16590-609 : 12 Hr Opana 40 mg Extended Release Tablet

NDC:	16590-609
Labeler:	Stat Rx USA LLC
Product Type:	Human Prescription Drug
Drug Name:	Opana ER
Dosage Form:	Oral Tablet, Film Coated, Extended Release
Application #:	NDA021610
Rev. Date:	Jun 22, 2006
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:	E693;40
Shapes:	Octagon (8 sides)
Colors:	Yellow
Size (mm):	8
Segments: ^*	2
^* Segments = the number of equally sized pieces which the pill can be broken into. In this case, a value of 2 indicates a scored pill which can be broken into 2 equal pieces.

NDC Package Codes:

16590-609-30: 30 TABLET, FILM COATED, EXTENDED RELEASE IN 1 BOTTLE (16590‑609‑30)
16590-609-60: 60 TABLET, FILM COATED, EXTENDED RELEASE IN 1 BOTTLE (16590‑609‑60)
16590-609-90: 90 TABLET, FILM COATED, EXTENDED RELEASE IN 1 BOTTLE (16590‑609‑90)

Active Ingredients:

Oxymorphone Hydrochloride

Dosage Strength:

40 mg

Inactive Ingredients:

Hypromelloses
Methylparaben
Propylene Glycol
Sodium Stearyl Fumarate
Titanium Dioxide
Triacetin
Fd&c Yellow No. 6
Ferrosoferric Oxide
Cellulose, Microcrystalline
D&c Yellow No. 10
Lactose Monohydrate

Pharmaceutical Classes:

Full Opioid Agonists [MoA]
Opioid Agonist [EPC]

NDC QR Code

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NDC 16590-609 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.