OMEPRAZOLE
OMEPRAZOLE DELAYED-RELEASE CAPSULES, USP These highlights do not include all the information needed to use OMEPRAZOLE DELAYED-RELEASE CAPSULES, USP, safely and effectively. See full prescribing information for OMEPRAZOLE DELAYED-RELEASE CAPSULES, USP. OMEPRAZOLE delayed-release capsules, USP, for oral administration Initial U.S. Approval: 1989
Approved
Approval ID
7b315cc7-6a5b-38fc-e053-2a91aa0aa19b
Product Type
HUMAN PRESCRIPTION DRUG LABEL
Effective Date
Oct 16, 2023
Manufacturers
FDA
Golden State Medical Supply, Inc.
DUNS: 603184490
Products 2
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 Code51407-129
Application NumberANDA203481
Product Classification
M
Marketing Category
C73584
G
Generic Name
OMEPRAZOLE
Product Specifications
Route of AdministrationORAL
Effective DateOctober 16, 2023
FDA Product Classification
INGREDIENTS (23)
ISOPROPYL ALCOHOLInactive
Code: ND2M416302
Classification: IACT
OLEIC ACIDInactive
Code: 2UMI9U37CP
Classification: IACT
HYPROMELLOSE, UNSPECIFIEDInactive
Code: 3NXW29V3WO
Classification: IACT
TALCInactive
Code: 7SEV7J4R1U
Classification: IACT
TITANIUM DIOXIDEInactive
Code: 15FIX9V2JP
Classification: IACT
METHACRYLIC ACID - ETHYL ACRYLATE COPOLYMER (1:1) TYPE AInactive
Code: NX76LV5T8J
Classification: IACT
SODIUM LAURYL SULFATEInactive
Code: 368GB5141J
Classification: IACT
POLYSORBATE 80Inactive
Code: 6OZP39ZG8H
Classification: IACT
TRIETHYL CITRATEInactive
Code: 8Z96QXD6UM
Classification: IACT
SUCROSEInactive
Code: C151H8M554
Classification: IACT
STARCH, CORNInactive
Code: O8232NY3SJ
Classification: IACT
GELATIN, UNSPECIFIEDInactive
Code: 2G86QN327L
Classification: IACT
AMMONIAInactive
Code: 5138Q19F1X
Classification: IACT
FERROSOFERRIC OXIDEInactive
Code: XM0M87F357
Classification: IACT
SILICON DIOXIDEInactive
Code: ETJ7Z6XBU4
Classification: IACT
DIBUTYL SEBACATEInactive
Code: 4W5IH7FLNY
Classification: IACT
ALCOHOLInactive
Code: 3K9958V90M
Classification: IACT
ETHYLCELLULOSE (20 MPA.S)Inactive
Code: BJG0S321QY
Classification: IACT
BUTYL ALCOHOLInactive
Code: 8PJ61P6TS3
Classification: IACT
POTASSIUM HYDROXIDEInactive
Code: WZH3C48M4T
Classification: IACT
PROPYLENE GLYCOLInactive
Code: 6DC9Q167V3
Classification: IACT
SHELLACInactive
Code: 46N107B71O
Classification: IACT
OMEPRAZOLEActive
Quantity: 20 mg in 1 1
Code: KG60484QX9
Classification: ACTIB
OMEPRAZOLE
Product Details
FDA regulatory identification and product classification information
FDA Identifiers
NDC Product Code51407-130
Application NumberANDA203481
Product Classification
M
Marketing Category
C73584
G
Generic Name
OMEPRAZOLE
Product Specifications
Route of AdministrationORAL
Effective DateOctober 16, 2023
FDA Product Classification
INGREDIENTS (23)
SUCROSEInactive
Code: C151H8M554
Classification: IACT
STARCH, CORNInactive
Code: O8232NY3SJ
Classification: IACT
TRIETHYL CITRATEInactive
Code: 8Z96QXD6UM
Classification: IACT
GELATIN, UNSPECIFIEDInactive
Code: 2G86QN327L
Classification: IACT
AMMONIAInactive
Code: 5138Q19F1X
Classification: IACT
FERROSOFERRIC OXIDEInactive
Code: XM0M87F357
Classification: IACT
SILICON DIOXIDEInactive
Code: ETJ7Z6XBU4
Classification: IACT
HYPROMELLOSE, UNSPECIFIEDInactive
Code: 3NXW29V3WO
Classification: IACT
TITANIUM DIOXIDEInactive
Code: 15FIX9V2JP
Classification: IACT
SODIUM LAURYL SULFATEInactive
Code: 368GB5141J
Classification: IACT
DIBUTYL SEBACATEInactive
Code: 4W5IH7FLNY
Classification: IACT
TALCInactive
Code: 7SEV7J4R1U
Classification: IACT
METHACRYLIC ACID - ETHYL ACRYLATE COPOLYMER (1:1) TYPE AInactive
Code: NX76LV5T8J
Classification: IACT
POLYSORBATE 80Inactive
Code: 6OZP39ZG8H
Classification: IACT
ETHYLCELLULOSE (20 MPA.S)Inactive
Code: BJG0S321QY
Classification: IACT
ISOPROPYL ALCOHOLInactive
Code: ND2M416302
Classification: IACT
ALCOHOLInactive
Code: 3K9958V90M
Classification: IACT
OLEIC ACIDInactive
Code: 2UMI9U37CP
Classification: IACT
BUTYL ALCOHOLInactive
Code: 8PJ61P6TS3
Classification: IACT
POTASSIUM HYDROXIDEInactive
Code: WZH3C48M4T
Classification: IACT
SHELLACInactive
Code: 46N107B71O
Classification: IACT
OMEPRAZOLEActive
Quantity: 40 mg in 1 1
Code: KG60484QX9
Classification: ACTIB
PROPYLENE GLYCOLInactive
Code: 6DC9Q167V3
Classification: IACT