DETROL LA Capsule Ref.[10552] Active ingredients: Tolterodine

Source: FDA, National Drug Code (US)  Revision Year: 2020 

Product description

DETROL LA Capsules contain tolterodine tartrate. The active moiety, tolterodine, is a muscarinic receptor antagonist. The chemical name of tolterodine tartrate is (R)-N,N-diisopropyl-3-(2-hydroxy-5-methylphenyl)-3-phenylpropanamine L-hydrogen tartrate. The empirical formula of tolterodine tartrate is C26H37NO7,. Its structure is:

Tolterodine tartrate is a white, crystalline powder with a molecular weight of 475.6. The pKa value is 9.87 and the solubility in water is 12 mg/mL. It is soluble in methanol, slightly soluble in ethanol, and practically insoluble in toluene. The partition coefficient (Log D) between n-octanol and water is 1.83 at pH 7.3.

DETROL LA 4 mg capsule for oral administration contains 4 mg of tolterodine tartrate. Inactive ingredients are sucrose, starch, hypromellose, ethylcellulose, medium chain triglycerides, oleic acid, gelatin, and FD&C Blue #2.

DETROL LA 2 mg capsule for oral administration contains 2 mg of tolterodine tartrate, and the following inactive ingredients: sucrose, starch, hypromellose, ethylcellulose, medium chain triglycerides, oleic acid, gelatin, yellow iron oxide, and FD&C Blue #2.

Both the 2 mg and 4 mg capsule strengths are imprinted with a pharmaceutical grade printing ink that contains shellac glaze, titanium dioxide, propylene glycol, and simethicone.

Dosage Forms and Strengths

The 2 mg capsules are blue-green with symbol and 2 printed in white ink.

The 4 mg capsules are blue with symbol and 4 printed in white ink.

How Supplied

DETROL LA Capsules are supplied as follows:

Bottles of 30:

2 mg Capsules – NDC 0009-5190-01
4 mg Capsules – NDC 0009-5191-01

Bottles of 500:

2 mg Capsules – NDC 0009-5190-03
4 mg Capsules – NDC 0009-5191-03

Bottles of 90:

2 mg Capsules – NDC 0009-5190-02
4 mg Capsules – NDC 0009-5191-02

Unit Dose Blisters:

2 mg Capsules – NDC 0009-5190-04
4 mg Capsules – NDC 0009-5191-04

Drugs

Drug Countries
DETROL Canada, United States

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