Pantoprazole Sodium
Pantoprazole Sodium Delayed-Release Tablets
Approved
Approval ID
7c958802-daad-4c7e-88eb-73be7d2261d8
Product Type
HUMAN PRESCRIPTION DRUG LABEL
Effective Date
Mar 31, 2009
Manufacturers
FDA
Contract Pharmacy Services-PA
DUNS: 945429777
Products 1
Detailed information about drug products covered under this FDA approval, including NDC codes, dosage forms, ingredients, and administration routes.
pantoprazole sodium
Product Details
FDA regulatory identification and product classification information
FDA Identifiers
NDC Product Code67046-535
Application NumberNDA020987
Product Classification
M
Marketing Category
C73594
G
Generic Name
pantoprazole sodium
Product Specifications
Route of AdministrationORAL
Effective DateMarch 31, 2009
FDA Product Classification
INGREDIENTS (14)
PANTOPRAZOLE SODIUMActive
Quantity: 40 mg in 1 1
Code: 6871619Q5X
Classification: ACTIM
Calcium StearateInactive
Code: 776XM7047L
Classification: IACT
Ferric Oxide YellowInactive
Code: EX438O2MRT
Classification: IACT
CrospovidoneInactive
Code: 68401960MK
Classification: IACT
MannitolInactive
Code: 3OWL53L36A
Classification: IACT
Polysorbate 80Inactive
Code: 6OZP39ZG8H
Classification: IACT
HypromelloseInactive
Code: 3NXW29V3WO
Classification: IACT
PovidoneInactive
Code: FZ989GH94E
Classification: IACT
Propylene GlycolInactive
Code: 6DC9Q167V3
Classification: IACT
Sodium CarbonateInactive
Code: 45P3261C7T
Classification: IACT
Sodium Lauryl SulfateInactive
Code: 368GB5141J
Classification: IACT
Titanium DioxideInactive
Code: 15FIX9V2JP
Classification: IACT
Triethyl CitrateInactive
Code: 8Z96QXD6UM
Classification: IACT
METHACRYLIC ACID - ETHYL ACRYLATE COPOLYMER (1:1) TYPE AInactive
Code: NX76LV5T8J
Classification: IACT