Depo-Medrol

Product NDC
0009-0306
11-digit product format
000090306
Labeler code
0009
Product ID
0009-0306_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
80 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 ACETATE80 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
d723478e-ad4a-ec23-6bd7-cfe33e1e3840Product name120140508

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
0009-0306-02Depo-Medrol5 mL in 1 VIAL, MULTI-DOSEINJECTION, SUSPENSION522
0009-0306-12Depo-Medrol25 in 1 PACKAGEINJECTION, SUSPENSION2522
0009-0306-12Depo-Medrol5 mL in 1 VIAL, MULTI-DOSEINJECTION, SUSPENSION522

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
0009-0306-02ML - Milliliter0009-0306b0d29b11-5614-4fb2-b45f-d19957d89fd712012-07-24
0009-0306-12ML - Milliliter0009-0306480595b6-0359-41f2-899f-4084cd256b2012012-07-24

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 [DISPENSING SOLUTIONS, INC.]1
methylprednisoloneACTIVE MOIETYX4W7ZR7023DEPO-MEDROL (METHYLPREDNISOLONE ACETATE) INJECTION, SUSPENSION [DISPENSING SOLUTIONS, INC.]1
benzyl alcoholINACTIVE INGREDIENTLKG8494WBHDEPO-MEDROL (METHYLPREDNISOLONE ACETATE) INJECTION, SUSPENSION [DISPENSING SOLUTIONS, INC.]1
hydrochloric acidINACTIVE INGREDIENTQTT17582CBDEPO-MEDROL (METHYLPREDNISOLONE ACETATE) INJECTION, SUSPENSION [DISPENSING SOLUTIONS, INC.]1
polyethylene glycol 3350INACTIVE INGREDIENTG2M7P15E5PDEPO-MEDROL (METHYLPREDNISOLONE ACETATE) INJECTION, SUSPENSION [DISPENSING SOLUTIONS, INC.]1
polysorbate 80INACTIVE INGREDIENT6OZP39ZG8HDEPO-MEDROL (METHYLPREDNISOLONE ACETATE) INJECTION, SUSPENSION [DISPENSING SOLUTIONS, INC.]1
sodium chlorideINACTIVE INGREDIENT451W47IQ8XDEPO-MEDROL (METHYLPREDNISOLONE ACETATE) INJECTION, SUSPENSION [DISPENSING SOLUTIONS, INC.]1
sodium hydroxideINACTIVE INGREDIENT55X04QC32IDEPO-MEDROL (METHYLPREDNISOLONE ACETATE) INJECTION, SUSPENSION [DISPENSING SOLUTIONS, INC.]1
sodium phosphate, dibasicINACTIVE INGREDIENTGR686LBA74DEPO-MEDROL (METHYLPREDNISOLONE ACETATE) INJECTION, SUSPENSION [DISPENSING SOLUTIONS, INC.]1
sodium phosphate, monobasicINACTIVE INGREDIENT3980JIH2SWDEPO-MEDROL (METHYLPREDNISOLONE ACETATE) INJECTION, SUSPENSION [DISPENSING SOLUTIONS, INC.]1

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
0009-0306DEPO-MEDROL (METHYLPREDNISOLONE ACETATE) INJECTION, SUSPENSION [PHARMACIA & UPJOHN COMPANY LLC]20Current NDC, Legacy NDC, 3 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
1358619DEPO-Medrol 80 MG/ML Injectable SuspensionPSNe8209047-c1e6-4081-a6d3-c603d9ee4f1414
1358617methylPREDNISolone acetate 80 MG/ML Injectable SuspensionPSNe8209047-c1e6-4081-a6d3-c603d9ee4f1414
1358619methylprednisolone acetate 80 MG/ML Injectable Suspension [Depo-Medrol]SBDe8209047-c1e6-4081-a6d3-c603d9ee4f1414
1358617methylprednisolone acetate 80 MG/ML Injectable SuspensionSCDe8209047-c1e6-4081-a6d3-c603d9ee4f1414
1358619Depo-Medrol 80 MG/ML Injectable SuspensionSYe8209047-c1e6-4081-a6d3-c603d9ee4f1414
1358619DEPO-Medrol 80 MG/ML Injectable SuspensionPSNc5ca262e-5558-4065-8ef5-e2e76f3635e51
1358617methylPREDNISolone acetate 80 MG/ML Injectable SuspensionPSNc5ca262e-5558-4065-8ef5-e2e76f3635e51
1358619methylprednisolone acetate 80 MG/ML Injectable Suspension [Depo-Medrol]SBDc5ca262e-5558-4065-8ef5-e2e76f3635e51
1358617methylprednisolone acetate 80 MG/ML Injectable SuspensionSCDc5ca262e-5558-4065-8ef5-e2e76f3635e51
1358619Depo-Medrol 80 MG/ML Injectable SuspensionSYc5ca262e-5558-4065-8ef5-e2e76f3635e51

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
0009-0306-02000090306025 mL in 1 VIAL, MULTI-DOSE (0009-0306-02) 5 ml1959-05-280000-00-00NoNoCurrent
0009-0306-120000903061225 VIAL, MULTI-DOSE in 1 PACKAGE (0009-0306-12) / 5 mL in 1 VIAL, MULTI-DOSE1959-05-280000-00-00NoNoCurrent