Application 009127

Type: NDA
Sponsor: PFIZER

Application Products#

Product, Drug, Ingredient table
Product	Drug	Ingredient	Form	Strength	Reference drug	Reference standard
003	CORTRIL	HYDROCORTISONE	TABLET;ORAL	20MG	No	No
005	CORTRIL	HYDROCORTISONE	TABLET;ORAL	10MG	No	No

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

Orange Book products#

Current product rows page 1 of 1 · 2 matching rows.

Application-product, Trade name, Ingredient table
Application-product	Trade name	Ingredient	Strength	Dosage form / route	TE codes	RLD / RS	Approval date
N009127-003	CORTRIL	HYDROCORTISONE	20MG	TABLET / ORAL		Approved before 1982
N009127-005	CORTRIL	HYDROCORTISONE	10MG	TABLET / ORAL		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 3 · 86 observed states.

Captured, Edition, Application-product table
Captured	Edition	Application-product	Trade name	Strength	Dosage form / route	RLD / RS	Source SHA-256
2026-09-14 22:38:34	2026-08	N009127-003	CORTRIL	20MG	TABLET / ORAL	Approved before 1982	`84e616aacf4f…`
2026-09-14 22:38:34	2026-08	N009127-005	CORTRIL	10MG	TABLET / ORAL	Approved before 1982	`84e616aacf4f…`
2026-08-18 06:07:40	2026-07	N009127-003	CORTRIL	20MG	TABLET / ORAL	Approved before 1982	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	N009127-005	CORTRIL	10MG	TABLET / ORAL	Approved before 1982	`caaa826d4ba7…`
2026-02-19 14:30 UTC	2026-02	N009127-003	CORTRIL	20MG	TABLET / ORAL	Approved before 1982	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	N009127-005	CORTRIL	10MG	TABLET / ORAL	Approved before 1982	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	N009127-003	CORTRIL	20MG	TABLET / ORAL	Approved before 1982	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	N009127-005	CORTRIL	10MG	TABLET / ORAL	Approved before 1982	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	N009127-003	CORTRIL	20MG	TABLET / ORAL	Approved before 1982	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	N009127-005	CORTRIL	10MG	TABLET / ORAL	Approved before 1982	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	N009127-003	CORTRIL	20MG	TABLET / ORAL	Approved before 1982	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	N009127-005	CORTRIL	10MG	TABLET / ORAL	Approved before 1982	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	N009127-003	CORTRIL	20MG	TABLET / ORAL	Approved before 1982	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	N009127-005	CORTRIL	10MG	TABLET / ORAL	Approved before 1982	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	N009127-003	CORTRIL	20MG	TABLET / ORAL	Approved before 1982	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	N009127-005	CORTRIL	10MG	TABLET / ORAL	Approved before 1982	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	N009127-003	CORTRIL	20MG	TABLET / ORAL	Approved before 1982	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	N009127-005	CORTRIL	10MG	TABLET / ORAL	Approved before 1982	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	N009127-003	CORTRIL	20MG	TABLET / ORAL	Approved before 1982	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	N009127-005	CORTRIL	10MG	TABLET / ORAL	Approved before 1982	`5bbf6a4d5a75…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	N009127-003	CORTRIL	20MG	TABLET / ORAL	Approved before 1982	`d8e5a09893c0…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	N009127-005	CORTRIL	10MG	TABLET / ORAL	Approved before 1982	`d8e5a09893c0…`
2024-10-29 15:01 UTC	2024-10	N009127-003	CORTRIL	20MG	TABLET / ORAL	Approved before 1982	`d06236e962d9…`
2024-10-29 15:01 UTC	2024-10	N009127-005	CORTRIL	10MG	TABLET / ORAL	Approved before 1982	`d06236e962d9…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	N009127-003	CORTRIL	20MG	TABLET / ORAL	Approved before 1982	`79d66fd596c7…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	N009127-005	CORTRIL	10MG	TABLET / ORAL	Approved before 1982	`79d66fd596c7…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	N009127-003	CORTRIL	20MG	TABLET / ORAL	Approved before 1982	`301d65b070ca…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	N009127-005	CORTRIL	10MG	TABLET / ORAL	Approved before 1982	`301d65b070ca…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	N009127-003	CORTRIL	20MG	TABLET / ORAL	Approved before 1982	`1e350fbaab3a…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	N009127-005	CORTRIL	10MG	TABLET / ORAL	Approved before 1982	`1e350fbaab3a…`
2024-05-31 18:47 UTC	2024-05	N009127-003	CORTRIL	20MG	TABLET / ORAL	Approved before 1982	`8072bd15b7f6…`
2024-05-31 18:47 UTC	2024-05	N009127-005	CORTRIL	10MG	TABLET / ORAL	Approved before 1982	`8072bd15b7f6…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	N009127-003	CORTRIL	20MG	TABLET / ORAL	Approved before 1982	`5c6f7cd8ea54…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	N009127-005	CORTRIL	10MG	TABLET / ORAL	Approved before 1982	`5c6f7cd8ea54…`
2022-04-08 23:34 UTC	2022-04	N009127-003	CORTRIL	20MG	TABLET / ORAL	Approved before 1982	`5d02ea3f76ae…`
2022-04-08 23:34 UTC	2022-04	N009127-005	CORTRIL	10MG	TABLET / ORAL	Approved before 1982	`5d02ea3f76ae…`
2022-04-04 05:41 UTC	2022-04	N009127-003	CORTRIL	20MG	TABLET / ORAL	Approved before 1982	`4b0b4de00fa7…`
2022-04-04 05:41 UTC	2022-04	N009127-005	CORTRIL	10MG	TABLET / ORAL	Approved before 1982	`4b0b4de00fa7…`
2019-12-13 00:20 UTC	2019-12	N009127-003	CORTRIL	20MG	TABLET / ORAL	Approved before 1982	`74a2ff9319b5…`
2019-12-13 00:20 UTC	2019-12	N009127-005	CORTRIL	10MG	TABLET / ORAL	Approved before 1982	`74a2ff9319b5…`

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.