51862-586 : Lorcet Plus Oral Tablet

NDC:	51862-586
Labeler:	Mayne Pharma Inc.
Product Type:	Human Prescription Drug
Drug Name:	Lorcet Plus
Dosage Form:	Oral Tablet
Application #:	ANDA090118
Rev. Date:	Dec 14, 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.

Appearance:

Markings:	170
Shapes:	Oval
Colors:	Yellow
Size (mm):	13
Segments: *	2
* Segments = the number of equally sized pieces which the pill can be broken into. In this case, a value of 2 indicates a scored pill which can be broken into 2 equal pieces.

NDC Package Codes:

• 51862-586-01: 100 TABLET IN 1 BOTTLE, PLASTIC (51862‑586‑01)
• 51862-586-05: 500 TABLET IN 1 BOTTLE, PLASTIC (51862‑586‑05)

Active Ingredients:

• Hydrocodone Bitartrate
• Acetaminophen

Inactive Ingredients:

• Croscarmellose Sodium
• Crospovidone (15 Mpa.s At 5%)
• Magnesium Stearate
• Microcrystalline Cellulose
• Povidone, Unspecified
• Starch, Corn
• Stearic Acid
• D&c Yellow No. 10

Pharmaceutical Classes:

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

Related Products:

Based on records with the same trade name.

• 0785-1122 Lorcet Plus 7.5/650 (Hydrocodone / Apap) Oral Tablet by Forest Laboratories, Inc.
• 55154-7302 Lorcet Plus 7.5/650 (Hydrocodone / Apap) Oral Tablet by Cardinal Health
• 65084-267 Lorcet Plus 7.5/650 (Hydrocodone / Apap) Oral Tablet by Rx Pak Division of Mckesson Corporation
• 68308-222 Lorcet Plus Oral Tablet by Midlothian Laboratories
• 68308-225 Lorcet Plus Oral Tablet by Mayne Pharma

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