58284-208 : Brixadi 8 mg/.16ml Subcutaneous Injection

NDC:	58284-208
Labeler:	Braeburn Inc.
Product Type:	Human Prescription Drug
Drug Name:	Brixadi
Dosage Form:	Subcutaneous Injection
Application #:	NDA210136
Rev. Date:	Jun 6, 2023
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:

• 58284-208-01: 1 SYRINGE, GLASS IN 1 CARTON (58284‑208‑01) / .16 ML IN 1 SYRINGE, GLASS

Active Ingredients:

• Buprenorphine

Pharmaceutical Classes:

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

Related Products:

Based on records with the same trade name.

• 58284-216 Brixadi 16 mg/.32ml Subcutaneous Injection by Braeburn Inc.
• 58284-224 Brixadi 24 mg/.48ml Subcutaneous Injection by Braeburn Inc.
• 58284-228 Brixadi 128 mg/.36ml Subcutaneous Injection by Braeburn Inc.
• 58284-232 Brixadi 32 mg/.64ml Subcutaneous Injection by Braeburn Inc.
• 58284-264 Brixadi 64 mg/.18ml Subcutaneous Injection by Braeburn Inc.
• 58284-296 Brixadi 96 mg/.27ml Subcutaneous Injection by Braeburn Inc.

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