Solu-Medrol

Product NDC
0404-9958
11-digit product format
004049958
Labeler code
0404
Product ID
0404-9958_f4c6a69e-cc09-4328-a863-8c32a7f73a68
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
Methylprednisolone Sodium Succinate
Dosage form
INJECTION, POWDER, FOR SOLUTION
Route
INTRAMUSCULAR; INTRAVENOUS
Labeler
Henry Schein, Inc.
Application
NDA011856
Marketing category
NDA
Marketing start
2022-01-12
Substance
METHYLPREDNISOLONE SODIUM SUCCINATE
Active strength
40 mg/mL
Pharmacologic classes
Corticosteroid Hormone Receptor Agonists [MoA], Corticosteroid [EPC]
NDC exclude flag
No
Listing certified through
2027-12-31
Current FDA listing
Yes

Additional Listing Data#

Finished product
Yes
Brand name base
Solu-Medrol
Listing expiration
2027-12-31

Active Ingredients#

Ingredient, Strength table
IngredientStrength
METHYLPREDNISOLONE SODIUM SUCCINATE40 mg/mL

Harmonized Identifiers#

Field, Values table
FieldValues
UniiLEC9GKY20K
Rxcui207191, 311659

DailyMed Product Concepts#

Product concept, Relation, Version table
Product conceptRelationVersionEffective
b3918abe-5cd1-b0ce-abd7-2dd6732cde26Product name520260128
e1637c7c-52c4-49a3-b36b-61be755aab29Product name420230717
9eb3e96d-a1d4-4de3-aa3d-a629eea44815Product name420220316

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
0404-9958-01Solu-Medrol1 in 1 BAGINJECTION, POWDER, FOR SOLUTION18
0404-9958-01Solu-Medrol1 mL in 1 VIAL, SINGLE-DOSEINJECTION, POWDER, FOR SOLUTION18

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
0404-9958SOLU-MEDROL (METHYLPREDNISOLONE SODIUM SUCCINATE) INJECTION, POWDER, FOR SOLUTION [HENRY SCHEIN, INC.]7Current NDC, Legacy NDC, 2 package rows20250322_decceb81-e922-4b72-a278-3ed80f4adb04.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
311659methylPREDNISolone sodium succinate 40 MG InjectionPSNdecceb81-e922-4b72-a278-3ed80f4adb048
207191SOLU-Medrol 40 MG InjectionPSNdecceb81-e922-4b72-a278-3ed80f4adb048
207191methylprednisolone 40 MG Injection [Solu-Medrol]SBDdecceb81-e922-4b72-a278-3ed80f4adb048
311659methylprednisolone 40 MG InjectionSCDdecceb81-e922-4b72-a278-3ed80f4adb048
311659methylprednisolone (as methylprednisolone sodium succinate) 40 MG InjectionSYdecceb81-e922-4b72-a278-3ed80f4adb048
207191Solu-Medrol (as methylprednisolone sodium succinate) 40 MG InjectionSYdecceb81-e922-4b72-a278-3ed80f4adb048
207191Solu-Medrol 40 MG InjectionSYdecceb81-e922-4b72-a278-3ed80f4adb048

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionMarketing startMarketing endSampleExclude flagStatus
0404-9958-01004049958011 VIAL, SINGLE-DOSE in 1 BAG (0404-9958-01) / 1 mL in 1 VIAL, SINGLE-DOSE2022-01-120000-00-00NoNoCurrent