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 10 of 12 · 222 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
Insect sting relief pad 01SODIUM BICARBONATECosmuses Cosmetics (Ningbo) Co., Ltd.1b0f0088-6482-6de7-e063-6294a90aeeb72024-06-17WarningsExact identifier
unii: 8MDF5V39QO
Omeprazole and Sodium BicarbonateOMEPRAZOLE AND SODIUM BICARBONATEANI Pharmaceuticals, Inc.63c3bd6c-a586-4ec0-8f45-ed936936dfeb2024-06-06Warnings, Adverse reactionsExact identifier
unii: 8MDF5V39QO
ErtapenemERTAPENEM SODIUMFosun Pharma USA Incc398450c-2b72-86a4-e053-2995a90ad1f02024-05-10Warnings, Adverse reactionsExact identifier
application number: ANDA212040
rxcui: 1734683
unii: 2T90KE67L0
SODIUM BICARBONATESODIUM BICARBONATESun Pharmaceutical Industries Limited5ae65432-04a1-4b6b-8536-2535064fc7822024-03-06Warnings, Adverse reactionsExact identifier
unii: 8MDF5V39QO
ErtapenemERTAPENEM SODIUMBluePoint Laboratories8eccc96f-4b59-49ee-9997-365a24f59a242024-03-05Warnings, Adverse reactionsExact identifier
rxcui: 1734683
unii: 2T90KE67L0
Sodium BicarbonateSODIUM BICARBONATESteriscience Specialties Private Limitedeb2996b4-c04c-4678-b8a9-5cbbe509bb702024-03-04Warnings, Adverse reactionsExact identifier
unii: 8MDF5V39QO
Sodium BicarbonateSODIUM BICARBONATEBryant Ranch Prepack4493d7c5-f2c3-416e-a5c1-35398fc7f61d2024-02-29Boxed warning, WarningsExact identifier
unii: 8MDF5V39QO
SODIUM BICARBONATESODIUM BICARBONATEHF Acquisition Co LLC, DBA HealthFirsta5eedf57-2783-b3d0-e053-2a95a90a9ff52024-02-22Warnings, Adverse reactionsExact identifier
unii: 8MDF5V39QO
SODIUM BICARBONATESODIUM BICARBONATEHF Acquisition Co LLC, DBA HealthFirst76131655-3a87-feac-e053-2991aa0a82a12024-01-28Warnings, Adverse reactionsExact identifier
unii: 8MDF5V39QO
N03 EXCHEMALLIUM SATIVUM, ARSENICUM ALBUM, BENZOICUM ACIDUM, BERBERIS VULGARIS, BETULA VERRUCOSA, CALCAREA CARBONICA, CARBOLICUM ACIDUM, CHELIDONIUM MAJUS, CHLORINUM, CITRICUM ACIDUM, HISTAMINUM, ICHTHYOLUM, JUNIPERUS COMMUNIS, LYCOPODIUM CLAVATUM, MERCURIUS SOLUBILIS, NATRUM BICARBONICUM, SODIUM HYPOCHLORITE, SOLIDAGO VIRGAUREA, SULPHURApex Energetics Inc.ba73a050-9a5d-1549-e053-2a95a90a62aa2024-01-08WarningsExact identifier
unii: 8MDF5V39QO
Sodium BicarbonateSODIUM BICARBONATEPharma Nobis, LLCe42f674b-1a70-6a3c-e053-2995a90afa722023-12-22WarningsExact identifier
unii: 8MDF5V39QO
HEB Extra Strength Effervescent Antacid and Pain ReliefASPIRIN, CITRIC ACID, SODIUM BICARBONATEH. E. Butt Grocery Company9e502bd0-8042-8674-e053-2995a90a3d152023-12-18WarningsExact identifier
unii: 8MDF5V39QO
Medis Sodium BicarbonateSODIUM BICARBONATEHumco Holding Group, Inc5da32469-58fc-14b1-e053-2a91aa0a74c42023-12-15WarningsExact identifier
unii: 8MDF5V39QO
ErtapenemERTAPENEM SODIUMApotex Corp468105b9-48b3-4477-82c7-e7fb92460e282023-12-13Warnings, Adverse reactionsExact identifier
rxcui: 1734683
unii: 2T90KE67L0
Sodium Bicarbonate AntacidSODIUM BICARBONATERugby Laboratoriese73b5871-4a87-4473-ab00-5e5395be017d2023-12-06WarningsExact identifier
unii: 8MDF5V39QO
INONALUMINUM HYDROXIDE, MAGNESIUM CARBONATE, SODIUM BICARBONATESato Pharmaceutical Co., Ltd.e86d9c57-c877-49f1-a405-95a9a226ccf32023-12-04WarningsExact identifier
unii: 8MDF5V39QO
ErtapenemERTAPENEM SODIUMSavior Lifetec Corporationc4da28cb-6725-4fa1-a7b0-e84f408fb36b2023-11-27Warnings, Adverse reactionsExact identifier
rxcui: 1734683
unii: 2T90KE67L0
Sodium BicarbonateSODIUM BICARBONATEA-S Medication Solutionsd89406d3-4356-4a8c-acc1-89efe1d270102023-11-14Warnings, Adverse reactionsExact identifier
unii: 8MDF5V39QO
Sodium BicarbonateSODIUM BICARBONATEMedical Purchasing Solutions, LLC09cf38c2-0b44-eca1-e063-6294a90a72d82023-11-10Warnings, Adverse reactionsExact identifier
unii: 8MDF5V39QO
omeprazole sodium bicarbonateOMEPRAZOLE SODIUM BICARBONATECipla USA Inc.9cdde58a-ae8a-451f-92cf-cab178e4ba922023-11-01Warnings, Adverse reactionsExact identifier
unii: 8MDF5V39QO

Reported adverse events (FAERS/openFDA)#

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