Lansoprazole (Page 12 of 12)

PRINCIPAL DISPLAY PANEL – 30 mg

NDC 51079-121-08

Lansoprazole
Delayed-Release
Capsules, USP
30 mg

80 Capsules (8 x 10)

Each capsule contains
30 mg of lansoprazole, USP
as enteric-coated pellets.

Usual Dosage: See accompanying
prescribing information and Medication Guide.

Store at 20° to 25°C (68° to 77°F). [See
USP Controlled Room Temperature.]

Code No.: MH/DRUGS/25/NKD/89

Manufactured for:
Mylan Pharmaceuticals Inc. Morgantown, WV 26505 U.S.A.

Made in India

Rx only

S-10592 R7

Packaged and Distributed by:

Mylan Institutional Inc.

Rockford, IL 61103 U.S.A.

This unit dose package is not child resistant.

For institutional use only.

Keep this and all drugs out of the reach of children.

This container provides light-resistance.

See window for lot number and expiration date.

Lansoprazole Delayed-Release 30 mg Capsules Unit Carton Label
(click image for full-size original)
Serialized Unit Carton
(click image for full-size original)
LANSOPRAZOLE lansoprazole capsule, delayed release pellets
Product Information
Product Type HUMAN PRESCRIPTION DRUG Item Code (Source) NDC:51079-121(NDC:0378-8030)
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
SILICON DIOXIDE
STARCH, CORN
HYDROXYPROPYL CELLULOSE, UNSPECIFIED
LOW-SUBSTITUTED HYDROXYPROPYL CELLULOSE, UNSPECIFIED
MAGNESIUM CARBONATE
METHACRYLIC ACID — ETHYL ACRYLATE COPOLYMER (1:1) TYPE A
POLYETHYLENE GLYCOL, UNSPECIFIED
POLYSORBATE 80
SUCROSE
TALC
TITANIUM DIOXIDE
FD&C BLUE NO. 1
FD&C RED NO. 3
GELATIN, UNSPECIFIED
PROPYLENE GLYCOL
SHELLAC
FERROSOFERRIC OXIDE
POTASSIUM HYDROXIDE
AMMONIA
Product Characteristics
Color pink (pink opaque) Score no score
Shape CAPSULE Size 21mm
Flavor Imprint Code MYLAN;8030
Contains
Packaging
# Item Code Package Description Multilevel Packaging
1 NDC:51079-121-08 80 BLISTER PACK in 1 CARTON contains a BLISTER PACK (51079-121-01)
1 NDC:51079-121-01 1 CAPSULE, DELAYED RELEASE PELLETS in 1 BLISTER PACK This package is contained within the CARTON (51079-121-08)
Marketing Information
Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
ANDA ANDA090763 12/01/2009
Labeler — Mylan Institutional Inc. (039615992)

Revised: 12/2018 Mylan Institutional Inc.

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