54868-4948 : Methadone Hydrochloride 10 mg Oral Tablet

NDC:	54868-4948
Labeler:	Physicians Total Care, Inc.
Product Type:	Human Prescription Drug
Drug Name:	Methadone Hydrochloride
Dosage Form:	Oral Tablet
Application #:	ANDA040517
Rev. Date:	Jan 7, 2004
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:	57;71;M
Shapes:	Rectangle (4 sides)
Colors:	White
Size (mm):	11
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.

The above image is provided by the U.S. National Library of Medicine (NLM) and is not part of the official label.

NDC Package Codes:

• 54868-4948-0: 60 TABLET IN 1 BOTTLE (54868‑4948‑0)
• 54868-4948-1: 100 TABLET IN 1 BOTTLE (54868‑4948‑1)
• 54868-4948-2: 120 TABLET IN 1 BOTTLE (54868‑4948‑2)
• 54868-4948-3: 50 TABLET IN 1 BOTTLE (54868‑4948‑3)
• 54868-4948-4: 300 TABLET IN 1 BOTTLE (54868‑4948‑4)
• 54868-4948-5: 30 TABLET IN 1 BOTTLE (54868‑4948‑5)
• 54868-4948-6: 90 TABLET IN 1 BOTTLE (54868‑4948‑6)
• 54868-4948-7: 150 TABLET IN 1 BOTTLE (54868‑4948‑7)

Active Ingredients:

• Methadone Hydrochloride

Inactive Ingredients:

• Lactose Monohydrate
• Magnesium Stearate
• Cellulose, Microcrystalline
• Silicon Dioxide

Pharmaceutical Classes:

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

Related Products:

Based on records with the same trade name.

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