Lansoprazole (Page 9 of 9)

PRINCIPAL DISPLAY PANEL

63187-152-30
(click image for full-size original)
LANSOPRAZOLE
lansoprazole capsule, delayed release
Product Information
Product Type HUMAN PRESCRIPTION DRUG Item Code (Source) NDC:63187-152(NDC:0093-7351)
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
FERROSOFERRIC OXIDE
GELATIN, UNSPECIFIED
HYPROMELLOSE 2910 (6 MPA.S)
MAGNESIUM CARBONATE
METHACRYLIC ACID — ETHYL ACRYLATE COPOLYMER (1:1) TYPE A
PROPYLENE GLYCOL
FERRIC OXIDE RED
SHELLAC
SUCROSE
STARCH, CORN
TALC
TITANIUM DIOXIDE
TRIETHYL CITRATE
POTASSIUM HYDROXIDE
Product Characteristics
Color GRAY (light-gray) , WHITE (flesh-colored) Score no score
Shape CAPSULE Size 19mm
Flavor Imprint Code 93;7351;93;7351
Contains
Packaging
# Item Code Package Description Multilevel Packaging
1 NDC:63187-152-30 30 CAPSULE, DELAYED RELEASE in 1 BOTTLE None
Marketing Information
Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
ANDA ANDA077255 11/11/2009
Labeler — Proficient Rx LP (079196022)
Establishment
Name Address ID/FEI Operations
Proficient Rx LP 079196022 REPACK (63187-152), RELABEL (63187-152)

Revised: 01/2021 Proficient Rx LP

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