60793-434 : Embeda (Morphine Sulfate 60 mg / Naltrexone Hydrochloride 2.4 mg) Extended Release Oral Capsule

NDC:	60793-434
Labeler:	King Pharmaceuticals, Inc.
Product Type:	Human Prescription Drug
Drug Name:	Embeda
Dosage Form:	Oral Capsule, Extended Release
Application #:	NDA022321
Rev. Date:	Aug 13, 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:	EMBEDA;60
Shapes:	Capsule
Colors:	Pink
Size (mm):	22
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:

• 60793-434-01: 200 CAPSULE, EXTENDED RELEASE IN 1 BOTTLE (60793‑434‑01)
• 60793-434-20: 30 CAPSULE, EXTENDED RELEASE IN 1 BOTTLE (60793‑434‑20)

Active Ingredients:

• Morphine Sulfate
• Naltrexone Hydrochloride

Inactive Ingredients:

• Talc
• Ethylcelluloses
• Sodium Chloride
• Polyethylene Glycols
• Hydroxypropyl Cellulose (Type H)
• Dibutyl Sebacate
• Diethyl Phthalate
• Magnesium Stearate
• Sodium Lauryl Sulfate
• Ascorbic Acid
• Gelatin
• Titanium Dioxide
• D&c Red No. 28
• Fd&c Red No. 40
• Fd&c Blue No. 1

Pharmaceutical Classes:

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

Related Products:

Based on records with the same trade name.

• 60793-430 Embeda (Morphine Sulfate 20 mg / Naltrexone Hydrochloride 0.8 mg) Extended Release Oral Capsule by King Pharmaceuticals, Inc.
• 60793-431 Embeda (Morphine Sulfate 30 mg / Naltrexone Hydrochloride 1.2 mg) Extended Release Oral Capsule by King Pharmaceuticals, Inc.
• 60793-433 Embeda (Morphine Sulfate 50 mg / Naltrexone Hydrochloride 2 mg) Extended Release Oral Capsule by King Pharmaceuticals, Inc.
• 60793-435 Embeda (Morphine Sulfate 80 mg / Naltrexone Hydrochloride 3.2 mg) Extended Release Oral Capsule by King Pharmaceuticals, Inc.
• 60793-437 Embeda (Morphine Sulfate 100 mg / Naltrexone Hydrochloride 4 mg) Extended Release Oral Capsule by King Pharmaceuticals, Inc.
• 16590-897 Embeda (Morphine Sulfate 20 mg / Naltrexone Hydrochloride 0.8 mg) Extended Release Oral Capsule by Stat Rx USA LLC

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