68788-9232 : Tramadol Hydrochloride 300 mg Oral Tablet, Extended Release

NDC:	68788-9232
Labeler:	Preferred Pharmaceuticals, Inc.
Product Type:	Human Prescription Drug
Drug Name:	Tramadol Hydrochloride
Dosage Form:	Oral Tablet, Extended Release
Application #:	ANDA201384
Rev. Date:	Oct 6, 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:	537
Shapes:	Round
Colors:	White
Size (mm):	13
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:

• 68788-9232-2: 20 TABLET, EXTENDED RELEASE IN 1 BOTTLE (68788‑9232‑2)
• 68788-9232-3: 30 TABLET, EXTENDED RELEASE IN 1 BOTTLE (68788‑9232‑3)
• 68788-9232-6: 60 TABLET, EXTENDED RELEASE IN 1 BOTTLE (68788‑9232‑6)
• 68788-9232-9: 90 TABLET, EXTENDED RELEASE IN 1 BOTTLE (68788‑9232‑9)

Active Ingredients:

• Tramadol Hydrochloride

Inactive Ingredients:

• Starch, Corn
• Hypromelloses
• Mannitol
• Magnesium Stearate
• Cellulose Acetate
• Polyethylene Glycols
• Shellac
• Butyl Alcohol
• Propylene Glycol
• Ammonia
• Ferrosoferric Oxide

Pharmaceutical Classes:

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

Related Products:

Based on records with the same trade name.

• 68788-7609 Tramadol Hydrochloride 100 mg Oral Tablet, Extended Release by Preferred Pharmaceuticals, Inc.
• 68788-7762 Tramadol Hydrochloride 200 mg Oral Tablet, Extended Release by Preferred Pharmaceuticals, Inc.
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• 68788-8367 Tramadol Hydrochloride 100 mg Oral Tablet, Extended Release by Preferred Pharmaceuticals, Inc.
• 68788-9237 Tramadol Hydrochloride 200 mg Oral Tablet, Extended Release by Preferred Pharmaceuticals, Inc.
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• 68788-9784 Tramadol Hydrochloride 150 mg 24 Hr Extended Release Capsule by Preferred Pharmaceuticals, Inc.
• 68788-6929 Tramadol Hydrochloride 50 mg Oral Tablet, Film Coated by Preferred Pharmaceuticals Inc.
• 68788-7284 Tramadol Hydrochloride 200 mg Oral Tablet, Extended Release by Preferred Pharmaceuticals Inc.
• 68788-7321 Tramadol Hydrochloride 50 mg Oral Tablet by Preferred Pharmaceuticals Inc.
• 68788-7373 Tramadol Hydrochloride 100 mg Oral Tablet, Extended Release by Preferred Pharmaceuticals Inc.
• 68788-7601 Tramadol Hydrochloride 200 mg Oral Tablet, Extended Release by Lupin Pharmaceuticals, Inc.
• 68788-8121 Tramadol Hydrochloride 50 mg Oral Tablet, Coated by Preferred Pharmaceuticals Inc.
• 68788-8717 Tramadol Hydrochloride 50 mg Oral Tablet by Preferred Pharmaceuticals Inc.
• 68788-8920 Tramadol Hydrochloride 150 mg Oral Capsule, Extended Release by Preferred Pharmaceuticals Inc.
• 68788-8921 Tramadol Hydrochloride 200 mg Oral Tablet, Extended Release by Preferred Pharmaceuticals Inc.
• 68788-9199 Tramadol Hydrochloride 50 mg Oral Tablet by Preferred Pharmaceuticals, Inc
• 0093-0058 Tramadol Hydrochloride 50 mg Oral Tablet by Teva Pharmaceuticals USA Inc
• 0093-3301 Tramadol Hydrochloride 50 mg Oral Tablet, Film Coated by Teva Pharmaceuticals USA, Inc.
• 0228-2714 Tramadol Hydrochloride 50 mg Oral Tablet by Actavis
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