42291-175 : Buprenorphine 8 mg / Naloxone 2 mg Sublingual Tablet

NDC:	42291-175
Labeler:	Avkare, Inc.
Product Type:	Human Prescription Drug
Drug Name:	Buprenorphine Hcl and Naloxone Hcl
Dosage Form:	Sublingual Tablet
Application #:	ANDA203136
Rev. Date:	Apr 2, 2013
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:	AN;415
Shapes:	Round
Colors:	Orange
Size (mm):	11
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.

The above image is provided by the U.S. National Library of Medicine (NLM) and is not part of the official label.

NDC Package Codes:

• 42291-175-30: 30 TABLET IN 1 BOTTLE (42291‑175‑30)

Active Ingredients:

• Buprenorphine
• Naloxone

Inactive Ingredients:

• Acesulfame Potassium
• Anhydrous Citric Acid
• Fd&c Yellow No. 6
• Lactose Monohydrate
• Magnesium Stearate
• Mannitol
• Povidone
• Sodium Citrate
• Starch, Corn

Pharmaceutical Classes:

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

Related Products:

Based on records with the same trade name.

• 42291-174 Buprenorphine 2 mg / Naloxone 0.5 mg Sublingual Tablet by Avkare, Inc.
• 0406-1923 Buprenorphine 2 mg / Naloxone 0.5 mg Sublingual Tablet by Mallinckrodt, Inc.
• 0406-1924 Buprenorphine 8 mg / Naloxone 2 mg Sublingual Tablet by Mallinckrodt, Inc.
• 50268-144 Buprenorphine Hcl and Naloxone Hcl Sublingual Tablet by Avpak
• 50268-145 Buprenorphine Hcl and Naloxone Hcl Sublingual Tablet by Avpak
• 54569-6408 Buprenorphine Hcl and Naloxone Hcl Sublingual Tablet by A-s Medication Solutions LLC
• 63629-5074 Buprenorphine Hcl and Naloxone Hcl Sublingual Tablet by Bryant Ranch Prepack
• 63629-7269 Buprenorphine Hcl and Naloxone Hcl Sublingual Tablet by Bryant Ranch Prepack
• 65162-415 Buprenorphine 8 mg / Naloxone 2 mg Sublingual Tablet by Amneal Pharmaceuticals, LLC
• 65162-416 Buprenorphine 2 mg / Naloxone 0.5 mg Sublingual Tablet by Amneal Pharmaceuticals, LLC
• 70518-1007 Buprenorphine Hcl and Naloxone Hcl Sublingual Tablet by Remedyrepack Inc.
• 70518-1684 Buprenorphine Hcl and Naloxone Hcl Sublingual Tablet by Remedyrepack Inc.
• 71335-1514 Buprenorphine 2 mg / Naloxone 0.5 mg Sublingual Tablet by Bryant Ranch Prepack

NDC QR Code

Scan the QR code below to easily reference this data in the future:



< Prev: 42291-174Next: 42291-176 >

Related Discussions: