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 3 of 4 · 79 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
Schuessler Tissue Salts Nat Phos Acid Neutralizer 10NATRUM PHOSPHORICUMMartin & Pleasance Pty Ltd82cb0ce1-8e56-4721-9ff9-31e66c912c602025-08-04WarningsExact identifier
unii: 22ADO53M6F
SOLU-MEDROLMETHYLPREDNISOLONE SODIUM SUCCINATEProPharma Distribution38698075-ac58-b5a4-e063-6294a90a78482025-07-18Warnings, Adverse reactionsExact identifier
rxcui: 1743704
unii: LEC9GKY20K
Schuessler Tissue Salts Nat Phos Acid Neutralizer 10NATRUM PHOSPHORICUMMartin & Pleasance Pty Ltd5a230b57-36dc-4aad-a0d4-0f5bb2dcf27c2025-07-07WarningsExact identifier
unii: 22ADO53M6F
SOLU-MEDROL(R) METHYLPREDNISOLONE SODIUM SUCCINATSOLU-MEDROL(R) METHYLPREDNISOLONE SODIUM SUCCINATHF Acquisition Co LLC, DBA HealthFirst99b3c99a-79d5-6c54-e053-2a95a90a28bc2025-01-08Warnings, Adverse reactionsExact identifier
unii: LEC9GKY20K
ChemtoxTRITICUM AESTIVUM, BERBERIS VULGARIS, GLYCYRRHIZA GLABRA, LAPPA MAJOR, RHAMNUS FRANGULA, RHAMNUS PURSHIANA, STILLINGIA SYLVATICA, TRIFOLIUM PRATENSE, XANTHOXYLUM FRAXINEUM, PHYTOLACCA DECANDRA, GLANDULA SUPRARENALIS SUIS, HEPAR SUIS, LYMPH NODE (SUIS), THYROIDINUM (SUIS), BELLADONNA, LYCOPODIUM CLAVATUM, NITRICUM ACIDUM, NUX VOMICA, PHOSPHORICUM ACIDUM, PHOSPHORUS, SALICYLICUM ACIDUM, CORTISONE ACETICUM, EUGENOL, STEARYL ALCOHOL, XYLITOL, FOLLICULINUM, BENZOICUM ACIDUM, CHLORINUM, POTASSIUM SORBATE,BioActive Nutritional, Inc.a480e5f4-5f9e-4b23-b257-b0ac1ebfc1152025-01-07WarningsExact identifier
unii: LKG8494WBH
Pain Relieving Cream LidocaineBENZYL ALCOHOL, LIDOCAINE HCITrifecta Pharmaceuticals USA LLC039a2036-54b2-cf28-e063-6294a90a8ce62024-12-31WarningsExact identifier
unii: LKG8494WBH
ITCH XBENZYL ALCOHOL/PRAMOXINE HYDROCHLORIDEBF ASCHER AND CO INC03c16d33-8f59-0184-e054-00144ff8d46c2024-12-05WarningsExact identifier
unii: LKG8494WBH
Salonpas LIDOCAINE PLUSBENZYL ALCOHOL, LIDOCAINE HYDROCHLORIDEHisamitsu America, Inc.364924d3-fac3-4f4e-9b40-decd4ec482452024-12-03WarningsExact identifier
unii: LKG8494WBH
Salonpas LIDOCAINE PLUSBENZYL ALCOHOL, LIDOCAINE HYDROCHLORIDEHisamitsu America, Inc.ea5b4a7f-d47d-4dbd-9288-c01329e387e52024-12-03WarningsExact identifier
unii: LKG8494WBH
Orajel Toothache RinseBENZYL ALCOHOL, ZINC CHLORIDEChurch & Dwight Co., Inc.41709710-5392-3119-e054-00144ff88e882024-11-27WarningsExact identifier
unii: LKG8494WBH
Meijer Pain Lidocaine Plus Relieving AnalgesicBENZYL ALCOHOL AND LIDOCAINE HYDROCHLORIDEMeijer Distribution, Incb7385140-3f63-4cbc-b557-de1d29d1ea362024-11-15WarningsExact identifier
unii: LKG8494WBH
ChemtoxTRITICUM AESTIVUM, BERBERIS VULGARIS, GLYCYRRHIZA GLABRA, LAPPA MAJOR, RHAMNUS FRANGULA, RHAMNUS PURSHIANA, STILLINGIA SYLVATICA, TRIFOLIUM PRATENSE, XANTHOXYLUM FRAXINEUM, PHYTOLACCA DECANDRA, GLANDULA SUPRARENALIS SUIS, HEPAR SUIS, LYMPH NODE (SUIS), THYROIDINUM (SUIS), BELLADONNA, LYCOPODIUM CLAVATUM, NITRICUM ACIDUM, NUX VOMICA, PHOSPHORICUM ACIDUM, PHOSPHORUS, SALICYLICUM ACIDUM, CORTISONE ACETICUM, EUGENOL, STEARYL ALCOHOL, XYLITOL, FOLLICULINUM, BENZOICUM ACIDUM, CHLORINUM, POTASSIUM SORBATE,BioActive Nutritional, Inc.9aa060f1-f8f6-46e6-a7d0-bd46a73f26762024-10-17WarningsExact identifier
unii: LKG8494WBH
Fast Freeze Lidocaine Roll-OnLIDOCAINE HYDROCHLORIDE, BENZYL ALCOHOLNatural Essentials, Inc.74b06366-5eb4-4eba-aa2b-2b672828294d2024-10-04WarningsExact identifier
unii: LKG8494WBH
CVS Health Lidocaine Plus Pain RelievingLIDOCAINE HYDROCHLORIDE, BENZYL ALCOHOLNATURAL ESSENTIALS, INC.1adb9b74-4a01-4461-b845-f3aedcb3f8102024-10-01WarningsExact identifier
unii: LKG8494WBH
22e281d7-3ac9-e0b0-e063-6394a90a29bd2a2d6c7a-f7cf-4c88-9512-e762b90199dd2024-09-24Warnings, Adverse reactionsExact identifier
spl set id: 2a2d6c7a-f7cf-4c88-9512-e762b90199dd
IvarestZINC OXIDE, BENZYL ALCOHOL, AND DIPHENHYDRAMINE HYDROCHLORIDEBlistex Inc6f68cbbb-6269-4bb3-8cc9-50b146703b422024-07-09WarningsExact identifier
unii: LKG8494WBH
Methylprednisolone sodium succinateMETHYLPREDNISOLONE SODIUM SUCCINATEDr. Reddy's Laboratories Inc738753c7-507d-4881-5194-02dd7597768b2024-06-17Warnings, Adverse reactionsExact identifier
rxcui: 1743704
rxcui: 314099
rxcui: 311659
unii: LEC9GKY20K
Sodium PhosphatesSODIUM PHOSPHATE, MONOBASIC, MONOHYDRATE AND SODIUM PHOSPHATE, DIBASIC ANHYDROUSAmerican Regent, Inc.dc0462ee-4486-418c-865f-e2a71bdb8e9e2024-06-06Warnings, Adverse reactionsExact identifier
unii: 22ADO53M6F
Walgreens Lidocaine Plus CreamBENZYL ALCOHOL AND LIDOCAINE HYDROCHLORIDEWalgreens Companye33e0097-31d6-8083-e053-2a95a90af5d22024-05-09WarningsExact identifier
unii: LKG8494WBH
HealthWise Lidocaine Plus CreamBENZYL ALCOHOL, LIDOCAINE HYDROCHLORIDEVeridian Healthcare16f26249-b508-2c6e-e063-6394a90a265b2024-04-25WarningsExact identifier
unii: LKG8494WBH

Reported adverse events (FAERS/openFDA)#

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