0378-7106 : Apap 325 mg / Oxycodone Hydrochloride 10 mg Oral Tablet

NDC:	0378-7106
Labeler:	Mylan Pharmaceuticals Inc.
Product Type:	Human Prescription Drug
Drug Name:	Oxycodone and Acetaminophen
Dosage Form:	Oral Tablet
Application #:	ANDA090177
Rev. Date:	Dec 16, 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:	106
Shapes:	Round
Colors:	White
Size (mm):	13
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:

• 0378-7106-01: 100 TABLET IN 1 BOTTLE (0378‑7106‑01)

Active Ingredients:

• Acetaminophen
• Oxycodone Hydrochloride

Inactive Ingredients:

• Silicon Dioxide
• Croscarmellose Sodium
• Crospovidone
• Cellulose, Microcrystalline
• Povidones
• Stearic Acid
• Starch, Corn

Pharmaceutical Classes:

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

Related Products:

Based on records with the same trade name.

• 0378-7103 Apap 325 mg / Oxycodone Hydrochloride 2.5 mg Oral Tablet by Mylan Pharmaceuticals Inc.
• 0378-7104 Apap 325 mg / Oxycodone Hydrochloride 5 mg Oral Tablet by Mylan Pharmaceuticals Inc.
• 0378-7105 Apap 325 mg / Oxycodone Hydrochloride 7.5 mg Oral Tablet by Mylan Pharmaceuticals Inc.
• 0378-7107 Apap 500 mg / Oxycodone Hydrochloride 7.5 mg Oral Tablet by Mylan Pharmaceuticals Inc.
• 0378-7108 Apap 650 mg / Oxycodone Hydrochloride 10 mg Oral Tablet by Mylan Pharmaceuticals Inc.
• 0054-0551 Oxycodone and Acetaminophen Oral Tablet by Roxane Laboratories, Inc.
• 0228-2980 Oxycodone and Acetaminophen Oral Tablet by Actavis Elizabeth LLC
• 0228-2981 Oxycodone and Acetaminophen Oral Tablet by Actavis Elizabeth LLC
• 0228-2982 Oxycodone and Acetaminophen Oral Tablet by Actavis Elizabeth LLC
• 0228-2983 Oxycodone and Acetaminophen Oral Tablet by Actavis Elizabeth LLC
• 0406-0512 Apap 325 mg / Oxycodone Hydrochloride 5 mg Oral Tablet by Mallinckrodt, Inc.
• 0406-0522 Apap 325 mg / Oxycodone Hydrochloride 7.5 mg Oral Tablet by Mallinckrodt, Inc.
• 0406-0523 Apap 325 mg / Oxycodone Hydrochloride 10 mg Oral Tablet by Mallinckrodt, Inc.
• 0406-0532 Apap 500 mg / Oxycodone Hydrochloride 5 mg Oral Capsule by Mallinckrodt, Inc.
• 0406-0582 Apap 500 mg / Oxycodone Hydrochloride 7.5 mg Oral Tablet by Mallinckrodt, Inc.
• 0527-1669 Oxycodone and Acetaminophen Oral Tablet by Lannett Company, Inc.
• 0527-1671 Oxycodone and Acetaminophen Oral Tablet by Lannett Company, Inc.
• 0555-0658 Apap 500 mg / Oxycodone Hydrochloride 5 mg Oral Capsule by Barr Laboratories Inc.
• 0591-0737 Apap 500 mg / Oxycodone Hydrochloride 5 mg Oral Capsule by Watson Laboratories, Inc.
• 0591-0749 Apap 325 mg / Oxycodone Hydrochloride 5 mg Oral Tablet by Watson Laboratories, Inc.
• More related products ...

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