Methylprednisolone Sodium Succinate

Product NDC
70518-4345
11-digit product format
705184345
Labeler code
70518
Product ID
70518-4345_36218d0a-50c8-3843-e063-6394a90aa28e
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
Methylprednisolone Sodium Succinate
Dosage form
INJECTION, POWDER, FOR SOLUTION
Route
INTRAMUSCULAR; INTRAVENOUS
Labeler
REMEDYREPACK INC.
Application
ANDA203125
Marketing category
ANDA
Marketing start
2025-05-27
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
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

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
70518-4345-0Methylprednisolone Sodium Succinate25 in 1 CARTONINJECTION, POWDER, FOR SOLUTION251
70518-4345-1Methylprednisolone Sodium Succinate1 in 1 VIAL, SINGLE-DOSEINJECTION, POWDER, FOR SOLUTION11

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
70518-4345METHYLPREDNISOLONE SODIUM SUCCINATE INJECTION, POWDER, FOR SOLUTION [REMEDYREPACK INC.]1Current NDC, 2 package rows20250529_ae524bdb-9fd0-49f9-802d-465a374c175b.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
1743704methylPREDNISolone sodium succinate 125 MG InjectionPSNae524bdb-9fd0-49f9-802d-465a374c175b1
1743704methylprednisolone 125 MG InjectionSCDae524bdb-9fd0-49f9-802d-465a374c175b1
1743704methylprednisolone (as methylprednisolone sodium succinate) 125 MG InjectionSYae524bdb-9fd0-49f9-802d-465a374c175b1

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionMarketing startSampleExclude flagStatus
70518-4345-07051843450025 VIAL, SINGLE-DOSE in 1 CARTON (70518-4345-0) / 1 INJECTION, POWDER, FOR SOLUTION in 1 VIAL, SINGLE-DOSE (70518-4345-1) 2025-05-27NoNoCurrent
70518-4345-1705184345011 in 1 VIAL, SINGLE-DOSEHistorical