NDC Code(s) : 54569-6149-0, 54569-6149-1
Packager : A-S Medication Solutions

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:54569-6149(NDC:51991-772)
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
ACETONE(UNII: 1364PS73AF)
HYPROMELLOSES(UNII: 3NXW29V3WO)
ISOPROPYL ALCOHOL(UNII: ND2M416302)
MAGNESIUM CARBONATE(UNII: 0E53J927NA)
METHACRYLIC ACID - ETHYL ACRYLATE COPOLYMER (1:1) TYPE A(UNII: NX76LV5T8J)
POLYETHYLENE GLYCOL 4000(UNII: 4R4HFI6D95)
POLYSORBATE 80(UNII: 6OZP39ZG8H)
SUCROSE(UNII: C151H8M554)
TALC(UNII: 7SEV7J4R1U)
TITANIUM DIOXIDE(UNII: 15FIX9V2JP)
Product Characteristics
Color BLUE (Dark Blue), PINK Score no score
Shape CAPSULE Size 19 mm
Flavor Imprint Code NATCO;30
Contains
Packaging
# Item Code Package Description Marketing Start Date Marketing End Date
1NDC:54569-6149-030 in 1 BOTTLE Type 0: Not a Combination Product
2NDC:54569-6149-190 in 1 BOTTLE Type 0: Not a Combination Product
Marketing Information
Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
ANDA ANDA201921 12/18/2012

PRINCIPAL DISPLAY PANEL

Label Image