NDC Code(s) : 68084-467-11, 68084-467-21, 68084-468-11, 68084-468-01
Packager : American Health Packaging

Category : HUMAN PRESCRIPTION DRUG LABEL

DEA Schedule : none

Marketing Status : New Drug Application

INGREDIENTS AND APPEARANCE

Lansoprazolelansoprazole CAPSULE, DELAYED RELEASE
Product Information
Product Type HUMAN PRESCRIPTION DRUG Item Code (Source) NDC:68084-467(NDC:55111-398)
Route of Administration ORAL DEA Schedule
Active Ingredient/Active Moiety
Ingredient Name Basis of Strength Strength
LANSOPRAZOLE(UNII: 0K5C5T2QPG)
(LANSOPRAZOLE - UNII:0K5C5T2QPG) 		LANSOPRAZOLE15 mg
Inactive Ingredients
Ingredient Name Strength
AMMONIA(UNII: 5138Q19F1X)
HYDROXYPROPYL CELLULOSE (TYPE H)(UNII: RFW2ET671P)
HYDROXYPROPYL CELLULOSE, LOW SUBSTITUTED(UNII: 2165RE0K14)
MAGNESIUM CARBONATE(UNII: 0E53J927NA)
METHACRYLIC ACID - ETHYL ACRYLATE COPOLYMER (1:1) TYPE A(UNII: NX76LV5T8J)
POLYETHYLENE GLYCOLS(UNII: 3WJQ0SDW1A)
POLYSORBATE 80(UNII: 6OZP39ZG8H)
PROPYLENE GLYCOL(UNII: 6DC9Q167V3)
SHELLAC(UNII: 46N107B71O)
STARCH, CORN(UNII: O8232NY3SJ)
SUCROSE(UNII: C151H8M554)
RAW SUGAR(UNII: 8M707QY5GH)
TITANIUM DIOXIDE(UNII: 15FIX9V2JP)
TALC(UNII: 7SEV7J4R1U)
GELATIN(UNII: 2G86QN327L)
FERRIC OXIDE RED(UNII: 1K09F3G675)
FERRIC OXIDE YELLOW(UNII: EX438O2MRT)
FD&C BLUE NO. 2(UNII: L06K8R7DQK)
SODIUM LAURYL SULFATE(UNII: 368GB5141J)
Product Characteristics
Color green, pink Score no score
Shape CAPSULE Size 16 mm
Flavor Imprint Code RDY;398
Contains
Packaging
# Item Code Package Description Marketing Start Date Marketing End Date
1NDC:68084-467-2130 in 1 BOX, UNIT-DOSE
1NDC:68084-467-111 in 1 BLISTER PACK Type 0: Not a Combination Product
Marketing Information
Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
ANDA ANDA091269 01/01/2012
Lansoprazolelansoprazole CAPSULE, DELAYED RELEASE
Product Information
Product Type HUMAN PRESCRIPTION DRUG Item Code (Source) NDC:68084-468(NDC:55111-399)
Route of Administration ORAL DEA Schedule
Active Ingredient/Active Moiety
Ingredient Name Basis of Strength Strength
LANSOPRAZOLE(UNII: 0K5C5T2QPG)
(LANSOPRAZOLE - UNII:0K5C5T2QPG) 		LANSOPRAZOLE30 mg
Inactive Ingredients
Ingredient Name Strength
AMMONIA(UNII: 5138Q19F1X)
HYDROXYPROPYL CELLULOSE (TYPE H)(UNII: RFW2ET671P)
HYDROXYPROPYL CELLULOSE, LOW SUBSTITUTED(UNII: 2165RE0K14)
MAGNESIUM CARBONATE(UNII: 0E53J927NA)
METHACRYLIC ACID - ETHYL ACRYLATE COPOLYMER (1:1) TYPE A(UNII: NX76LV5T8J)
POLYETHYLENE GLYCOLS(UNII: 3WJQ0SDW1A)
POLYSORBATE 80(UNII: 6OZP39ZG8H)
PROPYLENE GLYCOL(UNII: 6DC9Q167V3)
SHELLAC(UNII: 46N107B71O)
STARCH, CORN(UNII: O8232NY3SJ)
SUCROSE(UNII: C151H8M554)
RAW SUGAR(UNII: 8M707QY5GH)
TITANIUM DIOXIDE(UNII: 15FIX9V2JP)
TALC(UNII: 7SEV7J4R1U)
GELATIN(UNII: 2G86QN327L)
FERROSOFERRIC OXIDE(UNII: XM0M87F357)
FERRIC OXIDE RED(UNII: 1K09F3G675)
FERRIC OXIDE YELLOW(UNII: EX438O2MRT)
SODIUM LAURYL SULFATE(UNII: 368GB5141J)
Product Characteristics
Color black, pink Score no score
Shape CAPSULE Size 19 mm
Flavor Imprint Code RDY;399
Contains
Packaging
# Item Code Package Description Marketing Start Date Marketing End Date
1NDC:68084-468-01100 in 1 BOX, UNIT-DOSE
1NDC:68084-468-111 in 1 BLISTER PACK Type 0: Not a Combination Product
Marketing Information
Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
ANDA ANDA091269 09/15/2010

PRINCIPAL DISPLAY PANEL

15 mg Lansoprzole Carton

NDC 68084-467-21

Lansoprazole Delayed-Release
Capsules, USP

15 mg

30 Capsules (3 x 10)

Pharmacist : Dispense with the Accompanying
Medication Guide to Each Patient.

Each delayed release capsule contains:
Lansoprazole USP 15 mg (as enteric coated pellets).

Each capsule is imprinted with
RDY and LAN for product identification.

See enclosure for full prescribing information.

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

Keep this and all drugs out of reach of children.

Rx Only

The drug product contained in this package is from
NDC # 55111-398, Dr. Reddy's Laboratories Limited

Packaged and Distributed by:
American Health Packaging
Columbus, Ohio 43217

046721
Rev. 11/2013

PRINCIPAL DISPLAY PANEL

30 mg Lansoprazole Carton

NDC 68084-468-01

Lansoprazole
Delayed-Release
Capsules, USP

30 mg

100 Capsules (10 x 10)

Pharmacist: Dispense the Medication Guide
to each patient.

Each delayed release capsule contains:
Lansoprazole USP 30 mg (as enteric coated
pellets). Each capsule is imprinted with RDY and
399 for product identification.

See insert for full prescribing information.

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

Keep this and all drugs out of reach of children.

Rx Only

The drug product contained in this package is
from NDC # 55111-399, Dr. Reddy's Laboratories
Limited.

Packaged and Distributed by:
American Health Packaging
Columbus, Ohio 43217

047001
Rev. 03/2013

PRINCIPAL DISPLAY PANEL

30 mg Lansoprazole Blister

Lansoprazole
Delayed-Release
Capsule, USP

30 mg