Prevacid SoluTab
These highlights do not include all the information needed to use PREVACID safely and effectively. See full prescribing information for: PREVACID (lansoprazole) Delayed-Release CapsulesPREVACID SoluTab (lansoprazole) Delayed-Release Orally Disintegrating Tablets For oral administrationInitial U.S. Approval: 1995
Approved
Approval ID
d15c8f36-4dcc-4b28-b03c-4e81b2f9ad2e
Product Type
HUMAN PRESCRIPTION DRUG LABEL
Effective Date
Jan 4, 2011
Manufacturers
FDA
Rebel Distributors Corp
DUNS: 118802834
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 Code21695-106
Application NumberNDA021428
Product Classification
M
Marketing Category
C73594
G
Generic Name
lansoprazole
Product Specifications
Route of AdministrationORAL
Effective DateOctober 13, 2010
FDA Product Classification
INGREDIENTS (1)
lansoprazoleActive
Quantity: 30 mg in 1 1
Code: 0K5C5T2QPG
Classification: ACTIB