FDA.reportPublic FDA data

Methylprednisolone Sodium Succinate

Product NDC
0143-9182
11-digit product format
001439182
Labeler code
0143
Product ID
0143-9182_5ba132ce-e07c-46e3-afa5-800847136136
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
Methylprednisolone Sodium Succinate
Dosage form
INJECTION, POWDER, FOR SOLUTION
Route
INTRAMUSCULAR; INTRAVENOUS
Labeler
Hikma Pharmaceuticals USA Inc.
Application
ANDA202691
Marketing category
ANDA
Marketing start
2024-01-15
Substance
METHYLPREDNISOLONE SODIUM SUCCINATE
Active strength
1 g/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 SUCCINATE1 g/1

Harmonized Identifiers#

Field, Values table
FieldValues
UniiLEC9GKY20K
Rxcui314099

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
7cda52fc-125f-421c-8fea-bc1974370c49Product name220180703

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
0143-9182-01Methylprednisolone Sodium Succinate1 in 1 VIAL, MULTI-DOSEINJECTION, POWDER, FOR SOLUTION12
0143-9182-01Methylprednisolone Sodium Succinate1 in 1 CARTONINJECTION, POWDER, FOR SOLUTION12

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
0143-9182METHYLPREDNISOLONE SODIUM SUCCINATE INJECTION, POWDER, FOR SOLUTION [HIKMA PHARMACEUTICALS USA INC.]2Current NDC, 2 package rows20240319_060bcf13-ce9e-488c-ad43-9d66abb23b18.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
314099methylPREDNISolone 62.5 MG/ML Injectable SolutionPSN060bcf13-ce9e-488c-ad43-9d66abb23b182
314099methylprednisolone 62.5 MG/ML Injectable SolutionSCD060bcf13-ce9e-488c-ad43-9d66abb23b182
314099methylprednisolone (as methylprednisolone sodium succinate) 62.5 MG/ML Injectable SolutionSY060bcf13-ce9e-488c-ad43-9d66abb23b182

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionMarketing startSampleExclude flagStatus
0143-9182-01001439182011 VIAL, MULTI-DOSE in 1 CARTON (0143-9182-01) / 1 INJECTION, POWDER, FOR SOLUTION in 1 VIAL, MULTI-DOSE2024-01-15NoNoCurrent