59385-021 : Belbuca 75 ug/1 Buccal Film, Soluble



NDC59385-021
Labeler: Biodelivery Sciences International Inc
Product Type: Human Prescription Drug
Drug Name:  Belbuca
Dosage Form: Buccal Film, Soluble
Application #: NDA207932
Rev. Date: 
DEA Schedule: CIII (US) [1]

NDC 59385-021 QR Code


[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 less than 15 milligrams of Hydrocodone per dosage unit such as Vicodin, products containing not more than 90 milligrams of Codeine per dosage unit such as Tylenol with Codeine, other narcotics such as Suboxone, and non-narcotics such as Didrex, Ketamine, Phendimetrazine, and Anabolic Steroids). More Details: US Dept of Justice Controlled Substance Schedules.

NDC Package Codes:

  • 59385-021-60: 60 POUCH IN 1 BOX (59385‑021‑60) > 1 FILM, SOLUBLE IN 1 POUCH (59385‑021‑01)

Active Ingredients:

  • Buprenorphine Hydrochloride

Dosage Strength:

  • 75 ug/1

Pharmaceutical Classes:

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

Related Products:

Based on records with the same trade name.
  • 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
  • 59385-027 Belbuca 900 ug/1 Buccal Film, Soluble by Biodelivery Sciences International Inc
  • 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
  • 63481-685 Belbuca 600 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
< Prev: 59385-016Next: 59385-022 >

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