0378-0924 : Buprenorphine Hydrochloride Sublingual 8 mg Sublingual Tablet

NDC:	0378-0924
Labeler:	Mylan Pharmaceuticals Inc.
Product Type:	Human Prescription Drug
Drug Name:	Buprenorphine Hydrochloride Sublingual
Dosage Form:	Sublingual Tablet
Application #:	ANDA201066
Rev. Date:	Mar 6, 2015
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:	M;924
Shapes:	Round
Colors:	White
Size (mm):	10
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:

• 0378-0924-05: 500 TABLET IN 1 BOTTLE, PLASTIC (0378‑0924‑05)
• 0378-0924-93: 30 TABLET IN 1 BOTTLE, PLASTIC (0378‑0924‑93)

Active Ingredients:

• Buprenorphine Hydrochloride

Inactive Ingredients:

• Anhydrous Citric Acid
• Anhydrous Lactose
• Silicon Dioxide
• Starch, Corn
• Crospovidone
• Lactose Monohydrate
• Magnesium Stearate
• Mannitol
• Cellulose, Microcrystalline
• Sodium Citrate

Pharmaceutical Classes:

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

Related Products:

Based on records with the same trade name.

• 0378-0923 Buprenorphine Hydrochloride Sublingual 2 mg Sublingual Tablet by Mylan Pharmaceuticals Inc.
• 61786-678 Buprenorphine Hydrochloride Sublingual Sublingual 2 mg Sublingual Tablet by Remedyrepack Inc.
• 67046-996 Buprenorphine Hydrochloride Sublingual Sublingual 2 mg Sublingual Tablet by Contract Pharmacy Services-pa
• 67046-997 Buprenorphine Hydrochloride Sublingual Sublingual 8 mg Sublingual Tablet by Contract Pharmacy Services-pa
• 70518-0652 Buprenorphine Hydrochloride Sublingual Sublingual 2 mg Sublingual Tablet by Remedyrepack Inc.

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