0054-0176 : Buprenorphine 2 mg (As Buprenorphine Hydrochloride 2.16 mg) Sublingual Tablet

NDC:	0054-0176
Labeler:	Roxane Laboratories, Inc
Product Type:	Human Prescription Drug
Drug Name:	Buprenorphine Hcl
Dosage Form:	Sublingual Tablet
Application #:	ANDA078633
Rev. Date:	Oct 8, 2009
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.

Appearance:

Markings:	54;775
Shapes:	Round
Colors:	White
Size (mm):	13
Segments: *	1
* Segments = the number of equally sized pieces which the pill can be broken into. In this case, a value of 1 indicates a solid pill with no score lines.

NDC Package Codes:

• 0054-0176-13: 30 TABLET IN 1 BOTTLE (0054‑0176‑13)

Active Ingredients:

• Buprenorphine Hydrochloride

Inactive Ingredients:

• Anhydrous Citric Acid
• Starch, Corn
• Crospovidone
• Lactose Monohydrate
• Magnesium Stearate
• Mannitol
• Povidones
• Sodium Citrate

Pharmaceutical Classes:

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

Related Products:

Based on records with the same trade name.

• 0054-0177 Buprenorphine 8 mg (As Buprenorphine Hydrochloride 8.64 mg) Sublingual Tablet by Roxane Laboratories, Inc
• 0904-7154 Buprenorphine Hcl 2 mg Sublingual Tablet by Major Pharmaceuticals
• 0904-7155 Buprenorphine Hcl 8 mg Sublingual Tablet by Major Pharmaceuticals
• 43063-753 Buprenorphine Hcl 8 mg Sublingual Tablet by Pd-rx Pharmaceuticals, Inc.
• 55154-4962 Buprenorphine 2 mg (As Buprenorphine Hydrochloride 2.16 mg) Sublingual Tablet by Cardinal Health
• 55700-302 Buprenorphine Hcl 2 mg Sublingual Tablet by Lake Erie Medical Dba Quality Care Products LLC
• 55700-303 Buprenorphine Hcl 8 mg Sublingual Tablet by Lake Erie Medical Dba Quality Care Products LLC
• 58118-0176 Buprenorphine Hcl 2 mg Sublingual Tablet by Clinical Solutions Wholesale, LLC
• 58118-0177 Buprenorphine Hcl 8 mg Sublingual Tablet by Clinical Solutions Wholesale, LLC
• 67046-998 Buprenorphine Hcl 2 mg Sublingual Tablet by Contract Pharmacy Services-pa
• 67046-999 Buprenorphine Hcl 8 mg Sublingual Tablet by Contract Pharmacy Services-pa
• 68071-2915 Buprenorphine Hcl 8 mg Sublingual Tablet by Nucare Pharmaceuticals, Inc.
• 70518-2014 Buprenorphine Hcl 8 mg Sublingual Tablet by Remedyrepack Inc.
• 70518-2226 Buprenorphine Hcl 2 mg Sublingual Tablet by Remedyrepack Inc.
• 71335-1163 Buprenorphine Hcl 8 mg Sublingual Tablet by Bryant Ranch Prepack

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