FDA.reportPublic FDA data

Depo-Medrol

Product NDC
0009-3073
11-digit product format
000093073
Labeler code
0009
Product ID
0009-3073_742fcec7-8db3-4cc6-b276-42587a993810
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
methylprednisolone acetate
Dosage form
INJECTION, SUSPENSION
Route
INTRA-ARTICULAR; INTRALESIONAL; INTRAMUSCULAR; 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
Rxcui1743779, 1743781, 1743855, 1743856

DailyMed Product Concepts#

Product concept, Relation, Version table
Product conceptRelationVersionEffective
b3918abe-5cd1-b0ce-abd7-2dd6732cde26Product name520260128
070fbed5-7088-434a-a7ce-f2a64d8d40acProduct name220260107
bee66ce1-adb7-9d3b-67d9-582e4c54e80fProduct name520250819
860a93dc-4863-49cc-b284-6bbe8191bc48Product name420250214
eaba870a-6a9d-442e-8643-87b3f558a451Product name120250117
362d7abb-94e6-4c60-9a58-266894157713Product name120231023
e1637c7c-52c4-49a3-b36b-61be755aab29Product name420230717
9b4cf230-fd05-41d5-98c6-5db9ecb27b86Product name120230117
9eb3e96d-a1d4-4de3-aa3d-a629eea44815Product name420220316
7d755fa1-1087-4dcd-98f0-6d4bba479a57Product name320210602
aed701d5-9c75-dfaf-7154-cde46179faeaProduct name920200313
816b97af-edc5-4060-aff1-b814bdbcad50Product name120190415
fa8b5901-e681-426f-82fe-54f6d81ec698Product name420180619
332d03e4-aa24-4b11-841a-02bf41081920Product name120171221
c08ab52f-2fc8-4409-9d9f-ed8edc0bd070Product name120171221
419aab54-5d5a-4146-9453-026d4a9991beProduct name220170525
89dac932-b90a-4410-9ab1-84c53e57de25Product name120150316
68ed98f8-24c2-44a0-944a-6d36e82ce25aProduct name120141222
1cd42bc2-a430-c72b-636d-991b235fbf80Product name120140508
49fa150c-f0de-cce7-3d9c-993ed81c5698Product name120140508
4d7ae718-ed00-bae8-2abe-9eaec1eef7ffProduct name120140508
9137811f-f279-8640-5aeb-99fa2145d64dProduct name120140508
d723478e-ad4a-ec23-6bd7-cfe33e1e3840Product name120140508

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
0009-3073-01Depo-Medrol1 in 1 PACKAGEINJECTION, SUSPENSION127
0009-3073-01Depo-Medrol1 mL in 1 VIAL, SINGLE-DOSEINJECTION, SUSPENSION127
0009-3073-03Depo-Medrol1 mL in 1 VIAL, SINGLE-DOSEINJECTION, SUSPENSION127
0009-3073-03Depo-Medrol25 in 1 PACKAGEINJECTION, SUSPENSION2527
0009-3073-22Depo-Medrol1 in 1 PACKAGEINJECTION, SUSPENSION117
0009-3073-22Depo-Medrol1 mL in 1 VIAL, SINGLE-DOSEINJECTION, SUSPENSION117
0009-3073-23Depo-Medrol1 mL in 1 VIAL, SINGLE-DOSEINJECTION, SUSPENSION117
0009-3073-23Depo-Medrol25 in 1 PACKAGEINJECTION, SUSPENSION2517
0009-3073-01Multi-Specialty Kit1 in 1 PACKAGEINJECTION, SUSPENSION40 mg in 1mL1
0009-3073-01Multi-Specialty Kit1 mL in 1 VIAL, SINGLE-DOSEINJECTION, SUSPENSION2 mL40 mg in 1mL1

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
0009-3073-01ML - Milliliter0009-3073f2c67ef7-89c4-454b-bf7c-539fb485601112012-07-24
0009-3073-03ML - Milliliter0009-3073a87c022e-a1a3-4fc7-83b5-545b9db8203112012-07-24
0009-3073-22ML - Milliliter0009-3073292a8e6c-a5a0-4ffc-ad29-22641e1484d612012-07-24
0009-3073-23ML - Milliliter0009-3073b0bc7e16-1801-42c2-a1f5-1dbaf8a8b6e512012-07-24

DailyMed Socrata Ingredients#

Ingredient, Type, UNII table
IngredientTypeUNIIDailyMed labelSPL versionUploaded
METHYLPREDNISOLONE ACETATEACTIVE INGREDIENT43502P7F0PDEPO-MEDROL (METHYLPREDNISOLONE ACETATE) INJECTION, SUSPENSION [PHARMACIA AND UPJOHN COMPANY]12
METHYLPREDNISOLONEACTIVE MOIETYX4W7ZR7023DEPO-MEDROL (METHYLPREDNISOLONE ACETATE) INJECTION, SUSPENSION [PHARMACIA AND UPJOHN COMPANY]12
HYDROCHLORIC ACIDINACTIVE INGREDIENTQTT17582CBDEPO-MEDROL (METHYLPREDNISOLONE ACETATE) INJECTION, SUSPENSION [PHARMACIA AND UPJOHN COMPANY]12
POLYETHYLENE GLYCOL 3350INACTIVE INGREDIENTG2M7P15E5PDEPO-MEDROL (METHYLPREDNISOLONE ACETATE) INJECTION, SUSPENSION [PHARMACIA AND UPJOHN COMPANY]12
SODIUM CHLORIDEINACTIVE INGREDIENT451W47IQ8XDEPO-MEDROL (METHYLPREDNISOLONE ACETATE) INJECTION, SUSPENSION [PHARMACIA AND UPJOHN COMPANY]12
SODIUM HYDROXIDEINACTIVE INGREDIENT55X04QC32IDEPO-MEDROL (METHYLPREDNISOLONE ACETATE) INJECTION, SUSPENSION [PHARMACIA AND UPJOHN COMPANY]12
METHYLPREDNISOLONE ACETATEACTIVE INGREDIENT43502P7F0PDEPO-MEDROL (METHYLPREDNISOLONE ACETATE) INJECTION, SUSPENSION [PHARMACIA AND UPJOHN COMPANY]3
METHYLPREDNISOLONEACTIVE MOIETYX4W7ZR7023DEPO-MEDROL (METHYLPREDNISOLONE ACETATE) INJECTION, SUSPENSION [PHARMACIA AND UPJOHN COMPANY]3
HYDROCHLORIC ACIDINACTIVE INGREDIENTQTT17582CBDEPO-MEDROL (METHYLPREDNISOLONE ACETATE) INJECTION, SUSPENSION [PHARMACIA AND UPJOHN COMPANY]3
POLYETHYLENE GLYCOL 3350INACTIVE INGREDIENTG2M7P15E5PDEPO-MEDROL (METHYLPREDNISOLONE ACETATE) INJECTION, SUSPENSION [PHARMACIA AND UPJOHN COMPANY]3
SODIUM CHLORIDEINACTIVE INGREDIENT451W47IQ8XDEPO-MEDROL (METHYLPREDNISOLONE ACETATE) INJECTION, SUSPENSION [PHARMACIA AND UPJOHN COMPANY]3
SODIUM HYDROXIDEINACTIVE INGREDIENT55X04QC32IDEPO-MEDROL (METHYLPREDNISOLONE ACETATE) INJECTION, SUSPENSION [PHARMACIA AND UPJOHN COMPANY]3
Isopropyl AlcoholACTIVE INGREDIENTND2M416302MULTI-SPECIALTY KIT (DEPO-MEDROL, LIDOCAINE, ISOPROPYL ALCOHOL) KIT [PROFICIENT RX LP]1
Lidocaine HydrochlorideACTIVE INGREDIENTV13007Z41AMULTI-SPECIALTY KIT (DEPO-MEDROL, LIDOCAINE, ISOPROPYL ALCOHOL) KIT [PROFICIENT RX LP]1
Methylprednisolone AcetateACTIVE INGREDIENT43502P7F0PMULTI-SPECIALTY KIT (DEPO-MEDROL, LIDOCAINE, ISOPROPYL ALCOHOL) KIT [PROFICIENT RX LP]1
Isopropyl AlcoholACTIVE MOIETYND2M416302MULTI-SPECIALTY KIT (DEPO-MEDROL, LIDOCAINE, ISOPROPYL ALCOHOL) KIT [PROFICIENT RX LP]1
LidocaineACTIVE MOIETY98PI200987MULTI-SPECIALTY KIT (DEPO-MEDROL, LIDOCAINE, ISOPROPYL ALCOHOL) KIT [PROFICIENT RX LP]1
MethylprednisoloneACTIVE MOIETYX4W7ZR7023MULTI-SPECIALTY KIT (DEPO-MEDROL, LIDOCAINE, ISOPROPYL ALCOHOL) KIT [PROFICIENT RX LP]1
Hydrochloric AcidINACTIVE INGREDIENTQTT17582CBMULTI-SPECIALTY KIT (DEPO-MEDROL, LIDOCAINE, ISOPROPYL ALCOHOL) KIT [PROFICIENT RX LP]1
Polyethylene Glycol 3350INACTIVE INGREDIENTG2M7P15E5PMULTI-SPECIALTY KIT (DEPO-MEDROL, LIDOCAINE, ISOPROPYL ALCOHOL) KIT [PROFICIENT RX LP]1
Sodium ChlorideINACTIVE INGREDIENT451W47IQ8XMULTI-SPECIALTY KIT (DEPO-MEDROL, LIDOCAINE, ISOPROPYL ALCOHOL) KIT [PROFICIENT RX LP]1
Sodium HydroxideINACTIVE INGREDIENT55X04QC32IMULTI-SPECIALTY KIT (DEPO-MEDROL, LIDOCAINE, ISOPROPYL ALCOHOL) KIT [PROFICIENT RX LP]1
WaterINACTIVE INGREDIENT059QF0KO0RMULTI-SPECIALTY KIT (DEPO-MEDROL, LIDOCAINE, ISOPROPYL ALCOHOL) KIT [PROFICIENT RX LP]1

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
0009-3073DEPO-MEDROL (METHYLPREDNISOLONE ACETATE) INJECTION, SUSPENSION [PHARMACIA & UPJOHN COMPANY LLC]23Current NDC, Legacy NDC, 4 package rows20240618_9a7b3837-e038-48bf-97e9-78ad463760dc.zip
0009-3073DEPO-MEDROL (METHYLPREDNISOLONE ACETATE) INJECTION, SUSPENSION [PHARMACIA & UPJOHN COMPANY LLC]14Current NDC, Legacy NDC, 4 package rows20240807_bf1b104d-85cb-414d-a366-78068c82c883.zip
0009-3073MULTI-SPECIALTY KIT (DEPO-MEDROL, LIDOCAINE, ISOPROPYL ALCOHOL) KIT [PROFICIENT RX LP]1Current NDC, Legacy NDC20150408_92cb6339-75ab-48eb-b304-19db59695883.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
1743781DEPO-Medrol 40 MG in 1 ML InjectionPSN9a7b3837-e038-48bf-97e9-78ad463760dc27
1743856DEPO-Medrol 80 MG in 1 ML InjectionPSN9a7b3837-e038-48bf-97e9-78ad463760dc27
1743779methylPREDNISolone acetate 40 MG in 1 ML InjectionPSN9a7b3837-e038-48bf-97e9-78ad463760dc27
1743855methylPREDNISolone acetate 80 MG in 1 ML InjectionPSN9a7b3837-e038-48bf-97e9-78ad463760dc27
17437811 ML methylprednisolone acetate 40 MG/ML Injection [Depo-Medrol]SBD9a7b3837-e038-48bf-97e9-78ad463760dc27
17438561 ML methylprednisolone acetate 80 MG/ML Injection [Depo-Medrol]SBD9a7b3837-e038-48bf-97e9-78ad463760dc27
17437791 ML methylprednisolone acetate 40 MG/ML InjectionSCD9a7b3837-e038-48bf-97e9-78ad463760dc27
17438551 ML methylprednisolone acetate 80 MG/ML InjectionSCD9a7b3837-e038-48bf-97e9-78ad463760dc27
17437811 ML Depo-Medrol 40 MG/ML InjectionSY9a7b3837-e038-48bf-97e9-78ad463760dc27
17438561 ML Depo-Medrol 80 MG/ML InjectionSY9a7b3837-e038-48bf-97e9-78ad463760dc27
1743781Depo-Medrol 40 MG per 1 ML InjectionSY9a7b3837-e038-48bf-97e9-78ad463760dc27
1743856Depo-Medrol 80 MG per 1 ML InjectionSY9a7b3837-e038-48bf-97e9-78ad463760dc27
1743779methylprednisolone acetate 40 MG per 1 ML InjectionSY9a7b3837-e038-48bf-97e9-78ad463760dc27
1743855methylprednisolone acetate 80 MG per 1 ML InjectionSY9a7b3837-e038-48bf-97e9-78ad463760dc27
1743781DEPO-Medrol 40 MG in 1 ML InjectionPSNcb457bef-8823-4f3c-987b-eb0922494c4620
1743779methylPREDNISolone acetate 40 MG in 1 ML InjectionPSNcb457bef-8823-4f3c-987b-eb0922494c4620
17437811 ML methylprednisolone acetate 40 MG/ML Injection [Depo-Medrol]SBDcb457bef-8823-4f3c-987b-eb0922494c4620
17437791 ML methylprednisolone acetate 40 MG/ML InjectionSCDcb457bef-8823-4f3c-987b-eb0922494c4620
17437811 ML Depo-Medrol 40 MG/ML InjectionSYcb457bef-8823-4f3c-987b-eb0922494c4620
1743781Depo-Medrol 40 MG per 1 ML InjectionSYcb457bef-8823-4f3c-987b-eb0922494c4620
1743779methylprednisolone acetate 40 MG per 1 ML InjectionSYcb457bef-8823-4f3c-987b-eb0922494c4620
1743781DEPO-Medrol 40 MG in 1 ML InjectionPSNbf1b104d-85cb-414d-a366-78068c82c88317
1743856DEPO-Medrol 80 MG in 1 ML InjectionPSNbf1b104d-85cb-414d-a366-78068c82c88317
1743779methylPREDNISolone acetate 40 MG in 1 ML InjectionPSNbf1b104d-85cb-414d-a366-78068c82c88317
1743855methylPREDNISolone acetate 80 MG in 1 ML InjectionPSNbf1b104d-85cb-414d-a366-78068c82c88317
17437811 ML methylprednisolone acetate 40 MG/ML Injection [Depo-Medrol]SBDbf1b104d-85cb-414d-a366-78068c82c88317
17438561 ML methylprednisolone acetate 80 MG/ML Injection [Depo-Medrol]SBDbf1b104d-85cb-414d-a366-78068c82c88317
17437791 ML methylprednisolone acetate 40 MG/ML InjectionSCDbf1b104d-85cb-414d-a366-78068c82c88317
17438551 ML methylprednisolone acetate 80 MG/ML InjectionSCDbf1b104d-85cb-414d-a366-78068c82c88317
17437811 ML Depo-Medrol 40 MG/ML InjectionSYbf1b104d-85cb-414d-a366-78068c82c88317
17438561 ML Depo-Medrol 80 MG/ML InjectionSYbf1b104d-85cb-414d-a366-78068c82c88317
1743781Depo-Medrol 40 MG per 1 ML InjectionSYbf1b104d-85cb-414d-a366-78068c82c88317
1743856Depo-Medrol 80 MG per 1 ML InjectionSYbf1b104d-85cb-414d-a366-78068c82c88317
1743779methylprednisolone acetate 40 MG per 1 ML InjectionSYbf1b104d-85cb-414d-a366-78068c82c88317
1743855methylprednisolone acetate 80 MG per 1 ML InjectionSYbf1b104d-85cb-414d-a366-78068c82c88317
1743781DEPO-Medrol 40 MG in 1 ML InjectionPSN92cb6339-75ab-48eb-b304-19db596958831
797544isopropyl alcohol 70 % Medicated PadPSN92cb6339-75ab-48eb-b304-19db596958831
1737568lidocaine HCl 1 % in 2 ML InjectionPSN92cb6339-75ab-48eb-b304-19db596958831
1743779methylPREDNISolone acetate 40 MG in 1 ML InjectionPSN92cb6339-75ab-48eb-b304-19db596958831
17437811 ML methylprednisolone acetate 40 MG/ML Injection [Depo-Medrol]SBD92cb6339-75ab-48eb-b304-19db596958831
17437791 ML methylprednisolone acetate 40 MG/ML InjectionSCD92cb6339-75ab-48eb-b304-19db596958831
17375682 ML lidocaine hydrochloride 10 MG/ML InjectionSCD92cb6339-75ab-48eb-b304-19db596958831
797544isopropyl alcohol 0.7 ML/ML Medicated PadSCD92cb6339-75ab-48eb-b304-19db596958831
17437811 ML Depo-Medrol 40 MG/ML InjectionSY92cb6339-75ab-48eb-b304-19db596958831
1743781Depo-Medrol 40 MG per 1 ML InjectionSY92cb6339-75ab-48eb-b304-19db596958831
797544isopropyl alcohol 70 % Medicated PadSY92cb6339-75ab-48eb-b304-19db596958831
797544isopropyl alcohol 70 % Topical ClothSY92cb6339-75ab-48eb-b304-19db596958831
797544isopropyl alcohol 70 % Topical SwabSY92cb6339-75ab-48eb-b304-19db596958831
1737568lidocaine HCl 1 % per 2 ML InjectionSY92cb6339-75ab-48eb-b304-19db596958831
1737568lidocaine HCl 20 MG per 2 ML InjectionSY92cb6339-75ab-48eb-b304-19db596958831
1743779methylprednisolone acetate 40 MG per 1 ML InjectionSY92cb6339-75ab-48eb-b304-19db596958831

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionMarketing startMarketing endSampleExclude flagStatus
0009-3073-01000093073011 VIAL, SINGLE-DOSE in 1 PACKAGE (0009-3073-01) / 1 mL in 1 VIAL, SINGLE-DOSE1959-05-280000-00-00NoNoCurrent
0009-3073-030000930730325 VIAL, SINGLE-DOSE in 1 PACKAGE (0009-3073-03) / 1 mL in 1 VIAL, SINGLE-DOSE1959-05-280000-00-00NoNoCurrent
0009-3073-22000093073221 VIAL, SINGLE-DOSE in 1 PACKAGE (0009-3073-22) / 1 mL in 1 VIAL, SINGLE-DOSE1959-05-280000-00-00NoNoCurrent
0009-3073-230000930732325 VIAL, SINGLE-DOSE in 1 PACKAGE (0009-3073-23) / 1 mL in 1 VIAL, SINGLE-DOSE1959-05-280000-00-00NoNoCurrent