Prevacid
PREVACID (lansoprazole) Delayed-Release CapsulesPREVACID SoluTab (lansoprazole) Delayed-Release Orally Disintegrating Tablets For oral administrationInitial U.S. Approval: 1995
Approved
Approval ID
7140f8d9-e478-4f69-a4eb-3fd4c9414576
Product Type
HUMAN PRESCRIPTION DRUG LABEL
Effective Date
Oct 30, 2009
Manufacturers
FDA
Physicians Total Care, Inc.
DUNS: 194123980
Products 4
Detailed information about drug products covered under this FDA approval, including NDC codes, dosage forms, ingredients, and administration routes.
lansoprazole
Product Details
FDA regulatory identification and product classification information
FDA Identifiers
NDC Product Code54868-5795
Application NumberNDA021428
Product Classification
M
Marketing Category
C73594
G
Generic Name
lansoprazole
Product Specifications
Route of AdministrationORAL
Effective DateAugust 2, 2010
FDA Product Classification
INGREDIENTS (20)
TALCInactive
Code: 7SEV7J4R1U
Classification: IACT
LANSOPRAZOLEActive
Quantity: 15 mg in 1 1
Code: 0K5C5T2QPG
Classification: ACTIB
MANNITOLInactive
Code: 3OWL53L36A
Classification: IACT
METHACRYLIC ACIDInactive
Code: 1CS02G8656
Classification: IACT
HYDROXYPROPYL CELLULOSEInactive
Code: RFW2ET671P
Classification: IACT
LACTOSE MONOHYDRATEInactive
Code: EWQ57Q8I5X
Classification: IACT
CELLULOSE, MICROCRYSTALLINEInactive
Code: OP1R32D61U
Classification: IACT
TRIETHYL CITRATEInactive
Code: 8Z96QXD6UM
Classification: IACT
CROSPOVIDONEInactive
Code: 68401960MK
Classification: IACT
MAGNESIUM CARBONATEInactive
Code: 0E53J927NA
Classification: IACT
ASPARTAMEInactive
Code: Z0H242BBR1
Classification: IACT
GLYCERYL MONOSTEARATEInactive
Code: 230OU9XXE4
Classification: IACT
HYPROMELLOSESInactive
Code: 3NXW29V3WO
Classification: IACT
MAGNESIUM STEARATEInactive
Code: 70097M6I30
Classification: IACT
CITRIC ACID MONOHYDRATEInactive
Code: 2968PHW8QP
Classification: IACT
TITANIUM DIOXIDEInactive
Code: 15FIX9V2JP
Classification: IACT
POLYETHYLENE GLYCOLInactive
Code: 3WJQ0SDW1A
Classification: IACT
POLYSORBATE 80Inactive
Code: 6OZP39ZG8H
Classification: IACT
FERRIC OXIDE REDInactive
Code: 1K09F3G675
Classification: IACT
PHENYLALANINEInactive
Quantity: 2.5 mg in 1 1
Code: 47E5O17Y3R
Classification: IACT
lansoprazole
Product Details
FDA regulatory identification and product classification information
FDA Identifiers
NDC Product Code54868-5303
Application NumberNDA021428
Product Classification
M
Marketing Category
C73594
G
Generic Name
lansoprazole
Product Specifications
Route of AdministrationORAL
Effective DateAugust 2, 2010
FDA Product Classification
INGREDIENTS (20)
MANNITOLInactive
Code: 3OWL53L36A
Classification: IACT
METHACRYLIC ACIDInactive
Code: 1CS02G8656
Classification: IACT
HYDROXYPROPYL CELLULOSEInactive
Code: RFW2ET671P
Classification: IACT
LACTOSE MONOHYDRATEInactive
Code: EWQ57Q8I5X
Classification: IACT
CELLULOSE, MICROCRYSTALLINEInactive
Code: OP1R32D61U
Classification: IACT
TRIETHYL CITRATEInactive
Code: 8Z96QXD6UM
Classification: IACT
CROSPOVIDONEInactive
Code: 68401960MK
Classification: IACT
MAGNESIUM CARBONATEInactive
Code: 0E53J927NA
Classification: IACT
ASPARTAMEInactive
Code: Z0H242BBR1
Classification: IACT
GLYCERYL MONOSTEARATEInactive
Code: 230OU9XXE4
Classification: IACT
HYPROMELLOSESInactive
Code: 3NXW29V3WO
Classification: IACT
LANSOPRAZOLEActive
Quantity: 30 mg in 1 1
Code: 0K5C5T2QPG
Classification: ACTIB
MAGNESIUM STEARATEInactive
Code: 70097M6I30
Classification: IACT
CITRIC ACID MONOHYDRATEInactive
Code: 2968PHW8QP
Classification: IACT
TITANIUM DIOXIDEInactive
Code: 15FIX9V2JP
Classification: IACT
TALCInactive
Code: 7SEV7J4R1U
Classification: IACT
POLYETHYLENE GLYCOLInactive
Code: 3WJQ0SDW1A
Classification: IACT
POLYSORBATE 80Inactive
Code: 6OZP39ZG8H
Classification: IACT
FERRIC OXIDE REDInactive
Code: 1K09F3G675
Classification: IACT
PHENYLALANINEInactive
Quantity: 5.1 mg in 1 1
Code: 47E5O17Y3R
Classification: IACT
lansoprazole
Product Details
FDA regulatory identification and product classification information
FDA Identifiers
NDC Product Code54868-4079
Application NumberNDA020406
Product Classification
M
Marketing Category
C73594
G
Generic Name
lansoprazole
Product Specifications
Route of AdministrationORAL
Effective DateAugust 2, 2010
FDA Product Classification
INGREDIENTS (15)
STARCH, CORNInactive
Code: O8232NY3SJ
Classification: IACT
SUCROSEInactive
Code: C151H8M554
Classification: IACT
LANSOPRAZOLEActive
Quantity: 30 mg in 1 1
Code: 0K5C5T2QPG
Classification: ACTIB
methacrylic acid - ethyl acrylate copolymer (1:1) type AInactive
Code: NX76LV5T8J
Classification: IACT
HYDROXYPROPYL CELLULOSE, LOW SUBSTITUTEDInactive
Code: 2165RE0K14
Classification: IACT
MAGNESIUM CARBONATEInactive
Code: 0E53J927NA
Classification: IACT
TALCInactive
Code: 7SEV7J4R1U
Classification: IACT
POLYETHYLENE GLYCOLInactive
Code: 3WJQ0SDW1A
Classification: IACT
TITANIUM DIOXIDEInactive
Code: 15FIX9V2JP
Classification: IACT
SILICON DIOXIDEInactive
Code: ETJ7Z6XBU4
Classification: IACT
D&C RED NO. 28Inactive
Code: 767IP0Y5NH
Classification: IACT
POLYSORBATE 80Inactive
Code: 6OZP39ZG8H
Classification: IACT
HYDROXYPROPYL CELLULOSEInactive
Code: RFW2ET671P
Classification: IACT
FD&C BLUE NO. 1Inactive
Code: H3R47K3TBD
Classification: IACT
FD&C RED NO. 40Inactive
Code: WZB9127XOA
Classification: IACT
lansoprazole
Product Details
FDA regulatory identification and product classification information
FDA Identifiers
NDC Product Code54868-3867
Application NumberNDA020406
Product Classification
M
Marketing Category
C73594
G
Generic Name
lansoprazole
Product Specifications
Route of AdministrationORAL
Effective DateAugust 2, 2010
FDA Product Classification
INGREDIENTS (16)
STARCH, CORNInactive
Code: O8232NY3SJ
Classification: IACT
LANSOPRAZOLEActive
Quantity: 15 mg in 1 1
Code: 0K5C5T2QPG
Classification: ACTIB
METHACRYLIC ACID - ETHYL ACRYLATE COPOLYMER (1:1) TYPE AInactive
Code: NX76LV5T8J
Classification: IACT
MAGNESIUM CARBONATEInactive
Code: 0E53J927NA
Classification: IACT
SUCROSEInactive
Code: C151H8M554
Classification: IACT
HYDROXYPROPYL CELLULOSE, LOW SUBSTITUTEDInactive
Code: 2165RE0K14
Classification: IACT
TALCInactive
Code: 7SEV7J4R1U
Classification: IACT
TITANIUM DIOXIDEInactive
Code: 15FIX9V2JP
Classification: IACT
POLYETHYLENE GLYCOLInactive
Code: 3WJQ0SDW1A
Classification: IACT
POLYSORBATE 80Inactive
Code: 6OZP39ZG8H
Classification: IACT
HYDROXYPROPYL CELLULOSEInactive
Code: RFW2ET671P
Classification: IACT
SILICON DIOXIDEInactive
Code: ETJ7Z6XBU4
Classification: IACT
D&C RED NO. 28Inactive
Code: 767IP0Y5NH
Classification: IACT
FD&C BLUE NO. 1Inactive
Code: H3R47K3TBD
Classification: IACT
FD&C RED NO. 40Inactive
Code: WZB9127XOA
Classification: IACT
FD&C GREEN NO. 3Inactive
Code: 3P3ONR6O1S
Classification: IACT