FDA.reportPublic FDA data

Methylprednisolone sodium succinate

Product NDC
43598-128
11-digit product format
435980128
Labeler code
43598
Product ID
43598-128_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
500 mg/8mL
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 SUCCINATE500 mg/8mL

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
43598-128-11Methylprednisolone sodium succinate1 in 1 CARTONINJECTION14
43598-128-11Methylprednisolone sodium succinate8 mL in 1 VIAL, MULTI-DOSEINJECTION84

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
43598-128-11EA - Each43598-12839e71112-a947-4fd0-8a7a-4244516ccde712022-04-06

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
43598-128METHYLPREDNISOLONE 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
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 formatDescriptionMarketing startMarketing endSampleExclude flagStatus
43598-128-11435980128111 VIAL, MULTI-DOSE in 1 CARTON (43598-128-11) / 8 mL in 1 VIAL, MULTI-DOSE2022-03-240000-00-00NoNoCurrent