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. OMEPRAZOLE Delayed-Release Capsules, for oral use Initial U.S. Approval: 1989
Approved
Approval ID
5564c9dc-6f99-6639-e054-00144ff8d46c
Product Type
HUMAN PRESCRIPTION DRUG LABEL
Effective Date
Feb 12, 2021
Manufacturers
FDA
NuCare Pharmaceuticals,Inc.
DUNS: 010632300
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 Code68071-4024
Application NumberANDA091672
Product Classification
M
Marketing Category
C73584
G
Generic Name
Omeprazole
Product Specifications
Route of AdministrationORAL
Effective DateFebruary 12, 2021
FDA Product Classification
INGREDIENTS (11)
CETYL ALCOHOLInactive
Code: 936JST6JCN
Classification: IACT
HYPROMELLOSE PHTHALATE (31% PHTHALATE, 40 CST)Inactive
Code: G4U024CQK6
Classification: IACT
SODIUM LAURYL SULFATEInactive
Code: 368GB5141J
Classification: IACT
GELATIN, UNSPECIFIEDInactive
Code: 2G86QN327L
Classification: IACT
TITANIUM DIOXIDEInactive
Code: 15FIX9V2JP
Classification: IACT
FD&C BLUE NO. 1Inactive
Code: H3R47K3TBD
Classification: IACT
OMEPRAZOLEActive
Quantity: 20 mg in 1 1
Code: KG60484QX9
Classification: ACTIB
ANHYDROUS LACTOSEInactive
Code: 3SY5LH9PMK
Classification: IACT
SODIUM PHOSPHATE, DIBASIC, DIHYDRATEInactive
Code: 94255I6E2T
Classification: IACT
HYPROMELLOSE, UNSPECIFIEDInactive
Code: 3NXW29V3WO
Classification: IACT
MANNITOLInactive
Code: 3OWL53L36A
Classification: IACT