NDC Code(s) : 52125-946-08
Packager : REMEDYREPACK INC.

Category : HUMAN PRESCRIPTION DRUG LABEL

DEA Schedule : none

Marketing Status : New Drug Application

INGREDIENTS AND APPEARANCE

Prevacidlansoprazole CAPSULE, DELAYED RELEASE
Product Information
Product Type HUMAN PRESCRIPTION DRUG Item Code (Source) NDC:52125-946(NDC:64764-046)
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)
METHACRYLIC ACID - ETHYL ACRYLATE COPOLYMER (1:1) TYPE A(UNII: NX76LV5T8J)
HYDROXYPROPYL CELLULOSE, LOW SUBSTITUTED(UNII: 2165RE0K14)
STARCH, CORN(UNII: O8232NY3SJ)
MAGNESIUM CARBONATE(UNII: 0E53J927NA)
TALC(UNII: 7SEV7J4R1U)
POLYETHYLENE GLYCOLS(UNII: 3WJQ0SDW1A)
TITANIUM DIOXIDE(UNII: 15FIX9V2JP)
POLYSORBATE 80(UNII: 6OZP39ZG8H)
HYDROXYPROPYL CELLULOSE (TYPE H)(UNII: RFW2ET671P)
SILICON DIOXIDE(UNII: ETJ7Z6XBU4)
D&C RED NO. 28(UNII: 767IP0Y5NH)
FD&C BLUE NO. 1(UNII: H3R47K3TBD)
FD&C RED NO. 40(UNII: WZB9127XOA)
Product Characteristics
Color pink (Opaque), black (Opaque) Score no score
Shape CAPSULE Size 19 mm
Flavor Imprint Code TAP;PREVACID;30
Contains
Packaging
# Item Code Package Description Marketing Start Date Marketing End Date
1NDC:52125-946-0810 in 1 BOTTLE Type 0: Not a Combination Product09/06/2016
Marketing Information
Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
NDA NDA020406 06/09/2016 02/15/2017

PRINCIPAL DISPLAY PANEL

DRUG: Prevacid

GENERIC: lansoprazole

DOSAGE: CAPSULE, DELAYED RELEASE

ADMINSTRATION: ORAL

NDC: 52125-946-08

COLOR: pink

SHAPE: CAPSULE

SCORE: No score

SIZE: 19 mm

IMPRINT: TAP;PREVACID;30

PACKAGING: 10 in 1 BOTTLE

ACTIVE INGREDIENT(S):

  • lansoprazole 30mg in 1

INACTIVE INGREDIENT(S):

  • FD&C Red No. 40
  • HYDROXYPROPYL CELLULOSE (TYPE H)
  • polysorbate 80
  • silicon dioxide
  • D&C Red No. 28
  • FD&C Blue No. 1
  • titanium dioxide
  • hydroxypropyl cellulose, low substituted
  • methacrylic acid - ethyl acrylate copolymer (1:1) type A
  • polyethylene glycols
  • starch, corn
  • magnesium carbonate
  • sucrose
  • talc

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