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#

Cross-check layer: openFDA label JSON enriches search and identifies hydration gaps. The DailyMed Structured Product Label remains the canonical label presentation on FDA.report. Every label matching the complete exact-identifier union is deduplicated and paginated below.

Matched openFDA labels page 1 of 2 · 24 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
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
MeropenemMEROPENEMWG Critical Care, LLC240325ba-47a8-4ad1-bcab-6772069ee7902026-01-08Warnings, 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