16590-774 : Hydromorphone Hydrochloride 8 mg Oral Tablet

NDC:	16590-774
Labeler:	Stat Rx USA LLC
Product Type:	Human Prescription Drug
Drug Name:	Hydromorphone Hydrochloride
Dosage Form:	Oral Tablet
Application #:	NDA019892
Rev. Date:	Nov 23, 2009
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:	Pd;8
Shapes:	Triangle (3 sides)
Colors:	White
Size (mm):	7
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:

• 16590-774-30: 30 TABLET IN 1 BOTTLE (16590‑774‑30)
• 16590-774-60: 60 TABLET IN 1 BOTTLE (16590‑774‑60)
• 16590-774-90: 90 TABLET IN 1 BOTTLE (16590‑774‑90)

Active Ingredients:

• Hydromorphone Hydrochloride

Inactive Ingredients:

• Lactose
• Magnesium Stearate
• Sodium Metabisulfite

Pharmaceutical Classes:

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

Related Products:

Based on records with the same trade name.

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