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 2 of 4 · 79 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
Methylprednisolone Sodium SuccinateMETHYLPREDNISOLONE SODIUM SUCCINATECivica, Inc.2e6020f5-a486-41cc-8956-58b5f6751aa22026-02-17Warnings, Adverse reactionsExact identifier
rxcui: 1743704
rxcui: 311659
unii: LEC9GKY20K
Methylprednisolone Sodium SuccinateMETHYLPREDNISOLONE SODIUM SUCCINATEHikma Pharmaceuticals USA Inc.05d95a56-b03a-4d5b-9877-2853ac470fa12026-02-13Warnings, Adverse reactionsExact identifier
rxcui: 1743704
rxcui: 311659
unii: LEC9GKY20K
Methylprednisolone Sodium SuccinateMETHYLPREDNISOLONE SODIUM SUCCINATEHikma Pharmaceuticals USA Inc.2e540674-0915-4498-8e2b-751c7e97532a2026-02-13Warnings, Adverse reactionsExact identifier
rxcui: 314099
unii: LEC9GKY20K
SOLU-MEDROLMETHYLPREDNISOLONE SODIUM SUCCINATEREMEDYREPACK INC.1d5ef347-2e9a-432f-9a88-a7c4ba3002672026-01-30Warnings, Adverse reactionsExact identifier
rxcui: 1743704
unii: LEC9GKY20K
Solu-MedrolMETHYLPREDNISOLONE SODIUM SUCCINATECardinal Health 107, LLC7e38b09c-da41-4ee3-8f99-812d3276d5512025-12-19Warnings, Adverse reactionsExact identifier
rxcui: 311659
unii: LEC9GKY20K
SOLU-MEDROLMETHYLPREDNISOLONE SODIUM SUCCINATEProPharma Distribution42df21df-9284-4505-e063-6294a90a70242025-12-18Warnings, Adverse reactionsExact identifier
rxcui: 311659
unii: LEC9GKY20K
HepatatoxTRITICUM AESTIVUM, CHELIDONIUM MAJUS, TARAXACUM OFFICINALE, GLUTATHIONE, HEPAR SUIS, THYROIDINUM (SUIS), LYCOPODIUM CLAVATUM, NUX VOMICA, PHOSPHORICUM ACIDUM, ADRENOCORTICOTROPHIN, SALICYLICUM ACIDUM, CORTISONE ACETICUM, EUGENOL, STEARYL ALCOHOL, XYLITOL, FOLLICULINUM, BENZOICUM ACIDUM, CHLORINUM POTASSIUM SORBATE, SORBITOL, RESORCINUM, BENZYL ALCOHOL, LACTICUM ACIDUM, ISOPROPYL PALMITATE, BORICUM ACIDUM, ACETICUM ACIDUM, PHENYL BUTAZONE, PETROLEUM JELLY, PLUMBUM METALLICUMBioActive Nutritional, Inca113a9f1-4792-41a5-8d1b-a6756f356e152025-12-18WarningsExact identifier
unii: LKG8494WBH
Methylprednisolone Sodium SuccinateMETHYLPREDNISOLONETianjin Kingyork Pharmaceuticals Co., Ltd77a8d96c-37df-4f3a-9757-b2d4131ff82b2025-12-18Warnings, Adverse reactionsExact identifier
rxcui: 1743704
rxcui: 314099
rxcui: 311659
unii: LEC9GKY20K
Methylprednisolone Sodium SuccinateMETHYLPREDNISOLONEAmneal Pharmaceuticals LLCe86fbda8-00e4-4d54-841a-59dea6c15e702025-12-15Warnings, Adverse reactionsExact identifier
rxcui: 1743704
rxcui: 311659
unii: LEC9GKY20K
Thermacare Max Strength LidocaineTHERMACARE MAX STRENGTH LIDOCAINEClarion Brands LLC44fed887-d1e0-d205-e063-6294a90ac4162025-12-02WarningsExact identifier
unii: LKG8494WBH
SOLU-MEDROLMETHYLPREDNISOLONE SODIUM SUCCINATEPharmacia & Upjohn Company LLCcd99be87-c8d9-48d6-a8e5-e081052e3f192025-12-02Warnings, Adverse reactionsExact identifier
rxcui: 1743704
rxcui: 314099
rxcui: 311659
unii: LEC9GKY20K
Thermacare Heat Therapy Max Strength Lidocaine Pain Relief RollonTHERMACARE HEAT THERAPY MAX STRENGTH LIDOCAINE PAIN RELIEF ROLLONClarion Brands LLC4482d34d-eaca-5522-e063-6394a90a6afb2025-11-26WarningsExact identifier
unii: LKG8494WBH
Thermacare Heat Therapy Max Strength Lidocaine Pain Relief GelTHERMACARE HEAT THERAPY MAX STRENGTH LIDOCAINE PAIN RELIEF GELClarion Brands LLC445db02a-c8e8-6ebb-e063-6294a90a43012025-11-24WarningsExact identifier
unii: LKG8494WBH
Zilactin Early Relief Cold SoreBENZYL ALCOHOLASCENT CONSUMER PRODUCTS, INC42ef8bfa-c4d9-01cf-e063-6394a90ac88a2025-11-06WarningsExact identifier
unii: LKG8494WBH
Uro-MPMETHENAMINE, SODIUM PHOSPHATE, MONOBASIC, ANHYDROUS, PHENYL SALICYLATE, METHYLENE BLUE AND HYOSCYAMINE SULFATEMethod Pharmaceuticals, LLC1e1b0dee-1a3b-4846-a212-c9febb3fc17d2025-10-29Warnings, Adverse reactionsExact identifier
unii: KH7I04HPUU
Schuessler Tissue Salts Comb 12 General TonicCALCAREA FLUORICA,CALCAREA PHOSPHORICA,CALCAREA SULPHURICA,FERRUM PHOSPHORICUM,KALI PHOSPHORICUM,KALI MURIATICUM,KALI SULPHURICUM,MAGNESIA PHOSPHORICA,NATRUM MURIATICUM,NATRUM PHOSPHORICUM,NATRUM SULPHURICUM,SILICEAMartin & Pleasance Pty Ltd9083a01b-2fbe-4e04-9eec-bf4f65950ec72025-09-09WarningsExact identifier
unii: 22ADO53M6F
Schuessler Tissue Salts Comb 12 General TonicCALCAREA FLUORICA,CALCAREA PHOSPHORICA,CALCAREA SULPHURICA,FERRUM PHOSPHORICUM ,KALI PHOSPHORICUM,KALI MURIATICUM,KALI SULPHURICUM,MAGNESIA PHOSPHORICA,NATRUM MURIATICUM,NATRUM PHOSPHORICUM,NATRUM SULPHURICUM,SILICEAMartin & Pleasance Pty Ltdc14c79ab-85bb-45f2-83d1-1d9c298ffdfd2025-09-08WarningsExact identifier
unii: 22ADO53M6F
Schuessler Tissue Salts Comb 5 Nerve TonicCALCAREA PHOSPHORICA,MAGNESIA PHOSPHORICA,FERRUM PHOSPHORICUM ,NATRUM PHOSPHORICUM,KALI PHOSPHORICUMMartin & Pleasance Pty Ltd7fd350ec-af99-4eb2-8750-226edc7f24b02025-08-13WarningsExact identifier
unii: 22ADO53M6F
Schuessler Tissue Salts Comb 5 Nerve TonicCALCAREA PHOSPHORICA ,MAGNESIA PHOSPHORICA,FERRUM PHOSPHORICUM,NATRUM PHOSPHORICUM,KALI PHOSPHORICUMMartin & Pleasance Pty Ltdc0df631e-2935-4d55-a3c9-ee04ffdbe6fd2025-08-13WarningsExact identifier
unii: 22ADO53M6F
Sodium PhosphatesSODIUM PHOSPHATE, MONOBASIC, MONOHYDRATE AND SODIUM PHOSPHATE, DIBASIC ANHYDROUSCivica, Inc.8fd901e6-30cb-411a-b820-b9e79625ec7c2025-08-08Warnings, Adverse reactionsExact identifier
unii: 22ADO53M6F

Reported adverse events (FAERS/openFDA)#

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