PANTOPRAZOLE SODIUM
PANTOPRAZOLE SODIUM
Approved
Approval ID
491102c1-f04b-4b7b-e054-00144ff8d46c
Product Type
HUMAN PRESCRIPTION DRUG LABEL
Effective Date
Oct 14, 2019
Manufacturers
FDA
DIRECT RX
DUNS: 079254320
Products 2
Detailed information about drug products covered under this FDA approval, including NDC codes, dosage forms, ingredients, and administration routes.
PANTOPRAZOLE SODIUM
PRODUCT DETAILS
NDC Product Code61919-806
Application NumberANDA090074
Marketing CategoryC73584
Route of AdministrationORAL
Effective DateOctober 14, 2019
Generic NamePANTOPRAZOLE SODIUM
INGREDIENTS (12)
CALCIUM STEARATEInactive
Code: 776XM7047L
Classification: IACT
SODIUM CARBONATEInactive
Code: 45P3261C7T
Classification: IACT
CROSPOVIDONEInactive
Code: 2S7830E561
Classification: IACT
MANNITOLInactive
Code: 3OWL53L36A
Classification: IACT
TALCInactive
Code: 7SEV7J4R1U
Classification: IACT
HYPROMELLOSE 2910 (3 MPA.S)Inactive
Code: 0VUT3PMY82
Classification: IACT
HYDROXYPROPYL CELLULOSE (1600000 WAMW)Inactive
Code: RFW2ET671P
Classification: IACT
METHACRYLIC ACID - ETHYL ACRYLATE COPOLYMER (1:1) TYPE AInactive
Code: NX76LV5T8J
Classification: IACT
PROPYLENE GLYCOLInactive
Code: 6DC9Q167V3
Classification: IACT
TITANIUM DIOXIDEInactive
Code: 15FIX9V2JP
Classification: IACT
PANTOPRAZOLE SODIUMActive
Quantity: 20 mg in 1 1
Code: 6871619Q5X
Classification: ACTIM
TRIETHYL CITRATEInactive
Code: 8Z96QXD6UM
Classification: IACT
PANTOPRAZOLE SODIUM
PRODUCT DETAILS
NDC Product Code61919-134
Application NumberANDA077056
Marketing CategoryC73584
Route of AdministrationORAL
Effective DateOctober 14, 2019
Generic NamePANTOPRAZOLE SODIUM
INGREDIENTS (20)
HYPROMELLOSE 2910 (15 MPA.S)Inactive
Code: 36SFW2JZ0W
Classification: IACT
STEARIC ACIDInactive
Code: 4ELV7Z65AP
Classification: IACT
CELLULOSE, MICROCRYSTALLINEInactive
Code: OP1R32D61U
Classification: IACT
D&C YELLOW NO. 10Inactive
Code: 35SW5USQ3G
Classification: IACT
TRIETHYL CITRATEInactive
Code: 8Z96QXD6UM
Classification: IACT
CALCIUM STEARATEInactive
Code: 776XM7047L
Classification: IACT
FD&C YELLOW NO. 6Inactive
Code: H77VEI93A8
Classification: IACT
HYDROXYPROPYL CELLULOSE, LOW SUBSTITUTEDInactive
Code: 2165RE0K14
Classification: IACT
SHELLACInactive
Code: 46N107B71O
Classification: IACT
SODIUM CARBONATEInactive
Code: 45P3261C7T
Classification: IACT
LACTOSE MONOHYDRATEInactive
Code: EWQ57Q8I5X
Classification: IACT
TALCInactive
Code: 7SEV7J4R1U
Classification: IACT
CALCIUM CARBONATEInactive
Code: H0G9379FGK
Classification: IACT
FERRIC OXIDE YELLOWInactive
Code: EX438O2MRT
Classification: IACT
METHACRYLIC ACID - ETHYL ACRYLATE COPOLYMER (1:1) TYPE AInactive
Code: NX76LV5T8J
Classification: IACT
PROPYLENE GLYCOLInactive
Code: 6DC9Q167V3
Classification: IACT
PANTOPRAZOLE SODIUMActive
Quantity: 20 mg in 1 1
Code: 6871619Q5X
Classification: ACTIM
POLYETHYLENE GLYCOL 4000Inactive
Code: 4R4HFI6D95
Classification: IACT
TITANIUM DIOXIDEInactive
Code: 15FIX9V2JP
Classification: IACT
FERROSOFERRIC OXIDEInactive
Code: XM0M87F357
Classification: IACT