FDA.reportPublic FDA data

NDC 44567-820-01 - 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
44567-820
Requested NDC
44567-820-01
Package NDCs from labels
44567-820-01, 44567-820-10
Manufacturer
WG Critical Care, LLC | ACS Dobfar SpA
Effective date
2022-08-31
Current FDA listing
Not matched in FDA.report NDC product tables

DailyMed Labels#

Label, Manufacturer, Effective date table
LabelManufacturerEffective dateType
ertapenem - WG Critical Care, LLC | ACS Dobfar SpAWG Critical Care, LLC | ACS Dobfar SpA2022-08-31HUMAN PRESCRIPTION DRUG LABEL

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
44567-820-01ertapenem1 in 1 VIAL, SINGLE-DOSEINJECTION, POWDER, LYOPHILIZED,17
44567-820-10ertapenem10 in 1 CARTONINJECTION, POWDER, LYOPHILIZED,107

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
44567-820ERTAPENEM INJECTION, POWDER, LYOPHILIZED, FOR SOLUTION [WG CRITICAL CARE, LLC]7Current NDC, Legacy NDC, 2 package rows20221109_cf3cfa6b-211c-452b-b18b-e462b21e6909.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 5 of 12 · 224 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
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
Omeprazole and sodium bicarbonateOMEPRAZOLE, SODIUM BICARBONATEWalgreen Company8753a131-f8b1-48e1-993b-73c1ee635fef2025-11-04WarningsExact identifier
unii: 8MDF5V39QO
Omeprazole and Sodium BicarbonateOMEPRAZOLE, SODIUM BICARBONATECVS Pharmacy186732a3-13b9-4ea2-ba54-424f63298a2e2025-11-04WarningsExact identifier
unii: 8MDF5V39QO
basic care omeprazole and sodium bicarbonateOMEPRAZOLE, SODIUM BICARBONATEAmazon.com Services LLC4587f491-04ef-4c31-b7b6-bfafd31776fb2025-11-04WarningsExact identifier
unii: 8MDF5V39QO
Omeprazole and sodium bicarbonateOMEPRAZOLE, SODIUM BICARBONATEH E Bddc8d73f-f4a1-42a7-89ee-420346820f612025-11-03WarningsExact identifier
unii: 8MDF5V39QO
Walgreens Antacid Pain Relief Extra StrengthASPIRIN, CITRIC ACID, SODIUM BICARBONATEWalgreensb60df498-07db-500b-e053-2a95a90aff6a2025-10-17WarningsExact identifier
unii: 8MDF5V39QO
Equate Effervescent Antacid and Pain ReliefASPIRIN, CITRIC ACID, SODIUM BICARBONATEWalmart6271b34b-55a0-40a8-e053-2a91aa0acb222025-10-17Warnings, Adverse reactionsExact identifier
unii: 8MDF5V39QO
EQUATE SALINE PACKETSNASAL CLEANING SALTWALMART INC9e905ecb-d4d5-514a-e053-2a95a90adfbb2025-10-08WarningsExact identifier
unii: 8MDF5V39QO
EQUATE NETI POT SINUS WASHNASAL WASHWALMART INC9e90c1c1-4dcd-106e-e053-2995a90afd152025-10-08WarningsExact identifier
unii: 8MDF5V39QO
GURUNANDA NASAL SALINENASAL WASHGURUNANDA LLC2b4d78ae-b587-6dfe-e063-6394a90a88762025-10-08WarningsExact identifier
unii: 8MDF5V39QO
Omeprazole and Sodium BicarbonateOMEPRAZOLE AND SODIUM BICARBONATEAjanta Pharma USA Inc.cb657607-b038-47ee-b4e7-a5f419a14c332025-10-06Warnings, Adverse reactionsExact identifier
unii: 8MDF5V39QO
Sodium BicarbonateSODIUM BICARBONATEFresenius Kabi USA, LLC0ab55004-bb63-436d-ad77-cd37969053702025-09-23Warnings, Adverse reactionsExact identifier
unii: 8MDF5V39QO
Stomachin AntacidMAGNESIUM CARBONATE AND SODIUM BICARBONATEChang Kuo Chou Pharmaceutical Co., Ltd.60fa0650-8785-4cb3-8f88-1a437296252f2025-09-19WarningsExact identifier
unii: 8MDF5V39QO
GAVILYTE-NPOLYETHYLENE GLYCOL-3350, SODIUM CHLORIDE, POTASSIUM CHLORIDE AND SODIUM BICARBONATELupin Pharmaceuticals,Inc.27195187-75a3-431f-90d9-84da1b94e8492025-09-10Warnings, Adverse reactionsExact identifier
unii: 8MDF5V39QO
GaviLyte - C TMPOLYETHYLENE GLYCOL-3350 AND ELECTROLYTES WITH FLAVOR PACKLupin Pharmaceuticals,Inc.a8b15625-ca7c-4d57-9f36-3ac2a6d136652025-09-10Warnings, Adverse reactionsExact identifier
unii: 8MDF5V39QO
GAVILYTE G TMPOLYETHYLENE GLYCOL-3350 AND ELECTROLYTESLupin Pharmaceuticals,Inc.3978822b-6473-4072-9f80-20ceb9bea3552025-09-10Warnings, Adverse reactionsExact identifier
unii: 8MDF5V39QO
omeprazole and sodium bicarbonateOMEPRAZOLE, SODIUM BICARBONATEMeijer Distribution Incbb7c1c5d-b915-42f5-a5a2-5f61b088028d2025-09-05WarningsExact identifier
unii: 8MDF5V39QO
Polyethylene Glycol 3350 and electrolytes - UnflavoredPOLYETHYLENE GLYCOL 3350 AND ELECTROLYTES - UNFLAVOREDStrides Pharma Science Limited48c741a9-9039-4fdb-a875-86d4ea9682822025-09-05Warnings, Adverse reactionsExact identifier
unii: 8MDF5V39QO
ErtapenemERTAPENEM SODIUMQilu Antibiotics Pharmaceutical Co., Ltd.44496f7c-8407-4765-9cd6-1daa619a6db62025-09-03Warnings, Adverse reactionsExact identifier
rxcui: 1734683
unii: 2T90KE67L0

Reported adverse events (FAERS/openFDA)#

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