61919-820 : Oxycodone Hydrochloride 15 mg Oral Tablet

NDC:	61919-820
Labeler:	Direct_rx
Product Type:	Human Prescription Drug
Drug Name:	Oxycodone Hydrochloride
Dosage Form:	Oral Tablet
Application #:	ANDA203638
Rev. Date:	Aug 21, 2019
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:	A;49
Shapes:	Round
Colors:	Green
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.

NDC Package Codes:

• 61919-820-30: 30 TABLET IN 1 BOTTLE (61919‑820‑30)
• 61919-820-90: 90 TABLET IN 1 BOTTLE (61919‑820‑90)

Active Ingredients:

• Oxycodone Hydrochloride

Inactive Ingredients:

• Starch, Corn
• Lactose Monohydrate
• D&c Yellow No. 10
• Fd&c Blue No. 2
• Cellulose, Microcrystalline
• 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.

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• 0054-0390 Oxycodone Hydrochloride 5 mg/5ml Oral Solution by Roxane Laboratories, Inc.
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• 0093-5731 Oxycodone Hydrochloride 10 mg Oral Tablet, Film Coated, Extended Release by Teva Pharmaceuticals USA Inc
• 0093-5732 Oxycodone Hydrochloride 20 mg Oral Tablet, Film Coated, Extended Release by Teva Pharmaceuticals USA Inc
• 0093-5733 Oxycodone Hydrochloride 40 mg Oral Tablet, Film Coated, Extended Release by Teva Pharmaceuticals USA Inc
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• 0115-1557 Oxycodone Hydrochloride 15 mg Oral Tablet, Film Coated, Extended Release by Impax Generics
• 0115-1558 Oxycodone Hydrochloride 20 mg Oral Tablet, Film Coated, Extended Release by Impax Generics
• 0115-1559 Oxycodone Hydrochloride 30 mg Oral Tablet, Film Coated, Extended Release by Impax Generics
• 0115-1560 Oxycodone Hydrochloride 40 mg Oral Tablet, Film Coated, Extended Release by Impax Generics
• 0115-1561 Oxycodone Hydrochloride 60 mg Oral Tablet, Film Coated, Extended Release by Impax Generics
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• 0121-0826 Oxycodone Hydrochloride 100 mg/5ml Oral Solution by Pharmaceutical Associates, Inc.
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