FDA.reportPublic FDA data

NDC 63323-823-01 - 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
63323-823
Requested NDC
63323-823-01
Package NDCs from labels
63323-823-01, 63323-823-20
Manufacturer
Fresenius Kabi USA, LLC | ACS Dobfar S.p.A.
Effective date
2022-11-08
Current FDA listing
Not matched in FDA.report NDC product tables

DailyMed Labels#

Label, Manufacturer, Effective date table
LabelManufacturerEffective dateType
Ertapenem - Fresenius Kabi USA, LLC | ACS Dobfar S.p.A.Fresenius Kabi USA, LLC | ACS Dobfar S.p.A.2022-11-08HUMAN PRESCRIPTION DRUG LABEL

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
63323-823-01Ertapenem1 in 1 VIAL, SINGLE-DOSEINJECTION, POWDER, LYOPHILIZED,14
63323-823-20Ertapenem10 in 1 CARTONINJECTION, POWDER, LYOPHILIZED,104

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
63323-823ERTAPENEM (ERTAPENEM SODIUM) INJECTION, POWDER, LYOPHILIZED, FOR SOLUTION [FRESENIUS KABI USA, LLC]4Current NDC, Legacy NDC, 2 package rows20221111_666c9f33-ea9e-4667-b8bd-f8b1b6b6be51.zip

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
63323-823-01EA - Each63323-823642146af-4120-46ff-9719-cb20702451ab12019-12-10
63323-823-20EA - Each63323-823680f86c0-b2e8-4cd4-953a-616964fb413212019-12-10

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 9 of 11 · 214 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
ErtapenemERTAPENEMHospira, Inc.178a0356-4f6c-47fb-9913-f325a3c72f7b2024-11-06Warnings, Adverse reactionsExact identifier
application number: ANDA208790
rxcui: 1734683
unii: 2T90KE67L0
ErtapenemERTAPENEM SODIUMHikma Pharmaceuticals USA Inc.b88c0709-33fe-47db-8ae8-8bad6692d5d52024-11-05Warnings, Adverse reactionsExact identifier
rxcui: 1734683
unii: 2T90KE67L0
Sodium BicarbonateSODIUM BICARBONATERising Pharma Holdings, Inc.f5a90c33-f29d-4d4b-b5e6-0b3c2514ce3e2024-11-01Boxed warning, WarningsExact identifier
unii: 8MDF5V39QO
Omeprazole and Sodium BicarbonateOMEPRAZOLE AND SODIUM BICARBONATEScieGen Pharmaceuticals, Inc.a107804e-b308-4e79-9447-07d93016f70f2024-10-24Warnings, Adverse reactionsExact identifier
unii: 8MDF5V39QO
OHTAS ISAN ANTACIDCALCIUM CARBONATE, SODIUM BICARBONATEOHTA'S ISAN CO.,LTD.53380470-5748-6fa7-548e-7484ef204c0f2024-10-21WarningsExact identifier
unii: 8MDF5V39QO
OHTAS ISAN ANTACIDCALCIUM CARBONATE, SODIUM BICARBONATEOHTA'S ISAN CO.,LTD.8723fe90-8402-4511-b6c6-b71cf98513e32024-10-21WarningsExact identifier
unii: 8MDF5V39QO
Elliotts BSODIUM CATION, SODIUM BICARBONATE, ANHYDROUS DEXTROSE, MAGNESIUM SULFATE, POTASSIUM CHLORIDE, CALCIUM CHLORIDE, SODIUM PHOSPHATELukare Medical, LLC08036dbd-55b3-47b9-9890-000f253544f32024-10-16Warnings, Adverse reactionsExact identifier
unii: 8MDF5V39QO
SODIUM BICARBONATESODIUM BICARBONATE INJECTION,Long Grove Pharmaceuticals, LLCa26d709b-b294-4b02-9a88-7e840f099a332024-09-25Warnings, Adverse reactionsExact identifier
unii: 8MDF5V39QO
Insect sting relief latex 01SODIUM BICARBONATECosmuses Cosmetics (Ningbo) Co., Ltd.1b9e2d4c-bc0c-6ed0-e063-6294a90a91032024-08-19WarningsExact identifier
unii: 8MDF5V39QO
Quality Choice Effervescent Antacid and Pain Relief - Extra StrengthASPIRIN, ANHYDROUS CITRIC ACID, SODIUM BICARBONATEChain Drug Marketing Association1f926637-a61c-8eb7-e063-6394a90a65022024-08-13WarningsExact identifier
unii: 8MDF5V39QO
Omeprazole/Sodiium BicarbonateOMEPRAZOLE/SODIIUM BICARBONATEDirect_rx1f7f63c1-17c2-9a05-e063-6394a90abc6f2024-08-12Warnings, Adverse reactionsExact identifier
unii: 8MDF5V39QO
Omeprazole and Sodium BicarbonateOMEPRAZOLE AND SODIUM BICARBONATEDr. Reddy's Laboratories Inc.,ddee28fb-c871-a6d4-984f-515522b284122024-07-15WarningsExact identifier
unii: 8MDF5V39QO
ErtapenemERTAPENEMEugia US LLCf725a68c-31a2-482a-9744-19adc47506b52024-07-09Warnings, Adverse reactionsExact identifier
rxcui: 1734683
unii: 2T90KE67L0
ErtapenemERTAPENEMEugia US LLC31bcf16f-e0c1-47d1-9852-de898a856f6e2024-07-09Warnings, Adverse reactionsExact identifier
rxcui: 1734683
unii: 2T90KE67L0
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
rxcui: 1734683
unii: 2T90KE67L0
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

Reported adverse events (FAERS/openFDA)#

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