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 3 of 26 · 512 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
SODIUM BICARBONATESODIUM BICARBONATEHF Acquisition Co LLC, DBA HealthFirstd8516f38-6f92-32d1-e053-2995a90a96bf2026-06-19Warnings, Adverse reactionsExact identifier
unii: 8MDF5V39QO
LansoprazoleLANSOPRAZOLESafecor Health LLC47a8618c-e768-41bf-9116-634b564405d42026-06-18Warnings, Adverse reactionsExact identifier
unii: 0K5C5T2QPG
Sodium BicarbonateSODIUM BICARBONATE, INJECTIONCivica, Inc.3737e5e5-2296-4a3d-b8f1-dfea1eff19272026-06-15Warnings, Adverse reactionsExact identifier
unii: 8MDF5V39QO
E-Z-GAS IIANTACID/ANTIFLATULENTE-Z-EM, INC.4e12e1cb-b033-076d-e054-00144ff8d46c2026-06-15WarningsExact identifier
unii: 8MDF5V39QO
ACD ACITRIC ACID MONOHYDRATE, DEXTROSE MONOHYDRATE, AND TRISODIUM CITRATE DIHYDRATETerumo BCT, Ltd.395aec48-198a-4aed-8e38-7accfb3232f92026-06-15Warnings, Adverse reactionsExact identifier
unii: 2968PHW8QP
BM BM183 DROPSAGARICUS, BARYTA CARB, CALCAREA FLUOR, CINERARIA MAR, HEDERA HELIX, MAG CARB, CAUSTICUMTotal Operations Management LLC DBA:Bestmade Natural Products Micro54240c91-079d-25bd-e063-6394a90a89a62026-06-13WarningsExact identifier
unii: 0E53J927NA
BM BM183 DROPSAGARICUS, BARYTA CARB, CALCAREA FLUOR, CINERARIA MAR, HEDERA HELIX, MAG CARB, CAUSTICUMBM Private Limited540d2953-a7f4-1621-e063-6294a90acb132026-06-12WarningsExact identifier
unii: 0E53J927NA
Sodium BicarbonateSODIUM BICARBONATECardinal Health 107, LLC60c2a176-8854-4479-b853-d07fe9a1830c2026-06-12WarningsExact identifier
unii: 8MDF5V39QO
GUNA-CELLACETYLCARNITINE, L-AMPC-ALPHA-LIPOIC AC-A-TOCOPHEROL-ASCORBIC ACID-CALC CARB-CITRIC AC-COBALAMIN-COLCHICUM-CONIUM-CUPRIC SULF-HERRING SPERM DNA-FERROUS FUMARATE-FOLIC ACID-FUMARIC ACID-KALI ASPARTATE-MANG PHOS-MANG GLUCONATE-MANG PHOS II-PYRUVALDEHYDE-NAT OXALACETICUM-SODIUM PYRUVATE-NIACIN-PANTOTHENIC ACID-PH-PODOPHYLLUM PELTATUM-PYRIDOXINE HYDROCHLORIDE-RIBOFLAVIN-SACCHAROMYCES CEREVISIAE RNA-SELENOMETHIONINE-SUCCINIC ACID-SULFUR-THIAMINE HYDROCHLORIDE-ZINCGuna spa90db80ed-c037-4e8f-a7f6-304a65f9fe222026-06-11WarningsExact identifier
unii: 2968PHW8QP
SODIUM BICARBONATESODIUM BICARBONATEMedical Purchasing Solutions, LLC.5401e4ff-aa7a-3e97-e063-6294a90a24f02026-06-11Warnings, Adverse reactionsExact identifier
unii: 8MDF5V39QO
GUNA-FLAMACONITUM NAPELLUS - APIS MELLIFERA - ATROPA BELLADONNA - BASIC CUPRIC CARBONATE - BRYONIA ALBA ROOT - CALCIUM SULFIDE - CITRIC ACID MONOHYDRATE - FERRIC PHOSPHATE - INTERLEUKIN-10 - MELATONIN - METENKEFALIN - PHYTOLACCA AMERICANA ROOT - RANCID BEEF - SODIUM PYRUVATE - SUS SCROFA CONJUNCTIVA - SUS SCROFA PINEAL GLAND - SUS SCROFA PITUITARY GLAND - TRANSFORMING GROWTH FACTOR BETA-1 - ANTI-INTERLEUKIN-1.ALPHA. IMMUNOGLOBULIN G RABBIT -Guna spa7bda7eb0-8fd5-42d9-b336-39920bfc964d2026-06-10WarningsExact identifier
unii: 2968PHW8QP
Sodium BicarbonateSODIUM BICARBONATEExela Pharma Sciences, LLC2f05947f-a489-4298-a871-90db75b2a6c52026-06-09Warnings, Adverse reactionsExact identifier
unii: 8MDF5V39QO
Insomnia HPARSENICUM ALBUM, COFFEA CRUDA, KALI CARBONICUM, MAGNESIA CARBONICA, NUX VOMICA, PASSIFLORA INCARNATA, SEPIA, VALERIANA OFFICINALISBioActive Nutritional, Inc.cd17b39e-6531-407d-8007-8cb92a6e87442026-06-04WarningsExact identifier
unii: 0E53J927NA
Sodium Bicarbonate AntacidSODIUM BICARBONATENCS HealthCare of KY, LLC dba Vangard Labsfde4ea0c-152b-4b79-a6d8-2b0dbd9107aa2026-06-04WarningsExact identifier
unii: 8MDF5V39QO
ACID GONE ANTACIDALUMINUM HYDROXIDE AND MAGNESIUM CARBONATEMajor Pharmaceuticals3d353a92-92f1-4304-8895-31d39dccd88c2026-06-01WarningsExact identifier
unii: 0E53J927NA
Humco Sodium BicarbonateSODIUM BICARBONATEHumco Holding Group, Inc.aeaa34f6-216d-49f3-8393-c7bda96a3e322026-05-26WarningsExact identifier
unii: 8MDF5V39QO
Alka-Seltzer OriginalANHYDROUS CITRIC ACID, ASPIRIN, AND SODIUM BICARBONATESelect Consumer Group3ca80d74-1e8b-49d9-e063-6394a90a43122026-05-24WarningsExact identifier
unii: 8MDF5V39QO
BERKLEY AND JENSEN LANSOPRAZOLELANSOPRAZOLEBJWCb859e8dc-e42e-448d-89fa-2fc79d9cac322026-05-21WarningsExact identifier
unii: 0K5C5T2QPG
ACD ACITRIC ACID MONOHYDRATE, DEXTROSE MONOHYDRATE, AND TRISODIUM CITRATE DIHYDRATETerumo BCT, Ltd8e255bc7-a120-460a-a32d-43931f8115de2026-05-21Warnings, Adverse reactionsExact identifier
unii: 2968PHW8QP
LansoprazoleLANSOPRAZOLECardinal Health 107, LLCc9a43df0-efab-4486-860f-92afdb258c8b2026-05-20Warnings, Adverse reactionsExact identifier
rxcui: 351260
unii: 0K5C5T2QPG

Reported adverse events (FAERS/openFDA)#

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