FDA.reportPublic FDA data

SOLU-MEDROL

Product NDC
51662-1264
11-digit product format
516621264
Labeler code
51662
Product ID
51662-1264_1203ca7f-080c-4c49-e063-6294a90a90e0
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
SOLU-MEDROL
Dosage form
INJECTION, POWDER, FOR SOLUTION
Route
INTRAMUSCULAR; INTRAVENOUS
Labeler
HF Acquisition Co. LLC, DBA HealthFirst
Application
NDA011856
Marketing category
NDA
Marketing start
2018-09-02
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
2026-12-31
Current FDA listing
Yes

Additional Listing Data#

Finished product
Yes
Brand name base
SOLU-MEDROL
Listing expiration
2026-12-31

Active Ingredients#

Ingredient, Strength table
IngredientStrength
METHYLPREDNISOLONE SODIUM SUCCINATE40 mg/mL

Harmonized Identifiers#

Field, Values table
FieldValues
UniiLEC9GKY20K
Rxcui311659

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

FDA-Initiated Inactive NDC Indexing#

NDC, Effective, Action table
NDCEffectiveActionDocumentIndexing SPLRelated label
51662-1264-12020-02-07C16284748780-19d75b9d0-90a9-f424-e053-dadaa90a57ceSOLU-MEDROL® 40MG PER VIAL 1mL ACT-O-VIAL®
51662-1264-12020-01-31C16284748780-19d75b9d0-90a9-f424-e053-dadaa90a57ceSOLU-MEDROL® 40MG PER VIAL 1mL ACT-O-VIAL®

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
51662-1264-1SOLU-MEDROL1 mL in 1 VIAL, SINGLE-DOSEINJECTION, POWDER, FOR SOLUTION18
51662-1264-2SOLU-MEDROL1 mL in 1 POUCHINJECTION, POWDER, FOR SOLUTION18
51662-1264-3SOLU-MEDROL25 in 1 CASEINJECTION, POWDER, FOR SOLUTION258

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
51662-1264SOLU-MEDROL INJECTION, POWDER, FOR SOLUTION [HF ACQUISITION CO. LLC, DBA HEALTHFIRST]8Current NDC, Legacy NDC, 3 package rows20240224_74e5060c-8426-1b77-e053-2a91aa0a1f13.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
311659methylPREDNISolone sodium succinate 40 MG InjectionPSN74e5060c-8426-1b77-e053-2a91aa0a1f138
311659methylprednisolone 40 MG InjectionSCD74e5060c-8426-1b77-e053-2a91aa0a1f138
311659methylprednisolone (as methylprednisolone sodium succinate) 40 MG InjectionSY74e5060c-8426-1b77-e053-2a91aa0a1f138

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
51662-1264-1516621264011 mL in 1 VIAL, SINGLE-DOSE (51662-1264-1) 1 ml2018-09-020000-00-00NoNoCurrent
51662-1264-2516621264021 mL in 1 POUCH1 mlHistorical
51662-1264-35166212640325 POUCH in 1 CASE (51662-1264-3) / 1 mL in 1 POUCH (51662-1264-2) 25 pouch2020-04-280000-00-00NoNoCurrent