68084-354 : Oxycodone Hydrochloride 5 mg Oral Tablet

NDC:	68084-354
Labeler:	American Health Packaging
Product Type:	Human Prescription Drug
Drug Name:	Oxycodone Hydchloride
Dosage Form:	Oral Tablet
Application #:	ANDA091393
Rev. Date:	Dec 9, 2009
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:	K;18
Shapes:	Round
Colors:	White
Size (mm):	6
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.

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:

• 68084-354-01: 10 BLISTER PACK IN 1 CARTON (68084‑354‑01) > 10 TABLET IN 1 BLISTER PACK (68084‑354‑11)

Active Ingredients:

• Oxycodone Hydrochloride

Inactive Ingredients:

• Starch, Corn
• Lactose Monohydrate
• Cellulose, Microcrystalline
• Silicon Dioxide
• Sodium Starch Glycolate Type a Potato
• Stearic Acid

Pharmaceutical Classes:

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

Related Products:

Based on records with the same trade name.

• 35356-839 Oxycodone Hydrochloride 10 mg Oral Tablet by Lake Erie Medical Dba Quality Care Products LLC
• 49999-899 Oxycodone Hydrochloride 5 mg Oral Tablet by Lake Erie Medical & Surgical Supply Dba Quality Care Products LLC

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