51862-585 : Lorcet Oral Tablet

NDC:	51862-585
Labeler:	Mayne Pharma Inc.
Product Type:	Human Prescription Drug
Drug Name:	Lorcet
Dosage Form:	Oral Tablet
Application #:	ANDA090118
Rev. Date:	Dec 14, 2016
CSA Schedule:	CII (US) [1]

^[1] Schedule II / IIN Controlled Substance: High potential for abuse which may lead to severe psychological or physical dependence. (i.e. Narcotics such as Dilaudid, Methadone, Demerol, Oxycodone, Percocet, Fentanyl, Morphine, Opium, Codeine, and Hydrocodone ... Schedule IIN stimulants include non-narcotic Amphetamines such as Dexedrine, Adderall, Desoxyn, Methylphenidate (Ritalin) ... Other Schedule II substances include Amobarbital, Glutethimide, and Pentobarbital. More Details: US Dept of Justice Controlled Substance Schedules.

Appearance:

Markings:	126
Shapes:	Oval
Colors:	White
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:

• 51862-585-01: 100 TABLET IN 1 BOTTLE, PLASTIC (51862‑585‑01)
• 51862-585-05: 500 TABLET IN 1 BOTTLE, PLASTIC (51862‑585‑05)

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

Pharmaceutical Classes:

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

Related Products:

Based on records with the same trade name.

• 55154-7301 Lorcet 10/650 (Hydrocodone / Acetaminophen) Oral Tablet by Cardinal Health
• 55289-407 Lorcet 10/650 (Hydrocodone / Acetaminophen) Oral Tablet by Pd-rx Pharmaceuticals, Inc.
• 68308-221 Lorcet Oral Tablet by Midlothian Laboratories
• 68308-224 Lorcet Oral Tablet by Mayne Pharma

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