Dilatrate-SR (Page 3 of 3)

How Supplied

dilatrate®-SR (isosorbide dinitrate) 40 mg sustained release capsules are opaque pink and colorless capsules with white beadlets and are imprinted “Schwarz” and “0920”. They are supplied as follows:

Bottles of 100

NDC 0091-0920-01

Store at 20° — 25°C (68° — 77°F); excursions permitted between 15° — 30°C (59° — 86°F) [See USP Controlled Room Temperature].

Manufactured for:

Image from Drug Label Content

By Sandoz Inc.

Princeton, NJ 08540, USA

DILATRATE-SR
isosorbide dinitrate capsule, extended release
Product Information
Product Type HUMAN PRESCRIPTION DRUG Item Code (Source) NDC:0091-0920
Route of Administration ORAL DEA Schedule
Active Ingredient/Active Moiety
Ingredient Name Basis of Strength Strength
Isosorbide Dinitrate (Isosorbide Dinitrate) Isosorbide Dinitrate 40 mg
Inactive Ingredients
Ingredient Name Strength
Ethylcellulose
Lactose
Pharmaceutical Glaze
Starch
Sucrose
Talc
D&C Red 33
D&C Yellow 10
Gelatin
Titanium Dioxide
Product Characteristics
Color PINK (PINK) Score no score
Shape CAPSULE (CAPSULE) Size 19mm
Flavor Imprint Code Schwarz;0920
Contains
Coating false Symbol false
Packaging
# Item Code Package Description Multilevel Packaging
1 NDC:0091-0920-01 100 CAPSULE, EXTENDED RELEASE (100 CAPSULE) in 1 BOTTLE None
Labeler — Schwarz Pharma

Revised: 01/2008 Schwarz Pharma

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