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 17 of 19 · 368 matching rows.

Brand, Generic, Manufacturer table
Brand	Generic	Manufacturer	SPL set ID	Effective date	Available safety fields	Join
THERAPLEX AIM Anti-Itch Moisturizing	HYDROCORTISONE	THERAPLEX, LLC	d1b231b6-cc9f-488a-9121-501831473772	2024-04-27	Warnings	Name fallback generic name: HYDROCORTISONE
Hydrocortisone Cream with Aloe	HYDROCORTISONE	Cardinal Health 110 dba LEADER	16f2f3cb-4611-5867-e063-6394a90af107	2024-04-25	Warnings	Name fallback generic name: HYDROCORTISONE
Anti Itch	HYDROCORTISONE	Neilmed Pharmaceuticals Inc.	14b4f066-fde4-ac97-e063-6394a90ae64c	2024-04-20	Warnings	Name fallback generic name: HYDROCORTISONE
Walgreens Scalp Relief External analgesic	HYDROCORTISONE	Walgreen Company	da0a24c7-9295-4f22-b2c7-40000dad4b81	2024-04-18	Warnings	Name fallback generic name: HYDROCORTISONE
hydrocortisone	HYDROCORTISONE	Bryant Ranch Prepack	a2c18606-631f-4e89-8936-3d635a41c37d	2024-04-03	Adverse reactions	Name fallback generic name: HYDROCORTISONE
Hydrocortisone Cream	HYDROCORTISONE	Trifecta Pharmaceuticals USA	141aa2a7-8789-1127-e063-6294a90a2d23	2024-03-20	Warnings	Name fallback generic name: HYDROCORTISONE
Hydrocortisone	HYDROCORTISONE	TRIFECTA PHARMACEUTICALS USA LLC	1369e70f-7a61-7078-e063-6394a90a9a88	2024-03-11	Warnings	Name fallback generic name: HYDROCORTISONE
Cortisol	HYDROCORTISONE	Deseret Biologicals, Inc.	32ae980b-5a01-4d08-885a-1c0a8fbfbb2e	2024-03-06	Warnings	Name fallback generic name: HYDROCORTISONE
Hydrocortisone	HYDROCORTISONE	Proficient Rx LP	848574fe-a23e-4e15-8c29-d624f50b71de	2024-03-01	Adverse reactions	Name fallback generic name: HYDROCORTISONE
Hydrocortisone	HYDROCORTISONE	TRIFECTA PHARMACEUTICALS USA LLC	2999fecb-cb15-4023-ade4-ab5822b094d5	2024-02-29	Warnings	Name fallback generic name: HYDROCORTISONE
PREPARATION H HYDROCORTISONE	HYDROCORTISONE	Haleon US Holdings LLC	b8d531eb-4012-0450-0e4b-70a808464041	2024-02-29	Warnings	Name fallback generic name: HYDROCORTISONE
Maximum Strength Scalp Itch Relief Anti-itch	HYDROCORTISONE	Rite Aid	55569563-fc38-4f97-8e74-9f96e3173384	2024-02-28	Warnings	Name fallback generic name: HYDROCORTISONE
No Mess Hydrocortisone Applicator	HYDROCORTISONE	Walgreen Co.	cfefb517-9099-41c4-8a95-74414ca4032c	2024-02-16	Warnings	Name fallback generic name: HYDROCORTISONE
Hydrocortisone	HYDROCORTISONE	Proficient Rx LP	ccb62898-b614-45b9-95ea-23e5e31893a8	2024-02-01	Warnings	Name fallback generic name: HYDROCORTISONE
Hydrocortisone with Aloe	HYDROCORTISONE	Proficient Rx LP	0b26d92f-9d0e-46d4-a8bc-75d6da5f6199	2024-02-01	Warnings	Name fallback generic name: HYDROCORTISONE
Hydrocortisone	HYDROCORTISONE	Proficient Rx LP	c57d5f8e-5934-4cbb-999a-cdd55e5b105f	2024-02-01	Warnings	Name fallback generic name: HYDROCORTISONE
hydrocortisone	HYDROCORTISONE	Proficient Rx LP	47e9fe84-bd0c-40ea-85de-e950bcacc557	2024-02-01	Warnings	Name fallback generic name: HYDROCORTISONE
Green Guard Hydrocortisone 1%	HYDROCORTISONE	Unifirst First Aid Corporation	bd348e2a-57b1-3f17-e053-2a95a90a8bdc	2024-01-17	Warnings	Name fallback generic name: HYDROCORTISONE
Hydrocortisone	HYDROCORTISONE	Bryant Ranch Prepack	c4013d86-e134-43c3-ad75-7e680a9d2ae7	2024-01-11	Adverse reactions	Name fallback generic name: HYDROCORTISONE
hydrocortisone	HYDROCORTISONE	Padagis Israel Pharmaceuticals Ltd	f05b7fa6-26a9-4aca-8975-819ece891060	2023-12-31	Adverse reactions	Name fallback generic name: HYDROCORTISONE

Reported adverse events (FAERS/openFDA)#

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