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.LANSOPRAZOLE delayed-release capsules, for oral useFor oral administration Initial U.S. Approval: 1995
Approved
Approval ID
960d6601-aec5-4900-a400-385b6687a4bc
Product Type
HUMAN PRESCRIPTION DRUG LABEL
Effective Date
Jan 10, 2023
Manufacturers
FDA
Preferred Pharmaceuticals Inc.
DUNS: 791119022
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 Code68788-6390
Application NumberANDA091269
Product Classification
M
Marketing Category
C73584
G
Generic Name
lansoprazole
Product Specifications
Route of AdministrationORAL
Effective DateJanuary 10, 2023
FDA Product Classification
INGREDIENTS (20)
ammoniaInactive
Code: 5138Q19F1X
Classification: IACT
HYDROXYPROPYL CELLULOSE (1600000 WAMW)Inactive
Code: RFW2ET671P
Classification: IACT
magnesium carbonateInactive
Code: 0E53J927NA
Classification: IACT
LOW-SUBSTITUTED HYDROXYPROPYL CELLULOSE, UNSPECIFIEDInactive
Code: 2165RE0K14
Classification: IACT
lansoprazoleActive
Quantity: 15 mg in 1 1
Code: 0K5C5T2QPG
Classification: ACTIB
METHACRYLIC ACID AND ETHYL ACRYLATE COPOLYMERInactive
Code: NX76LV5T8J
Classification: IACT
propylene glycolInactive
Code: 6DC9Q167V3
Classification: IACT
POLYETHYLENE GLYCOL, UNSPECIFIEDInactive
Code: 3WJQ0SDW1A
Classification: IACT
starch, cornInactive
Code: O8232NY3SJ
Classification: IACT
shellacInactive
Code: 46N107B71O
Classification: IACT
raw sugarInactive
Code: 8M707QY5GH
Classification: IACT
sucroseInactive
Code: C151H8M554
Classification: IACT
titanium dioxideInactive
Code: 15FIX9V2JP
Classification: IACT
talcInactive
Code: 7SEV7J4R1U
Classification: IACT
ferric oxide redInactive
Code: 1K09F3G675
Classification: IACT
GELATIN, UNSPECIFIEDInactive
Code: 2G86QN327L
Classification: IACT
ferric oxide yellowInactive
Code: EX438O2MRT
Classification: IACT
FD&C BLUE NO. 2Inactive
Code: L06K8R7DQK
Classification: IACT
sodium lauryl sulfateInactive
Code: 368GB5141J
Classification: IACT
polysorbate 80Inactive
Code: 6OZP39ZG8H
Classification: IACT