FDA.reportPublic FDA data

SOLU-MEDROL

Product NDC
0009-0047
11-digit product format
000090047
Labeler code
0009
Product ID
0009-0047_c157d266-8633-4c2e-ae1f-0207e4f19b35
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
methylprednisolone sodium succinate
Dosage form
INJECTION, POWDER, FOR SOLUTION
Route
INTRAMUSCULAR; INTRAVENOUS
Labeler
Pharmacia & Upjohn Company LLC
Application
NDA011856
Marketing category
NDA
Marketing start
1959-04-02
Substance
METHYLPREDNISOLONE SODIUM SUCCINATE
Active strength
125 mg/2mL
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
SOLU-MEDROL
Listing expiration
2026-12-31

Active Ingredients#

Ingredient, Strength table
IngredientStrength
METHYLPREDNISOLONE SODIUM SUCCINATE125 mg/2mL

Harmonized Identifiers#

Field, Values table
FieldValues
UniiLEC9GKY20K
Rxcui207191, 207193, 311659, 314099, 1357886, 1357888, 1743704, 1743707, 1743720, 1743722, 1743726, 1743729

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
0009-0047-22SOLU-MEDROL25 in 1 CARTONINJECTION, POWDER, FOR SOLUTION2535
0009-0047-25SOLU-MEDROL2 mL in 1 VIALINJECTION, POWDER, FOR SOLUTION235
0009-0047-26SOLU-MEDROL25 in 1 CARTONINJECTION, POWDER, FOR SOLUTION2535
0009-0047-27SOLU-MEDROL2 mL in 1 VIALINJECTION, POWDER, FOR SOLUTION235
0009-0047-04SOLU-MEDROL2 mL in 1 VIALINJECTION, POWDER, FOR SOLUTION211
0009-0047-04SOLU-MEDROL25 in 1 CARTONINJECTION, POWDER, FOR SOLUTION2511

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
0009-0047-04EA - Each0009-0047a572dc6f-a996-4970-8061-7317320a4f9112018-08-13
0009-0047-22EA - Each0009-00478a9fca70-b985-4d56-ab2c-b677f442145012012-07-24
0009-0047-25EA - Each0009-00471d279bcb-0bbb-4c7c-a077-0b19a114c75a12013-02-13
0009-0047-26EA - Each0009-0047a6bb9d8e-775e-414b-a78c-e9be34f72b9112012-07-24
0009-0047-27EA - Each0009-00477bfba518-8122-45f4-8b32-7380abc4a0ef12013-02-13

DailyMed Socrata Ingredients#

Ingredient, Type, UNII table
IngredientTypeUNIIDailyMed labelSPL versionUploaded
methylprednisolone sodium succinateACTIVE INGREDIENTLEC9GKY20KSOLU-MEDROL (METHYLPREDNISOLONE SODIUM SUCCINATE) INJECTION, POWDER, FOR SOLUTION [CARDINAL HEALTH]13
methylprednisoloneACTIVE MOIETYX4W7ZR7023SOLU-MEDROL (METHYLPREDNISOLONE SODIUM SUCCINATE) INJECTION, POWDER, FOR SOLUTION [CARDINAL HEALTH]13
lactose monohydrateINACTIVE INGREDIENTEWQ57Q8I5XSOLU-MEDROL (METHYLPREDNISOLONE SODIUM SUCCINATE) INJECTION, POWDER, FOR SOLUTION [CARDINAL HEALTH]13
sodium phosphate, dibasicINACTIVE INGREDIENTGR686LBA74SOLU-MEDROL (METHYLPREDNISOLONE SODIUM SUCCINATE) INJECTION, POWDER, FOR SOLUTION [CARDINAL HEALTH]13
SODIUM PHOSPHATE, MONOBASIC, ANHYDROUSINACTIVE INGREDIENTKH7I04HPUUSOLU-MEDROL (METHYLPREDNISOLONE SODIUM SUCCINATE) INJECTION, POWDER, FOR SOLUTION [CARDINAL HEALTH]13
METHYLPREDNISOLONE SODIUM SUCCINATEACTIVE INGREDIENTLEC9GKY20KSOLU-MEDROL (METHYLPREDNISOLONE SODIUM SUCCINATE) INJECTION, POWDER, FOR SOLUTION SOLU-MEDROL (METHYLPREDNISOLONE SODIUM SUCCINATE) KIT [PHARMACIA AND UPJOHN COMPANY]10
METHYLPREDNISOLONEACTIVE MOIETYX4W7ZR7023SOLU-MEDROL (METHYLPREDNISOLONE SODIUM SUCCINATE) INJECTION, POWDER, FOR SOLUTION SOLU-MEDROL (METHYLPREDNISOLONE SODIUM SUCCINATE) KIT [PHARMACIA AND UPJOHN COMPANY]10
BENZYL ALCOHOLINACTIVE INGREDIENTLKG8494WBHSOLU-MEDROL (METHYLPREDNISOLONE SODIUM SUCCINATE) INJECTION, POWDER, FOR SOLUTION SOLU-MEDROL (METHYLPREDNISOLONE SODIUM SUCCINATE) KIT [PHARMACIA AND UPJOHN COMPANY]10
LACTOSE MONOHYDRATEINACTIVE INGREDIENTEWQ57Q8I5XSOLU-MEDROL (METHYLPREDNISOLONE SODIUM SUCCINATE) INJECTION, POWDER, FOR SOLUTION SOLU-MEDROL (METHYLPREDNISOLONE SODIUM SUCCINATE) KIT [PHARMACIA AND UPJOHN COMPANY]10
SODIUM PHOSPHATE, DIBASICINACTIVE INGREDIENTGR686LBA74SOLU-MEDROL (METHYLPREDNISOLONE SODIUM SUCCINATE) INJECTION, POWDER, FOR SOLUTION SOLU-MEDROL (METHYLPREDNISOLONE SODIUM SUCCINATE) KIT [PHARMACIA AND UPJOHN COMPANY]10
SODIUM PHOSPHATE, MONOBASIC, ANHYDROUSINACTIVE INGREDIENTKH7I04HPUUSOLU-MEDROL (METHYLPREDNISOLONE SODIUM SUCCINATE) INJECTION, POWDER, FOR SOLUTION SOLU-MEDROL (METHYLPREDNISOLONE SODIUM SUCCINATE) KIT [PHARMACIA AND UPJOHN COMPANY]10
WATERINACTIVE INGREDIENT059QF0KO0RSOLU-MEDROL (METHYLPREDNISOLONE SODIUM SUCCINATE) INJECTION, POWDER, FOR SOLUTION SOLU-MEDROL (METHYLPREDNISOLONE SODIUM SUCCINATE) KIT [PHARMACIA AND UPJOHN COMPANY]10
METHYLPREDNISOLONE SODIUM SUCCINATEACTIVE INGREDIENTLEC9GKY20KSOLU-MEDROL (METHYLPREDNISOLONE SODIUM SUCCINATE) INJECTION, POWDER, FOR SOLUTION [CARDINAL HEALTH]3
METHYLPREDNISOLONEACTIVE MOIETYX4W7ZR7023SOLU-MEDROL (METHYLPREDNISOLONE SODIUM SUCCINATE) INJECTION, POWDER, FOR SOLUTION [CARDINAL HEALTH]3
SODIUM PHOSPHATE, DIBASICINACTIVE INGREDIENTGR686LBA74SOLU-MEDROL (METHYLPREDNISOLONE SODIUM SUCCINATE) INJECTION, POWDER, FOR SOLUTION [CARDINAL HEALTH]3
SODIUM PHOSPHATE, MONOBASIC, ANHYDROUSINACTIVE INGREDIENTKH7I04HPUUSOLU-MEDROL (METHYLPREDNISOLONE SODIUM SUCCINATE) INJECTION, POWDER, FOR SOLUTION [CARDINAL HEALTH]3
METHYLPREDNISOLONE SODIUM SUCCINATEACTIVE INGREDIENTLEC9GKY20KSOLU-MEDROL (METHYLPREDNISOLONE SODIUM SUCCINATE) INJECTION, POWDER, FOR SOLUTION [US MEDSOURCE, LLC]1
METHYLPREDNISOLONEACTIVE MOIETYX4W7ZR7023SOLU-MEDROL (METHYLPREDNISOLONE SODIUM SUCCINATE) INJECTION, POWDER, FOR SOLUTION [US MEDSOURCE, LLC]1
SODIUM PHOSPHATE, DIBASICINACTIVE INGREDIENTGR686LBA74SOLU-MEDROL (METHYLPREDNISOLONE SODIUM SUCCINATE) INJECTION, POWDER, FOR SOLUTION [US MEDSOURCE, LLC]1
SODIUM PHOSPHATE, MONOBASIC, ANHYDROUSINACTIVE INGREDIENTKH7I04HPUUSOLU-MEDROL (METHYLPREDNISOLONE SODIUM SUCCINATE) INJECTION, POWDER, FOR SOLUTION [US MEDSOURCE, LLC]1

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
0009-0047SOLU-MEDROL (METHYLPREDNISOLONE SODIUM SUCCINATE) INJECTION, POWDER, FOR SOLUTION [PHARMACIA & UPJOHN COMPANY LLC]32Current NDC, Legacy NDC, 4 package rows20250515_cd99be87-c8d9-48d6-a8e5-e081052e3f19.zip
0009-0047SOLU-MEDROL (METHYLPREDNISOLONE SODIUM SUCCINATE) INJECTION, POWDER, FOR SOLUTION [PHARMACIA & UPJOHN COMPANY LLC]7Current NDC, Legacy NDC, 2 package rows20240807_7271310c-7764-4812-aa30-a5e90987c7a9.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
314099methylPREDNISolone 62.5 MG/ML Injectable SolutionPSNcd99be87-c8d9-48d6-a8e5-e081052e3f1935
1743726methylPREDNISolone sodium succinate 1 GM InjectionPSNcd99be87-c8d9-48d6-a8e5-e081052e3f1935
1743704methylPREDNISolone sodium succinate 125 MG InjectionPSNcd99be87-c8d9-48d6-a8e5-e081052e3f1935
1357886methylPREDNISolone sodium succinate 2 GM InjectionPSNcd99be87-c8d9-48d6-a8e5-e081052e3f1935
311659methylPREDNISolone sodium succinate 40 MG InjectionPSNcd99be87-c8d9-48d6-a8e5-e081052e3f1935
1743720methylPREDNISolone sodium succinate 500 MG InjectionPSNcd99be87-c8d9-48d6-a8e5-e081052e3f1935
1743729SOLU-Medrol 1 GM InjectionPSNcd99be87-c8d9-48d6-a8e5-e081052e3f1935
1743707SOLU-Medrol 125 MG InjectionPSNcd99be87-c8d9-48d6-a8e5-e081052e3f1935
1357888SOLU-Medrol 2 GM InjectionPSNcd99be87-c8d9-48d6-a8e5-e081052e3f1935
207191SOLU-Medrol 40 MG InjectionPSNcd99be87-c8d9-48d6-a8e5-e081052e3f1935
1743722SOLU-Medrol 500 MG InjectionPSNcd99be87-c8d9-48d6-a8e5-e081052e3f1935
207193SOLU-Medrol 62.5 MG/ML Injectable SolutionPSNcd99be87-c8d9-48d6-a8e5-e081052e3f1935
1743729methylprednisolone 1000 MG Injection [Solu-Medrol]SBDcd99be87-c8d9-48d6-a8e5-e081052e3f1935
1743707methylprednisolone 125 MG Injection [Solu-Medrol]SBDcd99be87-c8d9-48d6-a8e5-e081052e3f1935
1357888methylprednisolone 2000 MG Injection [Solu-Medrol]SBDcd99be87-c8d9-48d6-a8e5-e081052e3f1935
207191methylprednisolone 40 MG Injection [Solu-Medrol]SBDcd99be87-c8d9-48d6-a8e5-e081052e3f1935
1743722methylprednisolone 500 MG Injection [Solu-Medrol]SBDcd99be87-c8d9-48d6-a8e5-e081052e3f1935
207193methylprednisolone 62.5 MG/ML Injectable Solution [Solu-Medrol]SBDcd99be87-c8d9-48d6-a8e5-e081052e3f1935
1743726methylprednisolone 1000 MG InjectionSCDcd99be87-c8d9-48d6-a8e5-e081052e3f1935
1743704methylprednisolone 125 MG InjectionSCDcd99be87-c8d9-48d6-a8e5-e081052e3f1935
1357886methylprednisolone 2000 MG InjectionSCDcd99be87-c8d9-48d6-a8e5-e081052e3f1935
311659methylprednisolone 40 MG InjectionSCDcd99be87-c8d9-48d6-a8e5-e081052e3f1935
1743720methylprednisolone 500 MG InjectionSCDcd99be87-c8d9-48d6-a8e5-e081052e3f1935
314099methylprednisolone 62.5 MG/ML Injectable SolutionSCDcd99be87-c8d9-48d6-a8e5-e081052e3f1935
1743726methylprednisolone (as methylprednisolone sodium succinate) 1 GM InjectionSYcd99be87-c8d9-48d6-a8e5-e081052e3f1935
1743704methylprednisolone (as methylprednisolone sodium succinate) 125 MG InjectionSYcd99be87-c8d9-48d6-a8e5-e081052e3f1935
1357886methylprednisolone (as methylprednisolone sodium succinate) 2 GM InjectionSYcd99be87-c8d9-48d6-a8e5-e081052e3f1935
311659methylprednisolone (as methylprednisolone sodium succinate) 40 MG InjectionSYcd99be87-c8d9-48d6-a8e5-e081052e3f1935
1743720methylprednisolone (as methylprednisolone sodium succinate) 500 MG InjectionSYcd99be87-c8d9-48d6-a8e5-e081052e3f1935
314099methylprednisolone (as methylprednisolone sodium succinate) 62.5 MG/ML Injectable SolutionSYcd99be87-c8d9-48d6-a8e5-e081052e3f1935
1743729Solu-Medrol (as methylprednisolone sodium succinate) 1 GM InjectionSYcd99be87-c8d9-48d6-a8e5-e081052e3f1935
1743707Solu-Medrol (as methylprednisolone sodium succinate) 125 MG InjectionSYcd99be87-c8d9-48d6-a8e5-e081052e3f1935
1357888Solu-Medrol (as methylprednisolone sodium succinate) 2 GM InjectionSYcd99be87-c8d9-48d6-a8e5-e081052e3f1935
207191Solu-Medrol (as methylprednisolone sodium succinate) 40 MG InjectionSYcd99be87-c8d9-48d6-a8e5-e081052e3f1935
1743722Solu-Medrol (as methylprednisolone sodium succinate) 500 MG InjectionSYcd99be87-c8d9-48d6-a8e5-e081052e3f1935
207193Solu-Medrol (as methylprednisolone sodium succinate) 62.5 MG/ML Injectable SolutionSYcd99be87-c8d9-48d6-a8e5-e081052e3f1935
1743729Solu-Medrol 1000 MG InjectionSYcd99be87-c8d9-48d6-a8e5-e081052e3f1935
1743707Solu-Medrol 125 MG InjectionSYcd99be87-c8d9-48d6-a8e5-e081052e3f1935
1357888Solu-Medrol 2000 MG InjectionSYcd99be87-c8d9-48d6-a8e5-e081052e3f1935
207191Solu-Medrol 40 MG InjectionSYcd99be87-c8d9-48d6-a8e5-e081052e3f1935
1743722Solu-Medrol 500 MG InjectionSYcd99be87-c8d9-48d6-a8e5-e081052e3f1935
207193Solu-Medrol 62.5 MG/ML Injectable SolutionSYcd99be87-c8d9-48d6-a8e5-e081052e3f1935
1743704methylPREDNISolone sodium succinate 125 MG InjectionPSN8e5997ed-f4a5-43f7-abbd-c8e2219fe0e933
1743707SOLU-Medrol 125 MG InjectionPSN8e5997ed-f4a5-43f7-abbd-c8e2219fe0e933
1743707methylprednisolone 125 MG Injection [Solu-Medrol]SBD8e5997ed-f4a5-43f7-abbd-c8e2219fe0e933
1743704methylprednisolone 125 MG InjectionSCD8e5997ed-f4a5-43f7-abbd-c8e2219fe0e933
1743704methylprednisolone (as methylprednisolone sodium succinate) 125 MG InjectionSY8e5997ed-f4a5-43f7-abbd-c8e2219fe0e933
1743707Solu-Medrol (as methylprednisolone sodium succinate) 125 MG InjectionSY8e5997ed-f4a5-43f7-abbd-c8e2219fe0e933
1743707Solu-Medrol 125 MG InjectionSY8e5997ed-f4a5-43f7-abbd-c8e2219fe0e933
1743704methylPREDNISolone sodium succinate 125 MG InjectionPSN2af28649-2553-4bcc-9cb1-c73f7cec76d525
311659methylPREDNISolone sodium succinate 40 MG InjectionPSN2af28649-2553-4bcc-9cb1-c73f7cec76d525
1743707SOLU-Medrol 125 MG InjectionPSN2af28649-2553-4bcc-9cb1-c73f7cec76d525
207191SOLU-Medrol 40 MG InjectionPSN2af28649-2553-4bcc-9cb1-c73f7cec76d525
1743707methylprednisolone 125 MG Injection [Solu-Medrol]SBD2af28649-2553-4bcc-9cb1-c73f7cec76d525
207191methylprednisolone 40 MG Injection [Solu-Medrol]SBD2af28649-2553-4bcc-9cb1-c73f7cec76d525
1743704methylprednisolone 125 MG InjectionSCD2af28649-2553-4bcc-9cb1-c73f7cec76d525
311659methylprednisolone 40 MG InjectionSCD2af28649-2553-4bcc-9cb1-c73f7cec76d525
1743704methylprednisolone (as methylprednisolone sodium succinate) 125 MG InjectionSY2af28649-2553-4bcc-9cb1-c73f7cec76d525
311659methylprednisolone (as methylprednisolone sodium succinate) 40 MG InjectionSY2af28649-2553-4bcc-9cb1-c73f7cec76d525
1743707Solu-Medrol (as methylprednisolone sodium succinate) 125 MG InjectionSY2af28649-2553-4bcc-9cb1-c73f7cec76d525
207191Solu-Medrol (as methylprednisolone sodium succinate) 40 MG InjectionSY2af28649-2553-4bcc-9cb1-c73f7cec76d525
1743707Solu-Medrol 125 MG InjectionSY2af28649-2553-4bcc-9cb1-c73f7cec76d525
207191Solu-Medrol 40 MG InjectionSY2af28649-2553-4bcc-9cb1-c73f7cec76d525
1743704methylPREDNISolone sodium succinate 125 MG InjectionPSN68ef8ec4-16de-4a8c-8696-b0935966038014
1743707SOLU-Medrol 125 MG InjectionPSN68ef8ec4-16de-4a8c-8696-b0935966038014
1743707methylprednisolone 125 MG Injection [Solu-Medrol]SBD68ef8ec4-16de-4a8c-8696-b0935966038014
1743704methylprednisolone 125 MG InjectionSCD68ef8ec4-16de-4a8c-8696-b0935966038014
1743704methylprednisolone (as methylprednisolone sodium succinate) 125 MG InjectionSY68ef8ec4-16de-4a8c-8696-b0935966038014
1743707Solu-Medrol (as methylprednisolone sodium succinate) 125 MG InjectionSY68ef8ec4-16de-4a8c-8696-b0935966038014
1743707Solu-Medrol 125 MG InjectionSY68ef8ec4-16de-4a8c-8696-b0935966038014
1743704methylPREDNISolone sodium succinate 125 MG InjectionPSN1d5ef347-2e9a-432f-9a88-a7c4ba30026712
1743707SOLU-Medrol 125 MG InjectionPSN1d5ef347-2e9a-432f-9a88-a7c4ba30026712
1743707methylprednisolone 125 MG Injection [Solu-Medrol]SBD1d5ef347-2e9a-432f-9a88-a7c4ba30026712
1743704methylprednisolone 125 MG InjectionSCD1d5ef347-2e9a-432f-9a88-a7c4ba30026712
1743704methylprednisolone (as methylprednisolone sodium succinate) 125 MG InjectionSY1d5ef347-2e9a-432f-9a88-a7c4ba30026712
1743707Solu-Medrol (as methylprednisolone sodium succinate) 125 MG InjectionSY1d5ef347-2e9a-432f-9a88-a7c4ba30026712
1743707Solu-Medrol 125 MG InjectionSY1d5ef347-2e9a-432f-9a88-a7c4ba30026712
314099methylPREDNISolone 62.5 MG/ML Injectable SolutionPSN7271310c-7764-4812-aa30-a5e90987c7a911
1743704methylPREDNISolone sodium succinate 125 MG InjectionPSN7271310c-7764-4812-aa30-a5e90987c7a911
311659methylPREDNISolone sodium succinate 40 MG InjectionPSN7271310c-7764-4812-aa30-a5e90987c7a911

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
0009-0047-040000900470425 VIAL in 1 CARTON (0009-0047-04) / 2 mL in 1 VIAL25 vial1959-04-020000-00-00NoNoCurrent
0009-0047-220000900472225 VIAL in 1 CARTON (0009-0047-22) / 2 mL in 1 VIAL (0009-0047-25) 25 vial1959-04-020000-00-00NoNoCurrent
0009-0047-25000090047252 mL in 1 VIAL2 mlHistorical
0009-0047-260000900472625 VIAL in 1 CARTON (0009-0047-26) / 2 mL in 1 VIAL (0009-0047-27) 25 vial1959-04-020000-00-00NoNoCurrent
0009-0047-27000090047272 mL in 1 VIAL2 mlHistorical