FDA.reportPublic FDA data

DEPO-MEDROL

Product NDC
50090-0556
11-digit product format
500900556
Labeler code
50090
Product ID
50090-0556_82776182-5ffe-4380-8eb3-498f27c9a834
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
methylprednisolone acetate
Dosage form
INJECTION, SUSPENSION
Route
INTRALESIONAL; INTRAMUSCULAR; INTRASYNOVIAL; SOFT TISSUE
Labeler
A-S Medication Solutions
Application
NDA011757
Marketing category
NDA
Marketing start
1959-05-28
Substance
METHYLPREDNISOLONE ACETATE
Active strength
40 mg/mL
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
DEPO-MEDROL
Listing expiration
2026-12-31

Active Ingredients#

Ingredient, Strength table
IngredientStrength
METHYLPREDNISOLONE ACETATE40 mg/mL

Harmonized Identifiers#

Field, Values table
FieldValues
Unii43502P7F0P
Rxcui1358610, 1358612

DailyMed Product Concepts#

Product concept, Relation, Version table
Product conceptRelationVersionEffective
b3918abe-5cd1-b0ce-abd7-2dd6732cde26Product name520260128
362d7abb-94e6-4c60-9a58-266894157713Product name120231023
e1637c7c-52c4-49a3-b36b-61be755aab29Product name420230717
9eb3e96d-a1d4-4de3-aa3d-a629eea44815Product name420220316
816b97af-edc5-4060-aff1-b814bdbcad50Product name120190415
419aab54-5d5a-4146-9453-026d4a9991beProduct name220170525
89dac932-b90a-4410-9ab1-84c53e57de25Product name120150316
d723478e-ad4a-ec23-6bd7-cfe33e1e3840Product name120140508

FDA-Initiated Inactive NDC Indexing#

NDC, Effective, Action table
NDCEffectiveActionDocumentIndexing SPLRelated label
50090-0556-02023-05-10C16284748780-1f386c649-9a76-0266-e053-dadaa90a7c1aDEPO-MEDROL
50090-0556-02023-01-30C16284748780-1f386c649-9a76-0266-e053-dadaa90a7c1aDEPO-MEDROL

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
50090-0556-0DEPO-MEDROL10 mL in 1 VIAL, MULTI-DOSEINJECTION, SUSPENSION1019

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
50090-0556-0ML - Milliliter50090-05560aaf6f8b-71f4-4259-8f1b-0f4284ff459112018-09-05

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
50090-0556DEPO-MEDROL (METHYLPREDNISOLONE ACETATE) INJECTION, SUSPENSION [A-S MEDICATION SOLUTIONS]19Current NDC, Legacy NDC, 1 package rows20240612_aa151d12-bd33-4d26-848f-2195172c9700.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
1358612DEPO-Medrol 40 MG/ML Injectable SuspensionPSNaa151d12-bd33-4d26-848f-2195172c970019
1358610methylPREDNISolone acetate 40 MG/ML Injectable SuspensionPSNaa151d12-bd33-4d26-848f-2195172c970019
1358612methylprednisolone acetate 40 MG/ML Injectable Suspension [Depo-Medrol]SBDaa151d12-bd33-4d26-848f-2195172c970019
1358610methylprednisolone acetate 40 MG/ML Injectable SuspensionSCDaa151d12-bd33-4d26-848f-2195172c970019
1358612Depo-Medrol 40 MG/ML Injectable SuspensionSYaa151d12-bd33-4d26-848f-2195172c970019

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
50090-0556-05009005560010 mL in 1 VIAL, MULTI-DOSE (50090-0556-0) 10 ml2016-06-290000-00-00NoNoCurrent