10702-805 : Oxycodone Hcl 40 mg Oral Tablet, Film Coated, Extended Release

NDC:	10702-805
Labeler:	Kvk-tech, Inc.
Product Type:	Human Prescription Drug
Drug Name:	Oxycodone Hcl
Dosage Form:	Oral Tablet, Film Coated, Extended Release
Application #:	NDA022272
Rev. Date:	Apr 5, 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:	40;OP
Shapes:	Round
Colors:	Yellow
Size (mm):	7
Segments: *	1
* Segments = the number of equally sized pieces which the pill can be broken into. In this case, a value of 1 indicates a solid pill with no score lines.

NDC Package Codes:

• 10702-805-01: 100 TABLET, FILM COATED, EXTENDED RELEASE IN 1 BOTTLE (10702‑805‑01)

Active Ingredients:

• Oxycodone Hydrochloride

Inactive Ingredients:

• Butylated Hydroxytoluene
• Hypromelloses
• Polyethylene Glycol 400
• Polyethylene Glycol, Unspecified
• Magnesium Stearate
• Titanium Dioxide
• Polysorbate 80
• Ferric Oxide Yellow /

Pharmaceutical Classes:

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

Related Products:

Based on records with the same trade name.

• 10702-801 Oxycodone Hcl 10 mg Oral Tablet, Film Coated, Extended Release by Kvk-tech, Inc.
• 10702-803 Oxycodone Hcl 20 mg Oral Tablet, Film Coated, Extended Release by Kvk-tech, Inc.
• 55700-791 Oxycodone Hcl 10 mg Oral Tablet, Film Coated, Extended Release by Quality Care Products, LLC
• 61919-659 Oxycodone Hcl 15 mg Oral Tablet by Direct Rx
• 61919-671 Oxycodone Hcl 30 mg Oral Tablet by Direct Rx
• 63304-683 Oxycodone Hcl 40 mg Oral Tablet, Film Coated, Extended Release by Ranbaxy Pharmaceuticals Inc.
• 63304-684 Oxycodone Hcl 80 mg Oral Tablet, Film Coated, Extended Release by Ranbaxy Pharmaceuticals Inc.
• 69238-2294 Oxycodone Hcl 10 mg Oral Tablet, Film Coated, Extended Release by Amneal Pharmaceuticals Ny LLC
• 69238-2296 Oxycodone Hcl 20 mg Oral Tablet, Film Coated, Extended Release by Amneal Pharmaceuticals Ny LLC
• 69238-2298 Oxycodone Hcl 40 mg Oral Tablet, Film Coated, Extended Release by Amneal Pharmaceuticals Ny LLC
• 69238-2300 Oxycodone Hcl 80 mg Oral Tablet, Film Coated, Extended Release by Amneal Pharmaceuticals Ny LLC

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