13811-689 : Tramadol Hydrochloride 100 mg Oral Capsule

NDC:	13811-689
Labeler:	Trigen Laboratories, LLC
Product Type:	Human Prescription Drug
Drug Name:	Tramadol Hydrochloride Extended-release
Dosage Form:	Oral Capsule
Application #:	NDA022370
Rev. Date:	Jun 22, 2015
CSA Schedule:	CIV (US) [1]

^[1] Schedule IV Controlled Substance: Low potential for abuse relative to substances in Schedule III. Examples include Alprazolam (Xanax), Diazepam (Valium), Carisoprodol (Soma), Clonazepam (Klonopin), Lorazepam (Ativan), Clorazepate (Tranxene), Midazolam (Versed), Temazepam (Restoril), and Triazolam (Halcion).. More Details: US Dept of Justice Controlled Substance Schedules.

Appearance:

Markings:	G;252;100
Shapes:	Capsule
Colors:	White
Size (mm):	19
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:

• 13811-689-30: 30 CAPSULE IN 1 BOTTLE, PLASTIC (13811‑689‑30)

Active Ingredients:

• Tramadol Hydrochloride

Inactive Ingredients:

• Gelatin
• Titanium Dioxide
• Shellac
• Fd&c Blue No. 2
• Lactose Monohydrate
• Cellulose, Microcrystalline
• Sucrose Stearate
• Povidone K29/32
• Starch, Corn
• Magnesium Stearate
• Hypromellose 2910 (6 Mpa.s)
• Talc
• Polysorbate 80
• Ethyl Acrylate and Methyl Methacrylate Copolymer (2:1
• 750000 Mw)

Pharmaceutical Classes:

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

Related Products:

Based on records with the same trade name.

• 13811-690 Tramadol Hydrochloride 200 mg Oral Capsule by Trigen Laboratories, LLC
• 13811-691 Tramadol Hydrochloride 300 mg Oral Capsule by Trigen Laboratories, LLC

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