Ranitidine (Page 4 of 4)
Manufactured by:
Amneal Pharmaceuticals of NY
Hauppauge, NY 11788
Distributed by:
Amneal Pharmaceuticals
Glasgow, KY 42141
Rev. 02-2015-00
DESCRIPTION
The active ingredient in Ranitidine Tablets, USP 150 mg and Ranitidine Tablets, USP 300 mg is ranitidine hydrochloride (HCl), USP, a histamine H 2 -receptor antagonist. Chemically it is N[2-[[[5-[(dimethylamino)methyl]-2-furanyl]methyl]thio]ethyl]-N’-methyl-2-nitro-1,1-ethenediamine, HCl. It has the following structure:
The empirical formula is C 13 H 22 N 4 O 3 S·HCl, representing a molecular weight of 350.87. Ranitidine HCl is a white to pale yellow, granular substance that is soluble in water. It has a slightly bitter taste and sulfurlike odor.
Each Ranitidine Tablets, USP 150 mg for oral administration contains 167.4 mg of ranitidine HCl equivalent to 150 mg of ranitidine. Each tablet also contains the inactive ingredients colloidal silicon dioxide, croscarmellose sodium, hypromellose, magnesium stearate, microcrystalline cellulose, polydextrose, titanium dioxide, triethyl citrate and FD&C Yellow #6.
Each Ranitidine Tablets, USP 300 mg for oral administration contains 334.8 mg of ranitidine HCl equivalent to 300 mg of ranitidine. Each tablet also contains the inactive ingredients colloidal silicon dioxide, croscarmellose sodium, hypromellose, magnesium stearate, microcrystalline cellulose, polydextrose, titanium dioxide, triethyl citrate and D&C Yellow #10.
Principal Display Panel
Ranitidine Tablets, USP 150mg
20 Tablets
NDC 10544-516-20
RANITIDINE ranitidine tablet | ||||||||||||||||||
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Labeler — Blenheim Pharmacal, Inc. (171434587) |
Registrant — Blenheim Pharmacal, Inc. (171434587) |
Establishment | |||
Name | Address | ID/FEI | Operations |
Blenheim Pharmacal, Inc. | 171434587 | repack (10544-516) |
Revised: 03/2015 Blenheim Pharmacal, Inc.
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