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, USP, for oral use Initial U.S. Approval: 1995
Approved
Approval ID
7f1714ab-ad8e-4596-a983-c1e73720b187
Product Type
HUMAN PRESCRIPTION DRUG LABEL
Effective Date
Apr 15, 2021
Manufacturers
FDA
A-S Medication Solutions
DUNS: 830016429
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 Code50090-4596
Application NumberANDA207156
Product Classification
M
Marketing Category
C73584
G
Generic Name
Lansoprazole
Product Specifications
Route of AdministrationORAL
Effective DateOctober 14, 2020
FDA Product Classification
INGREDIENTS (22)
LANSOPRAZOLEActive
Quantity: 15 mg in 1 1
Code: 0K5C5T2QPG
Classification: ACTIB
FD&C BLUE NO. 1Inactive
Code: H3R47K3TBD
Classification: IACT
FD&C RED NO. 3Inactive
Code: PN2ZH5LOQY
Classification: IACT
HYPROMELLOSE 2910 (6 MPA.S)Inactive
Code: 0WZ8WG20P6
Classification: IACT
GELATIN, UNSPECIFIEDInactive
Code: 2G86QN327L
Classification: IACT
MAGNESIUM CARBONATEInactive
Code: 0E53J927NA
Classification: IACT
MANNITOLInactive
Code: 3OWL53L36A
Classification: IACT
METHACRYLIC ACID - ETHYL ACRYLATE COPOLYMER (1:1) TYPE AInactive
Code: NX76LV5T8J
Classification: IACT
POLYETHYLENE GLYCOL 6000Inactive
Code: 30IQX730WE
Classification: IACT
SODIUM STARCH GLYCOLATE TYPE A CORNInactive
Code: AG9B65PV6B
Classification: IACT
SUGARCANEInactive
Code: 81H2R5AOH3
Classification: IACT
TALCInactive
Code: 7SEV7J4R1U
Classification: IACT
SHELLACInactive
Code: 46N107B71O
Classification: IACT
TITANIUM DIOXIDEInactive
Code: 15FIX9V2JP
Classification: IACT
BUTYL ALCOHOLInactive
Code: 8PJ61P6TS3
Classification: IACT
ISOPROPYL ALCOHOLInactive
Code: ND2M416302
Classification: IACT
POLYSORBATE 80Inactive
Code: 6OZP39ZG8H
Classification: IACT
SODIUM LAURYL SULFATEInactive
Code: 368GB5141J
Classification: IACT
AMMONIAInactive
Code: 5138Q19F1X
Classification: IACT
ALCOHOLInactive
Code: 3K9958V90M
Classification: IACT
FERROSOFERRIC OXIDEInactive
Code: XM0M87F357
Classification: IACT
ALUMINUM CHLOROHYDREX PROPYLENE GLYCOLInactive
Code: PGG6VG42HP
Classification: IACT