SOLU-MEDROL

Product NDC
51662-1263
11-digit product format
516621263
Labeler code
51662
Product ID
51662-1263_101f02e1-5d9f-7fc6-e063-6294a90a1455
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
125 mg/2mL
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 SUCCINATE125 mg/2mL

Harmonized Identifiers#

Field, Values table
FieldValues
UniiLEC9GKY20K
Rxcui1743704

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
51662-1263-12020-02-07C16284748780-19d75b9d0-90a6-f424-e053-dadaa90a57ceSOLU-MEDROL® 125MG PER VIAL 2mL ACT-O-VIAL®
51662-1263-12020-01-31C16284748780-19d75b9d0-90a6-f424-e053-dadaa90a57ceSOLU-MEDROL® 125MG PER VIAL 2mL ACT-O-VIAL®

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
51662-1263-1SOLU-MEDROL1 mL in 1 VIAL, SINGLE-USEINJECTION, POWDER, FOR SOLUTION17
51662-1263-2SOLU-MEDROL1 mL in 1 POUCHINJECTION, POWDER, FOR SOLUTION17
51662-1263-3SOLU-MEDROL25 in 1 CASEINJECTION, POWDER, FOR SOLUTION257

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
51662-1263SOLU-MEDROL INJECTION, POWDER, FOR SOLUTION [HF ACQUISITION CO. LLC, DBA HEALTHFIRST]7Current NDC, Legacy NDC, 3 package rows20240131_74e448ed-f4b4-8d09-e053-2991aa0a7500.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
1743704methylPREDNISolone sodium succinate 125 MG InjectionPSN74e448ed-f4b4-8d09-e053-2991aa0a75007
1743704methylprednisolone 125 MG InjectionSCD74e448ed-f4b4-8d09-e053-2991aa0a75007
1743704methylprednisolone (as methylprednisolone sodium succinate) 125 MG InjectionSY74e448ed-f4b4-8d09-e053-2991aa0a75007

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
51662-1263-1516621263011 mL in 1 VIAL, SINGLE-USE (51662-1263-1) 1 ml2018-09-020000-00-00NoNoCurrent
51662-1263-2516621263021 mL in 1 POUCH1 mlHistorical
51662-1263-35166212630325 POUCH in 1 CASE (51662-1263-3) / 1 mL in 1 POUCH (51662-1263-2) 25 pouch2020-04-290000-00-00NoNoCurrent