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 4 of 4 · 79 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
SOLU-MEDROLSOLU-MEDROLHF Acquisition Co. LLC, DBA HealthFirst74e5060c-8426-1b77-e053-2a91aa0a1f132024-02-22Warnings, Adverse reactionsExact identifier
rxcui: 311659
unii: LEC9GKY20K
Monobasic Sodium Phosphate and Dibasic Sodium PhosphateMONOBASIC SODIUM PHOSPHATE AND DIBASIC SODIUM PHOSPHATELupin Pharmaceuticals,Inc.e2fcc382-6fac-4438-ad02-ebc8528dd59a2024-01-30Boxed warning, Warnings, Adverse reactionsExact identifier
unii: 22ADO53M6F
SOLU-MEDROLSOLU-MEDROLHF Acquisition Co. LLC, DBA HealthFirst74e448ed-f4b4-8d09-e053-2991aa0a75002024-01-29Warnings, Adverse reactionsExact identifier
rxcui: 1743704
unii: LEC9GKY20K
CVS Maximum Strength LIDOCAINE PLUSBENZYL ALCOHOL, LIDOCAINE HYDROCHLORIDECVS Pharmacy Inc.e6aff579-affb-41bb-8e36-53ea484cb0c52023-11-26WarningsExact identifier
unii: LKG8494WBH
LipotoxSQUALENE, CHOLESTERINUM, ESTRADIOL, PROGESTERONE, ASPARTAME, BENZALKONIUM CHLORIDE, FORMALINUM, METHYLENE CHLORIDE, METHYLPARABEN, PROPYLPARABEN, SODIUM BENZOATE, SODIUM CITRATE, TITANIUM DIOXIDE, ZINCUM OXYDATUM, ARSENICUM ALBUM, LYCOPODIUM CLAVATUM, NUX VOMICA, PHOSPHORICUM ACIDUM, PHOSPHORUS, ACETICUM ACIDUM, BENZOICUM ACIDUM, BENZYL ALCOHOL, BORICUM ACIDUM, CHLORINUM, CORTISONE ACETICUM, EUGENOL, FOLLICULINUM, ISOPROPYL PALMITATE, LACTICUM ACIDUM, PETROLEUM JELLY, PHENYL BUTAZONE, PLUMBUM METALLICUM,BioActive Nutritional, Inc.a1538692-ca00-4e52-9b7e-409767ee27e12023-09-05WarningsExact identifier
unii: LKG8494WBH
Anubis BarcelonaDMAE, ZIRHAFIRMANUBIS COSMETICS SLf2274f8c-08aa-eb02-e053-2a95a90a39982023-09-01WarningsExact identifier
unii: LKG8494WBH
Anubis BarcelonaPROPANEDIOL, GLYCERIN, MAGNESIUM ASCORBYL PHOSPHATEANUBIS COSMETICS SLeb53cba1-0509-43bc-e053-2995a90a5e092023-09-01WarningsExact identifier
unii: LKG8494WBH
SOLU-MEDROLMETHYLPREDNISOLONE SODIUM SUCCINATEMedical Purchasing Solutions, LLC6a26a977-95dd-cdae-e053-2a91aa0a8b0a2023-05-30Warnings, Adverse reactionsExact identifier
rxcui: 1743704
unii: LEC9GKY20K
SOLU-MEDROLMETHYLPREDNISOLONE SODIUM SUCCINATEMedical Purchasing Solutions, LLCdd2bfa31-9eae-2baa-e053-2a95a90a9db72023-05-23Warnings, Adverse reactionsExact identifier
rxcui: 311659
unii: LEC9GKY20K
SOLU-MEDROLMETHYLPREDNISOLONE SODIUM SUCCINATEMedical Purchasing Solutions, LLCb635e21b-d68d-f60b-e053-2995a90a0f462023-05-08Warnings, Adverse reactionsExact identifier
rxcui: 1743704
unii: LEC9GKY20K
Methylprednisolone Sodium SuccinateMETHYLPREDNISOLONE SODIUM SUCCINATEFresenius Kabi USA, LLCc5d22210-73c6-4697-a267-75e2435086422023-03-02Warnings, Adverse reactionsExact identifier
application number: ANDA040612
application number: ANDA040583
ndc (package): 63323-258-03
ndc (package): 63323-255-01
ndc (package): 63323-258-01
ndc (package): 63323-265-30
ndc (package): 63323-255-03
ndc (product): 63323-265
ndc (product): 63323-255
ndc (product): 63323-258
ndc11 (package): 63323025801
rxcui: 1743704
rxcui: 314099
rxcui: 311659
spl id: dc369096-3042-4942-9aeb-bbdf98f35bb8
spl set id: c5d22210-73c6-4697-a267-75e243508642
unii: LEC9GKY20K
K-Phos No. 2POTASSIUM PHOSPHATE, MONOBASIC AND SODIUM PHOSPHATE, MONOBASIC, ANHYDROUSBeach Products, Inc.9f446400-c403-4971-879e-1341f7f7d9da2023-02-23Adverse reactionsExact identifier
unii: KH7I04HPUU
K Phos NeutralSODIUM PHOSPHATE, DIBASIC, ANHYDROUS, POTASSIUM PHOSPHATE, MONOBASIC, AND SODIUM PHOSPHATE, MONOBASIC, MONOHYDRATEBeach Products, Inc.83376725-ee0f-40ad-bd90-31a61b9445cf2023-02-23Adverse reactionsExact identifier
unii: 22ADO53M6F
NAT. PHOS.SODIUM PHOSPHATE, DIBASIC, ANHYDROUSHyland's Inc.9ad86f9f-df9e-4e5c-bce4-571e1da441452022-12-19WarningsExact identifier
unii: 22ADO53M6F
Sodium PhosphatesSODIUM PHOSPHATE, MONOBASIC, MONOHYDRATE AND SODIUM PHOSPHATE, DIBASIC, ANHYDROUSFresenius Kabi USA, LLC5bf47be3-f3fe-452b-8113-9417964983452022-03-31Warnings, Adverse reactionsExact identifier
unii: 22ADO53M6F
Sodium PhosphatesSODIUM PHOSPHATE, MONOBASIC, MONOHYDRATEFresenius Kabi USA, LLCe6169d3b-39d2-47f9-8d5b-b53ec069a7222021-07-23Warnings, Adverse reactionsExact identifier
unii: 22ADO53M6F
c4e5206c-c518-10a3-e053-2995a90acb1db4e75a4f-e048-4b1d-b9c6-2d79e8b9a6b12021-06-16Warnings, Adverse reactionsExact identifier
spl set id: b4e75a4f-e048-4b1d-b9c6-2d79e8b9a6b1
Ivy-Dry SuperBENZYL ALCOHOL, CAMPHOR, MENTHOLIvy-Dry, Inc.4792a667-2378-4b3d-968d-9efb1866792f2017-12-27WarningsExact identifier
unii: LKG8494WBH
Homeoplex DGLYCERINUM, PHYTOLACCA DECANDRA, TARAXACUM OFFICINALE, ARSENICUM ALBUM, NITRICUM ACIDUM, NUX VOMICA, PETROLEUM, PHOSPHORICUM ACIDUM, PHOSPHORUS, ACETYLSALICYLICUM ACIDUM, GLONOINUM, INSULINUM (SUIS), LITHIUM CARBONICUM, THYROIDINUM (SUIS), SALICYLICUM ACIDUM, ADRENOCORTICOTROPHIN, CORTISONE ACETICUM, EUGENOL, STEARYL ALCOHOL, XYLITOL, FOLLICULINUM, BENZOICUM ACIDUM, CHLORINUM, POTASSIUM SORBATE, SORBITOL, RESORCINUM, BENZYL ALCOHOL, LACTICUM ACIDUM, ISOPROPYL PALMITATE, BORICUM ACIDUM, ACETICUM ACIDUM,Supplement Clinic, LLC.cd6b48ab-3566-484d-8deb-15ef6f8e7e8f2017-11-01WarningsExact identifier
unii: LKG8494WBH

Reported adverse events (FAERS/openFDA)#

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