Lansoprazole
These highlights do not include all the information needed to use Lansoprazole Delayed-Release Capsules safely and effectively. See full prescribing information for: Lansoprazole Delayed-Release Capsules For oral administrationInitial U.S. Approval: 1995
Approved
Approval ID
c119ed19-5dc6-4c03-b705-2616c65ef041
Product Type
HUMAN PRESCRIPTION DRUG LABEL
Effective Date
Sep 30, 2010
Manufacturers
FDA
Rebel Distributors Corp
DUNS: 118802834
Products 2
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 Code21695-652
Application NumberNDA020406
Product Classification
M
Marketing Category
C73594
G
Generic Name
lansoprazole
Product Specifications
Route of AdministrationORAL
Effective DateJune 30, 2009
FDA Product Classification
INGREDIENTS (15)
LansoprazoleActive
Quantity: 30 mg in 1 1
Code: 0K5C5T2QPG
Classification: ACTIB
starch, cornInactive
Code: O8232NY3SJ
Classification: IACT
hydroxypropyl cellulose, low substitutedInactive
Code: 2165RE0K14
Classification: IACT
sucroseInactive
Code: C151H8M554
Classification: IACT
magnesium carbonateInactive
Code: 0E53J927NA
Classification: IACT
talcInactive
Code: 7SEV7J4R1U
Classification: IACT
polyethylene glycolInactive
Code: 3WJQ0SDW1A
Classification: IACT
polysorbate 80Inactive
Code: 6OZP39ZG8H
Classification: IACT
titanium dioxideInactive
Code: 15FIX9V2JP
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 Red No. 40Inactive
Code: WZB9127XOA
Classification: IACT
FD&C Blue No. 1Inactive
Code: H3R47K3TBD
Classification: IACT
methacrylic acid - ethyl acrylate copolymer (1:1) type aInactive
Code: NX76LV5T8J
Classification: IACT
lansoprazole
Product Details
FDA regulatory identification and product classification information
FDA Identifiers
NDC Product Code21695-474
Application NumberNDA020406
Product Classification
M
Marketing Category
C73594
G
Generic Name
lansoprazole
Product Specifications
Route of AdministrationORAL
Effective DateJune 30, 2009
FDA Product Classification
INGREDIENTS (16)
LansoprazoleActive
Quantity: 15 mg in 1 1
Code: 0K5C5T2QPG
Classification: ACTIB
starch, cornInactive
Code: O8232NY3SJ
Classification: IACT
sucroseInactive
Code: C151H8M554
Classification: IACT
magnesium carbonateInactive
Code: 0E53J927NA
Classification: IACT
talcInactive
Code: 7SEV7J4R1U
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
FD&C Blue No. 1Inactive
Code: H3R47K3TBD
Classification: IACT
D&C Red No. 28Inactive
Code: 767IP0Y5NH
Classification: IACT
FD&C Green No. 3Inactive
Code: 3P3ONR6O1S
Classification: IACT
hydroxypropyl cellulose, low substitutedInactive
Code: 2165RE0K14
Classification: IACT
titanium dioxideInactive
Code: 15FIX9V2JP
Classification: IACT
FD&C Red No. 40Inactive
Code: WZB9127XOA
Classification: IACT
methacrylic acid - ethyl acrylate copolymer (1:1) type aInactive
Code: NX76LV5T8J
Classification: IACT