60846-900 : Reprexain Oral Tablet, Film Coated

NDC:	60846-900
Labeler:	Gemini Laboratories, LLC
Product Type:	Human Prescription Drug
Drug Name:	Reprexain
Dosage Form:	Oral Tablet, Film Coated
Application #:	ANDA076642
Rev. Date:	Dec 27, 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:	IP116
Shapes:	Capsule
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:

• 60846-900-01: 100 TABLET, FILM COATED IN 1 BOTTLE (60846‑900‑01)

Active Ingredients:

• Hydrocodone Bitartrate
• Ibuprofen

Inactive Ingredients:

• Carnauba Wax
• Silicon Dioxide
• Croscarmellose Sodium
• Hypromelloses
• Magnesium Stearate
• Cellulose, Microcrystalline
• Polyethylene Glycols
• Polydextrose
• Starch, Corn
• Titanium Dioxide

Pharmaceutical Classes:

• Opioid Agonist [EPC]
• Opioid Agonists [MoA]
• Cyclooxygenase Inhibitors [MoA]
• Nonsteroidal Anti-inflammatory Compounds [Chemical/Ingredient]
• Nonsteroidal Anti-inflammatory Drug [EPC]

Related Products:

Based on records with the same trade name.

• 60846-901 Reprexain Oral Tablet, Film Coated by Gemini Laboratories, LLC
• 60846-902 Reprexain Oral Tablet, Film Coated by Gemini Laboratories, LLC
• 16590-276 Reprexain (Hydrocodone Bitartrate 10 mg / Ibuprofen 200 mg) Oral Tablet by Stat Rx USA
• 16590-878 Reprexain 5/200 (Hydrocodone / Ibuprofen) Oral Tablet by Stat Rx USA
• 23710-900 Reprexain 2.5/200 Oral Tablet by Quinnova Pharmaceuticals, LLC
• 23710-901 Reprexain 5/200 (Hydrocodone / Ibuprofen) Oral Tablet by Quinnova Pharmaceuticals, LLC
• 23710-902 Reprexain (Hydrocodone Bitartrate 10 mg / Ibuprofen 200 mg) Oral Tablet by Quinnova Pharmaceuticals, LLC
• 63717-900 Reprexain 2.5/200 Oral Tablet by Hawthorn Pharmaceuticals, Inc.
• 63717-901 Reprexain 5/200 (Hydrocodone / Ibuprofen) Oral Tablet by Hawthorn Pharmaceuticals, Inc.
• 63717-902 Reprexain (Hydrocodone Bitartrate 10 mg / Ibuprofen 200 mg) Oral Tablet by Hawthorn Pharmaceuticals, Inc.

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