URECHOLINE Tablet Ref.[9982] Active ingredients: Bethanechol

Source: FDA, National Drug Code (US)  Revision Year: 2015 

Product description

Bethanechol chloride, USP, a cholinergic agent, is a synthetic ester which is structurally and pharmacologically related to acetylcholine.

It is designated chemically as 2-[(aminocarbonyl)oxy]-N, N, N-trimethyl-1-propanaminium chloride. Its structural formula is:

C7H17CIN202 M.W. 196.68

It is a white, hygroscopic crystalline powder having a slight amine-like odor, freely soluble in water.

Each tablet for oral administration contains 5 mg, 10 mg, 25 mg or 50 mg bethanechol chloride, USP. Tablets also contain the following inactive ingredients: anhydrous lactose, colloidal silicon dioxide, magnesium stearate, microcrystalline cellulose and sodium starch glycolate. The 25 mg and 50 mg tablets also contain D&C Yellow #10 aluminum lake and FD&C Yellow #6 aluminum lake.

How Supplied

Urecholine (Bethanechol Chloride Tablets USP) is available as follows:

5 mg: White, round, flat-face, beveled edge, scored tablet. Debossed with OP/697 on the scored side and plain on the other side.

Available in bottles of 100 (NDC 51285-697-02).

10 mg: White, round, flat-face, beveled edge, scored tablet. Debossed with OP/703 on the scored side and plain on the other side.

Available in bottles of 100 (NDC 51285-690-02).

25 mg: Yellow, round, flat-face, beveled edge, scored tablet. Debossed with OP/704 on the scored side and plain on the other side.

Available in bottles of 100 (NDC 51285-691-02).

50 mg: Yellow, round, flat-face, beveled edge, scored tablet. Debossed with OP/700 on the scored side and plain on the other side.

Available in bottles of 100 (NDC 51285-692-02).

TEVA PHARMACEUTICALS USA, INC., North Wales, PA 19454

Drugs

Drug Countries
URECHOLINE United States

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