Methylprednisolone sodium succinate

Product NDC: 70518-3684
11-digit product format: 705183684
Labeler code: 70518
Product ID: 70518-3684_4f7f478b-3341-44cd-e063-6294a90a3ac3
Type: HUMAN PRESCRIPTION DRUG
Nonproprietary name: Methylprednisolone sodium succinate
Dosage form: INJECTION
Route: INTRAMUSCULAR; INTRAVENOUS
Labeler: REMEDYREPACK INC.
Application: ANDA212396
Marketing category: ANDA
Marketing start: 2023-03-17
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: 2027-12-31
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 · 5 matching rows.

Application-product, Trade name, Ingredient table
Application-product	Trade name	Ingredient	Strength	Dosage form / route	TE codes	Approval date
A212396-001	METHYLPREDNISOLONE SODIUM SUCCINATE	METHYLPREDNISOLONE SODIUM SUCCINATE	EQ 40MG BASE/VIAL	INJECTABLE / INJECTION	AP	2021-04-20
A212396-002	METHYLPREDNISOLONE SODIUM SUCCINATE	METHYLPREDNISOLONE SODIUM SUCCINATE	EQ 125MG BASE/VIAL	INJECTABLE / INJECTION	AP	2021-04-20
A212396-003	METHYLPREDNISOLONE SODIUM SUCCINATE	METHYLPREDNISOLONE SODIUM SUCCINATE	EQ 500MG BASE/VIAL	INJECTABLE / INJECTION	AP	2021-04-20
A212396-004	METHYLPREDNISOLONE SODIUM SUCCINATE	METHYLPREDNISOLONE SODIUM SUCCINATE	EQ 1GM BASE/VIAL	INJECTABLE / INJECTION	AP	2021-04-20
A212396-005	METHYLPREDNISOLONE SODIUM SUCCINATE	METHYLPREDNISOLONE SODIUM SUCCINATE	EQ 2GM BASE/VIAL	INJECTABLE / INJECTION	AP	2021-04-20

Therapeutic equivalence codes#

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

Application-product, TE code table
Application-product	TE code
A212396-001	AP
A212396-002	AP
A212396-003	AP
A212396-004	AP
A212396-005	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 5 · 170 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	A212396-001	METHYLPREDNISOLONE SODIUM SUCCINATE	EQ 40MG BASE/VIAL	INJECTABLE / INJECTION	AP	2021-04-20	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	A212396-002	METHYLPREDNISOLONE SODIUM SUCCINATE	EQ 125MG BASE/VIAL	INJECTABLE / INJECTION	AP	2021-04-20	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	A212396-003	METHYLPREDNISOLONE SODIUM SUCCINATE	EQ 500MG BASE/VIAL	INJECTABLE / INJECTION	AP	2021-04-20	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	A212396-004	METHYLPREDNISOLONE SODIUM SUCCINATE	EQ 1GM BASE/VIAL	INJECTABLE / INJECTION	AP	2021-04-20	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	A212396-005	METHYLPREDNISOLONE SODIUM SUCCINATE	EQ 2GM BASE/VIAL	INJECTABLE / INJECTION	AP	2021-04-20	`caaa826d4ba7…`
2026-02-19 14:30 UTC	2026-02	A212396-001	METHYLPREDNISOLONE SODIUM SUCCINATE	EQ 40MG BASE/VIAL	INJECTABLE / INJECTION	AP	2021-04-20	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A212396-002	METHYLPREDNISOLONE SODIUM SUCCINATE	EQ 125MG BASE/VIAL	INJECTABLE / INJECTION	AP	2021-04-20	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A212396-003	METHYLPREDNISOLONE SODIUM SUCCINATE	EQ 500MG BASE/VIAL	INJECTABLE / INJECTION	AP	2021-04-20	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A212396-004	METHYLPREDNISOLONE SODIUM SUCCINATE	EQ 1GM BASE/VIAL	INJECTABLE / INJECTION	AP	2021-04-20	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A212396-005	METHYLPREDNISOLONE SODIUM SUCCINATE	EQ 2GM BASE/VIAL	INJECTABLE / INJECTION	AP	2021-04-20	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A212396-001	METHYLPREDNISOLONE SODIUM SUCCINATE	EQ 40MG BASE/VIAL	INJECTABLE / INJECTION	AP	2021-04-20	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A212396-002	METHYLPREDNISOLONE SODIUM SUCCINATE	EQ 125MG BASE/VIAL	INJECTABLE / INJECTION	AP	2021-04-20	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A212396-003	METHYLPREDNISOLONE SODIUM SUCCINATE	EQ 500MG BASE/VIAL	INJECTABLE / INJECTION	AP	2021-04-20	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A212396-004	METHYLPREDNISOLONE SODIUM SUCCINATE	EQ 1GM BASE/VIAL	INJECTABLE / INJECTION	AP	2021-04-20	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A212396-005	METHYLPREDNISOLONE SODIUM SUCCINATE	EQ 2GM BASE/VIAL	INJECTABLE / INJECTION	AP	2021-04-20	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	A212396-001	METHYLPREDNISOLONE SODIUM SUCCINATE	EQ 40MG BASE/VIAL	INJECTABLE / INJECTION	AP	2021-04-20	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A212396-002	METHYLPREDNISOLONE SODIUM SUCCINATE	EQ 125MG BASE/VIAL	INJECTABLE / INJECTION	AP	2021-04-20	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A212396-003	METHYLPREDNISOLONE SODIUM SUCCINATE	EQ 500MG BASE/VIAL	INJECTABLE / INJECTION	AP	2021-04-20	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A212396-004	METHYLPREDNISOLONE SODIUM SUCCINATE	EQ 1GM BASE/VIAL	INJECTABLE / INJECTION	AP	2021-04-20	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A212396-005	METHYLPREDNISOLONE SODIUM SUCCINATE	EQ 2GM BASE/VIAL	INJECTABLE / INJECTION	AP	2021-04-20	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A212396-001	METHYLPREDNISOLONE SODIUM SUCCINATE	EQ 40MG BASE/VIAL	INJECTABLE / INJECTION	AP	2021-04-20	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A212396-002	METHYLPREDNISOLONE SODIUM SUCCINATE	EQ 125MG BASE/VIAL	INJECTABLE / INJECTION	AP	2021-04-20	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A212396-003	METHYLPREDNISOLONE SODIUM SUCCINATE	EQ 500MG BASE/VIAL	INJECTABLE / INJECTION	AP	2021-04-20	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A212396-004	METHYLPREDNISOLONE SODIUM SUCCINATE	EQ 1GM BASE/VIAL	INJECTABLE / INJECTION	AP	2021-04-20	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A212396-005	METHYLPREDNISOLONE SODIUM SUCCINATE	EQ 2GM BASE/VIAL	INJECTABLE / INJECTION	AP	2021-04-20	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A212396-001	METHYLPREDNISOLONE SODIUM SUCCINATE	EQ 40MG BASE/VIAL	INJECTABLE / INJECTION	AP	2021-04-20	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A212396-002	METHYLPREDNISOLONE SODIUM SUCCINATE	EQ 125MG BASE/VIAL	INJECTABLE / INJECTION	AP	2021-04-20	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A212396-003	METHYLPREDNISOLONE SODIUM SUCCINATE	EQ 500MG BASE/VIAL	INJECTABLE / INJECTION	AP	2021-04-20	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A212396-004	METHYLPREDNISOLONE SODIUM SUCCINATE	EQ 1GM BASE/VIAL	INJECTABLE / INJECTION	AP	2021-04-20	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A212396-005	METHYLPREDNISOLONE SODIUM SUCCINATE	EQ 2GM BASE/VIAL	INJECTABLE / INJECTION	AP	2021-04-20	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A212396-001	METHYLPREDNISOLONE SODIUM SUCCINATE	EQ 40MG BASE/VIAL	INJECTABLE / INJECTION	AP	2021-04-20	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A212396-002	METHYLPREDNISOLONE SODIUM SUCCINATE	EQ 125MG BASE/VIAL	INJECTABLE / INJECTION	AP	2021-04-20	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A212396-003	METHYLPREDNISOLONE SODIUM SUCCINATE	EQ 500MG BASE/VIAL	INJECTABLE / INJECTION	AP	2021-04-20	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A212396-004	METHYLPREDNISOLONE SODIUM SUCCINATE	EQ 1GM BASE/VIAL	INJECTABLE / INJECTION	AP	2021-04-20	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A212396-005	METHYLPREDNISOLONE SODIUM SUCCINATE	EQ 2GM BASE/VIAL	INJECTABLE / INJECTION	AP	2021-04-20	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A212396-001	METHYLPREDNISOLONE SODIUM SUCCINATE	EQ 40MG BASE/VIAL	INJECTABLE / INJECTION	AP	2021-04-20	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A212396-002	METHYLPREDNISOLONE SODIUM SUCCINATE	EQ 125MG BASE/VIAL	INJECTABLE / INJECTION	AP	2021-04-20	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A212396-003	METHYLPREDNISOLONE SODIUM SUCCINATE	EQ 500MG BASE/VIAL	INJECTABLE / INJECTION	AP	2021-04-20	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A212396-004	METHYLPREDNISOLONE SODIUM SUCCINATE	EQ 1GM BASE/VIAL	INJECTABLE / INJECTION	AP	2021-04-20	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A212396-005	METHYLPREDNISOLONE SODIUM SUCCINATE	EQ 2GM BASE/VIAL	INJECTABLE / INJECTION	AP	2021-04-20	`2680178bc6a6…`

Observed Orange Book normalized TE history#

Normalized TE history page 1 of 5 · 165 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	A212396-001	AP	1	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	A212396-002	AP	1	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	A212396-003	AP	1	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	A212396-004	AP	1	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	A212396-005	AP	1	`caaa826d4ba7…`
2026-02-19 14:30 UTC	2026-02	A212396-001	AP	1	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A212396-002	AP	1	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A212396-003	AP	1	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A212396-004	AP	1	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A212396-005	AP	1	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A212396-001	AP	1	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A212396-002	AP	1	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A212396-003	AP	1	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A212396-004	AP	1	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A212396-005	AP	1	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	A212396-001	AP	1	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A212396-002	AP	1	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A212396-003	AP	1	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A212396-004	AP	1	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A212396-005	AP	1	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A212396-001	AP	1	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A212396-002	AP	1	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A212396-003	AP	1	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A212396-004	AP	1	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A212396-005	AP	1	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A212396-001	AP	1	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A212396-002	AP	1	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A212396-003	AP	1	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A212396-004	AP	1	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A212396-005	AP	1	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A212396-001	AP	1	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A212396-002	AP	1	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A212396-003	AP	1	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A212396-004	AP	1	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A212396-005	AP	1	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A212396-001	AP	1	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A212396-002	AP	1	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A212396-003	AP	1	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A212396-004	AP	1	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A212396-005	AP	1	`2680178bc6a6…`

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	125 mg/2mL

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 · 1 matching rows.

Identifier, FDA.report destination table
Identifier	FDA.report destination
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
f339882f-c380-4022-bdcd-94556a7926aa	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
70518-3684-0	Methylprednisolone sodium succinate	25 in 1 CARTON	INJECTION	25		5
70518-3684-1	Methylprednisolone sodium succinate	2 mL in 1 VIAL, SINGLE-DOSE	INJECTION	2		5

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDC	Dashboard title	SPL version	Validation	Dashboard ZIP
70518-3684	METHYLPREDNISOLONE SODIUM SUCCINATE INJECTION [REMEDYREPACK INC.]	3	Current NDC, 2 package rows	20241123_f339882f-c380-4022-bdcd-94556a7926aa.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 · 4 matching rows.

Brand, Generic, Manufacturer table
Brand	Generic	Manufacturer	SPL set ID	Effective date	Available safety fields	Join
METHYLPREDNISOLONE SODIUM SUCCINATE	METHYLPREDNISOLONE SODIUM SUCCINATE	HF Acquisition Co LLC, DBA HealthFirst	559427ac-9fc6-96f5-e063-6294a90a0b30	2026-07-24	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 212396 application number: ANDA212396
Methylprednisolone sodium succinate	METHYLPREDNISOLONE SODIUM SUCCINATE	REMEDYREPACK INC.	f339882f-c380-4022-bdcd-94556a7926aa	2026-04-15	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 212396 application number: ANDA212396 ndc (product): 70518-3684
Methylprednisolone Sodium Succinate	METHYLPREDNISOLONE	Tianjin Kingyork Pharmaceuticals Co., Ltd	77a8d96c-37df-4f3a-9757-b2d4131ff82b	2025-12-18	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 212396 application number: ANDA212396
Methylprednisolone sodium succinate	METHYLPREDNISOLONE SODIUM SUCCINATE	Dr. Reddy's Laboratories Inc	738753c7-507d-4881-5194-02dd7597768b	2024-06-17	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 212396 application number: ANDA212396

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	f339882f-c380-4022-bdcd-94556a7926aa	5
1743704	methylprednisolone 125 MG Injection	SCD	f339882f-c380-4022-bdcd-94556a7926aa	5
1743704	methylprednisolone (as methylprednisolone sodium succinate) 125 MG Injection	SY	f339882f-c380-4022-bdcd-94556a7926aa	5

Packages#

Package NDC, 11-digit format, Description table
Package NDC	11-digit format	Description	Units	Marketing start	Sample	Exclude flag	Status
70518-3684-0	70518368400	25 VIAL, SINGLE-DOSE in 1 CARTON (70518-3684-0) / 2 mL in 1 VIAL, SINGLE-DOSE (70518-3684-1)		2023-03-17	No	No	Current
70518-3684-1	70518368401	2 mL in 1 VIAL, SINGLE-DOSE	2 ml				Historical

Title, Manufacturer, Effective date table
Title	Manufacturer	Effective date	Type	Version
Methylprednisolone sodium succinate - REMEDYREPACK INC.	REMEDYREPACK INC.	2026-04-15	HUMAN PRESCRIPTION DRUG LABEL	5