16729-167 : Tramadol Hydrochloride 50 mg Oral Tablet

NDC:	16729-167
Labeler:	Accord Healthcare, Inc.
Product Type:	Human Prescription Drug
Drug Name:	Tramadol
Dosage Form:	Oral Tablet
Application #:	ANDA202390
Rev. Date:	Oct 1, 2013
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:	50
Shapes:	Round
Colors:	White
Size (mm):	8
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:

• 16729-167-00: 100 TABLET IN 1 BOTTLE (16729‑167‑00)
• 16729-167-01: 100 TABLET IN 1 BOTTLE (16729‑167‑01)
• 16729-167-16: 500 TABLET IN 1 BOTTLE (16729‑167‑16)
• 16729-167-17: 1000 TABLET IN 1 BOTTLE (16729‑167‑17)

Active Ingredients:

• Tramadol Hydrochloride

Inactive Ingredients:

• Starch, Corn
• Hypromelloses
• Lactose Monohydrate
• Magnesium Stearate
• cellulose, Microcrystalline
• Polyethylene Glycol 400
• polysorbate 80
• sodium Starch Glycolate Type a Potato
• titanium Dioxide

Pharmaceutical Classes:

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

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