12496-1212 : Suboxone Sublingual Film, Soluble


NDC12496-1212
Labeler: Reckitt Benckiser Pharmaceuticals Inc
Product Type: Human Prescription Drug
Drug Name:  Suboxone
Dosage Form: Sublingual Film, Soluble
Application #: NDA022410
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:

  • 12496-1212-3: 30 POUCH IN 1 CARTON (12496‑1212‑3) > 1 FILM, SOLUBLE IN 1 POUCH (12496‑1212‑1)

Active Ingredients:

  • Buprenorphine Hydrochloride
  • Naloxone Hydrochloride

Dosage Strength:

  • 12 mg
  • 3 mg

Pharmaceutical Classes:

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

Related Products:

Based on records with the same trade name.
  • 12496-1202 Suboxone Sublingual Film, Soluble by Reckitt Benckiser Pharmaceuticals Inc
  • 12496-1204 Suboxone Sublingual Film, Soluble by Reckitt Benckiser Pharmaceuticals Inc
  • 12496-1208 Suboxone Sublingual Film, Soluble by Reckitt Benckiser Pharmaceuticals Inc
  • 12496-1283 Suboxone 2/0.5 Sublingual Tablet by Reckitt Benckiser Pharmaceuticals Inc
  • 12496-1306 Suboxone 8/2 Sublingual Tablet by Reckitt Benckiser Pharmaceuticals Inc
  • 35356-004 Suboxone 8/2 Sublingual Tablet by Lake Erie Medical & Surgical Supply Dba Quality Care Products LLC
  • 43063-184 Suboxone 8/2 Sublingual Tablet by Pd-rx Pharmaceuticals, Inc.
  • 53217-328 Suboxone Sublingual Film, Soluble by Aidarex Pharmaceuticals LLC
  • 54569-6399 Suboxone Sublingual Film, Soluble by A-s Medication Solutions LLC
  • 54868-5707 Suboxone 8/2 Sublingual Tablet by Physicians Total Care, Inc.
  • 54868-5750 Suboxone 2/0.5 Sublingual Tablet by Physicians Total Care, Inc.
  • 55700-147 Suboxone Sublingual Film, Soluble by Lake Erie Medical Dba Quality Care Products LLC
  • 63629-4028 Suboxone Sublingual Film, Soluble by Bryant Ranch Prepack
  • 63629-4034 Suboxone 8/2 Sublingual Tablet by Bryant Ranch Prepack

NDC QR Code

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