FDA.reportPublic FDA data

NDC 63323-322-01 - 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
63323-322
Requested NDC
63323-322-01
Package NDCs from labels
63323-322-21, 63323-322-93, 63323-322-41, 63323-322-94, 63323-322-01, 63323-322-25
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
63323-322-01Imipenem and Cilastatin20 mL in 1 VIAL, SINGLE-DOSEINJECTION, POWDER, FOR SOLUTION2012
63323-322-25Imipenem and Cilastatin25 in 1 CARTONINJECTION, POWDER, FOR SOLUTION2512
63323-322-41Imipenem and Cilastatin20 mL in 1 VIAL, SINGLE-DOSEINJECTION, POWDER, FOR SOLUTION207
63323-322-94Imipenem and Cilastatin25 in 1 CARTONINJECTION, POWDER, FOR SOLUTION257
63323-322-21Imipenem and Cilastatin20 mL in 1 VIAL, SINGLE-DOSEINJECTION, POWDER, FOR SOLUTION205
63323-322-93Imipenem and Cilastatin25 in 1 CARTONINJECTION, POWDER, FOR SOLUTION255

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
63323-322IMIPENEM 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
63323-322IMIPENEM 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
63323-322IMIPENEM 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
63323-322-01EA - Each63323-32234deeaf8-735f-4d5d-8ce0-f7bca735d05f12022-01-06
63323-322-20EA - Each63323-32215d13752-d665-47b7-a49c-deac99c4cf1512012-07-24
63323-322-21EA - Each63323-322f295eda5-5f73-456c-93a6-9c36771eb01712022-04-06
63323-322-25EA - Each63323-3223224fb37-f888-4ac9-943f-4fd3d043976d12013-02-13
63323-322-41EA - Each63323-3221036c74b-ed3a-40f7-bbf1-87d3249cda1712022-10-06
63323-322-93EA - Each63323-32209ffc170-6c97-4df2-939c-49e83a8a41f712016-07-19
63323-322-94EA - Each63323-32289f6cade-0bdd-4c18-b4ce-d0e9ff9c765512015-01-05

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 9 of 11 · 207 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
Omeprazole and Sodium BicarbonateOMEPRAZOLE AND SODIUM BICARBONATEScieGen Pharmaceuticals, Inc.a107804e-b308-4e79-9447-07d93016f70f2024-10-24Warnings, Adverse reactionsExact identifier
unii: 8MDF5V39QO
OHTAS ISAN ANTACIDCALCIUM CARBONATE, SODIUM BICARBONATEOHTA'S ISAN CO.,LTD.53380470-5748-6fa7-548e-7484ef204c0f2024-10-21WarningsExact identifier
unii: 8MDF5V39QO
OHTAS ISAN ANTACIDCALCIUM CARBONATE, SODIUM BICARBONATEOHTA'S ISAN CO.,LTD.8723fe90-8402-4511-b6c6-b71cf98513e32024-10-21WarningsExact identifier
unii: 8MDF5V39QO
Elliotts BSODIUM CATION, SODIUM BICARBONATE, ANHYDROUS DEXTROSE, MAGNESIUM SULFATE, POTASSIUM CHLORIDE, CALCIUM CHLORIDE, SODIUM PHOSPHATELukare Medical, LLC08036dbd-55b3-47b9-9890-000f253544f32024-10-16Warnings, Adverse reactionsExact identifier
unii: 8MDF5V39QO
SODIUM BICARBONATESODIUM BICARBONATE INJECTION,Long Grove Pharmaceuticals, LLCa26d709b-b294-4b02-9a88-7e840f099a332024-09-25Warnings, Adverse reactionsExact identifier
unii: 8MDF5V39QO
Insect sting relief latex 01SODIUM BICARBONATECosmuses Cosmetics (Ningbo) Co., Ltd.1b9e2d4c-bc0c-6ed0-e063-6294a90a91032024-08-19WarningsExact identifier
unii: 8MDF5V39QO
Quality Choice Effervescent Antacid and Pain Relief - Extra StrengthASPIRIN, ANHYDROUS CITRIC ACID, SODIUM BICARBONATEChain Drug Marketing Association1f926637-a61c-8eb7-e063-6394a90a65022024-08-13WarningsExact identifier
unii: 8MDF5V39QO
Omeprazole/Sodiium BicarbonateOMEPRAZOLE/SODIIUM BICARBONATEDirect_rx1f7f63c1-17c2-9a05-e063-6394a90abc6f2024-08-12Warnings, Adverse reactionsExact identifier
unii: 8MDF5V39QO
Omeprazole and Sodium BicarbonateOMEPRAZOLE AND SODIUM BICARBONATEDr. Reddy's Laboratories Inc.,ddee28fb-c871-a6d4-984f-515522b284122024-07-15WarningsExact identifier
unii: 8MDF5V39QO
PRIMAXIN IVIMIPENEM AND CILASTATIN SODIUMMerck Sharp & Dohme LLCf41d8abd-7792-4918-1b93-bd83ea01955e2024-07-05Warnings, Adverse reactionsExact identifier
rxcui: 1726204
unii: 71OTZ9ZE0A
unii: 5428WXZ74M
Insect sting relief pad 01SODIUM BICARBONATECosmuses Cosmetics (Ningbo) Co., Ltd.1b0f0088-6482-6de7-e063-6294a90aeeb72024-06-17WarningsExact identifier
unii: 8MDF5V39QO
Omeprazole and Sodium BicarbonateOMEPRAZOLE AND SODIUM BICARBONATEANI Pharmaceuticals, Inc.63c3bd6c-a586-4ec0-8f45-ed936936dfeb2024-06-06Warnings, Adverse reactionsExact identifier
unii: 8MDF5V39QO
SODIUM BICARBONATESODIUM BICARBONATESun Pharmaceutical Industries Limited5ae65432-04a1-4b6b-8536-2535064fc7822024-03-06Warnings, Adverse reactionsExact identifier
unii: 8MDF5V39QO
Sodium BicarbonateSODIUM BICARBONATESteriscience Specialties Private Limitedeb2996b4-c04c-4678-b8a9-5cbbe509bb702024-03-04Warnings, Adverse reactionsExact identifier
unii: 8MDF5V39QO
Sodium BicarbonateSODIUM BICARBONATEBryant Ranch Prepack4493d7c5-f2c3-416e-a5c1-35398fc7f61d2024-02-29Boxed warning, WarningsExact identifier
unii: 8MDF5V39QO
SODIUM BICARBONATESODIUM BICARBONATEHF Acquisition Co LLC, DBA HealthFirsta5eedf57-2783-b3d0-e053-2a95a90a9ff52024-02-22Warnings, Adverse reactionsExact identifier
unii: 8MDF5V39QO
SODIUM BICARBONATESODIUM BICARBONATEHF Acquisition Co LLC, DBA HealthFirst76131655-3a87-feac-e053-2991aa0a82a12024-01-28Warnings, Adverse reactionsExact identifier
unii: 8MDF5V39QO
N03 EXCHEMALLIUM SATIVUM, ARSENICUM ALBUM, BENZOICUM ACIDUM, BERBERIS VULGARIS, BETULA VERRUCOSA, CALCAREA CARBONICA, CARBOLICUM ACIDUM, CHELIDONIUM MAJUS, CHLORINUM, CITRICUM ACIDUM, HISTAMINUM, ICHTHYOLUM, JUNIPERUS COMMUNIS, LYCOPODIUM CLAVATUM, MERCURIUS SOLUBILIS, NATRUM BICARBONICUM, SODIUM HYPOCHLORITE, SOLIDAGO VIRGAUREA, SULPHURApex Energetics Inc.ba73a050-9a5d-1549-e053-2a95a90a62aa2024-01-08WarningsExact identifier
unii: 8MDF5V39QO
Sodium BicarbonateSODIUM BICARBONATEPharma Nobis, LLCe42f674b-1a70-6a3c-e053-2995a90afa722023-12-22WarningsExact identifier
unii: 8MDF5V39QO
HEB Extra Strength Effervescent Antacid and Pain ReliefASPIRIN, CITRIC ACID, SODIUM BICARBONATEH. E. Butt Grocery Company9e502bd0-8042-8674-e053-2995a90a3d152023-12-18WarningsExact identifier
unii: 8MDF5V39QO

Reported adverse events (FAERS/openFDA)#

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