68788-7601 : Tramadol Hydrochloride 200 mg Oral Tablet, Extended Release

NDC:	68788-7601
Labeler:	Lupin Pharmaceuticals, Inc.
Product Type:	Human Prescription Drug
Drug Name:	Tramadol Hydrochloride
Dosage Form:	Oral Tablet, Extended Release
Application #:	ANDA200503
Rev. Date:	Feb 6, 2020
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:	L011
Shapes:	Round
Colors:	White
Size (mm):	9
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:

• 68788-7601-2: 20 TABLET, EXTENDED RELEASE IN 1 BOTTLE (68788‑7601‑2)
• 68788-7601-3: 30 TABLET, EXTENDED RELEASE IN 1 BOTTLE (68788‑7601‑3)
• 68788-7601-6: 60 TABLET, EXTENDED RELEASE IN 1 BOTTLE (68788‑7601‑6)
• 68788-7601-9: 90 TABLET, EXTENDED RELEASE IN 1 BOTTLE (68788‑7601‑9)

Active Ingredients:

• Tramadol Hydrochloride

Inactive Ingredients:

• Microcrystalline Cellulose
• Dibutyl Sebacate
• Ethylcellulose, Unspecified
• Ferrosoferric Oxide
• Povidone, Unspecified
• Propylene Glycol
• Shellac
• Silicon Dioxide
• Sodium Stearyl Fumarate /

Pharmaceutical Classes:

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

Related Products:

Based on records with the same trade name.

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• 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.
• 68788-7609 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.
• 68788-7763 Tramadol Hydrochloride 100 mg Oral Tablet, Extended Release by Preferred Pharmaceuticals, Inc.
• 68788-8121 Tramadol Hydrochloride 50 mg Oral Tablet, Coated by Preferred Pharmaceuticals Inc.
• 68788-8367 Tramadol Hydrochloride 100 mg Oral Tablet, Extended Release 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
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• 68788-9304 Tramadol Hydrochloride 50 mg Oral Tablet, Film Coated by Preferred Pharmaceuticals, Inc.
• 68788-9784 Tramadol Hydrochloride 150 mg 24 Hr Extended Release Capsule by Preferred Pharmaceuticals, Inc.
• 68180-383 Tramadol Hydrochloride 100 mg 24 Hr Extended Release Tablet by Lupin Pharmaceuticals, Inc.
• 68180-384 Tramadol Hydrochloride 200 mg 24 Hr Extended Release Tablet by Lupin Pharmaceuticals, Inc.
• 68180-385 Tramadol Hydrochloride 300 mg 24 Hr Extended Release Tablet by Lupin Pharmaceuticals, Inc.
• 68180-697 Tramadol Hydrochloride 100 mg Oral Tablet, Extended Release by Lupin Pharmaceuticals, Inc.
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