FDA.reportPublic FDA data

NDC 63323-349-01 - 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
63323-349-01
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 6 of 10 · 199 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
Leader Sinus Wash Saline Refill PacketsSODIUM BICARBONATE, SODIUM CHLORIDECardinal Health, 110 dba LEADERfb192a6d-318e-4d2b-89b6-42ac023e4fbd2025-07-09WarningsExact identifier
unii: 8MDF5V39QO
Sodium BicarbonateSODIUM BICARBONATEWestminster Pharmaceuticals, LLC9dcfc778-5fd6-4c68-8d37-a5385e3746172025-07-08WarningsExact identifier
unii: 8MDF5V39QO
SODIUM BICARBONATESODIUM BICARBONATEAnthea Pharma Private Limited0df8cf62-4b49-4ec4-aae4-c4a3e6d765492025-06-26Warnings, Adverse reactionsExact identifier
unii: 8MDF5V39QO
INFANT 4.2% SODIUM BICARBONATEINFANT 4.2% SODIUM BICARBONATEHF Acquisition Co LLC, DBA HealthFirst78c25911-0042-664e-e053-2a91aa0a57a12025-06-16Warnings, Adverse reactionsExact identifier
unii: 8MDF5V39QO
PRISMASOL BGK2/0MAGNESIUM CHLORIDE, DEXTROSE ANHYDROUS, LACTIC ACID, SODIUM CHLORIDE, SODIUM BICARBONATE, AND POTASSIUM CHLORIDEVantive US Healthcare LLC7f675fee-8940-4ece-bb0c-75ac79d8708c2025-05-31Warnings, Adverse reactionsExact identifier
unii: 8MDF5V39QO
AHHH Bite ReliefSODIUM BICARBONATE7827125a1e070-9228-4ec9-e063-6294a90ad78d2025-05-27WarningsExact identifier
unii: 8MDF5V39QO
Sinus Wash PacketSODIUM BICARBONATE, SODIUM CHLORIDEBETTER LIVING BRANDS LLC33ee7b77-0871-4df8-e063-6394a90ac4792025-04-29WarningsExact identifier
unii: 8MDF5V39QO
Alka-Seltzer Heartburn Relief Lemon LimeANHYDROUS CITRIC ACID, SODIUM BICARBONATE (HEAT-TREATED)Bayer Healthcare LLCcc21af24-9a5b-6831-e053-2a95a90a0af42025-04-01WarningsExact identifier
unii: 8MDF5V39QO
Alka-Seltzer Heartburn Relief Extra StrengthANHYDROUS CITRIC ACID, SODIUM BICARBONATE (HEAT-TREATED)Bayer Healthcare LLCdc1641f8-54c2-0d86-e053-2995a90a1dce2025-03-11WarningsExact identifier
unii: 8MDF5V39QO
Acid Reducer PowderOMEPRAZOLE AND SODIUM BICARBONATEDr. Reddy's Laboratories Inc.,6f8452f8-8c2c-6700-a11d-1531023056c52025-03-03WarningsExact identifier
unii: 8MDF5V39QO
Well at WalgreensSODIUM BICARBONATE, SODIUM CHLORIDEWalgreen Companycb5d3d9d-2481-4303-b6af-0002de8c90652025-01-31WarningsExact identifier
unii: 8MDF5V39QO
Sinus Wash PacketSODIUM BICARBONATE, SODIUM CHLORIDERITE AID CORPORATIONd5b44ae7-81e8-1413-e053-2995a90a59332025-01-31WarningsExact identifier
unii: 8MDF5V39QO
Sinus Wash Saline Refills MeijerSODIUM BICARBONATE, SODIUM CHLORIDEMeijer, Inc.dd7465fe-503a-4e34-e053-2995a90a27782025-01-31WarningsExact identifier
unii: 8MDF5V39QO
SinuCleanseSODIUM BICARBONATE, SODIUM CHLORIDEASCENT CONSUMER PRODUCTS, INC.ff4df6c5-c85f-406a-89d7-8c2853fd5e102025-01-31WarningsExact identifier
unii: 8MDF5V39QO
CVSSODIUM BICARBONATE, SODIUM CHLORIDECVS Pharmacybccefef8-f92d-42fc-90fc-86644d1df6552025-01-31WarningsExact identifier
unii: 8MDF5V39QO
Well at WalgreensSODIUM BICARBONATE, SODIUM CHLORIDEWalgreen Companybcd336b4-9189-44d5-ae6d-81e535eff6b52025-01-31WarningsExact identifier
unii: 8MDF5V39QO
SinuCleanseSODIUM BICARBONATE, SODIUM CHLORIDEASCENT CONSUMER PRODUCTS, INC.c33bf872-54aa-45e0-9e40-a6565a13f1982025-01-31WarningsExact identifier
unii: 8MDF5V39QO
Sodium Bicarbonate 10 gr (650 mg)SODIUM BICARBONATECitraGen Pharmaceuticals Inc.650fa284-5829-588f-e053-2991aa0a9a0e2025-01-30WarningsExact identifier
unii: 8MDF5V39QO
Sodium Bicarbonate 5 gr (325 mg)SODIUM BICARBONATECitraGen Pharmaceuticals Inc.68aadbd9-f1c6-8a23-e053-2991aa0afd962025-01-30WarningsExact identifier
unii: 8MDF5V39QO
Imipenem and CilastatinIMIPENEM AND CILASTATINWG Critical Care, LLC46f54df9-5afe-430c-aa19-0d84c2044b0b2025-01-16Warnings, Adverse reactionsExact identifier
unii: 5428WXZ74M

Reported adverse events (FAERS/openFDA)#

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