SOLU-MEDROL

Product NDC: 70385-2016
11-digit product format: 703852016
Labeler code: 70385
Product ID: 70385-2016_4cc6480c-df7e-0a78-e054-00144ff88e88
Type: HUMAN PRESCRIPTION DRUG
Nonproprietary name: methylprednisolone sodium succinate
Dosage form: INJECTION, POWDER, FOR SOLUTION
Route: INTRAMUSCULAR; INTRAVENOUS
Labeler: Sina Health Inc
Application: NDA011856
Marketing category: NDA
Marketing start: 1959-04-02
Marketing end: 0000-00-00
Substance: METHYLPREDNISOLONE SODIUM SUCCINATE
Active strength: 125 mg/mL
Pharmacologic classes: Corticosteroid [EPC],Corticosteroid Hormone Receptor Agonists [MoA]
NDC exclude flag: E
Listing certified through: 2018-12-31
Current FDA listing: Historical FDA.report record

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 · 2 matching rows.

Dataset, Scope, Product NDC table
Dataset	Scope	Product NDC	Package NDC	Code	Status	Reporting period	Source date
excluded product	product	70385-2016		I	Inactivated by FDA		2026-10-05
excluded package	package	70385-2016	70385-2016-1	I	Inactivated by FDA		2026-10-05

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 · 44 matching rows.

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

Captured / source date, Dataset, Scope table
Captured / source date	Dataset	Scope	Package NDC	Code	Status	Snapshot	Source SHA-256
2025-12-14 17:58 UTC · source 2025-12-05	excluded product	product		I	Inactivated by FDA	`d630ba8d3edf…`	`732f749b63fb…`
2025-12-14 17:58 UTC · source 2025-12-05	excluded package	package	70385-2016-1	I	Inactivated by FDA	`d630ba8d3edf…`	`732f749b63fb…`
2025-08-27 00:01 UTC · source 2025-08-26	excluded product	product		I	Inactivated by FDA	`f5e01cc5f278…`	`a2eaf40c39c3…`
2025-08-27 00:01 UTC · source 2025-08-26	excluded package	package	70385-2016-1	I	Inactivated by FDA	`f5e01cc5f278…`	`a2eaf40c39c3…`
2025-04-01 02:39 UTC · source 2025-03-31	excluded product	product		I	Inactivated by FDA	`2ef7874e63bc…`	`57b86245f4fa…`
2025-04-01 02:39 UTC · source 2025-03-31	excluded package	package	70385-2016-1	I	Inactivated by FDA	`2ef7874e63bc…`	`57b86245f4fa…`
2025-03-28 20:22 UTC · source 2025-03-28	excluded product	product		I	Inactivated by FDA	`a1b67e2a42f9…`	`c4cf2c586c0d…`
2025-03-28 20:22 UTC · source 2025-03-28	excluded package	package	70385-2016-1	I	Inactivated by FDA	`a1b67e2a42f9…`	`c4cf2c586c0d…`
2025-03-22 03:12 UTC · source 2025-03-21	excluded product	product		I	Inactivated by FDA	`cfe11265f3b6…`	`090c488252e2…`
2025-03-22 03:12 UTC · source 2025-03-21	excluded package	package	70385-2016-1	I	Inactivated by FDA	`cfe11265f3b6…`	`090c488252e2…`
2025-03-10 12:48 UTC · source 2025-03-10	excluded product	product		I	Inactivated by FDA	`cdf11ea48f46…`	`ba0047e9e063…`
2025-03-10 12:48 UTC · source 2025-03-10	excluded package	package	70385-2016-1	I	Inactivated by FDA	`cdf11ea48f46…`	`ba0047e9e063…`
2025-02-02 03:52 UTC · source 2025-01-31	excluded product	product		I	Inactivated by FDA	`302b2466d912…`	`e7b80fea0513…`
2025-02-02 03:52 UTC · source 2025-01-31	excluded package	package	70385-2016-1	I	Inactivated by FDA	`302b2466d912…`	`e7b80fea0513…`
2025-01-20 13:05 UTC · source 2025-01-20	excluded product	product		I	Inactivated by FDA	`ed331223b511…`	`672a5bd82f5f…`
2025-01-20 13:05 UTC · source 2025-01-20	excluded package	package	70385-2016-1	I	Inactivated by FDA	`ed331223b511…`	`672a5bd82f5f…`
2025-01-11 03:41 UTC · source 2025-01-10	excluded product	product		I	Inactivated by FDA	`0efc9e666f02…`	`f202fb6c5f17…`
2025-01-11 03:41 UTC · source 2025-01-10	excluded package	package	70385-2016-1	I	Inactivated by FDA	`0efc9e666f02…`	`f202fb6c5f17…`
2024-11-09 02:27 UTC · source 2024-11-08	excluded product	product		I	Inactivated by FDA	`ad56d346431e…`	`cc804d4bbf1e…`
2024-11-09 02:27 UTC · source 2024-11-08	excluded package	package	70385-2016-1	I	Inactivated by FDA	`ad56d346431e…`	`cc804d4bbf1e…`
2024-10-04 04:10 UTC · source 2024-10-03	excluded product	product		I	Inactivated by FDA	`367a005e9d99…`	`383a685ebd0f…`
2024-10-04 04:10 UTC · source 2024-10-03	excluded package	package	70385-2016-1	I	Inactivated by FDA	`367a005e9d99…`	`383a685ebd0f…`
2024-07-10 04:00 UTC · source 2024-07-09	excluded product	product		I	Inactivated by FDA	`557ba5c1ecfa…`	`9c80585c8c6e…`
2024-07-10 04:00 UTC · source 2024-07-09	excluded package	package	70385-2016-1	I	Inactivated by FDA	`557ba5c1ecfa…`	`9c80585c8c6e…`
2024-05-28 21:12 UTC · source 2024-05-28	excluded product	product		I	Inactivated by FDA	`8af77b9d5b6f…`	`d9bbb34c5368…`
2024-05-28 21:12 UTC · source 2024-05-28	excluded package	package	70385-2016-1	I	Inactivated by FDA	`8af77b9d5b6f…`	`d9bbb34c5368…`
2024-05-15 03:39 UTC · source 2024-05-14	excluded product	product		I	Inactivated by FDA	`834df4deac94…`	`adcc014656a3…`
2024-05-15 03:39 UTC · source 2024-05-14	excluded package	package	70385-2016-1	I	Inactivated by FDA	`834df4deac94…`	`adcc014656a3…`
2024-03-11 06:39 UTC · source 2024-03-08	excluded product	product		I	Inactivated by FDA	`1332a3947898…`	`d4bfe170f9cd…`
2024-03-11 06:39 UTC · source 2024-03-08	excluded package	package	70385-2016-1	I	Inactivated by FDA	`1332a3947898…`	`d4bfe170f9cd…`
2022-08-30 03:57 UTC · source 2022-08-29	excluded product	product		I	Inactivated by FDA	`fb8cb913e6d1…`	`eb8c232b6be0…`
2022-08-30 03:57 UTC · source 2022-08-29	excluded package	package	70385-2016-1	I	Inactivated by FDA	`fb8cb913e6d1…`	`eb8c232b6be0…`
2022-04-09 23:13 UTC · source 2022-04-08	excluded product	product		I	Inactivated by FDA	`86f5da6cb304…`	`a595104c45d7…`
2022-04-09 23:13 UTC · source 2022-04-08	excluded package	package	70385-2016-1	I	Inactivated by FDA	`86f5da6cb304…`	`a595104c45d7…`
2022-04-04 05:40 UTC · source 2022-04-01	excluded product	product		I	Inactivated by FDA	`bd6a592717d7…`	`303034d00443…`
2022-04-04 05:40 UTC · source 2022-04-01	excluded package	package	70385-2016-1	I	Inactivated by FDA	`bd6a592717d7…`	`303034d00443…`
2021-12-27 23:28 UTC · source 2021-12-27	excluded product	product		I	Inactivated by FDA	`8dfbde2a14a4…`	`c9ff85d89658…`
2021-12-27 23:28 UTC · source 2021-12-27	excluded package	package	70385-2016-1	I	Inactivated by FDA	`8dfbde2a14a4…`	`c9ff85d89658…`
2020-12-18 03:04 UTC · source 2020-12-17	excluded product	product		I	Inactivated by FDA	`e2bbac7714bc…`	`27bdfed8d636…`
2020-12-18 03:04 UTC · source 2020-12-17	excluded package	package	70385-2016-1	I	Inactivated by FDA	`e2bbac7714bc…`	`27bdfed8d636…`
2020-06-10 20:45 UTC · source 2020-06-10	excluded product	product		I	Inactivated by FDA	`9bebd1f3094a…`	`5416666fcb17…`
2020-06-10 20:45 UTC · source 2020-06-10	excluded package	package	70385-2016-1	I	Inactivated by FDA	`9bebd1f3094a…`	`5416666fcb17…`
2019-12-08 06:16 UTC · source 2019-12-05	excluded product	product		E	Excluded after deficient or non-compliant submission was not corrected	`110d247fa046…`	`a55b01930146…`
2019-12-08 06:16 UTC · source 2019-12-05	excluded package	package	70385-2016-1	E	Excluded after deficient or non-compliant submission was not corrected	`110d247fa046…`	`a55b01930146…`

Source provenance: Browse the complete Orange Book source catalog · source snapshot 43.

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.

Product history page 1 of 6 · 215 observed 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
2026-09-14 22:38:34	2026-08	N011856-003	SOLU-MEDROL	EQ 40MG BASE/VIAL	INJECTABLE / INJECTION	AP	RLD, RS, Approved before 1982		`84e616aacf4f…`
2026-09-14 22:38:34	2026-08	N011856-004	SOLU-MEDROL	EQ 125MG BASE/VIAL	INJECTABLE / INJECTION	AP	RLD, RS, Approved before 1982		`84e616aacf4f…`
2026-09-14 22:38:34	2026-08	N011856-005	SOLU-MEDROL	EQ 500MG BASE/VIAL	INJECTABLE / INJECTION	AP	RLD, RS, Approved before 1982		`84e616aacf4f…`
2026-09-14 22:38:34	2026-08	N011856-006	SOLU-MEDROL	EQ 1GM BASE/VIAL	INJECTABLE / INJECTION	AP	RLD, RS, Approved before 1982		`84e616aacf4f…`
2026-09-14 22:38:34	2026-08	N011856-007	SOLU-MEDROL	EQ 2GM BASE/VIAL	INJECTABLE / INJECTION	AP	RLD, RS	1985-02-27	`84e616aacf4f…`
2026-08-18 06:07:40	2026-07	N011856-003	SOLU-MEDROL	EQ 40MG BASE/VIAL	INJECTABLE / INJECTION	AP	RLD, RS, Approved before 1982		`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	N011856-004	SOLU-MEDROL	EQ 125MG BASE/VIAL	INJECTABLE / INJECTION	AP	RLD, RS, Approved before 1982		`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	N011856-005	SOLU-MEDROL	EQ 500MG BASE/VIAL	INJECTABLE / INJECTION	AP	RLD, RS, Approved before 1982		`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	N011856-006	SOLU-MEDROL	EQ 1GM BASE/VIAL	INJECTABLE / INJECTION	AP	RLD, RS, Approved before 1982		`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	N011856-007	SOLU-MEDROL	EQ 2GM BASE/VIAL	INJECTABLE / INJECTION	AP	RLD, RS	1985-02-27	`caaa826d4ba7…`
2026-02-19 14:30 UTC	2026-02	N011856-003	SOLU-MEDROL	EQ 40MG BASE/VIAL	INJECTABLE / INJECTION	AP	RLD, RS, Approved before 1982		`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	N011856-004	SOLU-MEDROL	EQ 125MG BASE/VIAL	INJECTABLE / INJECTION	AP	RLD, RS, Approved before 1982		`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	N011856-005	SOLU-MEDROL	EQ 500MG BASE/VIAL	INJECTABLE / INJECTION	AP	RLD, RS, Approved before 1982		`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	N011856-006	SOLU-MEDROL	EQ 1GM BASE/VIAL	INJECTABLE / INJECTION	AP	RLD, RS, Approved before 1982		`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	N011856-007	SOLU-MEDROL	EQ 2GM BASE/VIAL	INJECTABLE / INJECTION	AP	RLD, RS	1985-02-27	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	N011856-003	SOLU-MEDROL	EQ 40MG BASE/VIAL	INJECTABLE / INJECTION	AP	RLD, RS, Approved before 1982		`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	N011856-004	SOLU-MEDROL	EQ 125MG BASE/VIAL	INJECTABLE / INJECTION	AP	RLD, RS, Approved before 1982		`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	N011856-005	SOLU-MEDROL	EQ 500MG BASE/VIAL	INJECTABLE / INJECTION	AP	RLD, RS, Approved before 1982		`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	N011856-006	SOLU-MEDROL	EQ 1GM BASE/VIAL	INJECTABLE / INJECTION	AP	RLD, RS, Approved before 1982		`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	N011856-007	SOLU-MEDROL	EQ 2GM BASE/VIAL	INJECTABLE / INJECTION	AP	RLD, RS	1985-02-27	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	N011856-003	SOLU-MEDROL	EQ 40MG BASE/VIAL	INJECTABLE / INJECTION	AP	RLD, RS, Approved before 1982		`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	N011856-004	SOLU-MEDROL	EQ 125MG BASE/VIAL	INJECTABLE / INJECTION	AP	RLD, RS, Approved before 1982		`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	N011856-005	SOLU-MEDROL	EQ 500MG BASE/VIAL	INJECTABLE / INJECTION	AP	RLD, RS, Approved before 1982		`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	N011856-006	SOLU-MEDROL	EQ 1GM BASE/VIAL	INJECTABLE / INJECTION	AP	RLD, RS, Approved before 1982		`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	N011856-007	SOLU-MEDROL	EQ 2GM BASE/VIAL	INJECTABLE / INJECTION	AP	RLD, RS	1985-02-27	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	N011856-003	SOLU-MEDROL	EQ 40MG BASE/VIAL	INJECTABLE / INJECTION	AP	RLD, RS, Approved before 1982		`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	N011856-004	SOLU-MEDROL	EQ 125MG BASE/VIAL	INJECTABLE / INJECTION	AP	RLD, RS, Approved before 1982		`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	N011856-005	SOLU-MEDROL	EQ 500MG BASE/VIAL	INJECTABLE / INJECTION	AP	RLD, RS, Approved before 1982		`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	N011856-006	SOLU-MEDROL	EQ 1GM BASE/VIAL	INJECTABLE / INJECTION	AP	RLD, RS, Approved before 1982		`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	N011856-007	SOLU-MEDROL	EQ 2GM BASE/VIAL	INJECTABLE / INJECTION	AP	RLD, RS	1985-02-27	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	N011856-003	SOLU-MEDROL	EQ 40MG BASE/VIAL	INJECTABLE / INJECTION	AP	RLD, RS, Approved before 1982		`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	N011856-004	SOLU-MEDROL	EQ 125MG BASE/VIAL	INJECTABLE / INJECTION	AP	RLD, RS, Approved before 1982		`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	N011856-005	SOLU-MEDROL	EQ 500MG BASE/VIAL	INJECTABLE / INJECTION	AP	RLD, RS, Approved before 1982		`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	N011856-006	SOLU-MEDROL	EQ 1GM BASE/VIAL	INJECTABLE / INJECTION	AP	RLD, RS, Approved before 1982		`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	N011856-007	SOLU-MEDROL	EQ 2GM BASE/VIAL	INJECTABLE / INJECTION	AP	RLD, RS	1985-02-27	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	N011856-003	SOLU-MEDROL	EQ 40MG BASE/VIAL	INJECTABLE / INJECTION	AP	RLD, RS, Approved before 1982		`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	N011856-004	SOLU-MEDROL	EQ 125MG BASE/VIAL	INJECTABLE / INJECTION	AP	RLD, RS, Approved before 1982		`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	N011856-005	SOLU-MEDROL	EQ 500MG BASE/VIAL	INJECTABLE / INJECTION	AP	RLD, RS, Approved before 1982		`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	N011856-006	SOLU-MEDROL	EQ 1GM BASE/VIAL	INJECTABLE / INJECTION	AP	RLD, RS, Approved before 1982		`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	N011856-007	SOLU-MEDROL	EQ 2GM BASE/VIAL	INJECTABLE / INJECTION	AP	RLD, RS	1985-02-27	`03ed91905a0d…`

Observed Orange Book normalized TE history#

Normalized TE history page 1 of 6 · 215 observed states.

Captured, Edition, Application-product table
Captured	Edition	Application-product	TE code	Order	Source SHA-256
2026-09-14 22:38:34	2026-08	N011856-003	AP	1	`84e616aacf4f…`
2026-09-14 22:38:34	2026-08	N011856-004	AP	1	`84e616aacf4f…`
2026-09-14 22:38:34	2026-08	N011856-005	AP	1	`84e616aacf4f…`
2026-09-14 22:38:34	2026-08	N011856-006	AP	1	`84e616aacf4f…`
2026-09-14 22:38:34	2026-08	N011856-007	AP	1	`84e616aacf4f…`
2026-08-18 06:07:40	2026-07	N011856-003	AP	1	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	N011856-004	AP	1	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	N011856-005	AP	1	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	N011856-006	AP	1	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	N011856-007	AP	1	`caaa826d4ba7…`
2026-02-19 14:30 UTC	2026-02	N011856-003	AP	1	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	N011856-004	AP	1	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	N011856-005	AP	1	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	N011856-006	AP	1	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	N011856-007	AP	1	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	N011856-003	AP	1	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	N011856-004	AP	1	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	N011856-005	AP	1	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	N011856-006	AP	1	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	N011856-007	AP	1	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	N011856-003	AP	1	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	N011856-004	AP	1	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	N011856-005	AP	1	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	N011856-006	AP	1	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	N011856-007	AP	1	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	N011856-003	AP	1	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	N011856-004	AP	1	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	N011856-005	AP	1	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	N011856-006	AP	1	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	N011856-007	AP	1	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	N011856-003	AP	1	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	N011856-004	AP	1	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	N011856-005	AP	1	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	N011856-006	AP	1	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	N011856-007	AP	1	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	N011856-003	AP	1	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	N011856-004	AP	1	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	N011856-005	AP	1	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	N011856-006	AP	1	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	N011856-007	AP	1	`03ed91905a0d…`

Reported adverse events (FAERS/openFDA)#

Adverse event summaries are temporarily unavailable. Other product information remains available.

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

FDA-Initiated Inactive NDC Indexing#

NDC, Effective, Action table
NDC	Effective	Action	Document	Indexing SPL	Related label
70385-2016-1	2020-01-31	C162847	48780-1	9d75b9d0-b638-f424-e053-dadaa90a57ce	SOLU-MEDROL ® (methylprednisolone sodium succinate for injection, USP)

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDC	Product	Description	Form	Quantity	Strength	SPL version
70385-2016-1	SOLU-MEDROL	2 mL in 1 VIAL	INJECTION, POWDER, FOR SOLUTION	2		2
70385-2016-1	SOLU-MEDROL	1 in 1 BAG	INJECTION, POWDER, FOR SOLUTION	1		2

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDC	Dashboard title	SPL version	Validation	Dashboard ZIP
70385-2016	SOLU-MEDROL (METHYLPREDNISOLONE SODIUM SUCCINATE) INJECTION, POWDER, FOR SOLUTION [SINA HEALTH INC]	2	Legacy NDC, 2 package rows	20170410_4cc6480c-df7d-0a78-e054-00144ff88e88.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 · 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
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

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	4cc6480c-df7d-0a78-e054-00144ff88e88	2
1743707	SOLU-Medrol 125 MG Injection	PSN	4cc6480c-df7d-0a78-e054-00144ff88e88	2
1743707	methylprednisolone 125 MG Injection [Solu-Medrol]	SBD	4cc6480c-df7d-0a78-e054-00144ff88e88	2
1743704	methylprednisolone 125 MG Injection	SCD	4cc6480c-df7d-0a78-e054-00144ff88e88	2
1743704	methylprednisolone (as methylprednisolone sodium succinate) 125 MG Injection	SY	4cc6480c-df7d-0a78-e054-00144ff88e88	2
1743707	Solu-Medrol (as methylprednisolone sodium succinate) 125 MG Injection	SY	4cc6480c-df7d-0a78-e054-00144ff88e88	2
1743707	Solu-Medrol 125 MG Injection	SY	4cc6480c-df7d-0a78-e054-00144ff88e88	2

Packages#

Package NDC, 11-digit format, Description table
Package NDC	11-digit format	Description	Units	Status
70385-2016-1	70385201601	2 mL in 1 VIAL	2 ml	Historical

Title, Manufacturer, Effective date table
Title	Manufacturer	Effective date	Type	Version
SOLU-MEDROL ® (methylprednisolone sodium succinate for injection, USP)	Sina Health Inc	2017-04-09	HUMAN PRESCRIPTION DRUG LABEL	2