PANTOPRAZOLE SODIUM
PANTOPRAZOLE SODIUM DELAYED-RELEASE TABLETS
Approved
Approval ID
962951c7-1467-49f7-9ada-361e86fdfcb2
Product Type
HUMAN PRESCRIPTION DRUG LABEL
Effective Date
Aug 4, 2017
Manufacturers
FDA
California Pharmaceuticals LLC
DUNS: 021420944
Products 1
Detailed information about drug products covered under this FDA approval, including NDC codes, dosage forms, ingredients, and administration routes.
PANTOPRAZOLE
Product Details
FDA regulatory identification and product classification information
FDA Identifiers
NDC Product Code70332-300
Application NumberANDA205119
Product Classification
M
Marketing Category
C73584
G
Generic Name
PANTOPRAZOLE
Product Specifications
Route of AdministrationORAL
Effective DateAugust 4, 2017
FDA Product Classification
INGREDIENTS (20)
MANNITOLInactive
Code: 3OWL53L36A
Classification: IACT
METHACRYLIC ACID - METHYL METHACRYLATE COPOLYMER (1:1)Inactive
Code: 74G4R6TH13
Classification: IACT
PROPYLENE GLYCOLInactive
Code: 6DC9Q167V3
Classification: IACT
AMMONIAInactive
Code: 5138Q19F1X
Classification: IACT
CROSPOVIDONE (12 MPA.S AT 5%)Inactive
Code: 40UAA97IT9
Classification: IACT
HYDROXYPROPYL CELLULOSE, LOW SUBSTITUTEDInactive
Code: 2165RE0K14
Classification: IACT
HYPROMELLOSESInactive
Code: 3NXW29V3WO
Classification: IACT
FERROSOFERRIC OXIDEInactive
Code: XM0M87F357
Classification: IACT
FERRIC OXIDE YELLOWInactive
Code: EX438O2MRT
Classification: IACT
POLYETHYLENE GLYCOLSInactive
Code: 3WJQ0SDW1A
Classification: IACT
POVIDONEInactive
Code: FZ989GH94E
Classification: IACT
POLYVINYL ALCOHOL, UNSPECIFIEDInactive
Code: 532B59J990
Classification: IACT
SHELLACInactive
Code: 46N107B71O
Classification: IACT
SODIUM CARBONATEInactive
Code: 45P3261C7T
Classification: IACT
SODIUM HYDROXIDEInactive
Code: 55X04QC32I
Classification: IACT
SODIUM STEARYL FUMARATEInactive
Code: 7CV7WJK4UI
Classification: IACT
TALCInactive
Code: 7SEV7J4R1U
Classification: IACT
TITANIUM DIOXIDEInactive
Code: 15FIX9V2JP
Classification: IACT
TRIETHYL CITRATEInactive
Code: 8Z96QXD6UM
Classification: IACT
PANTOPRAZOLE SODIUMActive
Quantity: 40 mg in 1 1
Code: 6871619Q5X
Classification: ACTIM