42858-203 : Hydrocodone Bitartrate and Acetaminophen Oral Tablet

NDC:	42858-203
Labeler:	Rhodes Pharmaceuticals L.p.
Product Type:	Human Prescription Drug
Drug Name:	Hydrocodone Bitartrate and Acetaminophen
Dosage Form:	Oral Tablet
Application #:	ANDA202991
Rev. Date:	Apr 12, 2016
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:	R;P;H10;325
Shapes:	Oval
Colors:	White
Size (mm):	14
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:

• 42858-203-01: 100 TABLET IN 1 BOTTLE (42858‑203‑01)
• 42858-203-10: 100 BLISTER PACK IN 1 BOX, UNIT‑DOSE (42858‑203‑10) > 1 TABLET IN 1 BLISTER PACK
• 42858-203-50: 500 TABLET IN 1 BOTTLE (42858‑203‑50)
• 42858-203-90: 1000 TABLET IN 1 BOTTLE (42858‑203‑90)

Active Ingredients:

• Hydrocodone Bitartrate
• Acetaminophen

Inactive Ingredients:

• Silicon Dioxide
• Magnesium Stearate
• Crospovidone
• Povidone K30
• Starch, Corn
• Stearic Acid

Pharmaceutical Classes:

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

Related Products:

Based on records with the same trade name.

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