NDC Code(s) : 52125-665-02
Packager : REMEDYREPACK INC.

Category : HUMAN PRESCRIPTION DRUG LABEL

DEA Schedule : none

Marketing Status : New Drug Application

INGREDIENTS AND APPEARANCE

Lansoprazole Lansoprazole CAPSULE, DELAYED RELEASE
Product Information
Product Type HUMAN PRESCRIPTION DRUG Item Code (Source) NDC:52125-665(NDC:64679-670)
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
D&C RED NO. 33(UNII: 9DBA0SBB0L)
SHELLAC(UNII: 46N107B71O)
PROPYLENE GLYCOL(UNII: 6DC9Q167V3)
SILICON DIOXIDE(UNII: ETJ7Z6XBU4)
POTASSIUM HYDROXIDE(UNII: WZH3C48M4T)
TALC(UNII: 7SEV7J4R1U)
STARCH, CORN(UNII: O8232NY3SJ)
SUCROSE(UNII: C151H8M554)
POLYSORBATE 80(UNII: 6OZP39ZG8H)
FD&C BLUE NO. 1(UNII: H3R47K3TBD)
FERROSOFERRIC OXIDE(UNII: XM0M87F357)
GELATIN(UNII: 2G86QN327L)
HYPROMELLOSES(UNII: 3NXW29V3WO)
MAGNESIUM CARBONATE(UNII: 0E53J927NA)
METHACRYLIC ACID - METHYL METHACRYLATE COPOLYMER (1:1)(UNII: 74G4R6TH13)
POLYETHYLENE GLYCOL 6000(UNII: 30IQX730WE)
TITANIUM DIOXIDE(UNII: 15FIX9V2JP)
Product Characteristics
Color pink Score no score
Shape CAPSULE (CAPSULE, DELAYED RELEASE) Size 19 mm
Flavor Imprint Code W;670
Contains
Packaging
# Item Code Package Description Marketing Start Date Marketing End Date
1NDC:52125-665-0230 in 1 VIAL
Marketing Information
Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
ANDA ANDA202176 07/09/2013

PRINCIPAL DISPLAY PANEL

DRUG: Lansoprazole


GENERIC: Lansoprazole


DOSAGE: CAPSULE, DELAYED RELEASE


ADMINSTRATION: ORAL


NDC: 52125-665-02


ACTIVE INGREDIENT(S):

  • LANSOPRAZOLE 30mg in 1


INACTIVE INGREDIENT(S):

  • D&C RED NO. 33
  • SHELLAC
  • PROPYLENE GLYCOL
  • SILICON DIOXIDE
  • POTASSIUM HYDROXIDE
  • TALC
  • STARCH, CORN
  • SUCROSE
  • POLYSORBATE 80
  • FD&C BLUE NO. 1
  • FERROSOFERRIC OXIDE
  • GELATIN
  • HYPROMELLOSES
  • MAGNESIUM CARBONATE
  • METHACRYLIC ACID - METHYL METHACRYLATE COPOLYMER (1:1)
  • POLYETHYLENE GLYCOL 6000
  • TITANIUM DIOXIDE


COLOR: pink


SHAPE: CAPSULE


SCORE: No score


SIZE: 19 mm


IMPRINT: W;670


PACKAGING: 30 in 1 VIAL



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