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: 1989
Approved
Approval ID
73f77956-e7e7-4bc2-adab-67b164942d53
Product Type
HUMAN PRESCRIPTION DRUG LABEL
Effective Date
Sep 17, 2021
Manufacturers
FDA
Unit Dose Services
DUNS: 831995316
Products 1
Detailed information about drug products covered under this FDA approval, including NDC codes, dosage forms, ingredients, and administration routes.
Omeprazole
PRODUCT DETAILS
NDC Product Code50436-8158
Application NumberANDA075576
Marketing CategoryC73584
Route of AdministrationORAL
Effective DateNovember 12, 2020
Generic NameOmeprazole
INGREDIENTS (22)
poloxamer 407Inactive
Code: TUF2IVW3M2
Classification: IACT
POVIDONE, UNSPECIFIEDInactive
Code: FZ989GH94E
Classification: IACT
triethyl citrateInactive
Code: 8Z96QXD6UM
Classification: IACT
FD&C Red No. 40Inactive
Code: WZB9127XOA
Classification: IACT
GELATIN, UNSPECIFIEDInactive
Code: 2G86QN327L
Classification: IACT
titanium dioxideInactive
Code: 15FIX9V2JP
Classification: IACT
butyl alcoholInactive
Code: 8PJ61P6TS3
Classification: IACT
propylene glycolInactive
Code: 6DC9Q167V3
Classification: IACT
mannitolInactive
Code: 3OWL53L36A
Classification: IACT
meglumineInactive
Code: 6HG8UB2MUY
Classification: IACT
methacrylic acid - ethyl acrylate copolymer (1:1) type AInactive
Code: NX76LV5T8J
Classification: IACT
shellacInactive
Code: 46N107B71O
Classification: IACT
HYPROMELLOSE, UNSPECIFIEDInactive
Code: 3NXW29V3WO
Classification: IACT
D&C Red No. 28Inactive
Code: 767IP0Y5NH
Classification: IACT
FD&C Blue No. 1Inactive
Code: H3R47K3TBD
Classification: IACT
FD&C Yellow No. 6Inactive
Code: H77VEI93A8
Classification: IACT
ferric oxide yellowInactive
Code: EX438O2MRT
Classification: IACT
silicon dioxideInactive
Code: ETJ7Z6XBU4
Classification: IACT
sodium lauryl sulfateInactive
Code: 368GB5141J
Classification: IACT
OMEPRAZOLEActive
Quantity: 20 mg in 1 1
Code: KG60484QX9
Classification: ACTIB
CROSPOVIDONE (15 MPA.S AT 5%)Inactive
Code: 68401960MK
Classification: IACT
magnesium stearateInactive
Code: 70097M6I30
Classification: IACT