68788-9297 : Hydrocodone Bitartrate and Acetaminophen Oral Tablet

NDC:	68788-9297
Labeler:	Preferred Pharmaceuticals, Inc.
Product Type:	Human Prescription Drug
Drug Name:	Hydrocodone Bitartrate and Acetaminophen
Dosage Form:	Oral Tablet
Application #:	ANDA040746
Rev. Date:	Apr 21, 2015
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:	IP;110
Shapes:	Capsule
Colors:	White
Size (mm):	15
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:

• 68788-9297-1: 12 TABLET IN 1 BOTTLE (68788‑9297‑1)
• 68788-9297-2: 20 TABLET IN 1 BOTTLE (68788‑9297‑2)
• 68788-9297-3: 30 TABLET IN 1 BOTTLE (68788‑9297‑3)
• 68788-9297-4: 40 TABLET IN 1 BOTTLE (68788‑9297‑4)
• 68788-9297-5: 15 TABLET IN 1 BOTTLE (68788‑9297‑5)
• 68788-9297-6: 60 TABLET IN 1 BOTTLE (68788‑9297‑6)
• 68788-9297-8: 120 TABLET IN 1 BOTTLE (68788‑9297‑8)
• 68788-9297-9: 90 TABLET IN 1 BOTTLE (68788‑9297‑9)

Active Ingredients:

• Hydrocodone Bitartrate
• Acetaminophen

Inactive Ingredients:

• Silicon Dioxide
• Magnesium Stearate
• Cellulose, Microcrystalline
• Crospovidone
• Povidones
• 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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