services, Inc.
  • 51862-608 Buprenorphine Hydrochloride and Naloxone Hydrochloride Dihydrate Sublingual Tablet by Mayne Pharma Inc.
  • 55700-901 Buprenorphine Hydrochloride and Naloxone Hydrochloride Dihydrate Sublingual Tablet by Quality Care Products, LLC
  • 69189-0591 Buprenorphine Hydrochloride and Naloxone Hydrochloride Dihydrate Sublingual Tablet by Avera Mckennan Hospital
  • 70518-3844 Buprenorphine Hydrochloride and Naloxone Hydrochloride Dihydrate Sublingual Tablet by Remedyrepack Inc.
  • 70518-3862 Buprenorphine Hydrochloride and Naloxone Hydrochloride Dihydrate Sublingual Tablet by Remedyrepack Inc.
  • 70518-4001 Buprenorphine Hydrochloride and Naloxone Hydrochloride Dihydrate Sublingual Tablet by Remedyrepack Inc.
  • 70518-4002 Buprenorphine Hydrochloride and Naloxone Hydrochloride Dihydrate Sublingual Tablet by Remedyrepack Inc.
  • 71335-1653 Buprenorphine 2 mg / Naloxone 0.5 mg Sublingual Tablet by Bryant Ranch Prepack
  • More related products ...

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