52544-163 : Maxidone 10/750 (Hydrocodone Bitartrate / Apap) Oral Tablet

NDC:	52544-163
Labeler:	Watson Pharma, Inc.
Product Type:	Human Prescription Drug
Drug Name:	Maxidone
Dosage Form:	Oral Tablet
Application #:	ANDA040094
Rev. Date:	Mar 12, 2013
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:	Maxidone;634
Shapes:	Oval
Colors:	White
Size (mm):	19
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:

• 52544-163-01: 100 TABLET IN 1 BOTTLE, PLASTIC (52544‑163‑01)

Active Ingredients:

• Acetaminophen
• Hydrocodone Bitartrate

Inactive Ingredients:

• Anhydrous Lactose
• Croscarmellose Sodium
• Magnesium Stearate
• Cellulose, Microcrystalline
• Stearic Acid
• Povidones
• Crospovidone
• Starch, Corn

Pharmaceutical Classes:

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

Related Products:

Based on records with the same trade name.

• 52544-634 Maxidone 10/750 (Hydrocodone Bitartrate / Apap) Oral Tablet by Watson Pharma, Inc.

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