FDA.reportPublic FDA data

NDC 70594-076-01 - MEROPENEM

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
70594-076
Requested NDC
70594-076-01
Package NDCs from labels
70594-076-01, 70594-076-02
Manufacturer
Xellia Pharmaceuticals USA LLC
Effective date
2024-07-10
Current FDA listing
Not matched in FDA.report NDC product tables

DailyMed Labels#

Label, Manufacturer, Effective date table
LabelManufacturerEffective dateType
MEROPENEM - Xellia Pharmaceuticals USA LLCXellia Pharmaceuticals USA LLC2024-07-10HUMAN PRESCRIPTION DRUG LABEL

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
70594-076-01MEROPENEM1 in 1 VIAL, GLASSINJECTION, POWDER, FOR SOLUTION17
70594-076-02MEROPENEM10 in 1 CARTONINJECTION, POWDER, FOR SOLUTION107

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
70594-076MEROPENEM INJECTION, POWDER, FOR SOLUTION [XELLIA PHARMACEUTICALS USA LLC]7Current NDC, Legacy NDC, 2 package rows20241211_06d84c55-94ff-46e5-8477-b8881c12eb0a.zip

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
70594-076-01EA - Each70594-0763a2bd25a-5c22-4ccf-b37f-0926746c120712021-09-07
70594-076-02EA - Each70594-07654f1a282-9f29-40c7-aa18-77ffefeb381612021-09-07

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 1 of 2 · 23 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
MeropenemMEROPENEMHikma Pharmaceuticals USA Inc.8a2a545e-b336-416a-be73-9e0a7ccf61772026-08-26Warnings, Adverse reactionsExact identifier
rxcui: 1722934
rxcui: 1722939
unii: FV9J3JU8B1
MeropenemMEROPENEMSagent Pharmaceuticalse8848f4a-bca9-4978-b0a1-38483fd4d6392026-03-31Warnings, Adverse reactionsExact identifier
rxcui: 1722934
rxcui: 1722939
unii: FV9J3JU8B1
VABOMEREMEROPENEM-VABORBACTAMMelinta Therapeutics, LLCe237fd0f-3050-42a3-b43e-b6fb4824e93d2026-02-27Warnings, Adverse reactionsExact identifier
unii: FV9J3JU8B1
MeropenemMEROPENEMBluePoint Laboratoriesca5f501c-6520-4d09-aae2-4f5db74d468f2025-12-12Warnings, Adverse reactionsExact identifier
rxcui: 1722934
rxcui: 1722939
unii: FV9J3JU8B1
MEROPENEMMEROPENEMSavior Lifetec Corporation31dd2160-7dbd-51fa-e054-00144ff88e882025-11-24Warnings, Adverse reactionsExact identifier
rxcui: 1722934
rxcui: 1722939
unii: FV9J3JU8B1
MEROPENEMMEROPENEMSandoz Inc0d37e43b-ff8d-495d-b9af-4fd5fce53d562025-11-14Warnings, Adverse reactionsExact identifier
rxcui: 1722934
rxcui: 1722939
unii: FV9J3JU8B1
MeropenemMEROPENEMQilu Antibiotics Pharmaceutical Co., Ltd.1f9591ed-3a6c-422e-b1be-7b3e4fe5bf3c2025-09-16Warnings, Adverse reactionsExact identifier
rxcui: 1722934
rxcui: 1722939
unii: FV9J3JU8B1
MeropenemMEROPENEMCivica, Inc.35466216-55ed-4836-8cbc-c8aafb079dae2025-09-12Warnings, Adverse reactionsExact identifier
rxcui: 1722934
rxcui: 1722939
unii: FV9J3JU8B1
MEROPENEMMEROPENEMCivica, Incb0075b72-c3cc-f844-e053-2a95a90a417f2025-09-10Warnings, Adverse reactionsExact identifier
rxcui: 1722934
rxcui: 1722939
unii: FV9J3JU8B1
Meropenem and Sodium ChlorideMEROPENEM AND SODIUM CHLORIDEB. Braun Medical Inc.3b952a55-6ef7-45c8-be21-16eefe37ec2e2025-08-05Warnings, Adverse reactionsExact identifier
rxcui: 1722934
rxcui: 1722939
unii: FV9J3JU8B1
MeropenemMEROPENEMBROOKS STERISCIENCE LIMITED58e165b7-e230-4459-abf9-06d5ca1dd7b22025-07-31Warnings, Adverse reactionsExact identifier
rxcui: 1722934
rxcui: 1722939
unii: FV9J3JU8B1
MeropenemMEROPENEMEugia US LLCbf1d3433-9e3f-40a0-8bff-c8ceaa8bab7c2025-07-16Warnings, Adverse reactionsExact identifier
rxcui: 1722934
rxcui: 1722939
unii: FV9J3JU8B1
MeropenemMEROPENEMGland Pharma Limited4e4e2c0c-df54-4229-ab90-fa671ecedd572025-06-26Warnings, Adverse reactionsExact identifier
application number: ANDA206141
rxcui: 1722934
rxcui: 1722939
unii: FV9J3JU8B1
MeropenemMEROPENEMAmneal Pharmaceuticals LLCa456013b-b20e-4b29-b2f9-06f18f1ea6bd2025-06-09Warnings, Adverse reactionsExact identifier
rxcui: 1722934
rxcui: 1722939
unii: FV9J3JU8B1
MeropenemMEROPENEMHikma Pharmaceuticals USA Inc.d54fdbad-ca93-467c-92d7-c1bd88f3bbe32024-12-31Warnings, Adverse reactionsExact identifier
rxcui: 1722934
rxcui: 1722939
unii: FV9J3JU8B1
MeropenemMEROPENEMHospira, Inc.e9b6555f-20a1-4415-bb80-3d034cfab95b2024-11-06Warnings, Adverse reactionsExact identifier
rxcui: 1722934
rxcui: 1722939
unii: FV9J3JU8B1
MeropenemMEROPENEMHospira, Inc.092ebd9b-77a0-4877-afc3-dd8211730f712024-11-06Warnings, Adverse reactionsExact identifier
rxcui: 1722934
rxcui: 1722939
unii: FV9J3JU8B1
MEROPENEMMEROPENEMXellia Pharmaceuticals USA LLC06d84c55-94ff-46e5-8477-b8881c12eb0a2024-07-10Warnings, Adverse reactionsExact identifier
application number: ANDA206141
ndc (package): 70594-076-01
ndc (package): 70594-075-01
ndc (package): 70594-076-02
ndc (package): 70594-075-02
ndc (product): 70594-075
ndc (product): 70594-076
ndc11 (package): 70594007601
rxcui: 1722934
rxcui: 1722939
spl id: 3ee484ef-4e7f-464a-ac2e-7963d9dc5df6
spl set id: 06d84c55-94ff-46e5-8477-b8881c12eb0a
unii: FV9J3JU8B1
MeropenemMEROPENEMARMAS PHARMACEUTICALS INCe1122310-c3ed-42f1-b189-301c221ff1f02022-07-29Warnings, Adverse reactionsExact identifier
rxcui: 1722934
rxcui: 1722939
unii: FV9J3JU8B1
MeropenemMEROPENEMWG Critical Care, LLC6520ae3d-e149-499c-8152-36f6ab8616622021-06-30Warnings, Adverse reactionsExact identifier
rxcui: 1722934
rxcui: 1722939
unii: FV9J3JU8B1

Reported adverse events (FAERS/openFDA)#

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