Application 009866

Type: NDA
Sponsor: PHARMACIA AND UPJOHN

Application Products#

Product, Drug, Ingredient table
Product	Drug	Ingredient	Form	Strength	Reference drug	Reference standard
001	SOLU-CORTEF	HYDROCORTISONE SODIUM SUCCINATE	INJECTABLE;INJECTION	EQ 100MG BASE/VIAL	Yes	Yes
002	SOLU-CORTEF	HYDROCORTISONE SODIUM SUCCINATE	INJECTABLE;INJECTION	EQ 250MG BASE/VIAL	Yes	Yes
003	SOLU-CORTEF	HYDROCORTISONE SODIUM SUCCINATE	INJECTABLE;INJECTION	EQ 500MG BASE/VIAL	Yes	Yes
004	SOLU-CORTEF	HYDROCORTISONE SODIUM SUCCINATE	INJECTABLE;INJECTION	EQ 1GM BASE/VIAL	Yes	Yes

Source provenance: Browse the complete Orange Book source catalog · source snapshot 1.

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	TE codes	RLD / RS
N009866-001	SOLU-CORTEF	HYDROCORTISONE SODIUM SUCCINATE	EQ 100MG BASE/VIAL	INJECTABLE / INJECTION	AP	RLD, RS, Approved before 1982
N009866-002	SOLU-CORTEF	HYDROCORTISONE SODIUM SUCCINATE	EQ 250MG BASE/VIAL	INJECTABLE / INJECTION		RLD, RS, Approved before 1982
N009866-003	SOLU-CORTEF	HYDROCORTISONE SODIUM SUCCINATE	EQ 500MG BASE/VIAL	INJECTABLE / INJECTION		RLD, RS, Approved before 1982
N009866-004	SOLU-CORTEF	HYDROCORTISONE SODIUM SUCCINATE	EQ 1GM BASE/VIAL	INJECTABLE / INJECTION		RLD, RS, Approved before 1982

Therapeutic equivalence codes#

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

Application-product, TE code table
Application-product	TE code
N009866-001	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 · 164 observed states.

Captured, Edition, Application-product table
Captured	Edition	Application-product	Trade name	Strength	Dosage form / route	Product TE source text	RLD / RS	Source SHA-256
2026-02-19 14:30 UTC	2026-02	N009866-001	SOLU-CORTEF	EQ 100MG BASE/VIAL	INJECTABLE / INJECTION	AP	RLD, RS, Approved before 1982	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	N009866-002	SOLU-CORTEF	EQ 250MG BASE/VIAL	INJECTABLE / INJECTION		RLD, RS, Approved before 1982	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	N009866-003	SOLU-CORTEF	EQ 500MG BASE/VIAL	INJECTABLE / INJECTION		RLD, RS, Approved before 1982	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	N009866-004	SOLU-CORTEF	EQ 1GM BASE/VIAL	INJECTABLE / INJECTION		RLD, RS, Approved before 1982	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	N009866-001	SOLU-CORTEF	EQ 100MG BASE/VIAL	INJECTABLE / INJECTION	AP	RLD, RS, Approved before 1982	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	N009866-002	SOLU-CORTEF	EQ 250MG BASE/VIAL	INJECTABLE / INJECTION		RLD, RS, Approved before 1982	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	N009866-003	SOLU-CORTEF	EQ 500MG BASE/VIAL	INJECTABLE / INJECTION		RLD, RS, Approved before 1982	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	N009866-004	SOLU-CORTEF	EQ 1GM BASE/VIAL	INJECTABLE / INJECTION		RLD, RS, Approved before 1982	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	N009866-001	SOLU-CORTEF	EQ 100MG BASE/VIAL	INJECTABLE / INJECTION	AP	RLD, RS, Approved before 1982	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	N009866-002	SOLU-CORTEF	EQ 250MG BASE/VIAL	INJECTABLE / INJECTION		RLD, RS, Approved before 1982	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	N009866-003	SOLU-CORTEF	EQ 500MG BASE/VIAL	INJECTABLE / INJECTION		RLD, RS, Approved before 1982	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	N009866-004	SOLU-CORTEF	EQ 1GM BASE/VIAL	INJECTABLE / INJECTION		RLD, RS, Approved before 1982	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	N009866-001	SOLU-CORTEF	EQ 100MG BASE/VIAL	INJECTABLE / INJECTION	AP	RLD, RS, Approved before 1982	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	N009866-002	SOLU-CORTEF	EQ 250MG BASE/VIAL	INJECTABLE / INJECTION		RLD, RS, Approved before 1982	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	N009866-003	SOLU-CORTEF	EQ 500MG BASE/VIAL	INJECTABLE / INJECTION		RLD, RS, Approved before 1982	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	N009866-004	SOLU-CORTEF	EQ 1GM BASE/VIAL	INJECTABLE / INJECTION		RLD, RS, Approved before 1982	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	N009866-001	SOLU-CORTEF	EQ 100MG BASE/VIAL	INJECTABLE / INJECTION	AP	RLD, RS, Approved before 1982	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	N009866-002	SOLU-CORTEF	EQ 250MG BASE/VIAL	INJECTABLE / INJECTION		RLD, RS, Approved before 1982	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	N009866-003	SOLU-CORTEF	EQ 500MG BASE/VIAL	INJECTABLE / INJECTION		RLD, RS, Approved before 1982	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	N009866-004	SOLU-CORTEF	EQ 1GM BASE/VIAL	INJECTABLE / INJECTION		RLD, RS, Approved before 1982	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	N009866-001	SOLU-CORTEF	EQ 100MG BASE/VIAL	INJECTABLE / INJECTION	AP	RLD, RS, Approved before 1982	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	N009866-002	SOLU-CORTEF	EQ 250MG BASE/VIAL	INJECTABLE / INJECTION		RLD, RS, Approved before 1982	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	N009866-003	SOLU-CORTEF	EQ 500MG BASE/VIAL	INJECTABLE / INJECTION		RLD, RS, Approved before 1982	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	N009866-004	SOLU-CORTEF	EQ 1GM BASE/VIAL	INJECTABLE / INJECTION		RLD, RS, Approved before 1982	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	N009866-001	SOLU-CORTEF	EQ 100MG BASE/VIAL	INJECTABLE / INJECTION	AP	RLD, RS, Approved before 1982	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	N009866-002	SOLU-CORTEF	EQ 250MG BASE/VIAL	INJECTABLE / INJECTION		RLD, RS, Approved before 1982	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	N009866-003	SOLU-CORTEF	EQ 500MG BASE/VIAL	INJECTABLE / INJECTION		RLD, RS, Approved before 1982	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	N009866-004	SOLU-CORTEF	EQ 1GM BASE/VIAL	INJECTABLE / INJECTION		RLD, RS, Approved before 1982	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	N009866-001	SOLU-CORTEF	EQ 100MG BASE/VIAL	INJECTABLE / INJECTION	AP	RLD, RS, Approved before 1982	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	N009866-002	SOLU-CORTEF	EQ 250MG BASE/VIAL	INJECTABLE / INJECTION		RLD, RS, Approved before 1982	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	N009866-003	SOLU-CORTEF	EQ 500MG BASE/VIAL	INJECTABLE / INJECTION		RLD, RS, Approved before 1982	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	N009866-004	SOLU-CORTEF	EQ 1GM BASE/VIAL	INJECTABLE / INJECTION		RLD, RS, Approved before 1982	`5bbf6a4d5a75…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	N009866-001	SOLU-CORTEF	EQ 100MG BASE/VIAL	INJECTABLE / INJECTION	AP	RLD, RS, Approved before 1982	`d8e5a09893c0…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	N009866-002	SOLU-CORTEF	EQ 250MG BASE/VIAL	INJECTABLE / INJECTION		RLD, RS, Approved before 1982	`d8e5a09893c0…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	N009866-003	SOLU-CORTEF	EQ 500MG BASE/VIAL	INJECTABLE / INJECTION		RLD, RS, Approved before 1982	`d8e5a09893c0…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	N009866-004	SOLU-CORTEF	EQ 1GM BASE/VIAL	INJECTABLE / INJECTION		RLD, RS, Approved before 1982	`d8e5a09893c0…`
2024-10-29 15:01 UTC	2024-10	N009866-001	SOLU-CORTEF	EQ 100MG BASE/VIAL	INJECTABLE / INJECTION	AP	RLD, RS, Approved before 1982	`d06236e962d9…`
2024-10-29 15:01 UTC	2024-10	N009866-002	SOLU-CORTEF	EQ 250MG BASE/VIAL	INJECTABLE / INJECTION		RLD, RS, Approved before 1982	`d06236e962d9…`
2024-10-29 15:01 UTC	2024-10	N009866-003	SOLU-CORTEF	EQ 500MG BASE/VIAL	INJECTABLE / INJECTION		RLD, RS, Approved before 1982	`d06236e962d9…`
2024-10-29 15:01 UTC	2024-10	N009866-004	SOLU-CORTEF	EQ 1GM BASE/VIAL	INJECTABLE / INJECTION		RLD, RS, Approved before 1982	`d06236e962d9…`

Observed Orange Book normalized TE history#

Captured, Edition, Application-product table
Captured	Edition	Application-product	TE code	Order	Source SHA-256
2026-02-19 14:30 UTC	2026-02	N009866-001	AP	1	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	N009866-001	AP	1	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	N009866-001	AP	1	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	N009866-001	AP	1	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	N009866-001	AP	1	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	N009866-001	AP	1	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	N009866-001	AP	1	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	N009866-001	AP	1	`5bbf6a4d5a75…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	N009866-001	AP	1	`d8e5a09893c0…`
2024-10-29 15:01 UTC	2024-10	N009866-001	AP	1	`d06236e962d9…`
2026-07-26 02:55 UTC · 3 captures of this ZIP	2026-06	N009866-001	AP	1	`a50c72e98297…`

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 · 5 matching rows.

Brand, Generic, Manufacturer table
Brand	Generic	Manufacturer	SPL set ID	Effective date	Available safety fields	Join
Solu-Cortef	HYDROCORTISONE SODIUM SUCCINATE	Pharmacia & Upjohn Company LLC	65eefd58-b166-4d71-ade6-45c8fdf86922	2025-09-05	Warnings, Adverse reactions	Exact identifier application applno (NDA): 009866 application number: NDA009866 ndc (product): 0009-0011 ndc (product): 0009-0825 ndc (product): 0009-0016 ndc (product): 0009-0013 ndc (product): 0009-0005
Solu-Cortef	HYDROCORTISONE SODIUM SUCCINATE	Cardinal Health 107, LLC	f5bb0854-a477-4e59-914b-eeeaef92a596	2025-08-21	Warnings, Adverse reactions	Exact identifier application applno (NDA): 009866 application number: NDA009866 ndc (product): 55154-3942
Solu-Cortef	HYDROCORTISONE SODIUM SUCCINATE	ProPharma Distribution	386942d3-c75f-25f1-e063-6394a90a5af2	2025-07-18	Warnings, Adverse reactions	Exact identifier application applno (NDA): 009866 application number: NDA009866
SOLU-CORTEF	SOLU-CORTEF	HF Acquisition Co. LLC, DBA HealthFirst	74f8ccd6-b263-7cc4-e053-2991aa0a896d	2024-02-22	Warnings, Adverse reactions	Exact identifier application applno (NDA): 009866 application number: NDA009866 ndc (product): 51662-1262
SOLU-CORTEF	SOLU-CORTEF	HF Acquisition Co. LLC, DBA HealthFirst	74f84173-a43f-7788-e053-2991aa0a8fb2	2024-02-22	Warnings, Adverse reactions	Exact identifier application applno (NDA): 009866 application number: NDA009866 ndc (product): 51662-1261

NDC Listings For This Application#

NDC listings for this application page 1 of 1 · 38 matching rows.

NDC, Name, Nonproprietary name table
NDC	Name	Nonproprietary name	Labeler	Marketing category	Status
0009-0005	Solu-Cortef	hydrocortisone sodium succinate	Pharmacia and Upjohn Company LLC	NDA	Current
0009-0005	Solu-Cortef	hydrocortisone sodium succinate	Pharmacia & Upjohn Company LLC	NDA	Current
0009-0005	Solu-Cortef	hydrocortisone sodium succinate	Pharmacia & Upjohn Company LLC	NDA	Current
0009-0005	Solu-Cortef	hydrocortisone sodium succinate	Pharmacia and Upjohn Company LLC	NDA	Current
0009-0005	Solu-Cortef	hydrocortisone sodium succinate	Pharmacia and Upjohn Company LLC	NDA	Current
0009-0011	Solu-Cortef	hydrocortisone sodium succinate	Pharmacia and Upjohn Company LLC	NDA	Current
0009-0011	Solu-Cortef	hydrocortisone sodium succinate	Pharmacia & Upjohn Company LLC	NDA	Current
0009-0011	Solu-Cortef	hydrocortisone sodium succinate	Pharmacia & Upjohn Company LLC	NDA	Current
0009-0011	Solu-Cortef	hydrocortisone sodium succinate	Pharmacia and Upjohn Company LLC	NDA	Current
0009-0011	Solu-Cortef	hydrocortisone sodium succinate	Pharmacia and Upjohn Company LLC	NDA	Current
0009-0013	Solu-Cortef	hydrocortisone sodium succinate	Pharmacia and Upjohn Company LLC	NDA	Current
0009-0013	Solu-Cortef	hydrocortisone sodium succinate	Pharmacia & Upjohn Company LLC	NDA	Current
0009-0013	Solu-Cortef	hydrocortisone sodium succinate	Pharmacia & Upjohn Company LLC	NDA	Current
0009-0013	Solu-Cortef	hydrocortisone sodium succinate	Pharmacia and Upjohn Company LLC	NDA	Current
0009-0013	Solu-Cortef	hydrocortisone sodium succinate	Pharmacia and Upjohn Company LLC	NDA	Current
0009-0016	Solu-Cortef	hydrocortisone sodium succinate	Pharmacia and Upjohn Company LLC	NDA	Current
0009-0016	Solu-Cortef	hydrocortisone sodium succinate	Pharmacia & Upjohn Company LLC	NDA	Current
0009-0016	Solu-Cortef	hydrocortisone sodium succinate	Pharmacia & Upjohn Company LLC	NDA	Current
0009-0016	Solu-Cortef	hydrocortisone sodium succinate	Pharmacia and Upjohn Company LLC	NDA	Current
0009-0016	Solu-Cortef	hydrocortisone sodium succinate	Pharmacia and Upjohn Company LLC	NDA	Current
0009-0825	Solu-Cortef	hydrocortisone sodium succinate	Pharmacia and Upjohn Company LLC	NDA	Current
0009-0825	Solu-Cortef	hydrocortisone sodium succinate	Pharmacia & Upjohn Company LLC	NDA	Current
0009-0825	Solu-Cortef	hydrocortisone sodium succinate	Pharmacia & Upjohn Company LLC	NDA	Current
0009-0825	Solu-Cortef	hydrocortisone sodium succinate	Pharmacia and Upjohn Company LLC	NDA	Current
0009-0825	Solu-Cortef	hydrocortisone sodium succinate	Pharmacia and Upjohn Company LLC	NDA	Current
51662-1261	SOLU-CORTEF	SOLU-CORTEF	HF Acquisition Co. LLC, DBA HealthFirst	NDA	Current
51662-1261	SOLU-CORTEF	SOLU-CORTEF	HF Acquisition Co. LLC, DBA HealthFirst	NDA	Current
51662-1261	SOLU-CORTEF	SOLU-CORTEF	HF Acquisition Co. LLC, DBA HealthFirst	NDA	Current
51662-1261	SOLU-CORTEF	SOLU-CORTEF	HF Acquisition Co. LLC, DBA HealthFirst	NDA	Current
51662-1262	SOLU-CORTEF	SOLU-CORTEF	HF Acquisition Co. LLC, DBA HealthFirst	NDA	Current
51662-1262	SOLU-CORTEF	SOLU-CORTEF	HF Acquisition Co. LLC, DBA HealthFirst	NDA	Current
51662-1262	SOLU-CORTEF	SOLU-CORTEF	HF Acquisition Co. LLC, DBA HealthFirst	NDA	Current
51662-1262	SOLU-CORTEF	SOLU-CORTEF	HF Acquisition Co. LLC, DBA HealthFirst	NDA	Current
55154-3942	Solu-Cortef	hydrocortisone sodium succinate	Cardinal Health	NDA	Current
55154-3942	Solu-Cortef	hydrocortisone sodium succinate	Cardinal Health	NDA	Current
55154-3942	Solu-Cortef	hydrocortisone sodium succinate	Cardinal Health	NDA	Current
55154-3942	Solu-Cortef	hydrocortisone sodium succinate	Cardinal Health 107, LLC	NDA	Current
55154-3942	Solu-Cortef	hydrocortisone sodium succinate	Cardinal Health	NDA	Current

Documents#

Document, Submission type, Date table
Document	Submission type	Date
79123	SUPPL	2024-07-18
79122	SUPPL	2024-07-18
78705	SUPPL	2024-06-07
78671	SUPPL	2024-06-06
77121	SUPPL	2023-12-22
77103	SUPPL	2023-12-21
67698	SUPPL	2021-06-04
67627	SUPPL	2021-05-28
61017	SUPPL	2019-11-22
61014	SUPPL	2019-11-22
45260	SUPPL	2016-09-09
45259	SUPPL	2016-09-09
45255	SUPPL	2016-09-09
45254	SUPPL	2016-09-09
33008	SUPPL	2014-07-08
11884	SUPPL	2014-07-08
10734	SUPPL	2010-07-01
195	SUPPL	2010-06-28
11883	SUPPL	2009-11-09
194	SUPPL	2009-11-09
33007	SUPPL	2009-10-05
10733	SUPPL	2009-10-05