Solu-Medrol

Product NDC: 55154-3940
Requested package NDC: 55154-3940-5
11-digit product format: 551543940
Labeler code: 55154
Product ID: 55154-3940_a3a10eba-ccb5-4e30-8c3c-c5b41c84c8a8
Type: HUMAN PRESCRIPTION DRUG
Nonproprietary name: methylprednisolone sodium succinate
Dosage form: INJECTION, POWDER, FOR SOLUTION
Route: INTRAMUSCULAR; INTRAVENOUS
Labeler: Cardinal Health 107, LLC
Application: NDA011856
Marketing category: NDA
Marketing start: 1959-04-02
Substance: METHYLPREDNISOLONE SODIUM SUCCINATE
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

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 ndc (package): 55154-3940-5 ndc (product): 55154-3940 ndc11 (package): 55154394005
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
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: 2027-12-31

Active Ingredients#

Ingredient, Strength table
Ingredient	Strength
METHYLPREDNISOLONE SODIUM SUCCINATE	40 mg/mL

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 · 4 matching rows.

Identifier, FDA.report destination table
Identifier	FDA.report destination
207191	Internal RxNorm lookup
311659	Internal RxNorm lookup
1743704	Internal RxNorm lookup
1743707	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
2af28649-2553-4bcc-9cb1-c73f7cec76d5	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
55154-3940-5	Solu-Medrol	5 in 1 BAG	INJECTION, POWDER, FOR SOLUTION	5		25
55154-3940-5	Solu-Medrol	1 mL in 1 VIAL	INJECTION, POWDER, FOR SOLUTION	1		25

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDC	Billing unit	Product NDC	DailyMed indexing SPL	SPL version	Effective
55154-3940-5	EA - Each	55154-3940	ad05523b-5791-4917-ac8e-9f6b5d553e12	1	2018-12-13

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 [CARDINAL HEALTH]	13
methylprednisolone	ACTIVE MOIETY	X4W7ZR7023	SOLU-MEDROL (METHYLPREDNISOLONE SODIUM SUCCINATE) INJECTION, POWDER, FOR SOLUTION [CARDINAL HEALTH]	13
lactose monohydrate	INACTIVE INGREDIENT	EWQ57Q8I5X	SOLU-MEDROL (METHYLPREDNISOLONE SODIUM SUCCINATE) INJECTION, POWDER, FOR SOLUTION [CARDINAL HEALTH]	13
sodium phosphate, dibasic	INACTIVE INGREDIENT	GR686LBA74	SOLU-MEDROL (METHYLPREDNISOLONE SODIUM SUCCINATE) INJECTION, POWDER, FOR SOLUTION [CARDINAL HEALTH]	13
SODIUM PHOSPHATE, MONOBASIC, ANHYDROUS	INACTIVE INGREDIENT	KH7I04HPUU	SOLU-MEDROL (METHYLPREDNISOLONE SODIUM SUCCINATE) INJECTION, POWDER, FOR SOLUTION [CARDINAL HEALTH]	13

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDC	Dashboard title	SPL version	Validation	Dashboard ZIP
55154-3940	SOLU-MEDROL (METHYLPREDNISOLONE SODIUM SUCCINATE) INJECTION, POWDER, FOR SOLUTION [CARDINAL HEALTH 107, LLC]	23	Current NDC, Legacy NDC, 2 package rows	20241101_2af28649-2553-4bcc-9cb1-c73f7cec76d5.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
1743704	methylPREDNISolone sodium succinate 125 MG Injection	PSN	2af28649-2553-4bcc-9cb1-c73f7cec76d5	25
311659	methylPREDNISolone sodium succinate 40 MG Injection	PSN	2af28649-2553-4bcc-9cb1-c73f7cec76d5	25
1743707	SOLU-Medrol 125 MG Injection	PSN	2af28649-2553-4bcc-9cb1-c73f7cec76d5	25
207191	SOLU-Medrol 40 MG Injection	PSN	2af28649-2553-4bcc-9cb1-c73f7cec76d5	25
1743707	methylprednisolone 125 MG Injection [Solu-Medrol]	SBD	2af28649-2553-4bcc-9cb1-c73f7cec76d5	25
207191	methylprednisolone 40 MG Injection [Solu-Medrol]	SBD	2af28649-2553-4bcc-9cb1-c73f7cec76d5	25
1743704	methylprednisolone 125 MG Injection	SCD	2af28649-2553-4bcc-9cb1-c73f7cec76d5	25
311659	methylprednisolone 40 MG Injection	SCD	2af28649-2553-4bcc-9cb1-c73f7cec76d5	25
1743704	methylprednisolone (as methylprednisolone sodium succinate) 125 MG Injection	SY	2af28649-2553-4bcc-9cb1-c73f7cec76d5	25
311659	methylprednisolone (as methylprednisolone sodium succinate) 40 MG Injection	SY	2af28649-2553-4bcc-9cb1-c73f7cec76d5	25
1743707	Solu-Medrol (as methylprednisolone sodium succinate) 125 MG Injection	SY	2af28649-2553-4bcc-9cb1-c73f7cec76d5	25
207191	Solu-Medrol (as methylprednisolone sodium succinate) 40 MG Injection	SY	2af28649-2553-4bcc-9cb1-c73f7cec76d5	25
1743707	Solu-Medrol 125 MG Injection	SY	2af28649-2553-4bcc-9cb1-c73f7cec76d5	25
207191	Solu-Medrol 40 MG Injection	SY	2af28649-2553-4bcc-9cb1-c73f7cec76d5	25

Packages#

Package NDC, 11-digit format, Description table
Package NDC	11-digit format	Description	Units	Marketing start	Marketing end	Sample	Exclude flag	Status
55154-3940-5	55154394005	5 VIAL in 1 BAG (55154-3940-5) / 1 mL in 1 VIAL	5 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)	Cardinal Health 107, LLC	2026-05-20	HUMAN PRESCRIPTION DRUG LABEL	26