FDA.reportPublic FDA data

NDC 68083-351-01 - Ertapenem

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
68083-351
Requested NDC
68083-351-01
Package NDCs from labels
68083-351-01, 68083-351-10
Manufacturer
Gland Pharma Limited
Effective date
2022-04-12
Current FDA listing
Not matched in FDA.report NDC product tables

DailyMed Labels#

Label, Manufacturer, Effective date table
LabelManufacturerEffective dateType
Ertapenem - Gland Pharma LimitedGland Pharma Limited2022-04-12Human Prescription Drug Label

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
68083-351-01Ertapenem1 in 1 VIAL, SINGLE-DOSEINJECTION, POWDER, LYOPHILIZED,18
68083-351-10Ertapenem10 in 1 CARTONINJECTION, POWDER, LYOPHILIZED,108

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
68083-351ERTAPENEM (ERTAPENEM SODIUM) INJECTION, POWDER, LYOPHILIZED, FOR SOLUTION [GLAND PHARMA LIMITED]8Current NDC, Legacy NDC, 2 package rows20220414_f74cca2f-e775-4580-acae-3a0c47dd24d9.zip

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 4 of 12 · 222 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
Alka-Seltzer HeartburnANHYDROUS CITRIC ACID, SODIUM BICARBONATE (HEAT-TREATED)Bayer HealthCare LLC.55158e50-0327-2043-e054-00144ff8d46c2025-12-04WarningsExact identifier
unii: 8MDF5V39QO
Alka-Seltzer Extra StrengthANHYDROUS CITRIC ACID, SODIUM BICARBONATE, AND ASPIRINBayer HealthCare LLC.49b73bd5-6465-05eb-e054-00144ff88e882025-12-04WarningsExact identifier
unii: 8MDF5V39QO
Alka-Seltzer GoldALKA-SELTZER GOLDBayer HealthCare LLC.0824bedb-413b-2fa0-e054-00144ff88e882025-12-04WarningsExact identifier
unii: 8MDF5V39QO
Alka-Seltzer OriginalANHYDROUS CITRIC ACID, ASPIRIN, AND SODIUM BICARBONATEBayer HealthCare LLC.5be36a7f-7d1f-468d-9c29-92c8cd3ef1bc2025-12-04WarningsExact identifier
unii: 8MDF5V39QO
OMEPRAZOLE AND SODIUM BICARBONATEOMEPRAZOLE AND SODIUM BICARBONATEAurohealth LLC88ad2e92-2228-49b2-bcee-1770fd30cb142025-12-04WarningsExact identifier
unii: 8MDF5V39QO
BM Sodium bicarbonate (Nat Bicarb)SODIUM BICARBONATEBM Private Limited38044eae-7237-6add-e063-6294a90a827b2025-12-02WarningsExact identifier
unii: 8MDF5V39QO
Omeprazole and Sodium BicarbonateOMEPRAZOLE AND SODIUM BICARBONATEAjanta Pharma USA Inc.bd84ca00-6352-4cb3-bce2-05f4a5005a942025-11-30Warnings, Adverse reactionsExact identifier
unii: 8MDF5V39QO
Sodium BicarbonateSODIUM BICARBONATECivicaa10fdfbc-94a0-49ab-b26c-de1df042bc892025-11-24Warnings, Adverse reactionsExact identifier
unii: 8MDF5V39QO
SODIUM BICARBONATESODIUM BICARBONATEGlenmark Pharmaceuticals Inc., USAf38d0dfc-9bcc-4224-a202-885c9ad0beae2025-11-20Warnings, Adverse reactionsExact identifier
unii: 8MDF5V39QO
Itch Eraser SensitiveSODIUM BICARBONATETender Corporation d/b/a Adventure Ready Brands2250525a-45c2-42ea-e063-6394a90ac0012025-11-18WarningsExact identifier
unii: 8MDF5V39QO
After Bite KidsSODIUM BICARBONATETender Corporation d/b/a Adventure Ready Brands226c1420-d771-204f-e063-6294a90af9f62025-11-18WarningsExact identifier
unii: 8MDF5V39QO
Alka-Seltzer OriginalANHYDROUS CITRIC ACID, ASPIRIN, AND SODIUM BICARBONATER J General Corporationdbb0d067-71f0-45e4-bc98-548cf4a90b3a2025-11-17WarningsExact identifier
unii: 8MDF5V39QO
After Bite X TechSODIUM BICARBONATEAdventure Ready Brandse9e49ab4-3e1f-9fd4-e053-2a95a90a775a2025-11-17WarningsExact identifier
unii: 8MDF5V39QO
QUABIC-100HEMODIALYSIS GRADE SODIUM BICARBONATE SOLUTIONAqua Medica, S.A. de C.V.1484a825-40c6-a9c9-e063-6294a90a9ca42025-11-10WarningsExact identifier
unii: 8MDF5V39QO
GURUNANDA NASAL SALINENASAL WASHGURUNANDA LLC27dbf0bf-c273-2108-e063-6394a90a0a092025-11-10WarningsExact identifier
unii: 8MDF5V39QO
QUABIC-100HEMODIALYSIS GRADE SODIUM BICARBONATE SOLUTIONAqua Medica, S.A. de C.V.28152c9f-b15c-3707-e063-6394a90a70e92025-11-10WarningsExact identifier
unii: 8MDF5V39QO
QUABIC-300HEMODIALYSIS GRADE SODIUM BICARBONATE SOLUTIONAqua Medica, S.A. de C.V.c3cd7f0f-8d70-23af-e053-2a95a90a569b2025-11-10WarningsExact identifier
unii: 8MDF5V39QO
SODIUM BICARBONATESODIUM BICARBONATEHenry Schein, Inc.da484a2f-154f-48b4-8467-7a86729204c32025-11-07Warnings, Adverse reactionsExact identifier
unii: 8MDF5V39QO
Sodium BicarbonateSODIUM BICARBONATEHospira, Inc.ea20a5eb-641e-48cd-bcfa-74c04c45dfda2025-11-06Warnings, Adverse reactionsExact identifier
unii: 8MDF5V39QO
CEO-TWOLAXATIVEBeutlich Pharmaceuticals, LLC08670636-5795-4db0-e063-6294a90afa4b2025-11-05WarningsExact identifier
unii: 8MDF5V39QO

Reported adverse events (FAERS/openFDA)#

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