NDC Code(s) : 70756-806-30, 70756-807-30, 70756-807-90, 70756-807-51
Packager : Lifestar Pharma LLC.

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:70756-806
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
MAGNESIUM CARBONATE(UNII: 0E53J927NA)
SUCROSE(UNII: C151H8M554)
STARCH, CORN(UNII: O8232NY3SJ)
HYDROXYPROPYL CELLULOSE(UNII: RFW2ET671P)
TALC(UNII: 7SEV7J4R1U)
METHACRYLIC ACID - ETHYL ACRYLATE COPOLYMER (1:1) TYPE A(UNII: NX76LV5T8J)
POLYETHYLENE GLYCOL 400(UNII: B697894SGQ)
TITANIUM DIOXIDE(UNII: 15FIX9V2JP)
POLYSORBATE 80(UNII: 6OZP39ZG8H)
GELATIN(UNII: 2G86QN327L)
FD&C BLUE NO. 2(UNII: L06K8R7DQK)
FERRIC OXIDE YELLOW(UNII: EX438O2MRT)
Product Characteristics
Color green (opaque green), white (opaque white) Score no score
Shape CAPSULE Size 16 mm
Flavor Imprint Code 806
Contains
Packaging
# Item Code Package Description Marketing Start Date Marketing End Date
1NDC:70756-806-3030 in 1 BOTTLE Type 0: Not a Combination Product06/04/2018
Marketing Information
Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
ANDA ANDA205868 06/04/2018
LansoprazoleLansoprazole CAPSULE, DELAYED RELEASE
Product Information
Product Type HUMAN PRESCRIPTION DRUG Item Code (Source) NDC:70756-807
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
SUCROSE(UNII: C151H8M554)
MAGNESIUM CARBONATE(UNII: 0E53J927NA)
STARCH, CORN(UNII: O8232NY3SJ)
HYDROXYPROPYL CELLULOSE(UNII: RFW2ET671P)
TALC(UNII: 7SEV7J4R1U)
METHACRYLIC ACID - ETHYL ACRYLATE COPOLYMER (1:1) TYPE A(UNII: NX76LV5T8J)
POLYETHYLENE GLYCOL 400(UNII: B697894SGQ)
TITANIUM DIOXIDE(UNII: 15FIX9V2JP)
POLYSORBATE 80(UNII: 6OZP39ZG8H)
GELATIN(UNII: 2G86QN327L)
FERROSOFERRIC OXIDE(UNII: XM0M87F357)
Product Characteristics
Color black (opaque black), white (opaque white) Score no score
Shape CAPSULE Size 19 mm
Flavor Imprint Code 807
Contains
Packaging
# Item Code Package Description Marketing Start Date Marketing End Date
1NDC:70756-807-3030 in 1 BOTTLE Type 0: Not a Combination Product06/04/2018
2NDC:70756-807-9090 in 1 BOTTLE Type 0: Not a Combination Product06/04/2018
3NDC:70756-807-51500 in 1 BOTTLE Type 0: Not a Combination Product06/04/2018
Marketing Information
Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
ANDA ANDA205868 06/04/2018

LABELER - Lifestar Pharma LLC.(080268943)

REGISTRANT - Inventia Healthcare Limited(650452522)

Establishment
Name Address ID/FEI Business Operations
Inventia Healthcare Limited 677604412 analysis(70756-806, 70756-807), manufacture(70756-806, 70756-807)

PRINCIPAL DISPLAY PANEL

15mg-30s-bottle15mg-30s-bottle