FDA.reportPublic FDA data

NDC 0378-6982-85 - Lansoprazole

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
0378-6982
Requested NDC
0378-6982-85
Package NDCs from labels
0378-6982-32, 0378-6982-85, 0378-6982-88
Manufacturer
Mylan Pharmaceuticals Inc.
Effective date
2024-03-11
Current FDA listing
Not matched in FDA.report NDC product tables

DailyMed Labels#

Label, Manufacturer, Effective date table
LabelManufacturerEffective dateType
Lansoprazole - Mylan Pharmaceuticals Inc.Mylan Pharmaceuticals Inc.2024-03-11HUMAN PRESCRIPTION DRUG LABEL

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
0378-6982-32Lansoprazole10 in 1 BLISTER PACKTABLET, ORALLY DISINTEGRATING, D105
0378-6982-85Lansoprazole5 in 1 CARTONTABLET, ORALLY DISINTEGRATING, D55
0378-6982-88Lansoprazole2 in 1 BOXTABLET, ORALLY DISINTEGRATING, D25

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
0378-6982LANSOPRAZOLE TABLET, ORALLY DISINTEGRATING, DELAYED RELEASE [MYLAN PHARMACEUTICALS INC.]5Current NDC, Legacy NDC, 3 package rows20240330_20ff347c-ca18-497b-948d-1145035f2ffc.zip

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
0378-6982-32EA - Each0378-6982a648cd8c-74ea-4709-a9f1-752e9f7f2ed512018-12-13
0378-6982-85EA - Each0378-6982d5afe7ea-e099-489b-be8b-98d47a78528c12021-11-09
0378-6982-88EA - Each0378-6982859f6882-1ac1-4931-a0ed-db57e74f29d012018-12-13

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 · 512 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
Sodium BicarbonateSODIUM BICARBONATEHospira, Inc.ea9f4498-0d43-4043-8dd1-f22537841c212026-04-06Warnings, Adverse reactionsExact identifier
unii: 8MDF5V39QO
Sodium BicarbonateSODIUM BICARBONATEHospira, Inc.8664c7ce-707b-4c6c-9ce4-7160b5f877f82026-04-06Warnings, Adverse reactionsExact identifier
unii: 8MDF5V39QO
Omeprazole/BicarbonateOMEPRAZOLE AND SODIUM BICARBONATEProficient Rx LP4d642036-7175-4f29-9f07-dbd282231d4a2026-04-01Warnings, Adverse reactionsExact identifier
unii: 8MDF5V39QO
Rapidol Sodium BicarbonateSODIUM BICARBONATEPharmadel LLCb4c9a653-6f51-7c98-e053-2995a90ada372026-03-26WarningsExact identifier
unii: 8MDF5V39QO
LansoprazoleLANSOPRAZOLEAsclemed USA, Inc.71be1129-8562-476e-9d9b-99a21cbf52ec2026-03-24Warnings, Adverse reactionsExact identifier
unii: 0K5C5T2QPG
Sodium Bicarbonate AntacidSODIUM BICARBONATEAphena Pharma Solutions - Tennessee, LLCbba7d5bf-c94b-4ee4-a399-9a2818d84c782026-03-23WarningsExact identifier
unii: 8MDF5V39QO
LansoprazoleLANSOPRAZOLEMajor Pharmaceuticals854e4235-4815-4461-9b9b-d3d783fb775d2026-03-19Warnings, Adverse reactionsExact identifier
unii: 0K5C5T2QPG
equate omeprazole and sodium bicarbonateOMEPRAZOLE, SODIUM BICARBONATEWALMART INC.c24c3326-99da-4c7d-aecc-7b4a8ac3f04e2026-03-15WarningsExact identifier
unii: 8MDF5V39QO
Drop20FUCUS 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)Pick Enterprises Corpbaa96813-dc95-472e-a834-880a0cd484a72026-03-13WarningsExact identifier
unii: C151H8M554
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
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
Ear RingingARNICA MONTANA, CALCAREA CARBONICA, CHENOPODIUM ANTH, CHININUM SALICYLICUM, CIMICIFUGA RACEMOSA, COFFEA TOSTA, KALI IODATUM, KALMIA LATIFOLIA, MAGNESIA CARBONICA, MANGANUM ACETICUM, MANGANUM CARBONICUM, MERCURIUS VIVUS, NATRUM SALICYLICUM, SALICYLICUM ACIDUM, THIOSINAMINUM, AND THYROIDINUM.King Bio Inc.4227b9a3-b0c1-4c74-9edd-922e32e6e89d2026-03-04WarningsExact identifier
unii: 0E53J927NA
Sodium Bicarbonate 5 grSODIUM BICARBONATETWIN MED LLC12cad432-99db-4a9b-8619-82794e29409e2026-03-01WarningsExact identifier
unii: 8MDF5V39QO
Refresh Optive Mega-3 PFCARBOXYMETHYLCELLULOSE SODIUM, GLYCERIN, POLYSORBATE 80Allergan, Inc.326cb5d6-c784-404f-9a13-6d69262dda6e2026-03-01WarningsExact identifier
unii: 6OZP39ZG8H
LansoprazoleLANSOPRAZOLEWalgreen Companya72f92cc-db49-40ef-a249-6b7c50dc8ef22026-02-28WarningsExact identifier
rxcui: 351261
unii: 0K5C5T2QPG
TricitratesTRICITRATESChartwell Governmental & Specialty RX, LLC.c4ff0407-3930-4c48-afd4-d2cb3e1b18f42026-02-25Warnings, Adverse reactionsExact identifier
unii: 2968PHW8QP
Potassium Citrate and Citric AcidPOTASSIUM CITRATE AND CITRIC ACIDChartwell Governmental & Specialty RX, LLC.fd57a176-7faf-4053-b348-6ba5f192f05a2026-02-25Warnings, Adverse reactionsExact identifier
unii: 2968PHW8QP
Leader Extra Strength Effervescent Antacid and Pain RelieverASPIRIN, CITRIC ACID, SODIUM BICARBONATECardinal Healthc5d7bf5f-3e59-52f2-e053-2a95a90a4a002026-02-25WarningsExact identifier
unii: 8MDF5V39QO
GAVISCONALUMINUM HYDROXIDE AND MAGNESIUM CARBONATEHaleon US Holdings LLC2d74e5bc-1f10-4fb6-9258-cd906e3600132026-02-13WarningsExact identifier
unii: 0E53J927NA

Reported adverse events (FAERS/openFDA)#

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