58284-100 : Probuphine 80 mg Subcutaneous Implant

NDC:	58284-100
Labeler:	Braeburn Pharmaceuticals
Product Type:	Human Prescription Drug
Drug Name:	Probuphine
Dosage Form:	Subcutaneous Implant
Application #:	NDA204442
Rev. Date:	Jun 9, 2016
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:

• 58284-100-14: 4 POUCH IN 1 CARTON (58284‑100‑14) > 1 IMPLANT IN 1 POUCH

Active Ingredients:

• Buprenorphine Hydrochloride

Pharmaceutical Classes:

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

Related Products:

Based on records with the same trade name.

• 52440-100 Probuphine 80 mg Subcutaneous Implant by Titan Pharmaceuticals, Inc.

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