45865-357 : Tramadol Hydrochloride 50 mg Oral Tablet, Film Coated

NDC:	45865-357
Labeler:	Medsource Pharmaceuticals
Product Type:	Human Prescription Drug
Drug Name:	Tramadol Hydrochloride
Dosage Form:	Oral Tablet, Film Coated
Application #:	ANDA091498
Rev. Date:	Feb 14, 2014
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:	101;OUYI
Shapes:	Oval
Colors:	White
Size (mm):	10
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.

The above image is provided by the U.S. National Library of Medicine (NLM) and is not part of the official label.

NDC Package Codes:

• 45865-357-20: 20 TABLET, FILM COATED IN 1 BOTTLE (45865‑357‑20)
• 45865-357-30: 30 TABLET, FILM COATED IN 1 BOTTLE (45865‑357‑30)
• 45865-357-51: 120 TABLET, FILM COATED IN 1 BOTTLE (45865‑357‑51)
• 45865-357-60: 60 TABLET, FILM COATED IN 1 BOTTLE (45865‑357‑60)
• 45865-357-90: 90 TABLET, FILM COATED IN 1 BOTTLE (45865‑357‑90)

Active Ingredients:

• Tramadol Hydrochloride

Inactive Ingredients:

• Starch, Corn
• Hypromelloses
• Lactose Monohydrate
• Magnesium Stearate
• Cellulose, Microcrystalline
• Polyethylene Glycols
• Polyvinyl Alcohol
• Sodium Starch Glycolate Type a Potato
• Talc
• Titanium Dioxide

Pharmaceutical Classes:

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

Related Products:

Based on records with the same trade name.

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