Irbesartan (Page 5 of 5)
16 HOW SUPPLIED/STORAGE AND HANDLING
Irbesartan Tablets USP, 75 mg are white to off-white, biconvex, oval shaped uncoated tablets debossed with ‘T31’ on one side and plain on other side.
Bottles of 30 NDC 65862-637-30
Bottles of 90 NDC 65862-637-90
Bottles of 500 NDC 65862-637-05
10 x 10 Unit-dose Tablets NDC 65862-637-78
Irbesartan Tablets USP, 150 mg are white to off-white, biconvex, oval shaped uncoated tablets debossed with ‘T32’ on one side and plain on other side.
Bottles of 30 NDC 65862-638-30
Bottles of 90 NDC 65862-638-90
Bottles of 500 NDC 65862-638-05
10 x 10 Unit-dose Tablets NDC 65862-638-78
Irbesartan Tablets USP, 300 mg are white to off-white, biconvex, oval shaped uncoated tablets debossed with ‘T33’ on one side and plain on other side.
Bottles of 30 NDC 65862-639-30
Bottles of 90 NDC 65862-639-90
Bottles of 500 NDC 65862-639-05
10 x 10 Unit-dose Tablets NDC 65862-639-78
Storage
Store at 20° to 25°C (68° to 77°F). [See USP Controlled Room Temperature.]
17 PATIENT COUNSELING INFORMATION
Pregnancy
Advise female patients of childbearing age about the consequences of exposure to irbesartan during pregnancy. Discuss treatment options with women planning to become pregnant. Patients should be asked to report pregnancies to their physicians as soon as possible.
Potassium Supplements
Advise patients receiving irbesartan not to use potassium supplements or salt substitutes containing potassium without consulting their healthcare provider [see Drug Interactions (7.1)].
Distributed by:
Aurobindo Pharma USA, Inc.
279 Princeton-Hightstown Road
East Windsor, NJ 08520
Manufactured by:
Aurobindo Pharma Limited
Hyderabad-500 032, India Revised: 09/2021
PACKAGE LABEL-PRINCIPAL DISPLAY PANEL — 75 mg (90 Tablet Bottle)
NDC 65862-637-90 Rx only
Irbesartan Tablets, USP
75 mg
AUROBINDO 90 Tablets
PACKAGE LABEL-PRINCIPAL DISPLAY PANEL -75 mg Blister Carton (10 x 10 Unit-dose)
NDC 65862-637-78 Rx only
Irbesartan Tablets, USP
75 mg
AUROBINDO 100 Tablets (10 x 10 Unit-dose)
PACKAGE LABEL-PRINCIPAL DISPLAY PANEL- 150 mg (90 Tablet Bottle)
NDC 65862-638-90 Rx only
Irbesartan Tablets, USP
150 mg
AUROBINDO 90 Tablets
PACKAGE LABEL-PRINCIPAL DISPLAY PANEL -150 mg Blister Carton (10 x 10 Unit-dose)
NDC 65862-638-78 Rx only
Irbesartan Tablets, USP
150 mg
AUROBINDO 100 Tablets (10 x 10 Unit-dose)
PACKAGE LABEL-PRINCIPAL DISPLAY PANEL — 300 mg (90 Tablet Bottle)
NDC 65862-639-90 Rx only
Irbesartan Tablets, USP
300 mg
AUROBINDO 90 Tablets
PACKAGE LABEL-PRINCIPAL DISPLAY PANEL — 300 mg Blister Carton (10 x 10 Unit-dose)
NDC 65862-639-78 Rx only
Irbesartan Tablets, USP
300 mg
AUROBINDO 100 Tablets (10 x 10 Unit-dose)
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IRBESARTAN irbesartan tablet | |||||||||||||||||||||||||||||
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IRBESARTAN irbesartan tablet | |||||||||||||||||||||||||||||
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Labeler — Aurobindo Pharma Limited (650082092) |
Establishment | |||
Name | Address | ID/FEI | Operations |
Aurobindo Pharma Limited | 650381903 | ANALYSIS (65862-637), ANALYSIS (65862-638), ANALYSIS (65862-639), MANUFACTURE (65862-637), MANUFACTURE (65862-638), MANUFACTURE (65862-639) |
Revised: 09/2021 Aurobindo Pharma Limited
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