FDA.reportPublic FDA data

NDC 63323-349-41 - Imipenem and Cilastatin

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
63323-349
Requested NDC
63323-349-41
Package NDCs from labels
63323-349-21, 63323-349-93, 63323-349-41, 63323-349-94, 63323-349-01, 63323-349-25
Manufacturer
Fresenius Kabi USA, LLC | ACS Dobfar S.p.A. | Zambon Switzerland Ltd
Effective date
2022-10-11
Current FDA listing
Not matched in FDA.report NDC product tables

DailyMed Labels#

Label, Manufacturer, Effective date table
LabelManufacturerEffective dateType
IMIPENEM - Fresenius Kabi USA, LLC | ACS Dobfar S.p.A. | Zambon Switzerland LtdFresenius Kabi USA, LLC | ACS Dobfar S.p.A. | Zambon Switzerland Ltd2022-10-11HUMAN PRESCRIPTION DRUG LABEL
IMIPENEM - Fresenius Kabi USA, LLC | ACS Dobfar S.p.A. | Zambon Switzerland LtdFresenius Kabi USA, LLC | ACS Dobfar S.p.A. | Zambon Switzerland Ltd2022-10-10HUMAN PRESCRIPTION DRUG LABEL
IMIPENEM - Fresenius Kabi USA, LLC | ACS Dobfar S.p.A. | Zambon Switzerland LtdFresenius Kabi USA, LLC | ACS Dobfar S.p.A. | Zambon Switzerland Ltd2022-10-06HUMAN PRESCRIPTION DRUG LABEL

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
63323-349-01Imipenem and Cilastatin20 mL in 1 VIAL, SINGLE-DOSEINJECTION, POWDER, FOR SOLUTION2012
63323-349-25Imipenem and Cilastatin25 in 1 CARTONINJECTION, POWDER, FOR SOLUTION2512
63323-349-41Imipenem and Cilastatin20 mL in 1 VIAL, SINGLE-DOSEINJECTION, POWDER, FOR SOLUTION207
63323-349-94Imipenem and Cilastatin25 in 1 CARTONINJECTION, POWDER, FOR SOLUTION257
63323-349-21Imipenem and Cilastatin20 mL in 1 VIAL, SINGLE-DOSEINJECTION, POWDER, FOR SOLUTION205
63323-349-93Imipenem and Cilastatin25 in 1 CARTONINJECTION, POWDER, FOR SOLUTION255

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
63323-349IMIPENEM AND CILASTATIN (IMIPENEM AND CILASTATIN SODIUM) INJECTION, POWDER, FOR SOLUTION [FRESENIUS KABI USA, LLC]12Current NDC, Legacy NDC, 2 package rows20221020_6ab0ca9e-9a79-4cab-9f09-470eda06952e.zip
63323-349IMIPENEM AND CILASTATIN (IMIPENEM AND CILASTATIN SODIUM) INJECTION, POWDER, FOR SOLUTION IMIPENEM AND CILASTATIN (IMIPENEM AND CILASTATIN SODIUM) INJECTION, POWDER, FOR SOLUTION [FRESENIUS KABI USA, LLC]7Current NDC, Legacy NDC, 2 package rows20221027_0a1dd9b9-ada1-4bff-9dcb-18961254e9e8.zip
63323-349IMIPENEM AND CILASTATIN (IMIPENEM AND CILASTATIN SODIUM) INJECTION, POWDER, FOR SOLUTION IMIPENEM AND CILASTATIN (IMIPENEM AND CILASTATIN SODIUM) INJECTION, POWDER, FOR SOLUTION [FRESENIUS KABI USA, LLC]5Current NDC, Legacy NDC, 2 package rows20221103_ce771566-c4f2-447e-944a-6b908925c90b.zip

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
63323-349-01EA - Each63323-349f50db0b5-d335-4dbf-941f-0f0b369edb4912022-12-07
63323-349-20EA - Each63323-349b9f50790-8b8f-4859-a9a5-09eaa18ef95812012-07-24
63323-349-25EA - Each63323-3490e6995d8-249d-4b78-b0e7-49d68ded7a1412013-02-13
63323-349-93EA - Each63323-3495ef3d27e-c6b0-474c-9e11-3134e31809d312016-07-19
63323-349-94EA - Each63323-349a50513b0-965e-4537-b95f-0d14a7becca912015-01-05

DailyMed Socrata Ingredients#

Ingredient, Type, UNII table
IngredientTypeUNIIDailyMed labelSPL versionUploaded
CILASTATIN SODIUMACTIVE INGREDIENT5428WXZ74MIMIPENEM AND CILASTATIN (IMIPENEM AND CILASTATIN SODIUM) INJECTION, POWDER, FOR SOLUTION [FRESENIUS KABI USA, LLC]4
IMIPENEMACTIVE INGREDIENT71OTZ9ZE0AIMIPENEM AND CILASTATIN (IMIPENEM AND CILASTATIN SODIUM) INJECTION, POWDER, FOR SOLUTION [FRESENIUS KABI USA, LLC]4
CILASTATINACTIVE MOIETY141A6AMN38IMIPENEM AND CILASTATIN (IMIPENEM AND CILASTATIN SODIUM) INJECTION, POWDER, FOR SOLUTION [FRESENIUS KABI USA, LLC]4
IMIPENEM ANHYDROUSACTIVE MOIETYQ20IM7HE75IMIPENEM AND CILASTATIN (IMIPENEM AND CILASTATIN SODIUM) INJECTION, POWDER, FOR SOLUTION [FRESENIUS KABI USA, LLC]4
CILASTATIN SODIUMACTIVE INGREDIENT5428WXZ74MIMIPENEM AND CILASTATIN (IMIPENEM AND CILASTATIN SODIUM) INJECTION, POWDER, FOR SOLUTION [FRESENIUS KABI USA, LLC]2
IMIPENEMACTIVE INGREDIENT71OTZ9ZE0AIMIPENEM AND CILASTATIN (IMIPENEM AND CILASTATIN SODIUM) INJECTION, POWDER, FOR SOLUTION [FRESENIUS KABI USA, LLC]2
CILASTATINACTIVE MOIETY141A6AMN38IMIPENEM AND CILASTATIN (IMIPENEM AND CILASTATIN SODIUM) INJECTION, POWDER, FOR SOLUTION [FRESENIUS KABI USA, LLC]2
IMIPENEM ANHYDROUSACTIVE MOIETYQ20IM7HE75IMIPENEM AND CILASTATIN (IMIPENEM AND CILASTATIN SODIUM) 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 11 · 214 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
Xtreme Saline Rinse MixSODIUM BICARBONATE, SODIUM CHLORIDEXtreme Personal Care Inc776f417e-e443-4918-8c7a-1913b7dddcd42026-09-01WarningsExact identifier
unii: 8MDF5V39QO
Sodium BicarbonateSODIUM BICARBONATEREMEDYREPACK INC.96093b76-5d98-4d2b-b851-20207a8864db2026-08-28Warnings, Adverse reactionsExact identifier
unii: 8MDF5V39QO
Sodium BicarbonateSODIUM BICARBONATEExela Pharma Sciences, LLCf8806ec3-a1c0-47a9-9660-2628dca4623e2026-08-25Warnings, Adverse reactionsExact identifier
unii: 8MDF5V39QO
omeprazole and sodium bicarbonateOMEPRAZOLE, SODIUM BICARBONATEAmazon.com Services LLCbb453f26-c7df-4cce-8793-337cb5d5f9a92026-08-19WarningsExact identifier
unii: 8MDF5V39QO
sodium bicarbonateSODIUM BICARBONATEBaxter Healthcare Corporationb50c858a-00c8-4cb2-ad73-8797f19e656d2026-08-14Warnings, Adverse reactionsExact identifier
unii: 8MDF5V39QO
Sodium BicarbonateSODIUM BICARBONATEMilla Pharmaceuticals Inc.2d2035c2-e41b-4d57-a23c-fae16ad9a3552026-08-07Warnings, Adverse reactionsExact identifier
unii: 8MDF5V39QO
Sodium Bicarbonate 5 grSODIUM BICARBONATETWIN MED LLCe325d899-d9a6-5adb-e053-2995a90ac8612026-08-04WarningsExact identifier
unii: 8MDF5V39QO
DERMFREE INSECT BITE RELIEFSODIUM BICARBONATE 5% INSECT BITE RELIEFWenzhou Yuyuan Pharmaceutical Co., Ltd.5794886c-0d74-9f35-e063-6394a90a27d82026-07-27WarningsExact identifier
unii: 8MDF5V39QO
PEG 3350 and ElectrolytesPOLYETHYLENE GLYCOL 3350, SODIUM SULFATE ANHYDROUS, SODIUM BICARBONATE, SODIUM CHLORIDE, POTASSIUM CHLORIDEA-S Medication Solutions19daf830-7270-4661-81b1-ded38f867f282026-07-24Warnings, Adverse reactionsExact identifier
unii: 8MDF5V39QO
Sodium BicarbonateSODIUM BICARBONATEAmneal Pharmaceuticals Private Limitedac91e834-e693-43a2-829b-56793453e8cc2026-07-09Warnings, Adverse reactionsExact identifier
unii: 8MDF5V39QO
SODIUM BICARBONATESODIUM BICARBONATEHF Acquisition Co LLC, DBA HealthFirst9ee46a5b-d00e-4254-e053-2995a90aeb3a2026-06-29Warnings, Adverse reactionsExact identifier
unii: 8MDF5V39QO
SODIUM BICARBONATESODIUM BICARBONATEHF Acquisition Co LLC, DBA HealthFirstd8516f38-6f92-32d1-e053-2995a90a96bf2026-06-19Warnings, Adverse reactionsExact identifier
unii: 8MDF5V39QO
Sodium BicarbonateSODIUM BICARBONATE, INJECTIONCivica, Inc.3737e5e5-2296-4a3d-b8f1-dfea1eff19272026-06-15Warnings, Adverse reactionsExact identifier
unii: 8MDF5V39QO
E-Z-GAS IIANTACID/ANTIFLATULENTE-Z-EM, INC.4e12e1cb-b033-076d-e054-00144ff8d46c2026-06-15WarningsExact identifier
unii: 8MDF5V39QO
Sodium BicarbonateSODIUM BICARBONATECardinal Health 107, LLC60c2a176-8854-4479-b853-d07fe9a1830c2026-06-12WarningsExact identifier
unii: 8MDF5V39QO
SODIUM BICARBONATESODIUM BICARBONATEMedical Purchasing Solutions, LLC.5401e4ff-aa7a-3e97-e063-6294a90a24f02026-06-11Warnings, Adverse reactionsExact identifier
unii: 8MDF5V39QO
Sodium BicarbonateSODIUM BICARBONATEExela Pharma Sciences, LLC2f05947f-a489-4298-a871-90db75b2a6c52026-06-09Warnings, Adverse reactionsExact identifier
unii: 8MDF5V39QO
Sodium Bicarbonate AntacidSODIUM BICARBONATENCS HealthCare of KY, LLC dba Vangard Labsfde4ea0c-152b-4b79-a6d8-2b0dbd9107aa2026-06-04WarningsExact identifier
unii: 8MDF5V39QO
Humco Sodium BicarbonateSODIUM BICARBONATEHumco Holding Group, Inc.aeaa34f6-216d-49f3-8393-c7bda96a3e322026-05-26WarningsExact identifier
unii: 8MDF5V39QO
Alka-Seltzer OriginalANHYDROUS CITRIC ACID, ASPIRIN, AND SODIUM BICARBONATESelect Consumer Group3ca80d74-1e8b-49d9-e063-6394a90a43122026-05-24WarningsExact identifier
unii: 8MDF5V39QO

Reported adverse events (FAERS/openFDA)#

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