35356-561 : Ibuprofen 400 mg / Oxycodone Hydrochloride 5 mg Oral Tablet

NDC:	35356-561
Labeler:	Lake Erie Medical Dba Quality Care Products LLC
Product Type:	Human Prescription Drug
Drug Name:	Oxycodone Hydrochloride and Ibuprofen
Dosage Form:	Oral Tablet, Film Coated
Application #:	ANDA078769
Rev. Date:	Nov 4, 2008
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:	29
Shapes:	Oval
Colors:	Yellow
Size (mm):	17
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:

• 35356-561-30: 30 TABLET, FILM COATED IN 1 BOTTLE (35356‑561‑30)
• 35356-561-60: 60 TABLET, FILM COATED IN 1 BOTTLE (35356‑561‑60)
• 35356-561-90: 90 TABLET, FILM COATED IN 1 BOTTLE (35356‑561‑90)

Active Ingredients:

• Ibuprofen
• Oxycodone Hydrochloride

Inactive Ingredients:

• Calcium Stearate
• Croscarmellose Sodium
• Silicon Dioxide
• Hydroxypropyl Cellulose
• Cellulose, Microcrystalline
• Starch, Corn
• Stearic Acid
• Hypromelloses
• Lactose Monohydrate
• Polyethylene Glycols
• Ferric Oxide Yellow
• Titanium Dioxide
• Triacetin

Pharmaceutical Classes:

• Full Opioid Agonists [MoA]
• Opioid Agonist [EPC]
• Cyclooxygenase Inhibitors [MoA]
• Nonsteroidal Anti-inflammatory Compounds [Chemical/Ingredient]
• Nonsteroidal Anti-inflammatory Drug [EPC]

Related Products:

Based on records with the same trade name.

• 0228-4029 Ibuprofen 400 mg / Oxycodone Hydrochloride 5 mg Oral Tablet by Actavis Elizabeth LLC
• 0555-0778 Ibuprofen 400 mg / Oxycodone Hydrochloride 5 mg Oral Tablet by Barr Laboratories Inc.
• 0591-3494 Ibuprofen 400 mg / Oxycodone Hydrochloride 5 mg Oral Tablet by Watson Laboratories, Inc.

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