FDA.reportPublic FDA data

Depo-Medrol

Product NDC
0009-0280
11-digit product format
000090280
Labeler code
0009
Product ID
0009-0280_267dd735-f800-4735-ba1c-d39d00f0cee5
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
methylprednisolone acetate
Dosage form
INJECTION, SUSPENSION
Route
INTRALESIONAL; INTRAMUSCULAR; INTRASYNOVIAL; SOFT TISSUE
Labeler
Pharmacia & Upjohn Company LLC
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
2027-12-31
Current FDA listing
Yes

Additional Listing Data#

Finished product
Yes
Brand name base
Depo-Medrol
Listing expiration
2027-12-31

Active Ingredients#

Ingredient, Strength table
IngredientStrength
METHYLPREDNISOLONE ACETATE40 mg/mL

Harmonized Identifiers#

Field, Values table
FieldValues
Unii43502P7F0P
Rxcui1358510, 1358512, 1358610, 1358612, 1358617, 1358619

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
9869efd7-d6dd-0665-5b67-53adbe6ef15eProduct name120140508
d723478e-ad4a-ec23-6bd7-cfe33e1e3840Product name120140508

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
0009-0280-02Depo-Medrol1 in 1 CARTONINJECTION, SUSPENSION122
0009-0280-02Depo-Medrol5 mL in 1 VIAL, MULTI-DOSEINJECTION, SUSPENSION522
0009-0280-03Depo-Medrol10 mL in 1 VIAL, MULTI-DOSEINJECTION, SUSPENSION1022
0009-0280-51Depo-Medrol25 in 1 PACKAGEINJECTION, SUSPENSION2522
0009-0280-51Depo-Medrol5 mL in 1 VIAL, MULTI-DOSEINJECTION, SUSPENSION522
0009-0280-52Depo-Medrol10 mL in 1 VIAL, MULTI-DOSEINJECTION, SUSPENSION1022
0009-0280-52Depo-Medrol25 in 1 PACKAGEINJECTION, SUSPENSION2522

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
0009-0280-02ML - Milliliter0009-02805d1907a1-afcc-42e8-b241-417e305065b012012-07-24
0009-0280-03ML - Milliliter0009-02809adc594b-c5f8-43af-ae24-96cb0a8ea0fe12012-07-24
0009-0280-51ML - Milliliter0009-028036d76072-beac-4b42-ba66-9f469d4d9ef912012-07-24
0009-0280-52ML - Milliliter0009-0280e8e71950-b4ff-4bb1-95c2-34961ce5631412012-07-24

DailyMed Socrata Ingredients#

Ingredient, Type, UNII table
IngredientTypeUNIIDailyMed labelSPL versionUploaded
METHYLPREDNISOLONE ACETATEACTIVE INGREDIENT43502P7F0PDEPO-MEDROL (METHYLPREDNISOLONE ACETATE) INJECTION, SUSPENSION [PHARMACIA AND UPJOHN COMPANY]6
METHYLPREDNISOLONEACTIVE MOIETYX4W7ZR7023DEPO-MEDROL (METHYLPREDNISOLONE ACETATE) INJECTION, SUSPENSION [PHARMACIA AND UPJOHN COMPANY]6
BENZYL ALCOHOLINACTIVE INGREDIENTLKG8494WBHDEPO-MEDROL (METHYLPREDNISOLONE ACETATE) INJECTION, SUSPENSION [PHARMACIA AND UPJOHN COMPANY]6
HYDROCHLORIC ACIDINACTIVE INGREDIENTQTT17582CBDEPO-MEDROL (METHYLPREDNISOLONE ACETATE) INJECTION, SUSPENSION [PHARMACIA AND UPJOHN COMPANY]6
POLYETHYLENE GLYCOL 3350INACTIVE INGREDIENTG2M7P15E5PDEPO-MEDROL (METHYLPREDNISOLONE ACETATE) INJECTION, SUSPENSION [PHARMACIA AND UPJOHN COMPANY]6
POLYSORBATE 80INACTIVE INGREDIENT6OZP39ZG8HDEPO-MEDROL (METHYLPREDNISOLONE ACETATE) INJECTION, SUSPENSION [PHARMACIA AND UPJOHN COMPANY]6
SODIUM CHLORIDEINACTIVE INGREDIENT451W47IQ8XDEPO-MEDROL (METHYLPREDNISOLONE ACETATE) INJECTION, SUSPENSION [PHARMACIA AND UPJOHN COMPANY]6
SODIUM HYDROXIDEINACTIVE INGREDIENT55X04QC32IDEPO-MEDROL (METHYLPREDNISOLONE ACETATE) INJECTION, SUSPENSION [PHARMACIA AND UPJOHN COMPANY]6
SODIUM PHOSPHATE, DIBASICINACTIVE INGREDIENTGR686LBA74DEPO-MEDROL (METHYLPREDNISOLONE ACETATE) INJECTION, SUSPENSION [PHARMACIA AND UPJOHN COMPANY]6
SODIUM PHOSPHATE, MONOBASICINACTIVE INGREDIENT3980JIH2SWDEPO-MEDROL (METHYLPREDNISOLONE ACETATE) INJECTION, SUSPENSION [PHARMACIA AND UPJOHN COMPANY]6
methylprednisolone acetateACTIVE INGREDIENT43502P7F0PDEPO-MEDROL (METHYLPREDNISOLONE ACETATE) INJECTION, SUSPENSION [REBEL DISTRIBUTORS CORP]1
methylprednisoloneACTIVE MOIETYX4W7ZR7023DEPO-MEDROL (METHYLPREDNISOLONE ACETATE) INJECTION, SUSPENSION [REBEL DISTRIBUTORS CORP]1
benzyl alcoholINACTIVE INGREDIENTLKG8494WBHDEPO-MEDROL (METHYLPREDNISOLONE ACETATE) INJECTION, SUSPENSION [REBEL DISTRIBUTORS CORP]1
hydrochloric acidINACTIVE INGREDIENTQTT17582CBDEPO-MEDROL (METHYLPREDNISOLONE ACETATE) INJECTION, SUSPENSION [REBEL DISTRIBUTORS CORP]1
polyethylene glycol 3350INACTIVE INGREDIENTG2M7P15E5PDEPO-MEDROL (METHYLPREDNISOLONE ACETATE) INJECTION, SUSPENSION [REBEL DISTRIBUTORS CORP]1
polysorbate 80INACTIVE INGREDIENT6OZP39ZG8HDEPO-MEDROL (METHYLPREDNISOLONE ACETATE) INJECTION, SUSPENSION [REBEL DISTRIBUTORS CORP]1
sodium chlorideINACTIVE INGREDIENT451W47IQ8XDEPO-MEDROL (METHYLPREDNISOLONE ACETATE) INJECTION, SUSPENSION [REBEL DISTRIBUTORS CORP]1
sodium hydroxideINACTIVE INGREDIENT55X04QC32IDEPO-MEDROL (METHYLPREDNISOLONE ACETATE) INJECTION, SUSPENSION [REBEL DISTRIBUTORS CORP]1
sodium phosphate, dibasicINACTIVE INGREDIENTGR686LBA74DEPO-MEDROL (METHYLPREDNISOLONE ACETATE) INJECTION, SUSPENSION [REBEL DISTRIBUTORS CORP]1
sodium phosphate, monobasicINACTIVE INGREDIENT3980JIH2SWDEPO-MEDROL (METHYLPREDNISOLONE ACETATE) INJECTION, SUSPENSION [REBEL DISTRIBUTORS CORP]1

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
0009-0280DEPO-MEDROL (METHYLPREDNISOLONE ACETATE) INJECTION, SUSPENSION [PHARMACIA & UPJOHN COMPANY LLC]20Current NDC, Legacy NDC, 7 package rows20240618_823b0010-2b57-4e76-b5ac-4a8c2963438f.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
1358512DEPO-Medrol 20 MG/ML Injectable SuspensionPSN823b0010-2b57-4e76-b5ac-4a8c2963438f22
1358612DEPO-Medrol 40 MG/ML Injectable SuspensionPSN823b0010-2b57-4e76-b5ac-4a8c2963438f22
1358619DEPO-Medrol 80 MG/ML Injectable SuspensionPSN823b0010-2b57-4e76-b5ac-4a8c2963438f22
1358510methylPREDNISolone acetate 20 MG/ML Injectable SuspensionPSN823b0010-2b57-4e76-b5ac-4a8c2963438f22
1358610methylPREDNISolone acetate 40 MG/ML Injectable SuspensionPSN823b0010-2b57-4e76-b5ac-4a8c2963438f22
1358617methylPREDNISolone acetate 80 MG/ML Injectable SuspensionPSN823b0010-2b57-4e76-b5ac-4a8c2963438f22
1358512methylprednisolone acetate 20 MG/ML Injectable Suspension [Depo-Medrol]SBD823b0010-2b57-4e76-b5ac-4a8c2963438f22
1358612methylprednisolone acetate 40 MG/ML Injectable Suspension [Depo-Medrol]SBD823b0010-2b57-4e76-b5ac-4a8c2963438f22
1358619methylprednisolone acetate 80 MG/ML Injectable Suspension [Depo-Medrol]SBD823b0010-2b57-4e76-b5ac-4a8c2963438f22
1358510methylprednisolone acetate 20 MG/ML Injectable SuspensionSCD823b0010-2b57-4e76-b5ac-4a8c2963438f22
1358610methylprednisolone acetate 40 MG/ML Injectable SuspensionSCD823b0010-2b57-4e76-b5ac-4a8c2963438f22
1358617methylprednisolone acetate 80 MG/ML Injectable SuspensionSCD823b0010-2b57-4e76-b5ac-4a8c2963438f22
1358512Depo-Medrol 20 MG/ML Injectable SuspensionSY823b0010-2b57-4e76-b5ac-4a8c2963438f22
1358612Depo-Medrol 40 MG/ML Injectable SuspensionSY823b0010-2b57-4e76-b5ac-4a8c2963438f22
1358619Depo-Medrol 80 MG/ML Injectable SuspensionSY823b0010-2b57-4e76-b5ac-4a8c2963438f22
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
1358612DEPO-Medrol 40 MG/ML Injectable SuspensionPSNf7d4269e-eb4c-46aa-805f-8e8662c8090411
1358610methylPREDNISolone acetate 40 MG/ML Injectable SuspensionPSNf7d4269e-eb4c-46aa-805f-8e8662c8090411
1358612methylprednisolone acetate 40 MG/ML Injectable Suspension [Depo-Medrol]SBDf7d4269e-eb4c-46aa-805f-8e8662c8090411
1358610methylprednisolone acetate 40 MG/ML Injectable SuspensionSCDf7d4269e-eb4c-46aa-805f-8e8662c8090411
1358612Depo-Medrol 40 MG/ML Injectable SuspensionSYf7d4269e-eb4c-46aa-805f-8e8662c8090411
1358612DEPO-Medrol 40 MG/ML Injectable SuspensionPSN41fa78f5-8f41-415e-80f3-7fee7091df5e1
1358610methylPREDNISolone acetate 40 MG/ML Injectable SuspensionPSN41fa78f5-8f41-415e-80f3-7fee7091df5e1
1358612methylprednisolone acetate 40 MG/ML Injectable Suspension [Depo-Medrol]SBD41fa78f5-8f41-415e-80f3-7fee7091df5e1
1358610methylprednisolone acetate 40 MG/ML Injectable SuspensionSCD41fa78f5-8f41-415e-80f3-7fee7091df5e1
1358612Depo-Medrol 40 MG/ML Injectable SuspensionSY41fa78f5-8f41-415e-80f3-7fee7091df5e1

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
0009-0280-02000090280021 VIAL, MULTI-DOSE in 1 CARTON (0009-0280-02) / 5 mL in 1 VIAL, MULTI-DOSE1959-05-280000-00-00NoNoCurrent
0009-0280-030000902800310 mL in 1 VIAL, MULTI-DOSE (0009-0280-03) 10 ml1959-05-280000-00-00NoNoCurrent
0009-0280-510000902805125 VIAL, MULTI-DOSE in 1 PACKAGE (0009-0280-51) / 5 mL in 1 VIAL, MULTI-DOSE1959-05-280000-00-00NoNoCurrent
0009-0280-520000902805225 VIAL, MULTI-DOSE in 1 PACKAGE (0009-0280-52) / 10 mL in 1 VIAL, MULTI-DOSE1959-05-280000-00-00NoNoCurrent