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
FDA regulatory identification and product classification information
FDA Identifiers
NDC Product Code61919-806
Application NumberANDA090074
Product Classification
M
Marketing Category
C73584
G
Generic Name
PANTOPRAZOLE SODIUM
Product Specifications
Route of AdministrationORAL
Effective DateOctober 14, 2019
FDA Product Classification
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
FDA regulatory identification and product classification information
FDA Identifiers
NDC Product Code61919-134
Application NumberANDA077056
Product Classification
M
Marketing Category
C73584
G
Generic Name
PANTOPRAZOLE SODIUM
Product Specifications
Route of AdministrationORAL
Effective DateOctober 14, 2019
FDA Product Classification
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