Ranitidine Immediate Release (Page 5 of 5)

Dosage Adjustment for Patients with Impaired Renal Function

On the basis of experience with a group of subjects with severely impaired renal function treated with ranitidine, the recommended dosage in patients with a creatinine clearance <50 mL/min is 150 mg every 24 hours. Should the patient’s condition require, the frequency of dosing may be increased to every 12 hours or even further with caution. Hemodialysis reduces the level of circulating ranitidine. Ideally, the dosing schedule should be adjusted so that the timing of a scheduled dose coincides with the end of hemodialysis.
Elderly patients are more likely to have decreased renal function, therefore caution should be exercised in dose selection, and it may be useful to monitor renal function (see CLINICAL PHARMACOLOGY: Pharmacokinetics: Geriatrics and PRECAUTIONS: Geriatric Use).

HOW SUPPLIED

Ranitidine tablets, USP 150 mg (ranitidine HCl USP equivalent to 150 mg of ranitidine) are brown coloured, circular shaped, biconvex, beveled edge film-coated tablets debossed with “S on one side and plain on the other side. 429”
They are available in blister packs of 30 (NDC 58118-0803-8), bottles of 60 (NDC 64380-803-03), 100 (NDC 64380-803-06), 500 (NDC 64380-803-07) and 1000 (NDC 64380-803-08) tablets.

Ranitidine tablets, USP 300 mg (ranitidine HCl USP equivalent to 300 mg of ranitidine) are brown coloured, circular shaped, biconvex, beveled edge film-coated tablets debossed with “S on one side and plain on the other side. 430”

They are available in bottles of 30 (NDC 64380-804-04), 100 (NDC 64380-804-06) and 250 (NDC 64380-804-38) tablets.

Store at 20° to 25° C (68° and 77° F); excursions permitted between 15° and 30° C (59° and 86° F) [see USP Controlled Room Temperature]. Protect from light. Replace cap securely after each opening.

Manufactured by:
Strides Shasun Limited,
Unit II, R.S. No: 32, 33/11 and 34/2, PIMS Road,
Periyakalapet, Puducherry-605 014, India.
Revised: November 2016

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL — 150 mg

Rx only

Ranitidine Tablets, USP
150 mg

30 Tablets

Manufactured by:

Strides Shasun Limited
Puducherry – 605 014, India.
Mfg. Lic. No.: 16 13 4193
Distributed by:
Strides Pharma Inc. East Brunswick, NJ 08816

Repackaged by:

Clinical Solutions Wholesale

Franklin, TN 37067

Ranitidine 150mg tablet 30 count blister card
(click image for full-size original)
RANITIDINE IMMEDIATE RELEASE ranitidine tablet
Product Information
Product Type HUMAN PRESCRIPTION DRUG Item Code (Source) NDC:58118-0803(NDC:64380-803)
Route of Administration ORAL DEA Schedule
Active Ingredient/Active Moiety
Ingredient Name Basis of Strength Strength
RANITIDINE HYDROCHLORIDE (RANITIDINE) RANITIDINE 150 mg
Inactive Ingredients
Ingredient Name Strength
MAGNESIUM STEARATE
MICROCRYSTALLINE CELLULOSE
CROSCARMELLOSE SODIUM
SILICON DIOXIDE
HYPROMELLOSE, UNSPECIFIED
TITANIUM DIOXIDE
TRIACETIN
FERRIC OXIDE RED
Product Characteristics
Color brown Score no score
Shape ROUND (circular, biconvex, beveled edge) Size 10mm
Flavor Imprint Code S;429
Contains
Packaging
# Item Code Package Description Multilevel Packaging
1 NDC:58118-0803-8 30 TABLET in 1 BLISTER PACK None
Marketing Information
Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
ANDA ANDA205512 08/29/2016
Labeler — Clinical Solutions Wholesale, LLC (078710347)
Registrant — Clinical Solutions Wholesale, LLC (078710347)
Establishment
Name Address ID/FEI Operations
Clinical Solutions Wholesale, LLC 078710347 repack (58118-0803)

Revised: 07/2019 Clinical Solutions Wholesale, LLC

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