FDA.reportPublic FDA data

Methylprednisolone sodium succinate

Product NDC
43598-129
11-digit product format
435980129
Labeler code
43598
Product ID
43598-129_9846244f-7189-5a82-a2aa-8f123805ee1f
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
Methylprednisolone sodium succinate
Dosage form
INJECTION
Route
INTRAMUSCULAR; INTRAVENOUS
Labeler
Dr. Reddy's Laboratories Inc
Application
ANDA212396
Marketing category
ANDA
Marketing start
2022-03-24
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
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/2mL

Harmonized Identifiers#

Field, Values table
FieldValues
UniiLEC9GKY20K
Rxcui311659, 314099, 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
43598-129-01Methylprednisolone sodium succinate2 mL in 1 VIAL, SINGLE-DOSEINJECTION24
43598-129-25Methylprednisolone sodium succinate25 in 1 CARTONINJECTION254

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
43598-129-01EA - Each43598-12984266e20-5f6c-4b2c-a1df-732f9655f02012022-07-06
43598-129-25EA - Each43598-12907944302-bc2c-49ea-9e59-7a0b4e5d211c12022-04-06

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
43598-129METHYLPREDNISOLONE SODIUM SUCCINATE INJECTION [DR. REDDY'S LABORATORIES INC]4Current NDC, Legacy NDC, 2 package rows20240619_738753c7-507d-4881-5194-02dd7597768b.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
314099methylPREDNISolone 62.5 MG/ML Injectable SolutionPSN738753c7-507d-4881-5194-02dd7597768b4
1743704methylPREDNISolone sodium succinate 125 MG InjectionPSN738753c7-507d-4881-5194-02dd7597768b4
311659methylPREDNISolone sodium succinate 40 MG InjectionPSN738753c7-507d-4881-5194-02dd7597768b4
1743704methylprednisolone 125 MG InjectionSCD738753c7-507d-4881-5194-02dd7597768b4
311659methylprednisolone 40 MG InjectionSCD738753c7-507d-4881-5194-02dd7597768b4
314099methylprednisolone 62.5 MG/ML Injectable SolutionSCD738753c7-507d-4881-5194-02dd7597768b4
1743704methylprednisolone (as methylprednisolone sodium succinate) 125 MG InjectionSY738753c7-507d-4881-5194-02dd7597768b4
311659methylprednisolone (as methylprednisolone sodium succinate) 40 MG InjectionSY738753c7-507d-4881-5194-02dd7597768b4
314099methylprednisolone (as methylprednisolone sodium succinate) 62.5 MG/ML Injectable SolutionSY738753c7-507d-4881-5194-02dd7597768b4

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
43598-129-01435980129012 mL in 1 VIAL, SINGLE-DOSE2 mlHistorical
43598-129-254359801292525 VIAL, SINGLE-DOSE in 1 CARTON (43598-129-25) / 2 mL in 1 VIAL, SINGLE-DOSE (43598-129-01) 2022-03-240000-00-00NoNoCurrent