Ranitidine (Page 4 of 4)

Manufactured by:

Amneal Pharmaceuticals of NY

Hauppauge, NY 11788

Distributed by:

Amneal Pharmaceuticals

Glasgow, KY 42141

Rev. 04-2015-01

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:

structure
(click image for full-size original)

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.

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

RANITIDINE TABLEST 150MG #60

GENERIC FOR ZANTAC

NDC: 45865-0416-60

PDP
(click image for full-size original)
RANITIDINE ranitidine tablet
Product Information
Product Type HUMAN PRESCRIPTION DRUG Item Code (Source) NDC:45865-416(NDC:53746-253)
Route of Administration ORAL DEA Schedule
Active Ingredient/Active Moiety
Ingredient Name Basis of Strength Strength
RANITIDINE HYDROCHLORIDE (RANITIDINE) RANITIDINE 150 mg
Product Characteristics
Color orange Score no score
Shape ROUND (Biconvex) Size 9mm
Flavor Imprint Code IP;253
Contains
Packaging
# Item Code Package Description Multilevel Packaging
1 NDC:45865-416-60 60 TABLET in 1 BOTTLE None
Marketing Information
Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
ANDA ANDA077824 12/16/2009
Labeler — Medsource Pharmaceuticals (833685915)
Registrant — Medsource Pharmaceuticals (833685915)
Establishment
Name Address ID/FEI Operations
Medsource Pharmaceuticals 833685915 repack (45865-416)

Revised: 12/2019 Medsource Pharmaceuticals

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