16590-350 : Zydone 7.5/400 (Hydrocodone Bitartrate / Apap) Oral Tablet

NDC:	16590-350
Labeler:	Stat Rx USA LLC
Product Type:	Human Prescription Drug
Drug Name:	Zydone
Dosage Form:	Oral Tablet
Application #:	ANDA040288
Rev. Date:	Dec 1, 1998
CSA Schedule:	CIII (US) [1]

^[1] Schedule III / IIIN Controlled Substance: Has a potential for abuse less than substances in Schedules I or II and abuse may lead to moderate or low physical dependence or high psychological dependence. (i.e. Products containing not more than 90 milligrams of Codeine per dosage unit [such as Tylenol with Codeine], other narcotics such as Buprenorphine (Suboxone), and Schedule IIIN non-narcotics such as Didrex, Ketamine, Phendimetrazine, and Anabolic Steroids). More Details: US Dept of Justice Controlled Substance Schedules.

Appearance:

Markings:	E;7;5
Shapes:	Octagon (8 sides)
Colors:	Blue
Size (mm):	17
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:

• 16590-350-62: 84 TABLET IN 1 BOTTLE (16590‑350‑62)

Active Ingredients:

• Acetaminophen
• Hydrocodone Bitartrate

Inactive Ingredients:

• Silicon Dioxide
• Croscarmellose Sodium
• Crospovidone
• Cellulose, Microcrystalline
• Povidone
• Starch, Corn
• Stearic Acid
• Fd&c Blue No. 2

Pharmaceutical Classes:

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

Related Products:

Based on records with the same trade name.

• 63481-668 Zydone 5/400 (Hydrocodone Bitartrate / Apap) Oral Tablet by Endo Pharmaceuticals Inc.
• 63481-669 Zydone 7.5/400 (Hydrocodone Bitartrate / Apap) Oral Tablet by Endo Pharmaceuticals Inc.
• 63481-698 Zydone 10/400 (Hydrocodone Bitartrate / Apap) Oral Tablet by Endo Pharmaceuticals Inc.

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