Omeprazole
These highlights do not include all the information needed to use Omeprazole Delayed-Release Capsules safely and effectively. See full prescribing information for Omeprazole Delayed-Release Capsules. Initial U.S. Approval: 2002
Approved
Approval ID
61b34d13-3b8b-4491-b5a3-e9740b2aaccb
Product Type
HUMAN PRESCRIPTION DRUG LABEL
Effective Date
Apr 27, 2010
Manufacturers
FDA
Altura Pharmaceuticals, Inc.
DUNS: 006890545
Products 1
Detailed information about drug products covered under this FDA approval, including NDC codes, dosage forms, ingredients, and administration routes.
omeprazole
Product Details
FDA regulatory identification and product classification information
FDA Identifiers
NDC Product Code63874-553
Application NumberANDA075410
Product Classification
M
Marketing Category
C73584
G
Generic Name
omeprazole
Product Specifications
Route of AdministrationORAL
Effective DateApril 27, 2010
FDA Product Classification
INGREDIENTS (15)
OMEPRAZOLEActive
Quantity: 20 mg in 1 1
Code: KG60484QX9
Classification: ACTIB
CROSPOVIDONEInactive
Code: 68401960MK
Classification: IACT
GLYCERYL BEHENATEInactive
Code: R8WTH25YS2
Classification: IACT
HYPROMELLOSEInactive
Code: 3NXW29V3WO
Classification: IACT
SILICON DIOXIDEInactive
Code: ETJ7Z6XBU4
Classification: IACT
TITANIUM DIOXIDEInactive
Code: 15FIX9V2JP
Classification: IACT
TRIETHYL CITRATEInactive
Code: 8Z96QXD6UM
Classification: IACT
SODIUM LAURYL SULFATEInactive
Code: 368GB5141J
Classification: IACT
GELATINInactive
Code: 2G86QN327L
Classification: IACT
FERRIC OXIDE YELLOWInactive
Code: EX438O2MRT
Classification: IACT
LACTOSE MONOHYDRATEInactive
Code: EWQ57Q8I5X
Classification: IACT
METHACRYLIC ACID - ETHYL ACRYLATE COPOLYMER (1:1) TYPE AInactive
Code: NX76LV5T8J
Classification: IACT
TALCInactive
Code: 7SEV7J4R1U
Classification: IACT
FERROSOFERRIC OXIDEInactive
Code: XM0M87F357
Classification: IACT
SHELLACInactive
Code: 46N107B71O
Classification: IACT