13811-657 : Hydrocodone Bitartrate and Acetaminophen Oral Tablet

NDC:	13811-657
Labeler:	Trigen Laboratories, LLC
Product Type:	Human Prescription Drug
Drug Name:	Hydrocodone Bitartrate and Acetaminophen
Dosage Form:	Oral Tablet
Application #:	ANDA040846
Rev. Date:	Feb 10, 2014
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:	25;325;KLE
Shapes:	Oval
Colors:	White
Size (mm):	14
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:

• 13811-657-10: 100 TABLET IN 1 BOTTLE, PLASTIC (13811‑657‑10)

Active Ingredients:

• Acetaminophen
• Hydrocodone Bitartrate

Inactive Ingredients:

• Cellulose, Microcrystalline
• Crospovidone
• Magnesium Stearate
• Povidones
• Silicon Dioxide
• Starch, Corn
• Stearic Acid

Pharmaceutical Classes:

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

Related Products:

Based on records with the same trade name.

• 0121-0655 Hydrocodone Bitartrate and Acetaminophen Oral Solution by Pharmaceutical Associates, Inc.
• 0121-0772 Hydrocodone Bitartrate and Acetaminophen Oral Solution by Pharmaceutical Associates, Inc.
• 0121-1544 Hydrocodone Bitartrate and Acetaminophen Oral Solution by Pharmaceutical Associates, Inc.
• 0121-2316 Hydrocodone Bitartrate and Acetaminophen Oral Solution by Pharmaceutical Associates, Inc.
• 0121-4655 Hydrocodone Bitartrate and Acetaminophen Oral Solution by Pharmaceutical Associates, Inc.
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• 0121-4772 Hydrocodone Bitartrate and Acetaminophen Oral Solution by Pharmaceutical Associates, Inc.
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• 0179-0113 Apap 325 mg / Hydrocodone Bitartrate 5 mg Oral Tablet by Kaiser Foundation Hospitals
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• 0245-0410 Hydrocodone Bitartrate and Acetaminophen Oral Tablet by Upsher-smith Laboratories, Inc.
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• 0254-2034 Hydrocodone Bitartrate and Acetaminophen Oral Tablet by Par Pharmaceutical, Inc.
• 0254-2035 Hydrocodone Bitartrate and Acetaminophen Oral Tablet by Par Pharmaceutical, Inc.
• 0254-2036 Hydrocodone Bitartrate and Acetaminophen Oral Tablet by Par Pharmaceutical, Inc.
• 0258-3622 Apap 650 mg / Hydrocodone Bitartrate 7.5 mg Oral Tablet by Mikart, Inc.
• 0258-3658 Apap 650 mg / Hydrocodone Bitartrate 10 mg Oral Tablet by Inwood Labortories, Inc.
• More related products ...

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