Methylprednisolone Sodium Succinate

Product NDC: 55150-265
11-digit product format: 551500265
Labeler code: 55150
Product ID: 55150-265_1d8c98fc-8bb8-4caa-a745-5d42ddd2c8ec
Type: HUMAN PRESCRIPTION DRUG
Nonproprietary name: Methylprednisolone Sodium Succinate
Dosage form: INJECTION, POWDER, LYOPHILIZED, FOR SOLUTION
Route: INTRAMUSCULAR; INTRAVENOUS
Labeler: Eugia US LLC
Application: ANDA207667
Marketing category: ANDA
Marketing start: 2015-12-15
Substance: METHYLPREDNISOLONE SODIUM SUCCINATE
Active strength: 2 g/1
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 42.

Orange Book products#

Current product rows page 1 of 1 · 4 matching rows.

Application-product, Trade name, Ingredient table
Application-product	Trade name	Ingredient	Strength	Dosage form / route	Approval date
A207667-001	METHYLPREDNISOLONE SODIUM SUCCINATE	METHYLPREDNISOLONE SODIUM SUCCINATE	EQ 40MG BASE/VIAL	INJECTABLE / INJECTION	2015-12-15
A207667-002	METHYLPREDNISOLONE SODIUM SUCCINATE	METHYLPREDNISOLONE SODIUM SUCCINATE	EQ 125MG BASE/VIAL	INJECTABLE / INJECTION	2015-12-15
A207667-003	METHYLPREDNISOLONE SODIUM SUCCINATE	METHYLPREDNISOLONE SODIUM SUCCINATE	EQ 500MG BASE/VIAL	INJECTABLE / INJECTION	2015-12-15
A207667-004	METHYLPREDNISOLONE SODIUM SUCCINATE	METHYLPREDNISOLONE SODIUM SUCCINATE	EQ 2GM BASE/VIAL	INJECTABLE / INJECTION	2015-12-15

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.

Product history page 1 of 5 · 168 observed states.

Captured, Edition, Application-product table
Captured	Edition	Application-product	Trade name	Strength	Dosage form / route	Approval date	Source SHA-256
2026-08-18 06:07:40	2026-07	A207667-001	METHYLPREDNISOLONE SODIUM SUCCINATE	EQ 40MG BASE/VIAL	INJECTABLE / INJECTION	2015-12-15	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	A207667-002	METHYLPREDNISOLONE SODIUM SUCCINATE	EQ 125MG BASE/VIAL	INJECTABLE / INJECTION	2015-12-15	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	A207667-003	METHYLPREDNISOLONE SODIUM SUCCINATE	EQ 500MG BASE/VIAL	INJECTABLE / INJECTION	2015-12-15	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	A207667-004	METHYLPREDNISOLONE SODIUM SUCCINATE	EQ 2GM BASE/VIAL	INJECTABLE / INJECTION	2015-12-15	`caaa826d4ba7…`
2026-02-19 14:30 UTC	2026-02	A207667-001	METHYLPREDNISOLONE SODIUM SUCCINATE	EQ 40MG BASE/VIAL	INJECTABLE / INJECTION	2015-12-15	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A207667-002	METHYLPREDNISOLONE SODIUM SUCCINATE	EQ 125MG BASE/VIAL	INJECTABLE / INJECTION	2015-12-15	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A207667-003	METHYLPREDNISOLONE SODIUM SUCCINATE	EQ 500MG BASE/VIAL	INJECTABLE / INJECTION	2015-12-15	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A207667-004	METHYLPREDNISOLONE SODIUM SUCCINATE	EQ 2GM BASE/VIAL	INJECTABLE / INJECTION	2015-12-15	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A207667-001	METHYLPREDNISOLONE SODIUM SUCCINATE	EQ 40MG BASE/VIAL	INJECTABLE / INJECTION	2015-12-15	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A207667-002	METHYLPREDNISOLONE SODIUM SUCCINATE	EQ 125MG BASE/VIAL	INJECTABLE / INJECTION	2015-12-15	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A207667-003	METHYLPREDNISOLONE SODIUM SUCCINATE	EQ 500MG BASE/VIAL	INJECTABLE / INJECTION	2015-12-15	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A207667-004	METHYLPREDNISOLONE SODIUM SUCCINATE	EQ 2GM BASE/VIAL	INJECTABLE / INJECTION	2015-12-15	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	A207667-001	METHYLPREDNISOLONE SODIUM SUCCINATE	EQ 40MG BASE/VIAL	INJECTABLE / INJECTION	2015-12-15	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A207667-002	METHYLPREDNISOLONE SODIUM SUCCINATE	EQ 125MG BASE/VIAL	INJECTABLE / INJECTION	2015-12-15	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A207667-003	METHYLPREDNISOLONE SODIUM SUCCINATE	EQ 500MG BASE/VIAL	INJECTABLE / INJECTION	2015-12-15	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A207667-004	METHYLPREDNISOLONE SODIUM SUCCINATE	EQ 2GM BASE/VIAL	INJECTABLE / INJECTION	2015-12-15	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A207667-001	METHYLPREDNISOLONE SODIUM SUCCINATE	EQ 40MG BASE/VIAL	INJECTABLE / INJECTION	2015-12-15	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A207667-002	METHYLPREDNISOLONE SODIUM SUCCINATE	EQ 125MG BASE/VIAL	INJECTABLE / INJECTION	2015-12-15	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A207667-003	METHYLPREDNISOLONE SODIUM SUCCINATE	EQ 500MG BASE/VIAL	INJECTABLE / INJECTION	2015-12-15	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A207667-004	METHYLPREDNISOLONE SODIUM SUCCINATE	EQ 2GM BASE/VIAL	INJECTABLE / INJECTION	2015-12-15	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A207667-001	METHYLPREDNISOLONE SODIUM SUCCINATE	EQ 40MG BASE/VIAL	INJECTABLE / INJECTION	2015-12-15	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A207667-002	METHYLPREDNISOLONE SODIUM SUCCINATE	EQ 125MG BASE/VIAL	INJECTABLE / INJECTION	2015-12-15	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A207667-003	METHYLPREDNISOLONE SODIUM SUCCINATE	EQ 500MG BASE/VIAL	INJECTABLE / INJECTION	2015-12-15	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A207667-004	METHYLPREDNISOLONE SODIUM SUCCINATE	EQ 2GM BASE/VIAL	INJECTABLE / INJECTION	2015-12-15	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A207667-001	METHYLPREDNISOLONE SODIUM SUCCINATE	EQ 40MG BASE/VIAL	INJECTABLE / INJECTION	2015-12-15	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A207667-002	METHYLPREDNISOLONE SODIUM SUCCINATE	EQ 125MG BASE/VIAL	INJECTABLE / INJECTION	2015-12-15	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A207667-003	METHYLPREDNISOLONE SODIUM SUCCINATE	EQ 500MG BASE/VIAL	INJECTABLE / INJECTION	2015-12-15	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A207667-004	METHYLPREDNISOLONE SODIUM SUCCINATE	EQ 2GM BASE/VIAL	INJECTABLE / INJECTION	2015-12-15	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A207667-001	METHYLPREDNISOLONE SODIUM SUCCINATE	EQ 40MG BASE/VIAL	INJECTABLE / INJECTION	2015-12-15	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A207667-002	METHYLPREDNISOLONE SODIUM SUCCINATE	EQ 125MG BASE/VIAL	INJECTABLE / INJECTION	2015-12-15	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A207667-003	METHYLPREDNISOLONE SODIUM SUCCINATE	EQ 500MG BASE/VIAL	INJECTABLE / INJECTION	2015-12-15	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A207667-004	METHYLPREDNISOLONE SODIUM SUCCINATE	EQ 2GM BASE/VIAL	INJECTABLE / INJECTION	2015-12-15	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A207667-001	METHYLPREDNISOLONE SODIUM SUCCINATE	EQ 40MG BASE/VIAL	INJECTABLE / INJECTION	2015-12-15	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A207667-002	METHYLPREDNISOLONE SODIUM SUCCINATE	EQ 125MG BASE/VIAL	INJECTABLE / INJECTION	2015-12-15	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A207667-003	METHYLPREDNISOLONE SODIUM SUCCINATE	EQ 500MG BASE/VIAL	INJECTABLE / INJECTION	2015-12-15	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A207667-004	METHYLPREDNISOLONE SODIUM SUCCINATE	EQ 2GM BASE/VIAL	INJECTABLE / INJECTION	2015-12-15	`5bbf6a4d5a75…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A207667-001	METHYLPREDNISOLONE SODIUM SUCCINATE	EQ 40MG BASE/VIAL	INJECTABLE / INJECTION	2015-12-15	`d8e5a09893c0…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A207667-002	METHYLPREDNISOLONE SODIUM SUCCINATE	EQ 125MG BASE/VIAL	INJECTABLE / INJECTION	2015-12-15	`d8e5a09893c0…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A207667-003	METHYLPREDNISOLONE SODIUM SUCCINATE	EQ 500MG BASE/VIAL	INJECTABLE / INJECTION	2015-12-15	`d8e5a09893c0…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A207667-004	METHYLPREDNISOLONE SODIUM SUCCINATE	EQ 2GM BASE/VIAL	INJECTABLE / INJECTION	2015-12-15	`d8e5a09893c0…`

Observed Orange Book normalized TE history#

Normalized TE history page 1 of 2 · 56 observed states.

Captured, Edition, Application-product table
Captured	Edition	Application-product	TE code	Order	Source SHA-256
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	A207667-001	AP	1	`5c6f7cd8ea54…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	A207667-002	AP	1	`5c6f7cd8ea54…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	A207667-003	AP	1	`5c6f7cd8ea54…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	A207667-004	AP	1	`5c6f7cd8ea54…`
2022-04-08 23:34 UTC	2022-04	A207667-001	AP	1	`5d02ea3f76ae…`
2022-04-08 23:34 UTC	2022-04	A207667-002	AP	1	`5d02ea3f76ae…`
2022-04-08 23:34 UTC	2022-04	A207667-003	AP	1	`5d02ea3f76ae…`
2022-04-08 23:34 UTC	2022-04	A207667-004	AP	1	`5d02ea3f76ae…`
2022-04-04 05:41 UTC	2022-04	A207667-001	AP	1	`4b0b4de00fa7…`
2022-04-04 05:41 UTC	2022-04	A207667-002	AP	1	`4b0b4de00fa7…`
2022-04-04 05:41 UTC	2022-04	A207667-003	AP	1	`4b0b4de00fa7…`
2022-04-04 05:41 UTC	2022-04	A207667-004	AP	1	`4b0b4de00fa7…`
2019-12-13 00:20 UTC	2019-12	A207667-001	AP	1	`74a2ff9319b5…`
2019-12-13 00:20 UTC	2019-12	A207667-002	AP	1	`74a2ff9319b5…`
2019-12-13 00:20 UTC	2019-12	A207667-003	AP	1	`74a2ff9319b5…`
2019-12-13 00:20 UTC	2019-12	A207667-004	AP	1	`74a2ff9319b5…`
2022-03-09 01:35 UTC	2022-03	A207667-001	AP	1	`bb7c543d1eb4…`
2022-03-09 01:35 UTC	2022-03	A207667-002	AP	1	`bb7c543d1eb4…`
2022-03-09 01:35 UTC	2022-03	A207667-003	AP	1	`bb7c543d1eb4…`
2022-03-09 01:35 UTC	2022-03	A207667-004	AP	1	`bb7c543d1eb4…`
2021-12-28 21:50 UTC	2021-12	A207667-001	AP	1	`782e0a99824c…`
2021-12-28 21:50 UTC	2021-12	A207667-002	AP	1	`782e0a99824c…`
2021-12-28 21:50 UTC	2021-12	A207667-003	AP	1	`782e0a99824c…`
2021-12-28 21:50 UTC	2021-12	A207667-004	AP	1	`782e0a99824c…`
2021-05-05 16:15 UTC · 3 captures of this ZIP	2021-05	A207667-001	AP	1	`87673890dc5c…`
2021-05-05 16:15 UTC · 3 captures of this ZIP	2021-05	A207667-002	AP	1	`87673890dc5c…`
2021-05-05 16:15 UTC · 3 captures of this ZIP	2021-05	A207667-003	AP	1	`87673890dc5c…`
2021-05-05 16:15 UTC · 3 captures of this ZIP	2021-05	A207667-004	AP	1	`87673890dc5c…`
2021-03-12 10:30 UTC	2021-03	A207667-001	AP	1	`5aa47cf7b7d7…`
2021-03-12 10:30 UTC	2021-03	A207667-002	AP	1	`5aa47cf7b7d7…`
2021-03-12 10:30 UTC	2021-03	A207667-003	AP	1	`5aa47cf7b7d7…`
2021-03-12 10:30 UTC	2021-03	A207667-004	AP	1	`5aa47cf7b7d7…`
2020-12-22 03:56 UTC	2020-12	A207667-001	AP	1	`8869cabd3fbd…`
2020-12-22 03:56 UTC	2020-12	A207667-002	AP	1	`8869cabd3fbd…`
2020-12-22 03:56 UTC	2020-12	A207667-003	AP	1	`8869cabd3fbd…`
2020-12-22 03:56 UTC	2020-12	A207667-004	AP	1	`8869cabd3fbd…`
2020-11-12 02:37 UTC	2020-11	A207667-001	AP	1	`c0c555d07b60…`
2020-11-12 02:37 UTC	2020-11	A207667-002	AP	1	`c0c555d07b60…`
2020-11-12 02:37 UTC	2020-11	A207667-003	AP	1	`c0c555d07b60…`
2020-11-12 02:37 UTC	2020-11	A207667-004	AP	1	`c0c555d07b60…`

Additional Listing Data#

Finished product: Yes
Brand name base: Methylprednisolone Sodium Succinate
Listing expiration: 2027-12-31

Active Ingredients#

Ingredient, Strength table
Ingredient	Strength
METHYLPREDNISOLONE SODIUM SUCCINATE	2 g/1

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
311659	Internal RxNorm lookup
314099	Internal RxNorm lookup
1357886	Internal RxNorm lookup
1743704	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
2035f00e-2299-473a-b004-cb93f541cfa9	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
726062af-1135-4707-a1d7-57256991bbf9	Product name	2	20250226
e1637c7c-52c4-49a3-b36b-61be755aab29	Product name	4	20230717
9eb3e96d-a1d4-4de3-aa3d-a629eea44815	Product name	4	20220316
19c71a3d-ed9c-166b-a7e5-38c250c35631	Product name	1	20140508

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDC	Product	Description	Form	Quantity	Strength	SPL version
55150-265-50	Methylprednisolone Sodium Succinate	1 in 1 CARTON	INJECTION, POWDER, LYOPHILIZED,	1		5
55150-265-50	Methylprednisolone Sodium Succinate	1 in 1 VIAL, SINGLE-DOSE	INJECTION, POWDER, LYOPHILIZED,	1		5

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDC	Dashboard title	SPL version	Validation	Dashboard ZIP
55150-265	METHYLPREDNISOLONE SODIUM SUCCINATE INJECTION, POWDER, LYOPHILIZED, FOR SOLUTION [EUGIA US LLC]	5	Current NDC, Legacy NDC, 2 package rows	20240704_2035f00e-2299-473a-b004-cb93f541cfa9.zip

openFDA label cross-check#

OpenFDA label data provides additional search and identifier links. DailyMed’s Structured Product Label is the canonical label on FDA.report. Matching records are deduplicated before they are shown below.

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

Brand, Generic, Manufacturer table
Brand	Generic	Manufacturer	SPL set ID	Effective date	Available safety fields	Join
Methylprednisolone Sodium Succinate	METHYLPREDNISOLONE SODIUM SUCCINATE	Eugia US LLC	2035f00e-2299-473a-b004-cb93f541cfa9	2026-06-12	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 207667 application number: ANDA207667 ndc (product): 55150-265

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	2035f00e-2299-473a-b004-cb93f541cfa9	5
1743704	methylPREDNISolone sodium succinate 125 MG Injection	PSN	2035f00e-2299-473a-b004-cb93f541cfa9	5
1357886	methylPREDNISolone sodium succinate 2 GM Injection	PSN	2035f00e-2299-473a-b004-cb93f541cfa9	5
311659	methylPREDNISolone sodium succinate 40 MG Injection	PSN	2035f00e-2299-473a-b004-cb93f541cfa9	5
1743704	methylprednisolone 125 MG Injection	SCD	2035f00e-2299-473a-b004-cb93f541cfa9	5
1357886	methylprednisolone 2000 MG Injection	SCD	2035f00e-2299-473a-b004-cb93f541cfa9	5
311659	methylprednisolone 40 MG Injection	SCD	2035f00e-2299-473a-b004-cb93f541cfa9	5
314099	methylprednisolone 62.5 MG/ML Injectable Solution	SCD	2035f00e-2299-473a-b004-cb93f541cfa9	5
1743704	methylprednisolone (as methylprednisolone sodium succinate) 125 MG Injection	SY	2035f00e-2299-473a-b004-cb93f541cfa9	5
1357886	methylprednisolone (as methylprednisolone sodium succinate) 2 GM Injection	SY	2035f00e-2299-473a-b004-cb93f541cfa9	5
311659	methylprednisolone (as methylprednisolone sodium succinate) 40 MG Injection	SY	2035f00e-2299-473a-b004-cb93f541cfa9	5
314099	methylprednisolone (as methylprednisolone sodium succinate) 62.5 MG/ML Injectable Solution	SY	2035f00e-2299-473a-b004-cb93f541cfa9	5

Packages#

Package NDC, 11-digit format, Description table
Package NDC	11-digit format	Description	Marketing start	Marketing end	Sample	Exclude flag	Status
55150-265-50	55150026550	1 VIAL, SINGLE-DOSE in 1 CARTON (55150-265-50) / 1 INJECTION, POWDER, LYOPHILIZED, FOR SOLUTION in 1 VIAL, SINGLE-DOSE	2015-12-15	0000-00-00	No	No	Current

Title, Manufacturer, Effective date table
Title	Manufacturer	Effective date	Type	Version
METHYLPREDNISOLONE - Eugia US LLC \| EUGIA PHARMA SPECIALITIES LIMITED	Eugia US LLC \| EUGIA PHARMA SPECIALITIES LIMITED	2026-06-12	Human Prescription Drug Label	6