43063-379 : Apap 325 mg / Oxycodone Hydrochloride 7.5 mg Oral Tablet

NDC:	43063-379
Labeler:	Pd-rx Pharmaceuticals, Inc.
Product Type:	Human Prescription Drug
Drug Name:	Oxycodone and Acetaminophen
Dosage Form:	Oral Tablet
Application #:	ANDA040535
Rev. Date:	Sep 5, 2003
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:	WATSON;933
Shapes:	Round
Colors:	White
Size (mm):	11
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.

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:

• 43063-379-12: 12 TABLET IN 1 BOTTLE, PLASTIC (43063‑379‑12)
• 43063-379-30: 30 TABLET IN 1 BOTTLE, PLASTIC (43063‑379‑30)

Active Ingredients:

• Acetaminophen
• Oxycodone Hydrochloride

Inactive Ingredients:

• Colloidal Silicon Dioxide
• Magnesium Stearate
• Cellulose, Microcrystalline
• Starch, Pregelatinized Corn
• Stearic Acid

Pharmaceutical Classes:

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

Related Products:

Based on records with the same trade name.

• 43063-231 Apap 325 mg / Oxycodone Hydrochloride 10 mg Oral Tablet by Pd-rx Pharmaceuticals, Inc.
• 43063-279 Apap 325 mg / Oxycodone Hydrochloride 5 mg Oral Tablet by Pd-rx Pharmaceuticals, Inc.
• 43063-523 Oxycodone and Acetaminophen Oral Tablet by Pd-rx Pharmaceuticals, Inc.
• 43063-528 Oxycodone and Acetaminophen Oral Tablet by Pd-rx Pharmaceuticals, Inc.
• 43063-653 Oxycodone and Acetaminophen Oral Tablet by Pd-rx Pharmaceuticals, Inc.
• 43063-809 Oxycodone and Acetaminophen Oral Tablet by Pd-rx Pharmaceuticals, Inc.
• 55289-951 Apap 325 mg / Oxycodone Hydrochloride 5 mg Oral Tablet by Pd-rx 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
• 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.
• 0378-7106 Apap 325 mg / Oxycodone Hydrochloride 10 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.
• 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.
• More related products ...

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