35356-499 : Opana 5 mg Oral Tablet

NDC:	35356-499
Labeler:	Lake Erie Medical & Surgical Supply Dba Quality Care Products LLC
Product Type:	Human Prescription Drug
Drug Name:	Opana
Dosage Form:	Oral Tablet
Application #:	NDA021611
Rev. Date:	Feb 9, 2012
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:	E612;5
Shapes:	Round
Colors:	Blue
Size (mm):	9
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:

35356-499-01: 120 TABLET IN 1 BOTTLE (35356‑499‑01)
35356-499-30: 30 TABLET IN 1 BOTTLE (35356‑499‑30)

Active Ingredients:

Oxymorphone Hydrochloride

Dosage Strength:

5 mg

Inactive Ingredients:

Lactose Monohydrate
Magnesium Stearate
Starch, Corn
Fd&c Blue No. 2

Pharmaceutical Classes:

Full Opioid Agonists [MoA]
Opioid Agonist [EPC]

NDC QR Code

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NDC 35356-499 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.