FDA.reportPublic FDA data

NDC 42023-221-01 - 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
42023-221
Requested NDC
42023-221-01
Package NDCs from labels
42023-221-89, 42023-221-85, 42023-221-01, 42023-221-10
Manufacturer
ENDO USA, Inc. | Merck Sharp & Dohme LLC
Effective date
2026-03-02
Current FDA listing
Not matched in FDA.report NDC product tables

DailyMed Labels#

Label, Manufacturer, Effective date table
LabelManufacturerEffective dateType
ERTAPENEM - ENDO USA, Inc. | Merck Sharp & Dohme LLCENDO USA, Inc. | Merck Sharp & Dohme LLC2026-03-02HUMAN PRESCRIPTION DRUG LABEL
ERTAPENEM - ENDO USA, Inc. | Merck Sharp & Dohme LLCENDO USA, Inc. | Merck Sharp & Dohme LLC2026-03-02HUMAN PRESCRIPTION DRUG LABEL

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
42023-221-01ERTAPENEM1 in 1 VIAL, SINGLE-DOSEINJECTION, POWDER, LYOPHILIZED,113
42023-221-10ERTAPENEM10 in 1 PACKAGEINJECTION, POWDER, LYOPHILIZED,1013
42023-221-85ERTAPENEM10 in 1 PACKAGEINJECTION, POWDER, LYOPHILIZED,1013
42023-221-89ERTAPENEM1 in 1 VIAL, SINGLE-DOSEINJECTION, POWDER, LYOPHILIZED,113

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
42023-221ERTAPENEM (ERTAPENEM SODIUM) INJECTION, POWDER, LYOPHILIZED, FOR SOLUTION [ENDO USA, INC.]10Current NDC, Legacy NDC, 2 package rows20240716_657855f2-7c92-4aa8-9c3d-51d08e56a09a.zip
42023-221ERTAPENEM (ERTAPENEM SODIUM) INJECTION, POWDER, LYOPHILIZED, FOR SOLUTION [ENDO USA, INC.]9Current NDC, Legacy NDC, 2 package rows20240716_41304b1d-7db4-468a-ab1d-04e56fb50de4.zip

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
42023-221-01EA - Each42023-221ab48327d-4a9d-49ae-93cb-36b2e50be6f212018-08-13
42023-221-10EA - Each42023-2215bce14c2-8926-4eb4-a8cc-2bba14d9ebd912018-08-13
42023-221-85EA - Each42023-221cca54412-b1b8-4749-9c80-0c30149b3ec612018-12-13
42023-221-89EA - Each42023-221014f44b1-2664-42fc-bdd2-c33f5769861b12018-12-13

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 2 of 12 · 222 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
Market Basket Effervescent Antacid and Pain ReliefASPIRIN, CITRIC ACID, SODIUM BICARBONATEDemoulas Super Markets, Inc.e15439c7-0e3c-7752-e053-2995a90a1a402026-05-11WarningsExact identifier
unii: 8MDF5V39QO
Meijer Effervescent Antacid and Pain ReliefASPIRIN, ANHYDROUS CITRIC ACID, SODIUM BICARBONATEMeijer Distribution Inc7305972b-aa0f-4daa-e053-2991aa0adfd72026-05-11WarningsExact identifier
unii: 8MDF5V39QO
Sodium BicarbonateSODIUM BICARBONATEVitamex USA, Corp5195cab5-bdda-2ddf-e063-6394a90ac9fe2026-05-11WarningsExact identifier
unii: 8MDF5V39QO
Sodium BicarbonateSODIUM BICARBONATETWIN MED LLC0f867f56-4bc0-4a85-b9d2-a16282b7c82b2026-05-01WarningsExact identifier
unii: 8MDF5V39QO
Arm and Hammer Baking SodaSODIUM BICARBONATEChurch & Dwight Co., Inc.643fe204-4a7b-00e4-e053-2a91aa0aef062026-04-21WarningsExact identifier
unii: 8MDF5V39QO
SODIUM BICARBONATESODIUM BICARBONATEMedical Purchasing Solutions, LLC4f97d398-2118-0874-e063-6394a90a4ad12026-04-16Warnings, Adverse reactionsExact identifier
unii: 8MDF5V39QO
PEG 3350 and ElectrolytesPOLYETHYLENE GLYCOL 3350, SODIUM SULFATE ANHYDROUS, SODIUM BICARBONATE, SODIUM CHLORIDE, POTASSIUM CHLORIDEWilshire Pharmaceuticals, Inc.b251752d-7750-482a-9364-0acf4ad47cc82026-04-16Warnings, Adverse reactionsExact identifier
unii: 8MDF5V39QO
GoLYTELYPOLYETHYLENE GLYCOL 3350, SODIUM SULFATE ANHYDROUS, SODIUM BICARBONATE, SODIUM CHLORIDE, POTASSIUM CHLORIDEAzurity Pharmaceuticals, Inc.7609ecf7-0ce0-4fbb-9c27-30987f6895752026-04-15Warnings, Adverse reactionsExact identifier
unii: 8MDF5V39QO
TRILYTEPOLYETHYLENE GLYOCOL 3350, SODIUM CHLORIDE, SODIUM BICARBONATE AND POTASSIUM CHLORIDEAurobindo Pharma Limited79f5e596-8d51-4227-afcc-f5e3411509572026-04-15Warnings, Adverse reactionsExact identifier
unii: 8MDF5V39QO
PEG 3350, sodium chloride, sodium bicarbonate and potassium chloridePOLYETHYLENE GLYCOL 3350, SODIUM CHLORIDE, SODIUM BICARBONATE, POTASSIUM CHLORIDEWilshire Pharmaceuticals, Inc.4e442a72-b13b-4869-8a1d-59356095b0912026-04-14Warnings, Adverse reactionsExact identifier
unii: 8MDF5V39QO
Sodium Bicarbonate 10 gr. (650 mg)SODIUM BICARBONATEGendose Pharmaceuticals, LLC0a0cc46d-372e-4175-932a-065e82d8d3532026-04-13WarningsExact identifier
unii: 8MDF5V39QO
Sodium BicarbonateSODIUM BICARBONATEHospira, Inc.ea9f4498-0d43-4043-8dd1-f22537841c212026-04-06Warnings, Adverse reactionsExact identifier
unii: 8MDF5V39QO
Sodium BicarbonateSODIUM BICARBONATEHospira, Inc.8664c7ce-707b-4c6c-9ce4-7160b5f877f82026-04-06Warnings, Adverse reactionsExact identifier
unii: 8MDF5V39QO
Omeprazole/BicarbonateOMEPRAZOLE AND SODIUM BICARBONATEProficient Rx LP4d642036-7175-4f29-9f07-dbd282231d4a2026-04-01Warnings, Adverse reactionsExact identifier
unii: 8MDF5V39QO
Rapidol Sodium BicarbonateSODIUM BICARBONATEPharmadel LLCb4c9a653-6f51-7c98-e053-2995a90ada372026-03-26WarningsExact identifier
unii: 8MDF5V39QO
Sodium Bicarbonate AntacidSODIUM BICARBONATEAphena Pharma Solutions - Tennessee, LLCbba7d5bf-c94b-4ee4-a399-9a2818d84c782026-03-23WarningsExact identifier
unii: 8MDF5V39QO
equate omeprazole and sodium bicarbonateOMEPRAZOLE, SODIUM BICARBONATEWALMART INC.c24c3326-99da-4c7d-aecc-7b4a8ac3f04e2026-03-15WarningsExact identifier
unii: 8MDF5V39QO
SODIUM BICARBONATESODIUM BICARBONATEHospira, Inc.084f5572-8c1f-4802-b179-ca0cc838fc682026-03-09Warnings, Adverse reactionsExact identifier
unii: 8MDF5V39QO
Sodium BicarbonateSODIUM BICARBONATEHospira, Inc.0c24b592-4bc8-456f-acac-9c9525844a062026-03-09Warnings, Adverse reactionsExact identifier
unii: 8MDF5V39QO
ERTAPENEMERTAPENEM SODIUMENDO USA, Inc.41304b1d-7db4-468a-ab1d-04e56fb50de42026-03-02Warnings, Adverse reactionsExact identifier
application number: NDA021337
ndc (package): 42023-221-89
ndc (package): 42023-221-85
ndc (product): 42023-221
rxcui: 1734683
spl id: 137f9963-a021-47a5-8bb0-2a1621030708
spl set id: 41304b1d-7db4-468a-ab1d-04e56fb50de4
unii: 2T90KE67L0

Reported adverse events (FAERS/openFDA)#

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