35356-840 : Apap 650 mg / Oxycodone Hydrochloride 10 mg Oral Tablet

NDC:	35356-840
Labeler:	Lake Erie Medical Dba Quality Care Products LLC
Product Type:	Human Prescription Drug
Drug Name:	Oxycodone and Acetaminophen
Dosage Form:	Oral Tablet
Application #:	ANDA040789
Rev. Date:	Nov 27, 2007
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:	IP;206
Shapes:	Capsule
Colors:	White
Size (mm):	20
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:

35356-840-30: 30 TABLET IN 1 BOTTLE (35356‑840‑30)
35356-840-60: 60 TABLET IN 1 BOTTLE (35356‑840‑60)
35356-840-90: 90 TABLET IN 1 BOTTLE (35356‑840‑90)

Active Ingredients:

Acetaminophen
Oxycodone

Dosage Strength:

650 mg
10 mg

Inactive Ingredients:

Silicon Dioxide
Crospovidone
Magnesium Stearate
Cellulose, Microcrystalline
Povidone
Starch, Corn
Stearic Acid

Pharmaceutical Classes:

Full Opioid Agonists [MoA]
Opioid Agonist [EPC]

NDC QR Code

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NDC 35356-840 QR Code

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Note: The RxChat NDC Database uses publicly available data from the FDA and the U.S. National Library of Medicine (NLM); The NLM is not responsible for the data presented and does not endorse or recommend this or any other product. While we make every effort to ensure that the information presented is accurate, you should assume that all results are unvalidated. To report any errors or inconsistencies please contact us.