63187-705 : Trezix Oral Capsule

NDC:	63187-705
Labeler:	Proficient Rx Lp
Product Type:	Human Prescription Drug
Drug Name:	Trezix
Dosage Form:	Oral Capsule
Application #:	ANDA204785
Rev. Date:	Dec 1, 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:	TREZIX
Shapes:	Capsule
Colors:	Red
Size (mm):	20
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:

• 63187-705-00: 100 CAPSULE IN 1 BOTTLE (63187‑705‑00)
• 63187-705-30: 30 CAPSULE IN 1 BOTTLE (63187‑705‑30)
• 63187-705-60: 60 CAPSULE IN 1 BOTTLE (63187‑705‑60)
• 63187-705-72: 120 CAPSULE IN 1 BOTTLE (63187‑705‑72)
• 63187-705-90: 90 CAPSULE IN 1 BOTTLE (63187‑705‑90)

Active Ingredients:

• Acetaminophen
• Caffeine
• Dihydrocodeine Bitartrate

Inactive Ingredients:

• Crospovidone (15 Mpa.s At 5%)
• Magnesium Stearate
• Povidones
• Starch, Corn
• Stearic Acid
• Fd&c Red No. 40
• Gelatin

Pharmaceutical Classes:

• Central Nervous System Stimulant [EPC]
• Methylxanthine [EPC]
• Xanthines [CS]
• Central Nervous System Stimulation [PE]
• Full Opioid Agonists [MoA]
• Opioid Agonist [EPC]

Related Products:

Based on records with the same trade name.

• 63629-5637 Trezix Oral Capsule by Bryant Ranch Prepack
• 66992-340 Trezix Reformulated Oct 2011 (Apap 320.5 mg / Caffeine 30 mg / Dihydrocodeine Bitartrate 16 mg) Oral Capsule by Wraser LLC
• 66992-840 Trezix Oral Capsule by Wraser LLC

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