FDA.reportPublic FDA data

Methylprednisolone Sodium Succinate

Product NDC
82094-405
11-digit product format
820940405
Labeler code
82094
Product ID
82094-405_94c8ce6b-7622-4d1f-8b54-0ce959752ae5
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
Methylprednisolone
Dosage form
INJECTION, POWDER, LYOPHILIZED, FOR SOLUTION
Route
INTRAMUSCULAR; INTRAVENOUS
Labeler
Tianjin Kingyork Pharmaceuticals Co., Ltd
Application
ANDA212396
Marketing category
ANDA
Marketing start
2021-04-20
Substance
METHYLPREDNISOLONE SODIUM SUCCINATE
Active strength
2 g/30.6mL
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 SUCCINATE2 g/30.6mL

Harmonized Identifiers#

Field, Values table
FieldValues
UniiLEC9GKY20K
Rxcui311659, 314099, 1357886, 1743704

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
82094-405-01Methylprednisolone Sodium Succinate30.6 mL in 1 VIALINJECTION, POWDER, LYOPHILIZED,30.66
82094-405-50Methylprednisolone Sodium Succinate1 in 1 CARTONINJECTION, POWDER, LYOPHILIZED,16

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
82094-405METHYLPREDNISOLONE SODIUM SUCCINATE (METHYLPREDNISOLONE) INJECTION, POWDER, LYOPHILIZED, FOR SOLUTION [TIANJIN KINGYORK PHARMACEUTICALS CO., LTD]5Current NDC, Legacy NDC, 2 package rows20240809_77a8d96c-37df-4f3a-9757-b2d4131ff82b.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
314099methylPREDNISolone 62.5 MG/ML Injectable SolutionPSN77a8d96c-37df-4f3a-9757-b2d4131ff82b6
1743704methylPREDNISolone sodium succinate 125 MG InjectionPSN77a8d96c-37df-4f3a-9757-b2d4131ff82b6
1357886methylPREDNISolone sodium succinate 2 GM InjectionPSN77a8d96c-37df-4f3a-9757-b2d4131ff82b6
311659methylPREDNISolone sodium succinate 40 MG InjectionPSN77a8d96c-37df-4f3a-9757-b2d4131ff82b6
1743704methylprednisolone 125 MG InjectionSCD77a8d96c-37df-4f3a-9757-b2d4131ff82b6
1357886methylprednisolone 2000 MG InjectionSCD77a8d96c-37df-4f3a-9757-b2d4131ff82b6
311659methylprednisolone 40 MG InjectionSCD77a8d96c-37df-4f3a-9757-b2d4131ff82b6
314099methylprednisolone 62.5 MG/ML Injectable SolutionSCD77a8d96c-37df-4f3a-9757-b2d4131ff82b6
1743704methylprednisolone (as methylprednisolone sodium succinate) 125 MG InjectionSY77a8d96c-37df-4f3a-9757-b2d4131ff82b6
1357886methylprednisolone (as methylprednisolone sodium succinate) 2 GM InjectionSY77a8d96c-37df-4f3a-9757-b2d4131ff82b6
311659methylprednisolone (as methylprednisolone sodium succinate) 40 MG InjectionSY77a8d96c-37df-4f3a-9757-b2d4131ff82b6
314099methylprednisolone (as methylprednisolone sodium succinate) 62.5 MG/ML Injectable SolutionSY77a8d96c-37df-4f3a-9757-b2d4131ff82b6

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
82094-405-018209404050130.6 mL in 1 VIAL30.6 mlHistorical
82094-405-50820940405501 VIAL in 1 CARTON (82094-405-50) / 30.6 mL in 1 VIAL (82094-405-01) 1 vial2021-04-200000-00-00NoNoCurrent