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 18 of 19 · 368 matching rows.

Brand, Generic, Manufacturer table
Brand	Generic	Manufacturer	SPL set ID	Effective date	Available safety fields	Join
CeraVe Developed with Dermatologists Anti Itch	HYDROCORTISONE	L'Oreal USA Products Inc.	8d65e945-2557-486f-9279-ecbaa08f31c4	2023-12-31	Warnings	Name fallback generic name: HYDROCORTISONE
Petrocort Antipruritic Lip 21	HYDROCORTISONE	Clinical Formula LLC	7d408e08-d777-4dfb-bb5e-b4fe5d6f4c7b	2023-12-15	Warnings	Name fallback generic name: HYDROCORTISONE
Westlake Anti-itch	HYDROCORTISONE	Westlake Pharma LLC	0c53c982-3f23-a2d5-e063-6394a90acd55	2023-12-12	Warnings	Name fallback generic name: HYDROCORTISONE
Rite Aid Anti-itch	HYDROCORTISONE	Rite Aid	0c540422-1579-9217-e063-6294a90ad06a	2023-12-12	Warnings	Name fallback generic name: HYDROCORTISONE
Anti-itch Paraben Free	HYDROCORTISONE	Weeks & Leo Co., Inc.	0c5419c5-0929-7ca6-e063-6294a90ac0a7	2023-12-12	Warnings	Name fallback generic name: HYDROCORTISONE
Anti itch	HYDROCORTISONE	Weeks & Leo Co., Inc.	0c58b750-d3a6-5ed1-e063-6294a90a4321	2023-12-12	Warnings	Name fallback generic name: HYDROCORTISONE
Quatriderm Anti-itch	HYDROCORTISONE	OPMX LLC	83e59e10-9878-e5c2-e053-2a91aa0af25e	2023-12-04	Warnings	Name fallback generic name: HYDROCORTISONE
Bloop Itch Soothing Topical	HYDROCORTISONE	Three Nations Corp	0b64677e-d4bf-0929-e063-6294a90af137	2023-11-30	Warnings	Name fallback generic name: HYDROCORTISONE
Hydrocortisone	HYDROCORTISONE	A-S Medication Solutions	5ee2f62a-d8d5-4efd-bf6f-f79c10855631	2023-11-22	Adverse reactions	Name fallback generic name: HYDROCORTISONE
TOTAL RELIEF	HYDROCORTISONE	DR. MARDER SKINCARE, LLC	2c05459c-5a2c-45ab-b534-87f966b41681	2023-11-11	Warnings	Name fallback generic name: HYDROCORTISONE
KERA HC	HYDROCORTISONE	Clinical Therapeutic Solutions	ac215c8f-b224-480c-9295-3a34316293ba	2023-11-10	Warnings	Name fallback generic name: HYDROCORTISONE
SKIN A COOL Hydrocortisone Anti-Itch	HYDROCORTISONE	Ana-Cool, LLC	e3ea7406-e494-4038-9b28-8d0a28b4b834	2023-11-10	Warnings	Name fallback generic name: HYDROCORTISONE
Ana Cool Rapid Soothing Cooling Formula	HYDROCORTISONE	Ana-Cool, LLC	64b80cc2-e2d8-4535-aaf8-c031f4159cd1	2023-11-05	Warnings	Name fallback generic name: HYDROCORTISONE
Dr. Sheffield Hydrocortisone Anti itch	HYDROCORTISONE	Sheffield Pharmaceuticals LLC	71c9f2f4-2188-45eb-b55e-3856ac78070b	2023-10-30	Warnings	Name fallback generic name: HYDROCORTISONE
Thera plus Anti-itch with aloe Hydrocortisone	HYDROCORTISONE	Fourstar Group USA, Inc.	c69d0670-a65b-1680-e053-2995a90a2ee5	2023-10-26	Warnings	Name fallback generic name: HYDROCORTISONE
Assured	HYDROCORTISONE	Zhejiang Jingwei Pharmaceutic Al Co., Ltd.	bc97f364-9443-47b8-9c2d-b5dcc00cc9b7	2023-10-25	Warnings	Name fallback generic name: HYDROCORTISONE
Thera Plus	HYDROCORTISONE	Zhejiang Jingwei Pharmaceutical Co., Ltd.	bcc99e5a-2403-46da-9c9d-8411fa4104e0	2023-10-25	Warnings	Name fallback generic name: HYDROCORTISONE
Family Wellness	HYDROCORTISONE	Zhejiang Jingwei Pharmaceutical Co., Ltd.	cddc9c4a-7c58-4225-921a-05d6afb49178	2023-10-24	Warnings	Name fallback generic name: HYDROCORTISONE
Hydrocortisone	HYDROCORTISONE	Bryant Ranch Prepack	b33f51f5-7506-43d3-863b-406dc5c7d167	2023-07-18	Adverse reactions	Name fallback generic name: HYDROCORTISONE
Anusol HC	HYDROCORTISONE	Salix Pharmaceuticals, Inc	5a0439c8-50a0-4f85-9cb4-9e3a5b0c31e7	2023-06-01	Adverse reactions	Name fallback generic name: HYDROCORTISONE

Reported adverse events (FAERS/openFDA)#

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