63481-685 : Belbuca 600 ug/1 Buccal Film


NDC63481-685
Labeler: Endo Pharmaceuticals
Product Type: Human Prescription Drug
Drug Name:  Belbuca
Dosage Form: Buccal Film
Application #: NDA207932
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:

  • 63481-685-60: 60 POUCH IN 1 CARTON (63481‑685‑60) > 1 FILM IN 1 POUCH

Active Ingredients:

  • Buprenorphine Hydrochloride

Dosage Strength:

  • 600 ug/1

Pharmaceutical Classes:

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

Related Products:

Based on records with the same trade name.
  • 63481-161 Belbuca 75 ug/1 Buccal Film by Endo Pharmaceuticals
  • 63481-207 Belbuca 150 ug/1 Buccal Film by Endo Pharmaceuticals
  • 63481-348 Belbuca 300 ug/1 Buccal Film by Endo Pharmaceuticals
  • 63481-519 Belbuca 450 ug/1 Buccal Film by Endo Pharmaceuticals
  • 63481-820 Belbuca 750 ug/1 Buccal Film by Endo Pharmaceuticals
  • 63481-952 Belbuca 900 ug/1 Buccal Film by Endo Pharmaceuticals
  • 55700-867 Belbuca 450 ug/1 Buccal Film, Soluble by Quality Care Products, LLC
  • 59385-021 Belbuca 75 ug/1 Buccal Film, Soluble by Biodelivery Sciences International Inc
  • 59385-022 Belbuca 150 ug/1 Buccal Film, Soluble by Biodelivery Sciences International Inc
  • 59385-023 Belbuca 300 ug/1 Buccal Film, Soluble by Biodelivery Sciences International Inc
  • 59385-024 Belbuca 450 ug/1 Buccal Film, Soluble by Biodelivery Sciences International Inc
  • 59385-025 Belbuca 600 ug/1 Buccal Film, Soluble by Biodelivery Sciences International Inc
  • 59385-026 Belbuca 750 ug/1 Buccal Film, Soluble by Biodelivery Sciences International Inc
  • 59385-027 Belbuca 900 ug/1 Buccal Film, Soluble by Biodelivery Sciences International Inc

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