35356-825 : 12 Hr Opana 20 mg Extended Release Tablet

NDC:	35356-825
Labeler:	Lake Erie Medical Dba Quality Care Products LLC
Product Type:	Human Prescription Drug
Drug Name:	Opana ER
Dosage Form:	Oral Tablet, Extended Release
Application #:	NDA201655
Rev. Date:	Mar 20, 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:	E;20
Shapes:	Round
Colors:	Green
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:

35356-825-30: 30 TABLET, EXTENDED RELEASE IN 1 BOTTLE (35356‑825‑30)
35356-825-60: 60 TABLET, EXTENDED RELEASE IN 1 BOTTLE (35356‑825‑60)

Active Ingredients:

Oxymorphone Hydrochloride

Dosage Strength:

20 mg

Inactive Ingredients:

Hypromelloses
.alpha.-tocopherol
Citric Acid Monohydrate
Polyvinyl Alcohol
Titanium Dioxide
Polyethylene Glycols
Talc
Fd&c Blue No. 1
Fd&c Yellow No. 6
D&c Yellow No. 10

Pharmaceutical Classes:

Full Opioid Agonists [MoA]
Opioid Agonist [EPC]

NDC QR Code

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NDC 35356-825 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.