FDA.reportPublic FDA data

Methylprednisolone Sodium Succinate

Product NDC
72572-097
11-digit product format
725720097
Labeler code
72572
Product ID
72572-097_d23fe534-8717-46d3-b2f6-f89f57b30426
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
Methylprednisolone Sodium Succinate
Dosage form
INJECTION, POWDER, FOR SOLUTION
Route
INTRAMUSCULAR; INTRAVENOUS
Labeler
Civica, Inc.
Application
ANDA203125
Marketing category
ANDA
Marketing start
2025-12-01
Substance
METHYLPREDNISOLONE SODIUM SUCCINATE
Active strength
40 mg/1
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 SUCCINATE40 mg/1

Harmonized Identifiers#

Field, Values table
FieldValues
UniiLEC9GKY20K
Rxcui311659, 1743704

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

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
72572-097-01Methylprednisolone Sodium Succinate1 in 1 VIAL, SINGLE-DOSEINJECTION, POWDER, FOR SOLUTION12
72572-097-25Methylprednisolone Sodium Succinate25 in 1 CARTONINJECTION, POWDER, FOR SOLUTION252

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
72572-097-01EA - Each72572-097a8520b39-1ab5-4405-a1f5-686df63d867c12026-03-17
72572-097-25EA - Each72572-09718f5eade-885d-4f90-8bfa-63dc7815468712026-03-17

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
1743704methylPREDNISolone sodium succinate 125 MG InjectionPSN2e6020f5-a486-41cc-8956-58b5f6751aa22
311659methylPREDNISolone sodium succinate 40 MG InjectionPSN2e6020f5-a486-41cc-8956-58b5f6751aa22
1743704methylprednisolone 125 MG InjectionSCD2e6020f5-a486-41cc-8956-58b5f6751aa22
311659methylprednisolone 40 MG InjectionSCD2e6020f5-a486-41cc-8956-58b5f6751aa22
1743704methylprednisolone (as methylprednisolone sodium succinate) 125 MG InjectionSY2e6020f5-a486-41cc-8956-58b5f6751aa22
311659methylprednisolone (as methylprednisolone sodium succinate) 40 MG InjectionSY2e6020f5-a486-41cc-8956-58b5f6751aa22

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionMarketing startSampleExclude flagStatus
72572-097-01725720097011 in 1 VIAL, SINGLE-DOSEHistorical
72572-097-257257200972525 VIAL, SINGLE-DOSE in 1 CARTON (72572-097-25) / 1 INJECTION, POWDER, FOR SOLUTION in 1 VIAL, SINGLE-DOSE (72572-097-01) 2025-12-01NoNoHistorical