SOLU-MEDROL

Product NDC: 0009-0018
11-digit product format: 000090018
Labeler code: 0009
Product ID: 0009-0018_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: 1 g/8mL
Pharmacologic classes: Corticosteroid Hormone Receptor Agonists [MoA], Corticosteroid [EPC]
NDC exclude flag: No
Listing certified through: 2026-12-31
Current FDA listing: Yes

Source provenance: Browse the complete Orange Book source catalog · source snapshot 1.

Orange Book products#

Current product rows page 1 of 1 · 5 matching rows.

Application-product, Trade name, Ingredient table
Application-product	Trade name	Ingredient	Strength	Dosage form / route	TE codes	RLD / RS	Approval date
N011856-003	SOLU-MEDROL	METHYLPREDNISOLONE SODIUM SUCCINATE	EQ 40MG BASE/VIAL	INJECTABLE / INJECTION	AP	RLD, RS, Approved before 1982
N011856-004	SOLU-MEDROL	METHYLPREDNISOLONE SODIUM SUCCINATE	EQ 125MG BASE/VIAL	INJECTABLE / INJECTION	AP	RLD, RS, Approved before 1982
N011856-005	SOLU-MEDROL	METHYLPREDNISOLONE SODIUM SUCCINATE	EQ 500MG BASE/VIAL	INJECTABLE / INJECTION	AP	RLD, RS, Approved before 1982
N011856-006	SOLU-MEDROL	METHYLPREDNISOLONE SODIUM SUCCINATE	EQ 1GM BASE/VIAL	INJECTABLE / INJECTION	AP	RLD, RS, Approved before 1982
N011856-007	SOLU-MEDROL	METHYLPREDNISOLONE SODIUM SUCCINATE	EQ 2GM BASE/VIAL	INJECTABLE / INJECTION	AP	RLD, RS	1985-02-27

Therapeutic equivalence codes#

Current TE-code rows page 1 of 1 · 5 matching rows.

Application-product, TE code table
Application-product	TE code
N011856-003	AP
N011856-004	AP
N011856-005	AP
N011856-006	AP
N011856-007	AP

Observed Orange Book product history#

Observed FDA ZIP history: Each table is queried independently by exact application/product key from successfully parsed Orange Book snapshots. Capture times identify archived source observations; absence or a change between snapshots is not inferred. FDA publication files that were not recoverable as structured ZIP data are not represented as states.

Captured, Edition, Application-product table
Captured	Edition	Application-product	Trade name	Strength	Dosage form / route	Product TE source text	RLD / RS	Approval date	Source SHA-256
2026-08-01 22:54:32	2026-06	N011856-003	SOLU-MEDROL	EQ 40MG BASE/VIAL	INJECTABLE / INJECTION	AP	RLD, RS, Approved before 1982		`a50c72e98297…`
2026-08-01 22:54:32	2026-06	N011856-004	SOLU-MEDROL	EQ 125MG BASE/VIAL	INJECTABLE / INJECTION	AP	RLD, RS, Approved before 1982		`a50c72e98297…`
2026-08-01 22:54:32	2026-06	N011856-005	SOLU-MEDROL	EQ 500MG BASE/VIAL	INJECTABLE / INJECTION	AP	RLD, RS, Approved before 1982		`a50c72e98297…`
2026-08-01 22:54:32	2026-06	N011856-006	SOLU-MEDROL	EQ 1GM BASE/VIAL	INJECTABLE / INJECTION	AP	RLD, RS, Approved before 1982		`a50c72e98297…`
2026-08-01 22:54:32	2026-06	N011856-007	SOLU-MEDROL	EQ 2GM BASE/VIAL	INJECTABLE / INJECTION	AP	RLD, RS	1985-02-27	`a50c72e98297…`

Observed Orange Book normalized TE history#

Captured, Edition, Application-product table
Captured	Edition	Application-product	TE code	Order	Source SHA-256
2026-08-01 22:54:32	2026-06	N011856-003	AP	1	`a50c72e98297…`
2026-08-01 22:54:32	2026-06	N011856-004	AP	1	`a50c72e98297…`
2026-08-01 22:54:32	2026-06	N011856-005	AP	1	`a50c72e98297…`
2026-08-01 22:54:32	2026-06	N011856-006	AP	1	`a50c72e98297…`
2026-08-01 22:54:32	2026-06	N011856-007	AP	1	`a50c72e98297…`

openFDA label cross-check#

Cross-check layer: openFDA label JSON enriches search and identifies hydration gaps. The DailyMed Structured Product Label remains the canonical label presentation on FDA.report. Every label matching the complete exact-identifier union is deduplicated and paginated below.

Matched openFDA labels page 1 of 1 · 18 matching rows.

Brand, Generic, Manufacturer table
Brand	Generic	Manufacturer	SPL set ID	Effective date	Available safety fields	Join
SOLU-MEDROL	METHYLPREDNISOLONE SODIUM SUCCINATE	Sportpharm LLC	0cb0ba76-067f-46c4-a5d8-b585d5ecafe3	2026-07-23	Warnings, Adverse reactions	Exact identifier application applno (NDA): 011856 application number: NDA011856
Solu-Medrol	METHYLPREDNISOLONE SODIUM SUCCINATE	Cardinal Health 107, LLC	68ef8ec4-16de-4a8c-8696-b09359660380	2026-07-17	Warnings, Adverse reactions	Exact identifier application applno (NDA): 011856 application number: NDA011856
SOLU-MEDROL	METHYLPREDNISOLONE SODIUM SUCCINATE	Pharmacia & Upjohn Company LLC	7271310c-7764-4812-aa30-a5e90987c7a9	2026-06-25	Warnings, Adverse reactions	Exact identifier application applno (NDA): 011856 application number: NDA011856
Solu-Medrol	METHYLPREDNISOLONE SODIUM SUCCINATE	Henry Schein, Inc.	ea2f9b6f-2375-40a6-8b97-b607b9f3ac63	2026-06-04	Warnings, Adverse reactions	Exact identifier application applno (NDA): 011856 application number: NDA011856
SOLU-MEDROL	METHYLPREDNISOLONE SODIUM SUCCINATE	A-S Medication Solutions	8e5997ed-f4a5-43f7-abbd-c8e2219fe0e9	2026-05-29	Warnings, Adverse reactions	Exact identifier application applno (NDA): 011856 application number: NDA011856
Solu-Medrol	METHYLPREDNISOLONE SODIUM SUCCINATE	Cardinal Health 107, LLC	2af28649-2553-4bcc-9cb1-c73f7cec76d5	2026-05-20	Warnings, Adverse reactions	Exact identifier application applno (NDA): 011856 application number: NDA011856
Solu-Medrol	METHYLPREDNISOLONE SODIUM SUCCINATE	Henry Schein, Inc.	decceb81-e922-4b72-a278-3ed80f4adb04	2026-03-18	Warnings, Adverse reactions	Exact identifier application applno (NDA): 011856 application number: NDA011856
SOLU-MEDROL	METHYLPREDNISOLONE SODIUM SUCCINATE	REMEDYREPACK INC.	1d5ef347-2e9a-432f-9a88-a7c4ba300267	2026-01-30	Warnings, Adverse reactions	Exact identifier application applno (NDA): 011856 application number: NDA011856
Solu-Medrol	METHYLPREDNISOLONE SODIUM SUCCINATE	Cardinal Health 107, LLC	7e38b09c-da41-4ee3-8f99-812d3276d551	2025-12-19	Warnings, Adverse reactions	Exact identifier application applno (NDA): 011856 application number: NDA011856
SOLU-MEDROL	METHYLPREDNISOLONE SODIUM SUCCINATE	ProPharma Distribution	42df21df-9284-4505-e063-6294a90a7024	2025-12-18	Warnings, Adverse reactions	Exact identifier application applno (NDA): 011856 application number: NDA011856
SOLU-MEDROL	METHYLPREDNISOLONE SODIUM SUCCINATE	Pharmacia & Upjohn Company LLC	cd99be87-c8d9-48d6-a8e5-e081052e3f19	2025-12-02	Warnings, Adverse reactions	Exact identifier application applno (NDA): 011856 application number: NDA011856 ndc (product): 0009-0018
SOLU-MEDROL	METHYLPREDNISOLONE SODIUM SUCCINATE	ProPharma Distribution	38698075-ac58-b5a4-e063-6294a90a7848	2025-07-18	Warnings, Adverse reactions	Exact identifier application applno (NDA): 011856 application number: NDA011856
SOLU-MEDROL(R) METHYLPREDNISOLONE SODIUM SUCCINAT	SOLU-MEDROL(R) METHYLPREDNISOLONE SODIUM SUCCINAT	HF Acquisition Co LLC, DBA HealthFirst	99b3c99a-79d5-6c54-e053-2a95a90a28bc	2025-01-08	Warnings, Adverse reactions	Exact identifier application applno (NDA): 011856 application number: NDA011856
SOLU-MEDROL	SOLU-MEDROL	HF Acquisition Co. LLC, DBA HealthFirst	74e5060c-8426-1b77-e053-2a91aa0a1f13	2024-02-22	Warnings, Adverse reactions	Exact identifier application applno (NDA): 011856 application number: NDA011856
SOLU-MEDROL	SOLU-MEDROL	HF Acquisition Co. LLC, DBA HealthFirst	74e448ed-f4b4-8d09-e053-2991aa0a7500	2024-01-29	Warnings, Adverse reactions	Exact identifier application applno (NDA): 011856 application number: NDA011856
SOLU-MEDROL	METHYLPREDNISOLONE SODIUM SUCCINATE	Medical Purchasing Solutions, LLC	6a26a977-95dd-cdae-e053-2a91aa0a8b0a	2023-05-30	Warnings, Adverse reactions	Exact identifier application applno (NDA): 011856 application number: NDA011856
SOLU-MEDROL	METHYLPREDNISOLONE SODIUM SUCCINATE	Medical Purchasing Solutions, LLC	dd2bfa31-9eae-2baa-e053-2a95a90a9db7	2023-05-23	Warnings, Adverse reactions	Exact identifier application applno (NDA): 011856 application number: NDA011856
SOLU-MEDROL	METHYLPREDNISOLONE SODIUM SUCCINATE	Medical Purchasing Solutions, LLC	b635e21b-d68d-f60b-e053-2995a90a0f46	2023-05-08	Warnings, Adverse reactions	Exact identifier application applno (NDA): 011856 application number: NDA011856

Additional Listing Data#

Finished product: Yes
Brand name base: SOLU-MEDROL
Listing expiration: 2026-12-31

Active Ingredients#

Ingredient, Strength table
Ingredient	Strength
METHYLPREDNISOLONE SODIUM SUCCINATE	1 g/8mL

Harmonized UNII identifiers#

UNII identifiers page 1 of 1 · 1 matching rows.

Identifier, FDA.report destination table
Identifier	FDA.report destination
LEC9GKY20K	Internal UNII lookup

Harmonized RxCUI identifiers#

RxCUI identifiers page 1 of 1 · 12 matching rows.

Identifier, FDA.report destination table
Identifier	FDA.report destination
207191	Internal RxNorm lookup
207193	Internal RxNorm lookup
311659	Internal RxNorm lookup
314099	Internal RxNorm lookup
1357886	Internal RxNorm lookup
1357888	Internal RxNorm lookup
1743704	Internal RxNorm lookup
1743707	Internal RxNorm lookup
1743720	Internal RxNorm lookup
1743722	Internal RxNorm lookup
1743726	Internal RxNorm lookup
1743729	Internal RxNorm lookup

Harmonized SPL set identifiers#

SPL set identifiers page 1 of 1 · 1 matching rows.

Identifier, FDA.report destination table
Identifier	FDA.report destination
cd99be87-c8d9-48d6-a8e5-e081052e3f19	Available on FDA.report

DailyMed Product Concepts#

Product concept, Relation, Version table
Product concept	Relation	Version	Effective
b3918abe-5cd1-b0ce-abd7-2dd6732cde26	Product name	5	20260128
e1637c7c-52c4-49a3-b36b-61be755aab29	Product name	4	20230717
9eb3e96d-a1d4-4de3-aa3d-a629eea44815	Product name	4	20220316

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDC	Product	Description	Form	Quantity	Strength	SPL version
0009-0018-20	SOLU-MEDROL	8 mL in 1 VIAL	INJECTION, POWDER, FOR SOLUTION	8		35
0009-0018-20	SOLU-MEDROL	1 in 1 CARTON	INJECTION, POWDER, FOR SOLUTION	1		35

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDC	Billing unit	Product NDC	DailyMed indexing SPL	SPL version	Effective
0009-0018-20	EA - Each	0009-0018	7d9a0f89-9b21-4db6-aaa4-9fd7079f644b	1	2012-07-24

DailyMed Socrata Ingredients#

Ingredient, Type, UNII table
Ingredient	Type	UNII	DailyMed label	SPL version
METHYLPREDNISOLONE SODIUM SUCCINATE	ACTIVE INGREDIENT	LEC9GKY20K	SOLU-MEDROL (METHYLPREDNISOLONE SODIUM SUCCINATE) INJECTION, POWDER, FOR SOLUTION SOLU-MEDROL (METHYLPREDNISOLONE SODIUM SUCCINATE) KIT [PHARMACIA AND UPJOHN COMPANY]	10
METHYLPREDNISOLONE	ACTIVE MOIETY	X4W7ZR7023	SOLU-MEDROL (METHYLPREDNISOLONE SODIUM SUCCINATE) INJECTION, POWDER, FOR SOLUTION SOLU-MEDROL (METHYLPREDNISOLONE SODIUM SUCCINATE) KIT [PHARMACIA AND UPJOHN COMPANY]	10
BENZYL ALCOHOL	INACTIVE INGREDIENT	LKG8494WBH	SOLU-MEDROL (METHYLPREDNISOLONE SODIUM SUCCINATE) INJECTION, POWDER, FOR SOLUTION SOLU-MEDROL (METHYLPREDNISOLONE SODIUM SUCCINATE) KIT [PHARMACIA AND UPJOHN COMPANY]	10
LACTOSE MONOHYDRATE	INACTIVE INGREDIENT	EWQ57Q8I5X	SOLU-MEDROL (METHYLPREDNISOLONE SODIUM SUCCINATE) INJECTION, POWDER, FOR SOLUTION SOLU-MEDROL (METHYLPREDNISOLONE SODIUM SUCCINATE) KIT [PHARMACIA AND UPJOHN COMPANY]	10
SODIUM PHOSPHATE, DIBASIC	INACTIVE INGREDIENT	GR686LBA74	SOLU-MEDROL (METHYLPREDNISOLONE SODIUM SUCCINATE) INJECTION, POWDER, FOR SOLUTION SOLU-MEDROL (METHYLPREDNISOLONE SODIUM SUCCINATE) KIT [PHARMACIA AND UPJOHN COMPANY]	10
SODIUM PHOSPHATE, MONOBASIC, ANHYDROUS	INACTIVE INGREDIENT	KH7I04HPUU	SOLU-MEDROL (METHYLPREDNISOLONE SODIUM SUCCINATE) INJECTION, POWDER, FOR SOLUTION SOLU-MEDROL (METHYLPREDNISOLONE SODIUM SUCCINATE) KIT [PHARMACIA AND UPJOHN COMPANY]	10
WATER	INACTIVE INGREDIENT	059QF0KO0R	SOLU-MEDROL (METHYLPREDNISOLONE SODIUM SUCCINATE) INJECTION, POWDER, FOR SOLUTION SOLU-MEDROL (METHYLPREDNISOLONE SODIUM SUCCINATE) KIT [PHARMACIA AND UPJOHN COMPANY]	10

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDC	Dashboard title	SPL version	Validation	Dashboard ZIP
0009-0018	SOLU-MEDROL (METHYLPREDNISOLONE SODIUM SUCCINATE) INJECTION, POWDER, FOR SOLUTION [PHARMACIA & UPJOHN COMPANY LLC]	32	Current NDC, Legacy NDC, 2 package rows	20250515_cd99be87-c8d9-48d6-a8e5-e081052e3f19.zip

UNII, Preferred term, Registry number table
UNII	Preferred term	Registry number	Matched term
LEC9GKY20K	METHYLPREDNISOLONE SODIUM SUCCINATE	2375-03-3	METHYLPREDNISOLONE SODIUM SUCCINATE

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUI	RxNorm string	TTY	DailyMed	SPL version
314099	methylPREDNISolone 62.5 MG/ML Injectable Solution	PSN	cd99be87-c8d9-48d6-a8e5-e081052e3f19	35
1743726	methylPREDNISolone sodium succinate 1 GM Injection	PSN	cd99be87-c8d9-48d6-a8e5-e081052e3f19	35
1743704	methylPREDNISolone sodium succinate 125 MG Injection	PSN	cd99be87-c8d9-48d6-a8e5-e081052e3f19	35
1357886	methylPREDNISolone sodium succinate 2 GM Injection	PSN	cd99be87-c8d9-48d6-a8e5-e081052e3f19	35
311659	methylPREDNISolone sodium succinate 40 MG Injection	PSN	cd99be87-c8d9-48d6-a8e5-e081052e3f19	35
1743720	methylPREDNISolone sodium succinate 500 MG Injection	PSN	cd99be87-c8d9-48d6-a8e5-e081052e3f19	35
1743729	SOLU-Medrol 1 GM Injection	PSN	cd99be87-c8d9-48d6-a8e5-e081052e3f19	35
1743707	SOLU-Medrol 125 MG Injection	PSN	cd99be87-c8d9-48d6-a8e5-e081052e3f19	35
1357888	SOLU-Medrol 2 GM Injection	PSN	cd99be87-c8d9-48d6-a8e5-e081052e3f19	35
207191	SOLU-Medrol 40 MG Injection	PSN	cd99be87-c8d9-48d6-a8e5-e081052e3f19	35
1743722	SOLU-Medrol 500 MG Injection	PSN	cd99be87-c8d9-48d6-a8e5-e081052e3f19	35
207193	SOLU-Medrol 62.5 MG/ML Injectable Solution	PSN	cd99be87-c8d9-48d6-a8e5-e081052e3f19	35
1743729	methylprednisolone 1000 MG Injection [Solu-Medrol]	SBD	cd99be87-c8d9-48d6-a8e5-e081052e3f19	35
1743707	methylprednisolone 125 MG Injection [Solu-Medrol]	SBD	cd99be87-c8d9-48d6-a8e5-e081052e3f19	35
1357888	methylprednisolone 2000 MG Injection [Solu-Medrol]	SBD	cd99be87-c8d9-48d6-a8e5-e081052e3f19	35
207191	methylprednisolone 40 MG Injection [Solu-Medrol]	SBD	cd99be87-c8d9-48d6-a8e5-e081052e3f19	35
1743722	methylprednisolone 500 MG Injection [Solu-Medrol]	SBD	cd99be87-c8d9-48d6-a8e5-e081052e3f19	35
207193	methylprednisolone 62.5 MG/ML Injectable Solution [Solu-Medrol]	SBD	cd99be87-c8d9-48d6-a8e5-e081052e3f19	35
1743726	methylprednisolone 1000 MG Injection	SCD	cd99be87-c8d9-48d6-a8e5-e081052e3f19	35
1743704	methylprednisolone 125 MG Injection	SCD	cd99be87-c8d9-48d6-a8e5-e081052e3f19	35
1357886	methylprednisolone 2000 MG Injection	SCD	cd99be87-c8d9-48d6-a8e5-e081052e3f19	35
311659	methylprednisolone 40 MG Injection	SCD	cd99be87-c8d9-48d6-a8e5-e081052e3f19	35
1743720	methylprednisolone 500 MG Injection	SCD	cd99be87-c8d9-48d6-a8e5-e081052e3f19	35
314099	methylprednisolone 62.5 MG/ML Injectable Solution	SCD	cd99be87-c8d9-48d6-a8e5-e081052e3f19	35
1743726	methylprednisolone (as methylprednisolone sodium succinate) 1 GM Injection	SY	cd99be87-c8d9-48d6-a8e5-e081052e3f19	35
1743704	methylprednisolone (as methylprednisolone sodium succinate) 125 MG Injection	SY	cd99be87-c8d9-48d6-a8e5-e081052e3f19	35
1357886	methylprednisolone (as methylprednisolone sodium succinate) 2 GM Injection	SY	cd99be87-c8d9-48d6-a8e5-e081052e3f19	35
311659	methylprednisolone (as methylprednisolone sodium succinate) 40 MG Injection	SY	cd99be87-c8d9-48d6-a8e5-e081052e3f19	35
1743720	methylprednisolone (as methylprednisolone sodium succinate) 500 MG Injection	SY	cd99be87-c8d9-48d6-a8e5-e081052e3f19	35
314099	methylprednisolone (as methylprednisolone sodium succinate) 62.5 MG/ML Injectable Solution	SY	cd99be87-c8d9-48d6-a8e5-e081052e3f19	35
1743729	Solu-Medrol (as methylprednisolone sodium succinate) 1 GM Injection	SY	cd99be87-c8d9-48d6-a8e5-e081052e3f19	35
1743707	Solu-Medrol (as methylprednisolone sodium succinate) 125 MG Injection	SY	cd99be87-c8d9-48d6-a8e5-e081052e3f19	35
1357888	Solu-Medrol (as methylprednisolone sodium succinate) 2 GM Injection	SY	cd99be87-c8d9-48d6-a8e5-e081052e3f19	35
207191	Solu-Medrol (as methylprednisolone sodium succinate) 40 MG Injection	SY	cd99be87-c8d9-48d6-a8e5-e081052e3f19	35
1743722	Solu-Medrol (as methylprednisolone sodium succinate) 500 MG Injection	SY	cd99be87-c8d9-48d6-a8e5-e081052e3f19	35
207193	Solu-Medrol (as methylprednisolone sodium succinate) 62.5 MG/ML Injectable Solution	SY	cd99be87-c8d9-48d6-a8e5-e081052e3f19	35
1743729	Solu-Medrol 1000 MG Injection	SY	cd99be87-c8d9-48d6-a8e5-e081052e3f19	35
1743707	Solu-Medrol 125 MG Injection	SY	cd99be87-c8d9-48d6-a8e5-e081052e3f19	35
1357888	Solu-Medrol 2000 MG Injection	SY	cd99be87-c8d9-48d6-a8e5-e081052e3f19	35
207191	Solu-Medrol 40 MG Injection	SY	cd99be87-c8d9-48d6-a8e5-e081052e3f19	35
1743722	Solu-Medrol 500 MG Injection	SY	cd99be87-c8d9-48d6-a8e5-e081052e3f19	35
207193	Solu-Medrol 62.5 MG/ML Injectable Solution	SY	cd99be87-c8d9-48d6-a8e5-e081052e3f19	35

Packages#

Package NDC, 11-digit format, Description table
Package NDC	11-digit format	Description	Units	Marketing start	Marketing end	Sample	Exclude flag	Status
0009-0018-20	00009001820	1 VIAL in 1 CARTON (0009-0018-20) / 8 mL in 1 VIAL	1 vial	1959-04-02	0000-00-00	No	No	Current

Title, Manufacturer, Effective date table
Title	Manufacturer	Effective date	Type	Version
SOLU-MEDROL ® (methylprednisolone sodium succinate for injection, USP)	Pharmacia & Upjohn Company LLC	2025-12-02	HUMAN PRESCRIPTION DRUG LABEL	35