NDC Code(s) : 61786-200-02
Packager : REMEDYREPACK INC.

Category : HUMAN PRESCRIPTION DRUG LABEL

DEA Schedule : none

Marketing Status : New Drug Application

INGREDIENTS AND APPEARANCE

Pantoprazole SodiumPantoprazole Sodium TABLET, DELAYED RELEASE
Product Information
Product Type HUMAN PRESCRIPTION DRUG Item Code (Source) NDC:61786-200(NDC:0093-0011)
Route of Administration ORAL DEA Schedule
Active Ingredient/Active Moiety
Ingredient Name Basis of Strength Strength
PANTOPRAZOLE SODIUM(UNII: 6871619Q5X)
(PANTOPRAZOLE - UNII:D8TST4O562) 		PANTOPRAZOLE20 mg
Inactive Ingredients
Ingredient Name Strength
CALCIUM CARBONATE(UNII: H0G9379FGK)
CALCIUM STEARATE(UNII: 776XM7047L)
D&C YELLOW NO. 10(UNII: 35SW5USQ3G)
FD&C YELLOW NO. 6(UNII: H77VEI93A8)
HYPROMELLOSE 2910 (15 MPA.S)(UNII: 36SFW2JZ0W)
FERROSOFERRIC OXIDE(UNII: XM0M87F357)
FERRIC OXIDE YELLOW(UNII: EX438O2MRT)
LACTOSE MONOHYDRATE(UNII: EWQ57Q8I5X)
LOW-SUBSTITUTED HYDROXYPROPYL CELLULOSE, UNSPECIFIED(UNII: 2165RE0K14)
METHACRYLIC ACID - ETHYL ACRYLATE COPOLYMER (1:1) TYPE A(UNII: NX76LV5T8J)
MICROCRYSTALLINE CELLULOSE(UNII: OP1R32D61U)
POLYETHYLENE GLYCOL 4000(UNII: 4R4HFI6D95)
PROPYLENE GLYCOL(UNII: 6DC9Q167V3)
SHELLAC(UNII: 46N107B71O)
SODIUM CARBONATE(UNII: 45P3261C7T)
STEARIC ACID(UNII: 4ELV7Z65AP)
TALC(UNII: 7SEV7J4R1U)
TITANIUM DIOXIDE(UNII: 15FIX9V2JP)
TRIETHYL CITRATE(UNII: 8Z96QXD6UM)
Product Characteristics
Color yellow Score no score
Shape OVAL Size 8 mm
Flavor Imprint Code 93;11
Contains
Packaging
# Item Code Package Description Marketing Start Date Marketing End Date
1NDC:61786-200-0230 in 1 BLISTER PACK Type 0: Not a Combination Product24/02/2015
Marketing Information
Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
ANDA ANDA077056 02/24/2015

PRINCIPAL DISPLAY PANEL

DRUG: Pantoprazole Sodium

GENERIC: Pantoprazole Sodium

DOSAGE: TABLET, DELAYED RELEASE

ADMINSTRATION: ORAL

NDC: 61786-200-02

COLOR: yellow

SHAPE: OVAL

SCORE: No score

SIZE: 8 mm

IMPRINT: 93;11

PACKAGING: 30 in 1 BLISTER PACK

ACTIVE INGREDIENT(S):

  • PANTOPRAZOLE SODIUM 20mg in 1

INACTIVE INGREDIENT(S):

  • CALCIUM CARBONATE
  • PROPYLENE GLYCOL
  • POLYETHYLENE GLYCOL 4000
  • SHELLAC
  • MICROCRYSTALLINE CELLULOSE
  • SODIUM CARBONATE
  • TITANIUM DIOXIDE
  • STEARIC ACID
  • TALC
  • METHACRYLIC ACID - ETHYL ACRYLATE COPOLYMER (1:1) TYPE A
  • CALCIUM STEARATE
  • D&C YELLOW NO. 10
  • FD&C YELLOW NO. 6
  • HYPROMELLOSE 2910 (15 MPA.S)
  • LOW-SUBSTITUTED HYDROXYPROPYL CELLULOSE, UNSPECIFIED
  • FERRIC OXIDE YELLOW
  • LACTOSE MONOHYDRATE
  • FERROSOFERRIC OXIDE
  • TRIETHYL CITRATE

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