FDA.reportPublic FDA data

NDC 63323-258-01 - Methylprednisolone Sodium Succinate

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
63323-258
Requested NDC
63323-258-01
Package NDCs from labels
63323-258-01, 63323-258-03
Manufacturer
REMEDYREPACK INC.
Effective date
2024-03-12
Current FDA listing
Not matched in FDA.report NDC product tables

DailyMed Labels#

Label, Manufacturer, Effective date table
LabelManufacturerEffective dateType
Methylprednisolone Sodium Succinate - REMEDYREPACK INC.REMEDYREPACK INC.2024-03-12HUMAN PRESCRIPTION DRUG LABEL
Methylprednisolone Sodium Succinate - Fresenius Kabi USA, LLCFresenius Kabi USA, LLC2023-03-02HUMAN PRESCRIPTION DRUG LABEL
methylPREDNISolone Sodium Succinate for Injection, USPREMEDYREPACK INC.2020-11-16HUMAN PRESCRIPTION DRUG LABEL

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
63323-258-01Methylprednisolone Sodium Succinate2 mL in 1 VIAL, SINGLE-DOSEINJECTION, POWDER, LYOPHILIZED,27
63323-258-03Methylprednisolone Sodium Succinate25 in 1 TRAYINJECTION, POWDER, LYOPHILIZED,257

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
63323-258METHYLPREDNISOLONE SODIUM SUCCINATE (METHYLPREDNISOLONE SODIUM SUCCINATE) INJECTION, POWDER, LYOPHILIZED, FOR SOLUTION [FRESENIUS KABI USA, LLC ]7Current NDC, Legacy NDC, 2 package rows20230509_c5d22210-73c6-4697-a267-75e243508642.zip

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
63323-258-01EA - Each63323-2581ab8bf02-6730-4148-9b7c-4caf12626fca12024-07-12
63323-258-03EA - Each63323-2585689026c-6fa7-45f5-ab08-a9eb9d879c9d12013-02-13

DailyMed Socrata Ingredients#

Ingredient, Type, UNII table
IngredientTypeUNIIDailyMed labelSPL versionUploaded
METHYLPREDNISOLONE SODIUM SUCCINATEACTIVE INGREDIENTLEC9GKY20KMETHYLPREDNISOLONE SODIUM SUCCINATE INJECTION, POWDER, LYOPHILIZED, FOR SOLUTION [FRESENIUS KABI USA, LLC]3
METHYLPREDNISOLONEACTIVE MOIETYX4W7ZR7023METHYLPREDNISOLONE SODIUM SUCCINATE INJECTION, POWDER, LYOPHILIZED, FOR SOLUTION [FRESENIUS KABI USA, LLC]3
LACTOSE MONOHYDRATEINACTIVE INGREDIENTEWQ57Q8I5XMETHYLPREDNISOLONE SODIUM SUCCINATE INJECTION, POWDER, LYOPHILIZED, FOR SOLUTION [FRESENIUS KABI USA, LLC]3
SODIUM HYDROXIDEINACTIVE INGREDIENT55X04QC32IMETHYLPREDNISOLONE SODIUM SUCCINATE INJECTION, POWDER, LYOPHILIZED, FOR SOLUTION [FRESENIUS KABI USA, LLC]3
SODIUM PHOSPHATE, DIBASIC ANHYDROUSINACTIVE INGREDIENT22ADO53M6FMETHYLPREDNISOLONE SODIUM SUCCINATE INJECTION, POWDER, LYOPHILIZED, FOR SOLUTION [FRESENIUS KABI USA, LLC]3
SODIUM PHOSPHATE, DIBASIC, ANHYDROUSINACTIVE INGREDIENT22ADO53M6FMETHYLPREDNISOLONE SODIUM SUCCINATE INJECTION, POWDER, LYOPHILIZED, FOR SOLUTION [FRESENIUS KABI USA, LLC]3
SODIUM PHOSPHATE, MONOBASIC ANHYDROUSINACTIVE INGREDIENTKH7I04HPUUMETHYLPREDNISOLONE SODIUM SUCCINATE INJECTION, POWDER, LYOPHILIZED, FOR SOLUTION [FRESENIUS KABI USA, LLC]3

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 4 · 79 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
Methylprednisolone Sodium SuccinateMETHYLPREDNISOLONE SODIUM SUCCINATEREMEDYREPACK INC.ae524bdb-9fd0-49f9-802d-465a374c175b2026-09-08Warnings, Adverse reactionsExact identifier
rxcui: 1743704
unii: LEC9GKY20K
0.9% Benzyl Alcohol Solution (Laboratory Use Only)0.9% BENZYL ALCOHOL SOLUTION (LABORATORY USE ONLY)Guangzhou Huanmei Cosmetics Co., Ltd5976bde6-0999-ffc4-e063-6394a90aadcf2026-08-20WarningsExact identifier
unii: LKG8494WBH
METHYLPREDNISOLONE SODIUM SUCCINATEMETHYLPREDNISOLONE SODIUM SUCCINATEHF Acquisition Co LLC, DBA HealthFirst559427ac-9fc6-96f5-e063-6294a90a0b302026-07-24Warnings, Adverse reactionsExact identifier
rxcui: 1743704
unii: LEC9GKY20K
Lidocaine Plus Pain RelievingLIDOCAINE HYDROCHLORIDE, BENZYL ALCOHOLCVS Pharmacy49003aac-184c-ae33-e063-6294a90a29c02026-07-24WarningsExact identifier
unii: LKG8494WBH
SOLU-MEDROLMETHYLPREDNISOLONE SODIUM SUCCINATESportpharm LLC0cb0ba76-067f-46c4-a5d8-b585d5ecafe32026-07-23Warnings, Adverse reactionsExact identifier
rxcui: 1743704
unii: LEC9GKY20K
Solu-MedrolMETHYLPREDNISOLONE SODIUM SUCCINATECardinal Health 107, LLC68ef8ec4-16de-4a8c-8696-b093596603802026-07-17Warnings, Adverse reactionsExact identifier
rxcui: 1743704
unii: LEC9GKY20K
ChemstatGLYCERINUM, TARAXACUM OFFICINALE, PHYTOLACCA DECANDRA, ARSENICUM ALBUM, BOVISTA, CARBO VEGETABILIS, CARBONEUM SULPHURATUM, COFFEA CRUDA, NITRICUM ACIDUM, NUX VOMICA, PETROLEUM, PHOSPHORICUM ACIDUM, PHOSPHORUS, SULPHUR, ACETYLSALICYLICUM ACIDUM, FORMALINUM, GLONOINUM, INSULINUM (HUMAN), LITHIUM CARBONICUM, TEREBINTHINA, THYROIDINUM (SUIS), ACETICUM ACIDUM, BENZOICUM ACIDUM, BENZYL ALCOHOL, BORICUM ACIDUM, CHLORINUM, CORTISONE ACETICUM, EUGENOL, FOLLICULINUM, ISOPROPYL PALMITATE, LACTICUM ACIDUM,Energique, Inc.2e361b50-9268-4053-b13c-93af645498482026-06-25WarningsExact identifier
unii: LKG8494WBH
SOLU-MEDROLMETHYLPREDNISOLONE SODIUM SUCCINATEPharmacia & Upjohn Company LLC7271310c-7764-4812-aa30-a5e90987c7a92026-06-25Warnings, Adverse reactionsExact identifier
rxcui: 1743704
rxcui: 314099
rxcui: 311659
unii: LEC9GKY20K
Methylprednisolone Sodium SuccinateMETHYLPREDNISOLONE SODIUM SUCCINATEEugia US LLC2035f00e-2299-473a-b004-cb93f541cfa92026-06-12Warnings, Adverse reactionsExact identifier
rxcui: 1743704
rxcui: 314099
rxcui: 311659
unii: LEC9GKY20K
Solu-MedrolMETHYLPREDNISOLONE SODIUM SUCCINATEHenry Schein, Inc.ea2f9b6f-2375-40a6-8b97-b607b9f3ac632026-06-04Warnings, Adverse reactionsExact identifier
rxcui: 1743704
unii: LEC9GKY20K
SOLU-MEDROLMETHYLPREDNISOLONE SODIUM SUCCINATEA-S Medication Solutions8e5997ed-f4a5-43f7-abbd-c8e2219fe0e92026-05-29Warnings, Adverse reactionsExact identifier
rxcui: 1743704
unii: LEC9GKY20K
Solu-MedrolMETHYLPREDNISOLONE SODIUM SUCCINATECardinal Health 107, LLC2af28649-2553-4bcc-9cb1-c73f7cec76d52026-05-20Warnings, Adverse reactionsExact identifier
rxcui: 1743704
rxcui: 311659
unii: LEC9GKY20K
Sodium PhosphatesSODIUM PHOSPHATE, MONOBASIC, MONOHYDRATE AND SODIUM PHOSPHATE, DIBASIC, ANHYDROUSHospira, Inc.6f044d16-295e-43ff-72a3-b045c387bc5c2026-05-11Warnings, Adverse reactionsExact identifier
unii: 22ADO53M6F
ChemstatGLYCERINUM, TARAXACUM OFFICINALE, PHYTOLACCA DECANDRA, ARSENICUM ALBUM, NITRICUM ACIDUM, NUX VOMICA, PETROLEUM, PHOSPHORICUM ACIDUM, PHOSPHORUS, ACETYLSALICYLICUM ACIDUM, GLONOINUM, INSULINUM (HUMAN), LITHIUM CARBONICUM, THYROIDINUM (SUIS), ACETICUM ACIDUM, BENZOICUM ACIDUM, BENZYL ALCOHOL, BORICUM ACIDUM, CHLORINUM, CORTISONE ACETICUM, EUGENOL, FOLLICULINUM, ISOPROPYL PALMITATE, LACTICUM ACIDUM, PETROLEUM JELLY, PHENYL BUTAZONE, PLUMBUM METALLICUM, POTASSIUM SORBATE, RESORCINUM, SALICYLICUM ACIDUM,Energique, Inc.2831d28e-9cf1-4a72-9c6c-bb014d0595582026-05-06WarningsExact identifier
unii: LKG8494WBH
Methylprednisolone sodium succinateMETHYLPREDNISOLONE SODIUM SUCCINATEREMEDYREPACK INC.f339882f-c380-4022-bdcd-94556a7926aa2026-04-15Warnings, Adverse reactionsExact identifier
rxcui: 1743704
unii: LEC9GKY20K
Dibasic Sodium Phosphate, Monobasic Potassium Phosphate and Monobasic Sodium PhosphateDIBASIC SODIUM PHOSPHATE, MONOBASIC POTASSIUM PHOSPHATE AND MONOBASIC SODIUM PHOSPHATERising Pharma Holdings, Inc.b01eac95-dbe3-4b21-a922-187e0fc8ad232026-04-07Adverse reactionsExact identifier
unii: 22ADO53M6F
PHOSPHA 250 NEUTRALDIBASIC SODIUM PHOSPHATE, MONOBASIC POTASSIUM PHOSPHATE AND MONOBASIC SODIUM PHOSPHATERising Pharma Holdings, Inc.9432adfc-6add-4ab4-ae93-2e2daf348be22026-03-25Adverse reactionsExact identifier
unii: 22ADO53M6F
Solu-MedrolMETHYLPREDNISOLONE SODIUM SUCCINATEHenry Schein, Inc.decceb81-e922-4b72-a278-3ed80f4adb042026-03-18Warnings, Adverse reactionsExact identifier
rxcui: 311659
unii: LEC9GKY20K
Walgreens Unscented Pain RelievingLIDOCAINE HYDROCHLORIDE, BENZYL ALCOHOLWalgreen Co.41eadb4f-2ca5-42a1-e063-6294a90ab4e22026-03-04WarningsExact identifier
unii: LKG8494WBH
Methylprednisolone Sodium SuccinateMETHYLPREDNISOLONE SODIUM SUCCINATEHikma Pharmaceuticals USA Inc.060bcf13-ce9e-488c-ad43-9d66abb23b182026-02-17Warnings, Adverse reactionsExact identifier
rxcui: 314099
unii: LEC9GKY20K

Reported adverse events (FAERS/openFDA)#

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