Pantoprazole Sodium (Page 10 of 10)

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

DRUG: Pantoprazole Sodium

GENERIC: Pantoprazole Sodium

DOSAGE: Delayed-Release Tablets, USP

ADMINSTRATION: Oral

NDC: 64679-433-05

STRENGTH: 20 mg

COLOR: Yellow

SHAPE: Oval

SCORE: no score

SIZE: 9 mm

IMPRINT: W433

QTY: 100 Tablets

Label-20 mg-100T
(click image for full-size original)

DRUG: Pantoprazole Sodium

GENERIC: Pantoprazole Sodium

DOSAGE: Delayed-Release Tablets, USP

ADMINSTRATION: Oral

NDC: 64679-434-02

STRENGTH: 40 mg

COLOR: Yellow

SHAPE: Oval

SCORE: no score

SIZE: 12 mm

IMPRINT: W434

QTY: 1000 Tablets

Label-40 mg-1000T
(click image for full-size original)
PANTOPRAZOLE SODIUM pantoprazole sodium tablet, delayed release
Product Information
Product Type HUMAN PRESCRIPTION DRUG Item Code (Source) NDC:64679-433
Route of Administration ORAL DEA Schedule
Active Ingredient/Active Moiety
Ingredient Name Basis of Strength Strength
PANTOPRAZOLE SODIUM (PANTOPRAZOLE) PANTOPRAZOLE 20 mg
Inactive Ingredients
Ingredient Name Strength
AMMONIA
CALCIUM STEARATE
FD&C BLUE NO. 2
FERRIC OXIDE RED
FERRIC OXIDE YELLOW
FERROSOFERRIC OXIDE
HYPROMELLOSE 2910 (6 MPA.S)
MANNITOL
METHACRYLIC ACID — ETHYL ACRYLATE COPOLYMER (1:1) TYPE A
POLYETHYLENE GLYCOL 400
PROPYLENE GLYCOL
SHELLAC
SILICON DIOXIDE
SODIUM CARBONATE
SODIUM HYDROXIDE
SODIUM STARCH GLYCOLATE TYPE A POTATO
STARCH, CORN
TALC
TITANIUM DIOXIDE
TRIETHYL CITRATE
Product Characteristics
Color yellow (yellow) Score no score
Shape OVAL (biconvex oval shaped) Size 9mm
Flavor Imprint Code W433
Contains
Packaging
# Item Code Package Description Multilevel Packaging
1 NDC:64679-433-01 30 TABLET, DELAYED RELEASE in 1 BOTTLE None
2 NDC:64679-433-04 90 TABLET, DELAYED RELEASE in 1 BOTTLE None
3 NDC:64679-433-02 1000 TABLET, DELAYED RELEASE in 1 BOTTLE None
4 NDC:64679-433-05 100 TABLET, DELAYED RELEASE in 1 BOTTLE None
5 NDC:64679-433-03 100 BLISTER PACK in 1 CARTON contains a BLISTER PACK
5 10 TABLET, DELAYED RELEASE in 1 BLISTER PACK This package is contained within the CARTON (64679-433-03)
Marketing Information
Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
ANDA ANDA091231 01/19/2011
PANTOPRAZOLE SODIUM pantoprazole sodium tablet, delayed release
Product Information
Product Type HUMAN PRESCRIPTION DRUG Item Code (Source) NDC:64679-434
Route of Administration ORAL DEA Schedule
Active Ingredient/Active Moiety
Ingredient Name Basis of Strength Strength
PANTOPRAZOLE SODIUM (PANTOPRAZOLE) PANTOPRAZOLE 40 mg
Inactive Ingredients
Ingredient Name Strength
AMMONIA
CALCIUM STEARATE
FD&C BLUE NO. 2
FERRIC OXIDE RED
FERRIC OXIDE YELLOW
FERROSOFERRIC OXIDE
HYPROMELLOSE 2910 (6 MPA.S)
MANNITOL
METHACRYLIC ACID — ETHYL ACRYLATE COPOLYMER (1:1) TYPE A
POLYETHYLENE GLYCOL 400
PROPYLENE GLYCOL
SHELLAC
SILICON DIOXIDE
SODIUM CARBONATE
SODIUM HYDROXIDE
SODIUM STARCH GLYCOLATE TYPE A POTATO
STARCH, CORN
TALC
TITANIUM DIOXIDE
TRIETHYL CITRATE
Product Characteristics
Color yellow (yellow) Score no score
Shape OVAL (biconvex oval shaped) Size 12mm
Flavor Imprint Code W434
Contains
Packaging
# Item Code Package Description Multilevel Packaging
1 NDC:64679-434-01 30 TABLET, DELAYED RELEASE in 1 BOTTLE None
2 NDC:64679-434-04 90 TABLET, DELAYED RELEASE in 1 BOTTLE None
3 NDC:64679-434-02 1000 TABLET, DELAYED RELEASE in 1 BOTTLE None
4 NDC:64679-434-05 100 TABLET, DELAYED RELEASE in 1 BOTTLE None
5 NDC:64679-434-03 100 BLISTER PACK in 1 CARTON contains a BLISTER PACK
5 10 TABLET, DELAYED RELEASE in 1 BLISTER PACK This package is contained within the CARTON (64679-434-03)
Marketing Information
Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
ANDA ANDA091231 01/19/2011
Labeler — Wockhardt USA LLC. (170508365)
Registrant — Atlantide Pharmaceuticals AG (480475252)
Establishment
Name Address ID/FEI Operations
Wockhardt Limited 676257570 analysis (64679-433), analysis (64679-434), manufacture (64679-433), manufacture (64679-434), label (64679-433), label (64679-434), pack (64679-433), pack (64679-434)

Revised: 12/2020 Wockhardt USA LLC.

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