Irbesartan (Page 5 of 5)

16 HOW SUPPLIED/STORAGE AND HANDLING

Irbesartan Tablets USP, 150 mg are white, capsule shaped, biconvex tablets debossed with’159′ on one side and ‘H’ on the other side. They are supplied in
Bottles of 30 tablets (NDC 71205-452-30)
Bottles of 60 tablets (NDC 71205-452-60)
Bottles of 90 tablets (NDC 71205-452-90)
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 tablets not to use potassium supplements or salt substitutes containing potassium without consulting their healthcare provider [see Drug Interactions (7.1)].

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Manufactured for:
Camber Pharmaceuticals, Inc.
Piscataway, NJ 08854
By: HETEROTM
HETERO LABS LIMITED, 2034954
Unit V, Polepally, Jadcherla,
Mahabubnagar — 509 301, India.

Repackaged by:
Proficient Rx LP
Thousand Oaks, CA 91320
Revised: 09/2019

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

Container Label of 150 mg 30’s count:

71205-452-30
(click image for full-size original)
IRBESARTAN irbesartan tablet
Product Information
Product Type HUMAN PRESCRIPTION DRUG Item Code (Source) NDC:71205-452(NDC:31722-730)
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
CALCIUM STEARATE
CARBOXYMETHYLCELLULOSE CALCIUM
SILICON DIOXIDE
MICROCRYSTALLINE CELLULOSE
POVIDONE K30
Product Characteristics
Color WHITE Score no score
Shape CAPSULE Size 11mm
Flavor Imprint Code 159;H
Contains
Packaging
# Item Code Package Description Multilevel Packaging
1 NDC:71205-452-30 30 TABLET in 1 BOTTLE None
2 NDC:71205-452-60 60 TABLET in 1 BOTTLE None
3 NDC:71205-452-90 90 TABLET in 1 BOTTLE None
Marketing Information
Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
ANDA ANDA202910 09/27/2012
Labeler — Proficient Rx LP (079196022)
Establishment
Name Address ID/FEI Operations
Proficient Rx LP 079196022 REPACK (71205-452), RELABEL (71205-452)

Revised: 05/2022 Proficient Rx LP

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