Aspirin and Extended-Release Dipyridamole: Package Insert and Label Information (Page 4 of 4)

Distributed by:

Lannett Company, Inc.

Philadelphia, PA 19136

CIB71937B

Rev. 01/2020

Bottle Label
(click image for full-size original)
ASPIRIN AND EXTENDED-RELEASE DIPYRIDAMOLE aspirin and extended-release dipyridamole capsule, extended release
Product Information
Product Type HUMAN PRESCRIPTION DRUG Item Code (Source) NDC:62175-330
Route of Administration ORAL DEA Schedule
Active Ingredient/Active Moiety
Ingredient Name Basis of Strength Strength
ASPIRIN (ASPIRIN) ASPIRIN 25 mg
DIPYRIDAMOLE (DIPYRIDAMOLE) DIPYRIDAMOLE 200 mg
Inactive Ingredients
Ingredient Name Strength
AMMONIA
BUTYL ALCOHOL
DIMETHICONE
FERRIC OXIDE RED
FERRIC OXIDE YELLOW
FERROSOFERRIC OXIDE
GELATIN
HYDROGENATED CASTOR OIL
HYPROMELLOSE 2910 (15 MPA.S)
HYPROMELLOSE PHTHALATE (31% PHTHALATE, 40 CST)
ISOPROPYL ALCOHOL
METHACRYLIC ACID — METHYL METHACRYLATE COPOLYMER (1:2)
MICROCRYSTALLINE CELLULOSE
POVIDONE
PROPYLENE GLYCOL
SHELLAC
STARCH, CORN
TALC
TARTARIC ACID
TITANIUM DIOXIDE
TRIACETIN
Product Characteristics
Color PINK (opaque) , YELLOW (opaque) Score no score
Shape CAPSULE (capsule) Size 24mm
Flavor Imprint Code Lannett;330
Contains
Packaging
# Item Code Package Description Multilevel Packaging
1 NDC:62175-330-35 60 CAPSULE, EXTENDED RELEASE in 1 BOTTLE None
Marketing Information
Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
ANDA ANDA204552 03/20/2019
Labeler — Lannett Company, Inc. (006422406)

Revised: 01/2020 Lannett Company, Inc.

Page 4 of 4 1 2 3 4

DrugInserts.com provides trustworthy package insert and label information about marketed drugs as submitted by manufacturers to the US Food and Drug Administration. Package information is not reviewed or updated separately by DrugInserts.com. Every individual package label entry contains a unique identifier which can be used to secure further details directly from the US National Institutes of Health and/or the FDA.

https://druginserts.com/lib/rx/meds/aspirin-and-extended-release-dipyridamole-3/page/4/

Clinical Trials

DrugInserts.com

Information Sections

RSS Feeds

About

As the leading independent provider of trustworthy medication information, we source our database directly from the FDA's central repository of drug labels and package inserts under the Structured Product Labeling standard. Our material is not intended as a substitute for direct consultation with a qualified health professional.

Terms of Use | Copyright © 2021. All Rights Reserved.