Application 009864

Type: NDA
Sponsor: PHARMACIA AND UPJOHN

Application Products#

Product, Drug, Ingredient table
Product	Drug	Ingredient	Form	Strength	Reference drug	Reference standard
001	CORTEF	HYDROCORTISONE	INJECTABLE;INJECTION	50MG/ML	No	No

Source provenance: Browse the complete Orange Book source catalog · source snapshot 44.

Orange Book products#

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

Application-product, Trade name, Ingredient table
Application-product	Trade name	Ingredient	Strength	Dosage form / route	TE codes	RLD / RS	Approval date
N009864-001	CORTEF	HYDROCORTISONE	50MG/ML	INJECTABLE / INJECTION		Approved before 1982

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 2 · 44 observed states.

Captured, Edition, Application-product table
Captured	Edition	Application-product	Trade name	Strength	Dosage form / route	RLD / RS	Source SHA-256
2026-10-15 13:18:30	2026-09	N009864-001	CORTEF	50MG/ML	INJECTABLE / INJECTION	Approved before 1982	`c2088c7a36db…`
2026-09-14 22:38:34	2026-08	N009864-001	CORTEF	50MG/ML	INJECTABLE / INJECTION	Approved before 1982	`84e616aacf4f…`
2026-08-18 06:07:40	2026-07	N009864-001	CORTEF	50MG/ML	INJECTABLE / INJECTION	Approved before 1982	`caaa826d4ba7…`
2026-02-19 14:30 UTC	2026-02	N009864-001	CORTEF	50MG/ML	INJECTABLE / INJECTION	Approved before 1982	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	N009864-001	CORTEF	50MG/ML	INJECTABLE / INJECTION	Approved before 1982	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	N009864-001	CORTEF	50MG/ML	INJECTABLE / INJECTION	Approved before 1982	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	N009864-001	CORTEF	50MG/ML	INJECTABLE / INJECTION	Approved before 1982	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	N009864-001	CORTEF	50MG/ML	INJECTABLE / INJECTION	Approved before 1982	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	N009864-001	CORTEF	50MG/ML	INJECTABLE / INJECTION	Approved before 1982	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	N009864-001	CORTEF	50MG/ML	INJECTABLE / INJECTION	Approved before 1982	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	N009864-001	CORTEF	50MG/ML	INJECTABLE / INJECTION	Approved before 1982	`5bbf6a4d5a75…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	N009864-001	CORTEF	50MG/ML	INJECTABLE / INJECTION	Approved before 1982	`d8e5a09893c0…`
2024-10-29 15:01 UTC	2024-10	N009864-001	CORTEF	50MG/ML	INJECTABLE / INJECTION	Approved before 1982	`d06236e962d9…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	N009864-001	CORTEF	50MG/ML	INJECTABLE / INJECTION	Approved before 1982	`79d66fd596c7…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	N009864-001	CORTEF	50MG/ML	INJECTABLE / INJECTION	Approved before 1982	`301d65b070ca…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	N009864-001	CORTEF	50MG/ML	INJECTABLE / INJECTION	Approved before 1982	`1e350fbaab3a…`
2024-05-31 18:47 UTC	2024-05	N009864-001	CORTEF	50MG/ML	INJECTABLE / INJECTION	Approved before 1982	`8072bd15b7f6…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	N009864-001	CORTEF	50MG/ML	INJECTABLE / INJECTION	Approved before 1982	`5c6f7cd8ea54…`
2022-04-08 23:34 UTC	2022-04	N009864-001	CORTEF	50MG/ML	INJECTABLE / INJECTION	Approved before 1982	`5d02ea3f76ae…`
2022-04-04 05:41 UTC	2022-04	N009864-001	CORTEF	50MG/ML	INJECTABLE / INJECTION	Approved before 1982	`4b0b4de00fa7…`
2019-12-13 00:20 UTC	2019-12	N009864-001	CORTEF	50MG/ML	INJECTABLE / INJECTION	Approved before 1982	`74a2ff9319b5…`
2022-03-09 01:35 UTC	2022-03	N009864-001	CORTEF	50MG/ML	INJECTABLE / INJECTION	Approved before 1982	`bb7c543d1eb4…`
2021-12-28 21:50 UTC	2021-12	N009864-001	CORTEF	50MG/ML	INJECTABLE / INJECTION	Approved before 1982	`782e0a99824c…`
2021-05-05 16:15 UTC · 3 captures of this ZIP	2021-05	N009864-001	CORTEF	50MG/ML	INJECTABLE / INJECTION	Approved before 1982	`87673890dc5c…`
2021-03-12 10:30 UTC	2021-03	N009864-001	CORTEF	50MG/ML	INJECTABLE / INJECTION	Approved before 1982	`5aa47cf7b7d7…`
2020-12-22 03:56 UTC	2020-12	N009864-001	CORTEF	50MG/ML	INJECTABLE / INJECTION	Approved before 1982	`8869cabd3fbd…`
2020-11-12 02:37 UTC	2020-11	N009864-001	CORTEF	50MG/ML	INJECTABLE / INJECTION	Approved before 1982	`c0c555d07b60…`
2019-12-14 00:12 UTC	2019-12	N009864-001	CORTEF	50MG/ML	INJECTABLE / INJECTION	Approved before 1982	`3f01610625f2…`
2019-09-15 20:21 UTC	2019-09	N009864-001	CORTEF	50MG/ML	INJECTABLE / INJECTION	Approved before 1982	`b00525d2431f…`
2019-07-19 19:46 UTC	2019-07	N009864-001	CORTEF	50MG/ML	INJECTABLE / INJECTION	Approved before 1982	`ea99ee380514…`
2024-03-16 18:09 UTC · 4 captures of this ZIP	2024-03	N009864-001	CORTEF	50MG/ML	INJECTABLE / INJECTION	Approved before 1982	`6a51e52b5d6a…`
2024-02-18 07:12 UTC	2024-02	N009864-001	CORTEF	50MG/ML	INJECTABLE / INJECTION	Approved before 1982	`1c564ffb4f44…`
2023-12-20 04:57 UTC	2023-12	N009864-001	CORTEF	50MG/ML	INJECTABLE / INJECTION	Approved before 1982	`ea1830bbd6c7…`
2023-11-28 05:40 UTC · 2 captures of this ZIP	2023-11	N009864-001	CORTEF	50MG/ML	INJECTABLE / INJECTION	Approved before 1982	`a72a2bbeb626…`
2023-10-25 00:34 UTC · 2 captures of this ZIP	2023-10	N009864-001	CORTEF	50MG/ML	INJECTABLE / INJECTION	Approved before 1982	`9b2671bbb829…`
2023-07-15 15:27 UTC · 2 captures of this ZIP	2023-07	N009864-001	CORTEF	50MG/ML	INJECTABLE / INJECTION	Approved before 1982	`a67488948f0b…`
2023-06-13 01:57 UTC · 3 captures of this ZIP	2023-06	N009864-001	CORTEF	50MG/ML	INJECTABLE / INJECTION	Approved before 1982	`3f0d92c62455…`
2023-05-13 08:27 UTC	2023-05	N009864-001	CORTEF	50MG/ML	INJECTABLE / INJECTION	Approved before 1982	`053a50430f4f…`
2023-01-26 05:58 UTC	2023-01	N009864-001	CORTEF	50MG/ML	INJECTABLE / INJECTION	Approved before 1982	`3bdfa0b2c4d7…`
2022-11-12 20:34 UTC · 5 captures of this ZIP	2022-11	N009864-001	CORTEF	50MG/ML	INJECTABLE / INJECTION	Approved before 1982	`3a93d1ddd44b…`

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 16 of 19 · 368 matching rows.

Brand, Generic, Manufacturer table
Brand	Generic	Manufacturer	SPL set ID	Effective date	Available safety fields	Join
Hydrocortisone	HYDROCORTISONE	Bryant Ranch Prepack	0ae1ba79-3992-4910-b03f-6f9b0f26e300	2024-09-12	Adverse reactions	Name fallback generic name: HYDROCORTISONE
Itch and Rash Cream	HYDROCORTISONE	Wildman Business Group	1f95757d-a434-f02a-e063-6294a90a2d12	2024-09-01	Warnings	Name fallback generic name: HYDROCORTISONE
Hydrocortisone	HYDROCORTISONE	Bryant Ranch Prepack	84c95149-9064-4b4d-a7d0-93dfefca1370	2024-08-22	Adverse reactions	Name fallback generic name: HYDROCORTISONE
CVS Health Maximum Strength Scalp Relief Anti-itch	HYDROCORTISONE	CVS Health	b5ef0005-8b76-4205-8be0-db3a7ed7d1c4	2024-08-19	Warnings	Name fallback generic name: HYDROCORTISONE
Hydrocortisone	HYDROCORTISONE	NuCare Pharmaceuticals,Inc.	5bb279c6-d572-43a2-e053-2991aa0a686e	2024-08-14	Adverse reactions	Name fallback generic name: HYDROCORTISONE
Hydrocortisone	HYDROCORTISONE	Nantong Health & Beyond Hygienic Products Inc.	fbbbcc67-b46d-d41a-e053-6294a90aa55d	2024-08-08	Warnings	Name fallback generic name: HYDROCORTISONE
hydrocortisone	HYDROCORTISONE	Bryant Ranch Prepack	e64cae82-fd7b-47c8-ada9-4dcb283f1d1f	2024-08-07	Adverse reactions	Name fallback generic name: HYDROCORTISONE
CVS Health Hydrocortisone Anti Itch	HYDROCORTISONE	CVS Health	546a1b8a-8254-432a-85c4-38ebee5ad568	2024-08-07	Warnings	Name fallback generic name: HYDROCORTISONE
Hydrocortisone	HYDROCORTISONE	Proficient Rx LP	e1166b3a-a304-4030-ab51-eb55c6e91afd	2024-08-01	Adverse reactions	Name fallback generic name: HYDROCORTISONE
Hydrocortisone	HYDROCORTISONE	Bryant Ranch Prepack	2dda4f32-e0f6-4e8d-8d75-10da5b762790	2024-07-22	Adverse reactions	Name fallback generic name: HYDROCORTISONE
HYDROCORTISONE	HYDROCORTISONE	Bryant Ranch Prepack	47bfae62-bf25-413e-93fc-3c72c901f1a5	2024-07-18	Warnings, Adverse reactions	Name fallback generic name: HYDROCORTISONE
Hydrocortisone	HYDROCORTISONE	NuCare Pharmaceuticals,Inc.	ac3947c9-5a66-b4e7-e053-2995a90a6f67	2024-07-17	Adverse reactions	Name fallback generic name: HYDROCORTISONE
HYDROCORTISONE	HYDROCORTISONE	Bryant Ranch Prepack	6c676166-2471-478c-b662-f8c9c168977b	2024-07-17	Warnings, Adverse reactions	Name fallback generic name: HYDROCORTISONE
HYDROCORTISONE	HYDROCORTISONE	Bryant Ranch Prepack	134fae59-f928-4304-86ca-2271b593caf4	2024-07-15	Warnings, Adverse reactions	Name fallback generic name: HYDROCORTISONE
HYDROCORTISONE	HYDROCORTISONE	Amneal Pharmaceuticals of New York LLC	9fe627ad-4aba-4bd1-8590-6cc2d61674ba	2024-07-03	Warnings, Adverse reactions	Name fallback generic name: HYDROCORTISONE
astonea	HYDROCORTISONE	ASTONEA LABS PRIVATE LIMITED	de09e859-c5fd-0cc5-e053-2a95a90a147e	2024-06-25	Warnings	Name fallback generic name: HYDROCORTISONE
Hydrocortisone	HYDROCORTISONE	NuCare Pharmaceuticals,Inc.	720357e2-6f01-737d-e053-2a95a90ae54b	2024-06-10	Adverse reactions	Name fallback generic name: HYDROCORTISONE
Hydrocortisone 1%	HYDROCORTISONE	Chain Drug Marketing Association Inc.	1c834ba0-86b6-8e61-e063-6394a90a192d	2024-06-04	Warnings	Name fallback generic name: HYDROCORTISONE
MyMedic Hydrocortisone	HYDROCORTISONE	Nantong Health & Beyond Hygienic Products Inc.	197fc623-2fb9-184c-e063-6394a90a4104	2024-05-28	Warnings	Name fallback generic name: HYDROCORTISONE
TheraCare Hydrocortisone Cream	HYDROCORTISONE	Veridian Healthcare	01cb7b47-2c3c-707d-e063-6294a90a5d97	2024-05-21	Warnings	Name fallback generic name: HYDROCORTISONE

Reported adverse events (FAERS/openFDA)#

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