Methylprednisolone Sodium Succinate

Product NDC: 63323-255
Requested package NDC: 63323-255-03
11-digit product format: 633230255
Labeler code: 63323
Product ID: 63323-255_dc369096-3042-4942-9aeb-bbdf98f35bb8
Type: HUMAN PRESCRIPTION DRUG
Nonproprietary name: METHYLPREDNISOLONE SODIUM SUCCINATE
Dosage form: INJECTION, POWDER, LYOPHILIZED, FOR SOLUTION
Route: INTRAMUSCULAR; INTRAVENOUS
Labeler: Fresenius Kabi USA, LLC
Application: ANDA040583
Marketing category: ANDA
Marketing start: 2004-11-30
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: 2026-12-31
Current FDA listing: Yes

NDC auxiliary status#

These records are reproduced from FDA’s unfinished, excluded, and compounder listings. They describe what appeared in the source files; a missing record does not establish a regulatory status. View all current auxiliary records, including entries without an NDC. · View the auxiliary file history.

Current NDC status page 1 of 1 · 1 matching rows.

Dataset, Scope, Product NDC table
Dataset	Scope	Product NDC	Package NDC	Code	Status	Reporting period	Source date
excluded package	package	63323-255	63323-255-03	D	Discontinued by firm		2026-08-17

Observed NDC auxiliary status history#

This history shows the information present in each captured FDA auxiliary file. It is not a continuous regulatory timeline, and a missing record does not establish a status.

Historic NDC status page 1 of 1 · 12 matching rows.

View current auxiliary records. · View the auxiliary file history.

Captured / source date, Snapshot, Source SHA-256 table
Captured / source date	Snapshot	Source SHA-256
2025-12-14 17:58 UTC · source 2025-12-05	`d630ba8d3edf…`	`732f749b63fb…`
2025-08-27 00:01 UTC · source 2025-08-26	`f5e01cc5f278…`	`a2eaf40c39c3…`
2025-04-01 02:39 UTC · source 2025-03-31	`2ef7874e63bc…`	`57b86245f4fa…`
2025-03-28 20:22 UTC · source 2025-03-28	`a1b67e2a42f9…`	`c4cf2c586c0d…`
2025-03-22 03:12 UTC · source 2025-03-21	`cfe11265f3b6…`	`090c488252e2…`
2025-03-10 12:48 UTC · source 2025-03-10	`cdf11ea48f46…`	`ba0047e9e063…`
2025-02-02 03:52 UTC · source 2025-01-31	`302b2466d912…`	`e7b80fea0513…`
2025-01-20 13:05 UTC · source 2025-01-20	`ed331223b511…`	`672a5bd82f5f…`
2025-01-11 03:41 UTC · source 2025-01-10	`0efc9e666f02…`	`f202fb6c5f17…`
2024-11-09 02:27 UTC · source 2024-11-08	`ad56d346431e…`	`cc804d4bbf1e…`
2024-10-04 04:10 UTC · source 2024-10-03	`367a005e9d99…`	`383a685ebd0f…`
2024-07-10 04:00 UTC · source 2024-07-09	`557ba5c1ecfa…`	`9c80585c8c6e…`

Source provenance: Browse the complete Orange Book source catalog · source snapshot 42.

Orange Book products#

Current product rows page 1 of 1 · 2 matching rows.

Application-product, Trade name, Ingredient table
Application-product	Trade name	Ingredient	Strength	Dosage form / route	TE codes	RLD / RS	Approval date
A040583-001	METHYLPREDNISOLONE SODIUM SUCCINATE	METHYLPREDNISOLONE SODIUM SUCCINATE	EQ 40MG BASE/VIAL	INJECTABLE / INJECTION	AP		2004-07-30
A040583-002	METHYLPREDNISOLONE SODIUM SUCCINATE	METHYLPREDNISOLONE SODIUM SUCCINATE	EQ 125MG BASE/VIAL	INJECTABLE / INJECTION	AP		2004-07-30

Therapeutic equivalence codes#

Current TE-code rows page 1 of 1 · 2 matching rows.

Application-product, TE code table
Application-product	TE code
A040583-001	AP
A040583-002	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.

Product history page 1 of 3 · 84 observed states.

Captured, Edition, Application-product table
Captured	Edition	Application-product	Trade name	Strength	Dosage form / route	Product TE source text	Approval date	Source SHA-256
2026-08-18 06:07:40	2026-07	A040583-001	METHYLPREDNISOLONE SODIUM SUCCINATE	EQ 40MG BASE/VIAL	INJECTABLE / INJECTION	AP	2004-07-30	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	A040583-002	METHYLPREDNISOLONE SODIUM SUCCINATE	EQ 125MG BASE/VIAL	INJECTABLE / INJECTION	AP	2004-07-30	`caaa826d4ba7…`
2026-02-19 14:30 UTC	2026-02	A040583-001	METHYLPREDNISOLONE SODIUM SUCCINATE	EQ 40MG BASE/VIAL	INJECTABLE / INJECTION	AP	2004-07-30	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A040583-002	METHYLPREDNISOLONE SODIUM SUCCINATE	EQ 125MG BASE/VIAL	INJECTABLE / INJECTION	AP	2004-07-30	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A040583-001	METHYLPREDNISOLONE SODIUM SUCCINATE	EQ 40MG BASE/VIAL	INJECTABLE / INJECTION	AP	2004-07-30	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A040583-002	METHYLPREDNISOLONE SODIUM SUCCINATE	EQ 125MG BASE/VIAL	INJECTABLE / INJECTION	AP	2004-07-30	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	A040583-001	METHYLPREDNISOLONE SODIUM SUCCINATE	EQ 40MG BASE/VIAL	INJECTABLE / INJECTION	AP	2004-07-30	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A040583-002	METHYLPREDNISOLONE SODIUM SUCCINATE	EQ 125MG BASE/VIAL	INJECTABLE / INJECTION	AP	2004-07-30	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A040583-001	METHYLPREDNISOLONE SODIUM SUCCINATE	EQ 40MG BASE/VIAL	INJECTABLE / INJECTION	AP	2004-07-30	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A040583-002	METHYLPREDNISOLONE SODIUM SUCCINATE	EQ 125MG BASE/VIAL	INJECTABLE / INJECTION	AP	2004-07-30	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A040583-001	METHYLPREDNISOLONE SODIUM SUCCINATE	EQ 40MG BASE/VIAL	INJECTABLE / INJECTION	AP	2004-07-30	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A040583-002	METHYLPREDNISOLONE SODIUM SUCCINATE	EQ 125MG BASE/VIAL	INJECTABLE / INJECTION	AP	2004-07-30	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A040583-001	METHYLPREDNISOLONE SODIUM SUCCINATE	EQ 40MG BASE/VIAL	INJECTABLE / INJECTION	AP	2004-07-30	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A040583-002	METHYLPREDNISOLONE SODIUM SUCCINATE	EQ 125MG BASE/VIAL	INJECTABLE / INJECTION	AP	2004-07-30	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A040583-001	METHYLPREDNISOLONE SODIUM SUCCINATE	EQ 40MG BASE/VIAL	INJECTABLE / INJECTION	AP	2004-07-30	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A040583-002	METHYLPREDNISOLONE SODIUM SUCCINATE	EQ 125MG BASE/VIAL	INJECTABLE / INJECTION	AP	2004-07-30	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A040583-001	METHYLPREDNISOLONE SODIUM SUCCINATE	EQ 40MG BASE/VIAL	INJECTABLE / INJECTION	AP	2004-07-30	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A040583-002	METHYLPREDNISOLONE SODIUM SUCCINATE	EQ 125MG BASE/VIAL	INJECTABLE / INJECTION	AP	2004-07-30	`5bbf6a4d5a75…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A040583-001	METHYLPREDNISOLONE SODIUM SUCCINATE	EQ 40MG BASE/VIAL	INJECTABLE / INJECTION	AP	2004-07-30	`d8e5a09893c0…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A040583-002	METHYLPREDNISOLONE SODIUM SUCCINATE	EQ 125MG BASE/VIAL	INJECTABLE / INJECTION	AP	2004-07-30	`d8e5a09893c0…`
2024-10-29 15:01 UTC	2024-10	A040583-001	METHYLPREDNISOLONE SODIUM SUCCINATE	EQ 40MG BASE/VIAL	INJECTABLE / INJECTION	AP	2004-07-30	`d06236e962d9…`
2024-10-29 15:01 UTC	2024-10	A040583-002	METHYLPREDNISOLONE SODIUM SUCCINATE	EQ 125MG BASE/VIAL	INJECTABLE / INJECTION	AP	2004-07-30	`d06236e962d9…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A040583-001	METHYLPREDNISOLONE SODIUM SUCCINATE	EQ 40MG BASE/VIAL	INJECTABLE / INJECTION	AP	2004-07-30	`79d66fd596c7…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A040583-002	METHYLPREDNISOLONE SODIUM SUCCINATE	EQ 125MG BASE/VIAL	INJECTABLE / INJECTION	AP	2004-07-30	`79d66fd596c7…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A040583-001	METHYLPREDNISOLONE SODIUM SUCCINATE	EQ 40MG BASE/VIAL	INJECTABLE / INJECTION	AP	2004-07-30	`301d65b070ca…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A040583-002	METHYLPREDNISOLONE SODIUM SUCCINATE	EQ 125MG BASE/VIAL	INJECTABLE / INJECTION	AP	2004-07-30	`301d65b070ca…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A040583-001	METHYLPREDNISOLONE SODIUM SUCCINATE	EQ 40MG BASE/VIAL	INJECTABLE / INJECTION	AP	2004-07-30	`1e350fbaab3a…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A040583-002	METHYLPREDNISOLONE SODIUM SUCCINATE	EQ 125MG BASE/VIAL	INJECTABLE / INJECTION	AP	2004-07-30	`1e350fbaab3a…`
2024-05-31 18:47 UTC	2024-05	A040583-001	METHYLPREDNISOLONE SODIUM SUCCINATE	EQ 40MG BASE/VIAL	INJECTABLE / INJECTION	AP	2004-07-30	`8072bd15b7f6…`
2024-05-31 18:47 UTC	2024-05	A040583-002	METHYLPREDNISOLONE SODIUM SUCCINATE	EQ 125MG BASE/VIAL	INJECTABLE / INJECTION	AP	2004-07-30	`8072bd15b7f6…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	A040583-001	METHYLPREDNISOLONE SODIUM SUCCINATE	EQ 40MG BASE/VIAL	INJECTABLE / INJECTION	AP	2004-07-30	`5c6f7cd8ea54…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	A040583-002	METHYLPREDNISOLONE SODIUM SUCCINATE	EQ 125MG BASE/VIAL	INJECTABLE / INJECTION	AP	2004-07-30	`5c6f7cd8ea54…`
2022-04-08 23:34 UTC	2022-04	A040583-001	METHYLPREDNISOLONE SODIUM SUCCINATE	EQ 40MG BASE/VIAL	INJECTABLE / INJECTION	AP	2004-07-30	`5d02ea3f76ae…`
2022-04-08 23:34 UTC	2022-04	A040583-002	METHYLPREDNISOLONE SODIUM SUCCINATE	EQ 125MG BASE/VIAL	INJECTABLE / INJECTION	AP	2004-07-30	`5d02ea3f76ae…`
2022-04-04 05:41 UTC	2022-04	A040583-001	METHYLPREDNISOLONE SODIUM SUCCINATE	EQ 40MG BASE/VIAL	INJECTABLE / INJECTION	AP	2004-07-30	`4b0b4de00fa7…`
2022-04-04 05:41 UTC	2022-04	A040583-002	METHYLPREDNISOLONE SODIUM SUCCINATE	EQ 125MG BASE/VIAL	INJECTABLE / INJECTION	AP	2004-07-30	`4b0b4de00fa7…`
2019-12-13 00:20 UTC	2019-12	A040583-001	METHYLPREDNISOLONE SODIUM SUCCINATE	EQ 40MG BASE/VIAL	INJECTABLE / INJECTION	AP	2004-07-30	`74a2ff9319b5…`
2019-12-13 00:20 UTC	2019-12	A040583-002	METHYLPREDNISOLONE SODIUM SUCCINATE	EQ 125MG BASE/VIAL	INJECTABLE / INJECTION	AP	2004-07-30	`74a2ff9319b5…`
2022-03-09 01:35 UTC	2022-03	A040583-001	METHYLPREDNISOLONE SODIUM SUCCINATE	EQ 40MG BASE/VIAL	INJECTABLE / INJECTION	AP	2004-07-30	`bb7c543d1eb4…`
2022-03-09 01:35 UTC	2022-03	A040583-002	METHYLPREDNISOLONE SODIUM SUCCINATE	EQ 125MG BASE/VIAL	INJECTABLE / INJECTION	AP	2004-07-30	`bb7c543d1eb4…`

Observed Orange Book normalized TE history#

Normalized TE history page 1 of 3 · 84 observed states.

Captured, Edition, Application-product table
Captured	Edition	Application-product	TE code	Order	Source SHA-256
2026-08-18 06:07:40	2026-07	A040583-001	AP	1	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	A040583-002	AP	1	`caaa826d4ba7…`
2026-02-19 14:30 UTC	2026-02	A040583-001	AP	1	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A040583-002	AP	1	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A040583-001	AP	1	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A040583-002	AP	1	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	A040583-001	AP	1	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A040583-002	AP	1	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A040583-001	AP	1	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A040583-002	AP	1	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A040583-001	AP	1	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A040583-002	AP	1	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A040583-001	AP	1	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A040583-002	AP	1	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A040583-001	AP	1	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A040583-002	AP	1	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A040583-001	AP	1	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A040583-002	AP	1	`5bbf6a4d5a75…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A040583-001	AP	1	`d8e5a09893c0…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A040583-002	AP	1	`d8e5a09893c0…`
2024-10-29 15:01 UTC	2024-10	A040583-001	AP	1	`d06236e962d9…`
2024-10-29 15:01 UTC	2024-10	A040583-002	AP	1	`d06236e962d9…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A040583-001	AP	1	`79d66fd596c7…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A040583-002	AP	1	`79d66fd596c7…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A040583-001	AP	1	`301d65b070ca…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A040583-002	AP	1	`301d65b070ca…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A040583-001	AP	1	`1e350fbaab3a…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A040583-002	AP	1	`1e350fbaab3a…`
2024-05-31 18:47 UTC	2024-05	A040583-001	AP	1	`8072bd15b7f6…`
2024-05-31 18:47 UTC	2024-05	A040583-002	AP	1	`8072bd15b7f6…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	A040583-001	AP	1	`5c6f7cd8ea54…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	A040583-002	AP	1	`5c6f7cd8ea54…`
2022-04-08 23:34 UTC	2022-04	A040583-001	AP	1	`5d02ea3f76ae…`
2022-04-08 23:34 UTC	2022-04	A040583-002	AP	1	`5d02ea3f76ae…`
2022-04-04 05:41 UTC	2022-04	A040583-001	AP	1	`4b0b4de00fa7…`
2022-04-04 05:41 UTC	2022-04	A040583-002	AP	1	`4b0b4de00fa7…`
2019-12-13 00:20 UTC	2019-12	A040583-001	AP	1	`74a2ff9319b5…`
2019-12-13 00:20 UTC	2019-12	A040583-002	AP	1	`74a2ff9319b5…`
2022-03-09 01:35 UTC	2022-03	A040583-001	AP	1	`bb7c543d1eb4…`
2022-03-09 01:35 UTC	2022-03	A040583-002	AP	1	`bb7c543d1eb4…`

Additional Listing Data#

Finished product: Yes
Brand name base: Methylprednisolone Sodium Succinate
Listing expiration: 2026-12-31

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 · 3 matching rows.

Identifier, FDA.report destination table
Identifier	FDA.report destination
311659	Internal RxNorm lookup
314099	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
c5d22210-73c6-4697-a267-75e243508642	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
63323-255-01	Methylprednisolone Sodium Succinate	1 mL in 1 VIAL, SINGLE-DOSE	INJECTION, POWDER, LYOPHILIZED,	1		7
63323-255-03	Methylprednisolone Sodium Succinate	25 in 1 TRAY	INJECTION, POWDER, LYOPHILIZED,	25		7

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDC	Billing unit	Product NDC	DailyMed indexing SPL	SPL version	Effective
63323-255-01	EA - Each	63323-255	63f84f0d-3ca4-447e-b94b-8d30ab4cb97c	1	2025-01-14
63323-255-03	EA - Each	63323-255	d986fcf1-92fd-4936-b7f9-7c7ce070113e	1	2013-02-13

DailyMed Socrata Ingredients#

Ingredient, Type, UNII table
Ingredient	Type	UNII	DailyMed label	SPL version
METHYLPREDNISOLONE SODIUM SUCCINATE	ACTIVE INGREDIENT	LEC9GKY20K	METHYLPREDNISOLONE SODIUM SUCCINATE INJECTION, POWDER, LYOPHILIZED, FOR SOLUTION [FRESENIUS KABI USA, LLC]	3
METHYLPREDNISOLONE	ACTIVE MOIETY	X4W7ZR7023	METHYLPREDNISOLONE SODIUM SUCCINATE INJECTION, POWDER, LYOPHILIZED, FOR SOLUTION [FRESENIUS KABI USA, LLC]	3
LACTOSE MONOHYDRATE	INACTIVE INGREDIENT	EWQ57Q8I5X	METHYLPREDNISOLONE SODIUM SUCCINATE INJECTION, POWDER, LYOPHILIZED, FOR SOLUTION [FRESENIUS KABI USA, LLC]	3
SODIUM HYDROXIDE	INACTIVE INGREDIENT	55X04QC32I	METHYLPREDNISOLONE SODIUM SUCCINATE INJECTION, POWDER, LYOPHILIZED, FOR SOLUTION [FRESENIUS KABI USA, LLC]	3
SODIUM PHOSPHATE, DIBASIC ANHYDROUS	INACTIVE INGREDIENT	22ADO53M6F	METHYLPREDNISOLONE SODIUM SUCCINATE INJECTION, POWDER, LYOPHILIZED, FOR SOLUTION [FRESENIUS KABI USA, LLC]	3
SODIUM PHOSPHATE, DIBASIC, ANHYDROUS	INACTIVE INGREDIENT	22ADO53M6F	METHYLPREDNISOLONE SODIUM SUCCINATE INJECTION, POWDER, LYOPHILIZED, FOR SOLUTION [FRESENIUS KABI USA, LLC]	3
SODIUM PHOSPHATE, MONOBASIC ANHYDROUS	INACTIVE INGREDIENT	KH7I04HPUU	METHYLPREDNISOLONE SODIUM SUCCINATE INJECTION, POWDER, LYOPHILIZED, FOR SOLUTION [FRESENIUS KABI USA, LLC]	3

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDC	Dashboard title	SPL version	Validation	Dashboard ZIP
63323-255	METHYLPREDNISOLONE SODIUM SUCCINATE (METHYLPREDNISOLONE SODIUM SUCCINATE) INJECTION, POWDER, LYOPHILIZED, FOR SOLUTION [FRESENIUS KABI USA, LLC ]	7	Current NDC, Legacy NDC, 2 package rows	20230509_c5d22210-73c6-4697-a267-75e243508642.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	Fresenius Kabi USA, LLC	c5d22210-73c6-4697-a267-75e243508642	2023-03-02	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 040583 application number: ANDA040583 ndc (package): 63323-255-03 ndc (product): 63323-255 ndc11 (package): 63323025503

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	c5d22210-73c6-4697-a267-75e243508642	7
1743704	methylPREDNISolone sodium succinate 125 MG Injection	PSN	c5d22210-73c6-4697-a267-75e243508642	7
311659	methylPREDNISolone sodium succinate 40 MG Injection	PSN	c5d22210-73c6-4697-a267-75e243508642	7
1743704	methylprednisolone 125 MG Injection	SCD	c5d22210-73c6-4697-a267-75e243508642	7
311659	methylprednisolone 40 MG Injection	SCD	c5d22210-73c6-4697-a267-75e243508642	7
314099	methylprednisolone 62.5 MG/ML Injectable Solution	SCD	c5d22210-73c6-4697-a267-75e243508642	7
1743704	methylprednisolone (as methylprednisolone sodium succinate) 125 MG Injection	SY	c5d22210-73c6-4697-a267-75e243508642	7
311659	methylprednisolone (as methylprednisolone sodium succinate) 40 MG Injection	SY	c5d22210-73c6-4697-a267-75e243508642	7
314099	methylprednisolone (as methylprednisolone sodium succinate) 62.5 MG/ML Injectable Solution	SY	c5d22210-73c6-4697-a267-75e243508642	7

Packages#

Package NDC, 11-digit format, Description table
Package NDC	11-digit format	Description	Marketing start	Marketing end	Sample	Exclude flag	Status
63323-255-03	63323025503	25 VIAL, SINGLE-DOSE in 1 TRAY (63323-255-03) / 1 mL in 1 VIAL, SINGLE-DOSE (63323-255-01)	2004-11-30	0000-00-00	No	No	Current

Title, Manufacturer, Effective date table
Title	Manufacturer	Effective date	Type	Version
Methylprednisolone Sodium Succinate	Fresenius Kabi USA, LLC	2023-03-02	HUMAN PRESCRIPTION DRUG LABEL	7