Prescription Drug Information: Lansoprazole (Page 10 of 10)

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL SECTION

Lansoprazole Delayed- Release Capsules USP, 30 mg Container Label

IMAGE LABEL
(click image for full-size original)
LANSOPRAZOLE lansoprazole capsule, delayed release
Product Information
Product Type HUMAN PRESCRIPTION DRUG Item Code (Source) NDC:33261-674(NDC:55111-399)
Route of Administration ORAL DEA Schedule
Active Ingredient/Active Moiety
Ingredient Name Basis of Strength Strength
LANSOPRAZOLE (LANSOPRAZOLE) LANSOPRAZOLE 30 mg
Inactive Ingredients
Ingredient Name Strength
AMMONIA
HYDROXYPROPYL CELLULOSE (TYPE H)
HYDROXYPROPYL CELLULOSE, LOW SUBSTITUTED
MAGNESIUM CARBONATE
METHACRYLIC ACID — ETHYL ACRYLATE COPOLYMER (1:1) TYPE A
POLYETHYLENE GLYCOLS
POLYSORBATE 80
PROPYLENE GLYCOL
SHELLAC
STARCH, CORN
SUCROSE
RAW SUGAR
TITANIUM DIOXIDE
TALC
GELATIN
FERROSOFERRIC OXIDE
FERRIC OXIDE RED
FERRIC OXIDE YELLOW
SODIUM LAURYL SULFATE
Product Characteristics
Color PINK, BLACK Score no score
Shape CAPSULE Size 19mm
Flavor Imprint Code
Contains
Packaging
# Item Code Package Description Multilevel Packaging
1 NDC:33261-674-30 30 CAPSULE, DELAYED RELEASE (30 CAPSULE) in 1 BOTTLE, PLASTIC None
Marketing Information
Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
ANDA ANDA091269 10/15/2010
Labeler — Aidarex Pharmaceuticals LLC (801503249)

Revised: 01/2014 Aidarex Pharmaceuticals LLC

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