FDA.reportPublic FDA data

Methylprednisolone Sodium Succinate

Product NDC
55150-263
11-digit product format
551500263
Labeler code
55150
Product ID
55150-263_1d8c98fc-8bb8-4caa-a745-5d42ddd2c8ec
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
Methylprednisolone Sodium Succinate
Dosage form
INJECTION, POWDER, LYOPHILIZED, FOR SOLUTION
Route
INTRAMUSCULAR; INTRAVENOUS
Labeler
Eugia US LLC
Application
ANDA207667
Marketing category
ANDA
Marketing start
2015-12-15
Substance
METHYLPREDNISOLONE SODIUM SUCCINATE
Active strength
125 mg/1
Pharmacologic classes
Corticosteroid Hormone Receptor Agonists [MoA], Corticosteroid [EPC]
NDC exclude flag
No
Listing certified through
2026-12-31
Current FDA listing
Yes

Additional Listing Data#

Finished product
Yes
Brand name base
Methylprednisolone Sodium Succinate
Listing expiration
2026-12-31

Active Ingredients#

Ingredient, Strength table
IngredientStrength
METHYLPREDNISOLONE SODIUM SUCCINATE125 mg/1

Harmonized Identifiers#

Field, Values table
FieldValues
UniiLEC9GKY20K
Rxcui311659, 314099, 1357886, 1743704

DailyMed Product Concepts#

Product concept, Relation, Version table
Product conceptRelationVersionEffective
b3918abe-5cd1-b0ce-abd7-2dd6732cde26Product name520260128
726062af-1135-4707-a1d7-57256991bbf9Product name220250226
e1637c7c-52c4-49a3-b36b-61be755aab29Product name420230717
9eb3e96d-a1d4-4de3-aa3d-a629eea44815Product name420220316
19c71a3d-ed9c-166b-a7e5-38c250c35631Product name120140508

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
55150-263-03Methylprednisolone Sodium Succinate25 in 1 CARTONINJECTION, POWDER, LYOPHILIZED,255
55150-263-03Methylprednisolone Sodium Succinate1 in 1 VIAL, SINGLE-DOSEINJECTION, POWDER, LYOPHILIZED,15

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
55150-263METHYLPREDNISOLONE SODIUM SUCCINATE INJECTION, POWDER, LYOPHILIZED, FOR SOLUTION [EUGIA US LLC]5Current NDC, Legacy NDC, 2 package rows20240704_2035f00e-2299-473a-b004-cb93f541cfa9.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
314099methylPREDNISolone 62.5 MG/ML Injectable SolutionPSN2035f00e-2299-473a-b004-cb93f541cfa95
1743704methylPREDNISolone sodium succinate 125 MG InjectionPSN2035f00e-2299-473a-b004-cb93f541cfa95
1357886methylPREDNISolone sodium succinate 2 GM InjectionPSN2035f00e-2299-473a-b004-cb93f541cfa95
311659methylPREDNISolone sodium succinate 40 MG InjectionPSN2035f00e-2299-473a-b004-cb93f541cfa95
1743704methylprednisolone 125 MG InjectionSCD2035f00e-2299-473a-b004-cb93f541cfa95
1357886methylprednisolone 2000 MG InjectionSCD2035f00e-2299-473a-b004-cb93f541cfa95
311659methylprednisolone 40 MG InjectionSCD2035f00e-2299-473a-b004-cb93f541cfa95
314099methylprednisolone 62.5 MG/ML Injectable SolutionSCD2035f00e-2299-473a-b004-cb93f541cfa95
1743704methylprednisolone (as methylprednisolone sodium succinate) 125 MG InjectionSY2035f00e-2299-473a-b004-cb93f541cfa95
1357886methylprednisolone (as methylprednisolone sodium succinate) 2 GM InjectionSY2035f00e-2299-473a-b004-cb93f541cfa95
311659methylprednisolone (as methylprednisolone sodium succinate) 40 MG InjectionSY2035f00e-2299-473a-b004-cb93f541cfa95
314099methylprednisolone (as methylprednisolone sodium succinate) 62.5 MG/ML Injectable SolutionSY2035f00e-2299-473a-b004-cb93f541cfa95

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionMarketing startMarketing endSampleExclude flagStatus
55150-263-035515002630325 VIAL, SINGLE-DOSE in 1 CARTON (55150-263-03) / 1 INJECTION, POWDER, LYOPHILIZED, FOR SOLUTION in 1 VIAL, SINGLE-DOSE2015-12-150000-00-00NoNoCurrent