0054-4218 : Dolophine 5 mg Oral Tablet

NDC:	0054-4218
Labeler:	Roxane Laboratories, Inc
Product Type:	Human Prescription Drug
Drug Name:	Dolophine
Dosage Form:	Oral Tablet
Application #:	NDA006134
Rev. Date:	Aug 13, 1947
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:	54;162
Shapes:	Round
Colors:	White
Size (mm):	6
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:

• 0054-4218-25: 100 TABLET IN 1 BOTTLE, PLASTIC (0054‑4218‑25)

Active Ingredients:

• Methadone Hydrochloride

Inactive Ingredients:

• Magnesium Stearate
• Cellulose, Microcrystalline
• Starch, Corn

Pharmaceutical Classes:

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

Related Products:

Based on records with the same trade name.

• 0054-4219 Dolophine 10 mg Oral Tablet by Roxane Laboratories, Inc

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