SOLU-MEDROL

Product NDC
70518-2023
11-digit product format
705182023
Labeler code
70518
Product ID
70518-2023_499b1561-882b-8553-e063-6294a90ad423
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
methylprednisolone sodium succinate
Dosage form
INJECTION, POWDER, FOR SOLUTION
Route
INTRAMUSCULAR; INTRAVENOUS
Labeler
REMEDYREPACK INC.
Application
NDA011856
Marketing category
NDA
Marketing start
2019-04-15
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
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 SUCCINATE125 mg/2mL

Harmonized Identifiers#

Field, Values table
FieldValues
UniiLEC9GKY20K
Rxcui1743704, 1743707

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
70518-2023-0SOLU-MEDROL2 mL in 1 VIALINJECTION, POWDER, FOR SOLUTION212
70518-2023-1SOLU-MEDROL25 in 1 CARTONINJECTION, POWDER, FOR SOLUTION2512

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
70518-2023SOLU-MEDROL (METHYLPREDNISOLONE SODIUM SUCCINATE) INJECTION, POWDER, FOR SOLUTION [REMEDYREPACK INC.]8Current NDC, Legacy NDC, 2 package rows20250308_1d5ef347-2e9a-432f-9a88-a7c4ba300267.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
1743704methylPREDNISolone sodium succinate 125 MG InjectionPSN1d5ef347-2e9a-432f-9a88-a7c4ba30026712
1743707SOLU-Medrol 125 MG InjectionPSN1d5ef347-2e9a-432f-9a88-a7c4ba30026712
1743707methylprednisolone 125 MG Injection [Solu-Medrol]SBD1d5ef347-2e9a-432f-9a88-a7c4ba30026712
1743704methylprednisolone 125 MG InjectionSCD1d5ef347-2e9a-432f-9a88-a7c4ba30026712
1743704methylprednisolone (as methylprednisolone sodium succinate) 125 MG InjectionSY1d5ef347-2e9a-432f-9a88-a7c4ba30026712
1743707Solu-Medrol (as methylprednisolone sodium succinate) 125 MG InjectionSY1d5ef347-2e9a-432f-9a88-a7c4ba30026712
1743707Solu-Medrol 125 MG InjectionSY1d5ef347-2e9a-432f-9a88-a7c4ba30026712

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
70518-2023-0705182023002 mL in 1 VIAL2 mlHistorical
70518-2023-17051820230125 VIAL in 1 CARTON (70518-2023-1) / 2 mL in 1 VIAL (70518-2023-0) 25 vial2019-04-150000-00-00NoNoCurrent
70518-2023-27051820230225 VIAL in 1 CARTON (70518-2023-2) > 2 mL in 1 VIAL (70518-2023-3) 25 vial2021-08-270000-00-00NoNoCurrent