Lansoprazole
These highlights do not include all the information needed to use lansoprazole delayed-release orally disintegrating tablets safely and effectively. See full prescribing information for lansoprazole delayed-release orally disintegrating tablets. LANSOPRAZOLE delayed-release orally disintegrating tablets for oral useInitial U.S. Approval: 1995
Approved
Approval ID
a2f317f0-33ee-4298-bb5d-dd631d7bee25
Product Type
HUMAN PRESCRIPTION DRUG LABEL
Effective Date
Oct 15, 2010
Manufacturers
FDA
Physicians Total Care, Inc.
DUNS: 194123980
Products 1
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 Code54868-6205
Application NumberANDA078730
Product Classification
M
Marketing Category
C73584
G
Generic Name
Lansoprazole
Product Specifications
Route of AdministrationORAL
Effective DateDecember 6, 2010
FDA Product Classification
INGREDIENTS (20)
LANSOPRAZOLEActive
Quantity: 30 mg in 1 1
Code: 0K5C5T2QPG
Classification: ACTIB
3-HEXENYL ACETATE, CIS-Inactive
Code: 6INA6GC5I6
Classification: IACT
ASPARTAMEInactive
Code: Z0H242BBR1
Classification: IACT
SILICON DIOXIDEInactive
Code: ETJ7Z6XBU4
Classification: IACT
ETHYL BUTYRATEInactive
Code: UFD2LZ005D
Classification: IACT
ETHYL ISOVALERATEInactive
Code: 9ZZ5597636
Classification: IACT
.GAMMA.-DECALACTONEInactive
Code: 7HLS05KP9O
Classification: IACT
ACACIAInactive
Code: 5C5403N26O
Classification: IACT
LACTOSEInactive
Code: J2B2A4N98G
Classification: IACT
MAGNESIUM CARBONATEInactive
Code: 0E53J927NA
Classification: IACT
HYPROMELLOSESInactive
Code: 3NXW29V3WO
Classification: IACT
MAGNESIUM STEARATEInactive
Code: 70097M6I30
Classification: IACT
MALTODEXTRINInactive
Code: 7CVR7L4A2D
Classification: IACT
STARCH, CORNInactive
Code: O8232NY3SJ
Classification: IACT
METHACRYLIC ACID - ETHYL ACRYLATE COPOLYMER (1:1) TYPE AInactive
Code: NX76LV5T8J
Classification: IACT
SUCROSEInactive
Code: C151H8M554
Classification: IACT
TALCInactive
Code: 7SEV7J4R1U
Classification: IACT
METHYL CINNAMATEInactive
Code: 533CV2ZCQL
Classification: IACT
TITANIUM DIOXIDEInactive
Code: 15FIX9V2JP
Classification: IACT
TRIETHYL CITRATEInactive
Code: 8Z96QXD6UM
Classification: IACT