SOLU-CORTEF

Product NDC: 51662-1261
11-digit product format: 516621261
Labeler code: 51662
Product ID: 51662-1261_1203ca7f-080b-4c49-e063-6294a90a90e0
Type: HUMAN PRESCRIPTION DRUG
Nonproprietary name: SOLU-CORTEF
Dosage form: INJECTION, POWDER, FOR SOLUTION
Route: INTRAMUSCULAR; INTRAVENOUS
Labeler: HF Acquisition Co. LLC, DBA HealthFirst
Application: NDA009866
Marketing category: NDA
Marketing start: 2018-09-03
Substance: HYDROCORTISONE SODIUM SUCCINATE
Active strength: 100 mg/2mL
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 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…`

Additional Listing Data#

Finished product: Yes
Brand name base: SOLU-CORTEF
Listing expiration: 2026-12-31

Active Ingredients#

Ingredient, Strength table
Ingredient	Strength
HYDROCORTISONE SODIUM SUCCINATE	100 mg/2mL

Harmonized UNII identifiers#

UNII identifiers page 1 of 1 · 1 matching rows.

Identifier, FDA.report destination table
Identifier	FDA.report destination
50LQB69S1Z	Internal UNII lookup

Harmonized RxCUI identifiers#

RxCUI identifiers page 1 of 1 · 1 matching rows.

Identifier, FDA.report destination table
Identifier	FDA.report destination
238755	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
74f84173-a43f-7788-e053-2991aa0a8fb2	Available on FDA.report

DailyMed Product Concepts#

Product concept, Relation, Version table
Product concept	Relation	Version	Effective
15bd4439-874a-4934-9954-248e5455d460	Product name	1	20260310
9962b773-9f2e-22cc-0032-535e48ac417b	Product name	3	20250724
56bb0587-1bf2-48b2-9d93-fc9f59d1eeb2	Product name	1	20250325
4d56e8eb-d741-d4a5-de3f-2bab1af75a60	Product name	7	20220608
626d7260-31b5-4412-84fd-579746adb6b3	Product name	1	20210513
8a011600-5e61-4c59-ab7b-54ab658a3b71	Product name	2	20181127
a919621a-248d-3c7a-1084-9f9ce286fdfd	Product name	2	20181009
e7d5a174-836b-a0af-b014-cb0826c69ddc	Product name	2	20181004
fcce390d-6460-4701-87cf-940d8800a1c3	Product name	2	20180212
bf065fa6-1e3b-e4c3-0bde-2dc842ceeea1	Product name	2	20150218
02657a3f-1489-66ea-f740-5ab9524e57d7	Product name	1	20140508
26f3d783-2cc1-4327-e77d-71804cf675a2	Product name	1	20140508
36fdc54c-bbeb-981e-8a53-4d768e283892	Product name	1	20140508
58f3f9b7-3b9b-a9c1-1c9f-18ac777192b8	Product name	1	20140508
61e59a42-186b-9f4b-aec3-fb49a6debc31	Product name	1	20140508
705740e1-dee5-2610-c5a3-4c59cd9d62af	Product name	1	20140508
7bdc4804-3832-c0df-e519-72b6d47c9792	Product name	1	20140508
a7051cba-790b-a699-81f8-dbbbdbd9b5ac	Product name	1	20140508
abaf203f-619e-f265-559f-8c81af5cb1c2	Product name	1	20140508
acc4d8bb-0e29-e9f8-65f8-31e94184a9c0	Product name	1	20140508
b045ad64-0f28-9a02-2f9b-b34d94fb2278	Product name	1	20140508
bfd28ffb-d550-3fe9-f65b-10bcb7f971fd	Product name	1	20140508
da108d9e-edc8-17a3-8c28-3251c6a8accc	Product name	1	20140508
fe21f3fd-a378-0654-1972-db3c3b64470e	Product name	1	20140508

FDA-Initiated Inactive NDC Indexing#

NDC, Effective, Action table
NDC	Effective	Action	Document	Indexing SPL	Related label
51662-1261-1	2020-02-07	C162847	48780-1	9d75b9d0-0bfe-f424-e053-dadaa90a57ce	SOLU-CORTEF® 100mg 2mL ACT-O-VIAL®
51662-1261-1	2020-01-31	C162847	48780-1	9d75b9d0-0bfe-f424-e053-dadaa90a57ce	SOLU-CORTEF® 100mg 2mL ACT-O-VIAL®

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDC	Product	Description	Form	Quantity	SPL version
51662-1261-1	SOLU-CORTEF	2 mL in 1 VIAL, SINGLE-DOSE	INJECTION, POWDER, FOR SOLUTION	2	6
51662-1261-2	SOLU-CORTEF	2 mL in 1 VIAL, SINGLE-DOSE	INJECTION, POWDER, FOR SOLUTION	2	6
51662-1261-2	SOLU-CORTEF	1 in 1 POUCH	INJECTION, POWDER, FOR SOLUTION	1	6
51662-1261-3	SOLU-CORTEF	25 in 1 CASE	INJECTION, POWDER, FOR SOLUTION	25	6

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDC	Dashboard title	SPL version	Validation	Dashboard ZIP
51662-1261	SOLU-CORTEF INJECTION, POWDER, FOR SOLUTION [HF ACQUISITION CO. LLC, DBA HEALTHFIRST]	6	Current NDC, Legacy NDC, 4 package rows	20240224_74f84173-a43f-7788-e053-2991aa0a8fb2.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 · 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
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
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
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

UNII, Preferred term, Registry number table
UNII	Preferred term	Registry number	Matched term
50LQB69S1Z	HYDROCORTISONE SODIUM SUCCINATE	125-04-2	HYDROCORTISONE SODIUM SUCCINATE

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUI	RxNorm string	TTY	DailyMed	SPL version
238755	hydrocortisone sodium succinate 100 MG Injection	PSN	74f84173-a43f-7788-e053-2991aa0a8fb2	6
238755	hydrocortisone 100 MG Injection	SCD	74f84173-a43f-7788-e053-2991aa0a8fb2	6
238755	hydrocortisone (as hydrocortisone sodium succinate) 100 MG Injection	SY	74f84173-a43f-7788-e053-2991aa0a8fb2	6

Packages#

Package NDC, 11-digit format, Description table
Package NDC	11-digit format	Description	Units	Marketing start	Marketing end	Sample	Exclude flag	Status
51662-1261-1	51662126101	2 mL in 1 VIAL, SINGLE-DOSE (51662-1261-1)	2 ml	2018-09-03	0000-00-00	No	No	Current
51662-1261-2	51662126102	2 mL in 1 VIAL, SINGLE-DOSE	2 ml					Historical
51662-1261-3	51662126103	25 POUCH in 1 CASE (51662-1261-3) / 1 VIAL, SINGLE-DOSE in 1 POUCH (51662-1261-2) / 2 mL in 1 VIAL, SINGLE-DOSE	25 pouch	2022-11-10	0000-00-00	No	No	Current

Title, Manufacturer, Effective date table
Title	Manufacturer	Effective date	Type	Version
SOLU-CORTEF® 100mg 2mL ACT-O-VIAL®	HF Acquisition Co. LLC, DBA HealthFirst	2024-02-22	HUMAN PRESCRIPTION DRUG LABEL	6