FDA.reportPublic FDA data

NDC 63323-508-01 - 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
63323-508
Requested NDC
63323-508-01
Package NDCs from labels
63323-508-21, 63323-508-31, 63323-508-45, 63323-508-25, 63323-508-01, 63323-508-30
Manufacturer
Fresenius Kabi USA, LLC | ACS Dobfar S.p.A. | Zambon Switzerland Ltd
Effective date
2021-03-12
Current FDA listing
Not matched in FDA.report NDC product tables

DailyMed Labels#

Label, Manufacturer, Effective date table
LabelManufacturerEffective dateType
Meropenem - Fresenius Kabi USA, LLC | ACS Dobfar S.p.A. | Zambon Switzerland LtdFresenius Kabi USA, LLC | ACS Dobfar S.p.A. | Zambon Switzerland Ltd2021-03-12HUMAN PRESCRIPTION DRUG LABEL
Meropenem - Fresenius Kabi USA, LLC | ACS Dobfar S.p.A. | Zambon Switzerland LtdFresenius Kabi USA, LLC | ACS Dobfar S.p.A. | Zambon Switzerland Ltd2021-03-10HUMAN PRESCRIPTION DRUG LABEL
Meropenem - Fresenius Kabi USA, LLC | ACS Dobfar S.p.A. | Zambon Switzerland LtdFresenius Kabi USA, LLC | ACS Dobfar S.p.A. | Zambon Switzerland Ltd2020-10-19HUMAN PRESCRIPTION DRUG LABEL

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
63323-508-21Meropenem20 mL in 1 VIALINJECTION, POWDER, FOR SOLUTION2016
63323-508-31Meropenem10 in 1 CARTONINJECTION, POWDER, FOR SOLUTION1016
63323-508-01Meropenem20 mL in 1 VIALINJECTION, POWDER, FOR SOLUTION2015
63323-508-30Meropenem10 in 1 CARTONINJECTION, POWDER, FOR SOLUTION1015
63323-508-25Meropenem25 in 1 CARTONINJECTION, POWDER, FOR SOLUTION2511
63323-508-45Meropenem20 mL in 1 VIALINJECTION, POWDER, FOR SOLUTION2011

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
63323-508MEROPENEM (MEROPENEM) INJECTION, POWDER, FOR SOLUTION [FRESENIUS KABI USA, LLC ]16Current NDC, Legacy NDC, 2 package rows20210317_12714f80-d6e5-4453-b66c-62f57c16ddfc.zip
63323-508MEROPENEM (MEROPENEM) INJECTION, POWDER, FOR SOLUTION [FRESENIUS KABI USA, LLC ]15Current NDC, Legacy NDC, 2 package rows20210310_185181e3-c004-4d61-b992-5df94fe57a90.zip
63323-508MEROPENEM (MEROPENEM) INJECTION, POWDER, FOR SOLUTION [FRESENIUS KABI USA, LLC]11Current NDC, Legacy NDC, 2 package rows20210316_7a68d899-2678-43a9-a9c1-ef8f916b562f.zip

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
63323-508-01EA - Each63323-5086d12e068-d73e-44ef-a6a1-6e3c72d9875c12021-09-07
63323-508-21EA - Each63323-5086c26f88d-9008-4dcc-99fc-918eaad44c9c12025-08-11
63323-508-25EA - Each63323-5088bcecc6e-1ea7-449b-8f80-9a05767f442a12015-01-05
63323-508-30EA - Each63323-508ca5ad3e0-e93b-4729-8e7b-347c6797869f12012-07-24
63323-508-31EA - Each63323-5088c633b01-bf77-42bb-808b-e1563504122212013-03-03
63323-508-45EA - Each63323-508bf89449d-3a53-46bb-b81b-8674c866e28712022-04-06

DailyMed Socrata Ingredients#

Ingredient, Type, UNII table
IngredientTypeUNIIDailyMed labelSPL versionUploaded
MEROPENEMACTIVE INGREDIENTFV9J3JU8B1MEROPENEM INJECTION, POWDER, FOR SOLUTION [FRESENIUS KABI USA, LLC]8
MEROPENEM ANHYDROUSACTIVE MOIETYYOP6PX0BAOMEROPENEM INJECTION, POWDER, FOR SOLUTION [FRESENIUS KABI USA, LLC]8
MEROPENEMACTIVE INGREDIENTFV9J3JU8B1MEROPENEM INJECTION, POWDER, FOR SOLUTION [FRESENIUS KABI USA, LLC]5
MEROPENEM ANHYDROUSACTIVE MOIETYYOP6PX0BAOMEROPENEM INJECTION, POWDER, FOR SOLUTION [FRESENIUS KABI USA, LLC]5
MEROPENEMACTIVE INGREDIENTFV9J3JU8B1MEROPENEM INJECTION, POWDER, FOR SOLUTION [FRESENIUS KABI USA, LLC]2
MEROPENEM ANHYDROUSACTIVE MOIETYYOP6PX0BAOMEROPENEM INJECTION, POWDER, FOR SOLUTION [FRESENIUS KABI USA, LLC]2

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
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
application number: ANDA091404
rxcui: 1722934
rxcui: 1722939
unii: FV9J3JU8B1
MeropenemMEROPENEMHospira, Inc.092ebd9b-77a0-4877-afc3-dd8211730f712024-11-06Warnings, Adverse reactionsExact identifier
application number: ANDA091404
rxcui: 1722934
rxcui: 1722939
unii: FV9J3JU8B1
MEROPENEMMEROPENEMXellia Pharmaceuticals USA LLC06d84c55-94ff-46e5-8477-b8881c12eb0a2024-07-10Warnings, Adverse reactionsExact identifier
rxcui: 1722934
rxcui: 1722939
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.