Source: FDA, National Drug Code (US) Revision Year: 2020
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 |
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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 |
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DETROL LA Capsules are supplied as follows: Bottles of 30: 2 mg Capsules – NDC 0009-5190-01 Bottles of 500: 2 mg Capsules – NDC 0009-5190-03 Bottles of 90: 2 mg Capsules – NDC 0009-5190-02 Unit Dose Blisters: 2 mg Capsules – NDC 0009-5190-04 |
| Drug | Countries | |
|---|---|---|
| DETROL | Canada, United States |
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