47781-355 : Buprenorphine and Naloxone Buccal; Sublingual Film


NDC47781-355
Labeler: Alvogen Inc.
Product Type: Human Prescription Drug
Drug Name: Buprenorphine and Naloxone Sublingual Film
Dosage Form: Buccal; Sublingual Film
Application #: ANDA205954
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:

  • 47781-355-03: 30 POUCH IN 1 CARTON (47781‑355‑03) > 1 FILM IN 1 POUCH (47781‑355‑11)

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.
  • 47781-356 Buprenorphine and Naloxone Buccal; Sublingual Film by Alvogen Inc.
  • 47781-357 Buprenorphine and Naloxone Buccal; Sublingual Film by Alvogen Inc.
  • 47781-358 Buprenorphine and Naloxone Buccal; Sublingual Film by Alvogen Inc.
  • 52427-692 Buprenorphine and Naloxone Buccal; Sublingual Film by Almatica Pharma Inc.
  • 52427-694 Buprenorphine and Naloxone Buccal; Sublingual Film by Almatica Pharma Inc.
  • 52427-698 Buprenorphine and Naloxone Buccal; Sublingual Film by Almatica Pharma Inc.
  • 52427-712 Buprenorphine and Naloxone Buccal; Sublingual Film by Almatica Pharma Inc.

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