TRAMADOL HYDROCHLORIDE

DESCRIPTION SECTION

Tramadol Hydrochloride Tablets, USP for oral use, are an opioid agonist. The chemical name for tramadol hydrochloride is (±) cis-2-[(dimethylamino) methyl]-1-(3- methoxyphenyl) cyclohexanol hydrochloride. The structural formula is:

[tramadol-hcl-tabs-structure]

The molecular weight of tramadol hydrochloride is 299.8. Tramadol hydrochloride is a white crystalline powder. It is readily soluble in water and ethanol and has a pKa of 9.41. The n-octanol/water log partition coefficient (logP) is 1.35 at pH 7. Tramadol Hydrochloride Tablets, USP 50 mg and Tramadol Hydrochloride Tablets, USP 100 mg contain 50 mg and 100 mg of tramadol hydrochloride respectively and are white in color. Inactive ingredients in the tablet are hypromellose, lactose anhydrous, magnesium stearate, microcrystalline cellulose, polyethylene glycol, polysorbate 80, pregelatinized starch,sodium starch glycolate and titanium dioxide.

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HOW SUPPLIED SECTION

16 HOW SUPPLIED/STORAGE AND HANDLING

Tramadol Hydrochloride Tablets, USP 50 mg are white to off white, capsule- shaped film coated tablet debossed with “018” on one side and scored on other side.

Bottles of 100 tablets……. NDC 72888-080-01

Bottles of 500 tablets…..... NDC 72888-080-05

Bottles of 1,000 tablets…...NDC 72888-080-00

Tramadol Hydrochloride Tablets, USP 100 mg are white to off white, capsule- shaped film coated tablet debossed with “019” on one side and scored on other side.

Bottles of 100 tablets……. NDC 72888-008-01

Bottles of 500 tablets…..... NDC 72888-008-05

Bottles of 1,000 tablets…... NDC 72888-008-00

Dispense in a tight container. Store at 20°C to 25°C (68°F to 77°F); excursions permitted to 15°C to 30°C (59°F to 86°F). [see USP Controlled Room Temperature].

Store tramadol hydrochloride tablets securely and dispose of properly [ see PATIENT COUNSELLING INFORMATION (17)]

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