FDA.reportPublic FDA data

NDC 64380-182-01 - Omeprazole/Sodium Bicarbonate

This NDC is not currently matched to an FDA NDC product listing in FDA.report, but it is a valid NDC-form code. FDA.report is showing the available DailyMed label context for the product root.

Product NDC
64380-182
Requested NDC
64380-182-01
Package NDCs from labels
64380-182-01, 64380-182-02
Manufacturer
Strides Pharma Science Limited | Strides Pharma Global Pte. Ltd. | Strides Pharma, Inc
Effective date
2023-09-21
Current FDA listing
Not matched in FDA.report NDC product tables

DailyMed Labels#

Label, Manufacturer, Effective date table
LabelManufacturerEffective dateType
omeprazole - Strides Pharma Science Limited | Strides Pharma Global Pte. Ltd. | Strides Pharma, IncStrides Pharma Science Limited | Strides Pharma Global Pte. Ltd. | Strides Pharma, Inc2023-09-21HUMAN PRESCRIPTION DRUG LABEL

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
64380-182-01Omeprazole/Sodium Bicarbonate20 mg in 1 POUCHPOWDER, FOR SUSPENSION205
64380-182-02Omeprazole/Sodium Bicarbonate30 in 1 CARTONPOWDER, FOR SUSPENSION305

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
64380-182OMEPRAZOLE/SODIUM BICARBONATE (OMEPRAZOLE) POWDER, FOR SUSPENSION [STRIDES PHARMA SCIENCE LIMITED]5Current NDC, Legacy NDC, 2 package rows20231213_cf6d293e-d70d-443e-8292-d693e93aab55.zip

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
64380-182-01EA - Each64380-18253ebcb29-69d6-4058-ba68-980f8ff31d5912022-10-06
64380-182-02EA - Each64380-1825c866ff3-9208-4017-9eb8-902279deed4912022-08-04

openFDA label cross-check#

OpenFDA label data provides additional search and identifier links. DailyMed’s Structured Product Label is the canonical label on FDA.report. Matching records are deduplicated before they are shown below.

Matched openFDA labels page 5 of 26 · 513 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
Appetrol 20FUCUS VESICULOSUS, CHELIDONIUM MAJUS, KALI PHOSPHORICUM, LYCOPODIUM CLAVATUM, NATRUM MURIATICUM, QUERCUS GLANDIUM SPIRITUS, QUERCUS ROBUR, NUX VOMICA, PHYTOLACCA DECANDRA, ORNITHOGALUM UMBELLATUM, AGNUS CASTUS, BERBERIS AQUIFOLIUM, BERBERIS VULGARIS, SACCHARUM OFFICINALE, SOLIDAGO VIRGAUREA, CALCAREA CARBONICA, CARBO VEGETABILIS, MAGNESIA PHOSPHORICA, NATRUM PHOSPHORICUM, SINAPIS ARVENSIS, FLOS, UBIDECARENONUM, GRAPHITES, HYPOPHYSIS SUIS, PLACENTA TOTALIS SUIS, HYPOTHALAMUS (BOVINE)Carbalor LLCd66234a3-2477-42be-8f7b-283e3a5f87ed2026-03-12WarningsExact identifier
unii: C151H8M554
OmeprazoleOMEPRAZOLENuCare Pharmaceuticals,Inc.af707c0a-5193-3f83-e053-2995a90a78ef2026-03-11Warnings, Adverse reactionsExact identifier
unii: KG60484QX9
OmeprazoleOMEPRAZOLENuCare Pharmaceuticals,Inc.e07af8c9-559c-5a93-e053-2a95a90a2c632026-03-11Warnings, Adverse reactionsExact identifier
unii: KG60484QX9
SODIUM BICARBONATESODIUM BICARBONATEHospira, Inc.084f5572-8c1f-4802-b179-ca0cc838fc682026-03-09Warnings, Adverse reactionsExact identifier
unii: 8MDF5V39QO
Sodium BicarbonateSODIUM BICARBONATEHospira, Inc.0c24b592-4bc8-456f-acac-9c9525844a062026-03-09Warnings, Adverse reactionsExact identifier
unii: 8MDF5V39QO
OmeprazoleOMEPRAZOLEDr. Reddy's Laboratories Limited603d2d06-c5e8-4378-a422-8dca1a410af72026-03-02Warnings, Adverse reactionsExact identifier
unii: KG60484QX9
OmeprazoleOMEPRAZOLENorthStar Rx LLC40a75dc7-49b7-5c9d-6c5f-d4682ec6922e2026-03-02Warnings, Adverse reactionsExact identifier
unii: KG60484QX9
Sodium Bicarbonate 5 grSODIUM BICARBONATETWIN MED LLC12cad432-99db-4a9b-8619-82794e29409e2026-03-01WarningsExact identifier
unii: 8MDF5V39QO
Leader Extra Strength Effervescent Antacid and Pain RelieverASPIRIN, CITRIC ACID, SODIUM BICARBONATECardinal Healthc5d7bf5f-3e59-52f2-e053-2a95a90a4a002026-02-25WarningsExact identifier
unii: 8MDF5V39QO
SODIUM BICARBONATESODIUM BICARBONATEAmneal Pharmaceuticals Private Limitedba92f45a-0187-4709-aa70-462b8dae09e92026-02-09Warnings, Adverse reactionsExact identifier
unii: 8MDF5V39QO
omeprazoleOMEPRAZOLEHyVee Inca5df7dac-00f4-4d97-9586-cde3055890ac2026-02-04WarningsExact identifier
unii: KG60484QX9
omeprazoleOMEPRAZOLEHyVee Incfd22d4df-9679-4c2d-9bc4-3619288fb4cc2026-02-01WarningsExact identifier
unii: KG60484QX9
omeprazoleOMEPRAZOLEHyVee Inccf9919e6-a839-4bad-a007-80d5bf6f81db2026-01-30WarningsExact identifier
unii: KG60484QX9
ADRIAN BICARBONATO SODIUM BICARBONATE USP-4 oz, 8 oz and 16 ozSODIUM BICARBONATEEvi Labs4979a339-4ad4-9cdd-e063-6394a90a0acc2026-01-28WarningsExact identifier
unii: 8MDF5V39QO
OmeprazoleOMEPRAZOLEPreferred Pharmaceuticals Inc.288bdd5e-a0ac-4c5c-abe0-93183a28dcdd2026-01-20Warnings, Adverse reactionsExact identifier
unii: KG60484QX9
Equate Comfort Flow Sinus washSINUS WASHWALMART INC9e911eef-ca99-9902-e053-2a95a90aab0e2026-01-19WarningsExact identifier
unii: 8MDF5V39QO
OmeprazoleOMEPRAZOLEGlenmark Pharmaceuticals Inc., USAc6c22be1-659d-4e71-b292-701e27da201b2026-01-19Warnings, Adverse reactionsExact identifier
unii: KG60484QX9
D-D SUDIUM BICARBONATE U.S.P. BICARBONATO DE SODA PUROSODIUM BICARBONATEEvi Labs485f9eb1-6535-c47c-e063-6394a90ae32c2026-01-14WarningsExact identifier
unii: 8MDF5V39QO
OmeprazoleOMEPRAZOLEPreferred Pharmaceuticals Inc.fa0395a7-4353-4d64-9de8-d15857a7031c2026-01-13Warnings, Adverse reactionsExact identifier
unii: KG60484QX9
Amalgam 6003AMALGAMProfessional Complementary Health Formulas1af74f69-a23a-45a2-a20e-92bf8b0ccb222026-01-08WarningsExact identifier
unii: TTV12P4NEE

Reported adverse events (FAERS/openFDA)#

Adverse event summaries are temporarily unavailable. Other product information remains available.