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 (90 Tablet Bottle)
(click image for full-size original)

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 -75 mg Blister Carton (10 x 10 Unit-dose)
(click image for full-size original)

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 (90 Tablet Bottle)
(click image for full-size original)

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 -150 mg Blister Carton (10 x 10 Unit-dose)
(click image for full-size original)

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 (90 Tablet Bottle)
(click image for full-size original)

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)

PACKAGE LABEL-PRINCIPAL DISPLAY PANEL -- 300 mg Blister Carton (10 x 10 Unit-dose)
(click image for full-size original)
IRBESARTAN irbesartan tablet
Product Information
Product Type HUMAN PRESCRIPTION DRUG Item Code (Source) NDC:65862-637
Route of Administration ORAL DEA Schedule
Active Ingredient/Active Moiety
Ingredient Name Basis of Strength Strength
IRBESARTAN (IRBESARTAN) IRBESARTAN 75 mg
Inactive Ingredients
Ingredient Name Strength
SILICON DIOXIDE
DIBASIC CALCIUM PHOSPHATE DIHYDRATE
HYPROMELLOSE 2910 (5 MPA.S)
MICROCRYSTALLINE CELLULOSE
POLYSORBATE 80
SODIUM STARCH GLYCOLATE TYPE A POTATO
SODIUM STEARYL FUMARATE
TALC
Product Characteristics
Color WHITE (White to Off-white) Score no score
Shape OVAL (Biconvex) Size 11mm
Flavor Imprint Code T31
Contains
Packaging
# Item Code Package Description Multilevel Packaging
1 NDC:65862-637-30 30 TABLET in 1 BOTTLE None
2 NDC:65862-637-90 90 TABLET in 1 BOTTLE None
3 NDC:65862-637-05 500 TABLET in 1 BOTTLE None
4 NDC:65862-637-78 10 BLISTER PACK in 1 CARTON contains a BLISTER PACK (65862-637-10)
4 NDC:65862-637-10 10 TABLET in 1 BLISTER PACK This package is contained within the CARTON (65862-637-78)
Marketing Information
Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
ANDA ANDA203081 09/27/2012
IRBESARTAN irbesartan tablet
Product Information
Product Type HUMAN PRESCRIPTION DRUG Item Code (Source) NDC:65862-638
Route of Administration ORAL DEA Schedule
Active Ingredient/Active Moiety
Ingredient Name Basis of Strength Strength
IRBESARTAN (IRBESARTAN) IRBESARTAN 150 mg
Inactive Ingredients
Ingredient Name Strength
SILICON DIOXIDE
DIBASIC CALCIUM PHOSPHATE DIHYDRATE
HYPROMELLOSE 2910 (5 MPA.S)
MICROCRYSTALLINE CELLULOSE
POLYSORBATE 80
SODIUM STARCH GLYCOLATE TYPE A POTATO
SODIUM STEARYL FUMARATE
TALC
Product Characteristics
Color WHITE (White to Off-white) Score no score
Shape OVAL (Biconvex) Size 14mm
Flavor Imprint Code T32
Contains
Packaging
# Item Code Package Description Multilevel Packaging
1 NDC:65862-638-30 30 TABLET in 1 BOTTLE None
2 NDC:65862-638-90 90 TABLET in 1 BOTTLE None
3 NDC:65862-638-05 500 TABLET in 1 BOTTLE None
4 NDC:65862-638-78 10 BLISTER PACK in 1 CARTON contains a BLISTER PACK (65862-638-10)
4 NDC:65862-638-10 10 TABLET in 1 BLISTER PACK This package is contained within the CARTON (65862-638-78)
Marketing Information
Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
ANDA ANDA203081 09/27/2012
IRBESARTAN irbesartan tablet
Product Information
Product Type HUMAN PRESCRIPTION DRUG Item Code (Source) NDC:65862-639
Route of Administration ORAL DEA Schedule
Active Ingredient/Active Moiety
Ingredient Name Basis of Strength Strength
IRBESARTAN (IRBESARTAN) IRBESARTAN 300 mg
Inactive Ingredients
Ingredient Name Strength
SILICON DIOXIDE
DIBASIC CALCIUM PHOSPHATE DIHYDRATE
HYPROMELLOSE 2910 (5 MPA.S)
MICROCRYSTALLINE CELLULOSE
POLYSORBATE 80
SODIUM STARCH GLYCOLATE TYPE A POTATO
SODIUM STEARYL FUMARATE
TALC
Product Characteristics
Color WHITE (White to Off-white) Score no score
Shape OVAL (Biconvex) Size 17mm
Flavor Imprint Code T33
Contains
Packaging
# Item Code Package Description Multilevel Packaging
1 NDC:65862-639-30 30 TABLET in 1 BOTTLE None
2 NDC:65862-639-90 90 TABLET in 1 BOTTLE None
3 NDC:65862-639-05 500 TABLET in 1 BOTTLE None
4 NDC:65862-639-78 10 BLISTER PACK in 1 CARTON contains a BLISTER PACK (65862-639-10)
4 NDC:65862-639-10 10 TABLET in 1 BLISTER PACK This package is contained within the CARTON (65862-639-78)
Marketing Information
Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
ANDA ANDA203081 09/27/2012
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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