FDA.reportPublic FDA data

Methylprednisolone sodium succinate

Product NDC
70518-3684
11-digit product format
705183684
Labeler code
70518
Product ID
70518-3684_4f7f478b-3341-44cd-e063-6294a90a3ac3
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
Methylprednisolone sodium succinate
Dosage form
INJECTION
Route
INTRAMUSCULAR; INTRAVENOUS
Labeler
REMEDYREPACK INC.
Application
ANDA212396
Marketing category
ANDA
Marketing start
2023-03-17
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
Methylprednisolone sodium succinate
Listing expiration
2027-12-31

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
726062af-1135-4707-a1d7-57256991bbf9Product name220250226
e1637c7c-52c4-49a3-b36b-61be755aab29Product name420230717
9eb3e96d-a1d4-4de3-aa3d-a629eea44815Product name420220316
19c71a3d-ed9c-166b-a7e5-38c250c35631Product name120140508

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
70518-3684-0Methylprednisolone sodium succinate25 in 1 CARTONINJECTION255
70518-3684-1Methylprednisolone sodium succinate2 mL in 1 VIAL, SINGLE-DOSEINJECTION25

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
70518-3684METHYLPREDNISOLONE SODIUM SUCCINATE INJECTION [REMEDYREPACK INC.]3Current NDC, 2 package rows20241123_f339882f-c380-4022-bdcd-94556a7926aa.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
1743704methylPREDNISolone sodium succinate 125 MG InjectionPSNf339882f-c380-4022-bdcd-94556a7926aa5
1743704methylprednisolone 125 MG InjectionSCDf339882f-c380-4022-bdcd-94556a7926aa5
1743704methylprednisolone (as methylprednisolone sodium succinate) 125 MG InjectionSYf339882f-c380-4022-bdcd-94556a7926aa5

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startSampleExclude flagStatus
70518-3684-07051836840025 VIAL, SINGLE-DOSE in 1 CARTON (70518-3684-0) / 2 mL in 1 VIAL, SINGLE-DOSE (70518-3684-1) 2023-03-17NoNoHistorical
70518-3684-1705183684012 mL in 1 VIAL, SINGLE-DOSE2 mlHistorical