Application 008697

Type: NDA
Sponsor: PHARMACIA AND UPJOHN

Application Products#

Product, Drug, Ingredient table
Product	Drug	Ingredient	Form	Strength	Reference drug	Reference standard
001	CORTEF	HYDROCORTISONE	TABLET;ORAL	10MG	Yes	No
002	CORTEF	HYDROCORTISONE	TABLET;ORAL	20MG	Yes	Yes
003	CORTEF	HYDROCORTISONE	TABLET;ORAL	5MG	Yes	No

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

Orange Book products#

Current product rows page 1 of 1 · 3 matching rows.

Application-product, Trade name, Ingredient table
Application-product	Trade name	Ingredient	Strength	Dosage form / route	TE codes	RLD / RS
N008697-001	CORTEF	HYDROCORTISONE	10MG	TABLET / ORAL	AB	RLD, Approved before 1982
N008697-002	CORTEF	HYDROCORTISONE	20MG	TABLET / ORAL	AB	RLD, RS, Approved before 1982
N008697-003	CORTEF	HYDROCORTISONE	5MG	TABLET / ORAL	AB	RLD, Approved before 1982

Therapeutic equivalence codes#

Current TE-code rows page 1 of 1 · 3 matching rows.

Application-product, TE code table
Application-product	TE code
N008697-001	AB
N008697-002	AB
N008697-003	AB

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 3 of 4 · 132 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
2020-11-12 02:37 UTC	2020-11	N008697-003	CORTEF	5MG	TABLET / ORAL	AB	RLD, Approved before 1982	`c0c555d07b60…`
2019-12-14 00:12 UTC	2019-12	N008697-001	CORTEF	10MG	TABLET / ORAL	AB	RLD, Approved before 1982	`3f01610625f2…`
2019-12-14 00:12 UTC	2019-12	N008697-002	CORTEF	20MG	TABLET / ORAL	AB	RLD, RS, Approved before 1982	`3f01610625f2…`
2019-12-14 00:12 UTC	2019-12	N008697-003	CORTEF	5MG	TABLET / ORAL	AB	RLD, Approved before 1982	`3f01610625f2…`
2019-09-15 20:21 UTC	2019-09	N008697-001	CORTEF	10MG	TABLET / ORAL	AB	RLD, Approved before 1982	`b00525d2431f…`
2019-09-15 20:21 UTC	2019-09	N008697-002	CORTEF	20MG	TABLET / ORAL	AB	RLD, RS, Approved before 1982	`b00525d2431f…`
2019-09-15 20:21 UTC	2019-09	N008697-003	CORTEF	5MG	TABLET / ORAL	AB	RLD, Approved before 1982	`b00525d2431f…`
2019-07-19 19:46 UTC	2019-07	N008697-001	CORTEF	10MG	TABLET / ORAL	AB	RLD, Approved before 1982	`ea99ee380514…`
2019-07-19 19:46 UTC	2019-07	N008697-002	CORTEF	20MG	TABLET / ORAL	AB	RLD, RS, Approved before 1982	`ea99ee380514…`
2019-07-19 19:46 UTC	2019-07	N008697-003	CORTEF	5MG	TABLET / ORAL	AB	RLD, Approved before 1982	`ea99ee380514…`
2024-03-16 18:09 UTC · 4 captures of this ZIP	2024-03	N008697-001	CORTEF	10MG	TABLET / ORAL	AB	RLD, Approved before 1982	`6a51e52b5d6a…`
2024-03-16 18:09 UTC · 4 captures of this ZIP	2024-03	N008697-002	CORTEF	20MG	TABLET / ORAL	AB	RLD, RS, Approved before 1982	`6a51e52b5d6a…`
2024-03-16 18:09 UTC · 4 captures of this ZIP	2024-03	N008697-003	CORTEF	5MG	TABLET / ORAL	AB	RLD, Approved before 1982	`6a51e52b5d6a…`
2024-02-18 07:12 UTC	2024-02	N008697-001	CORTEF	10MG	TABLET / ORAL	AB	RLD, Approved before 1982	`1c564ffb4f44…`
2024-02-18 07:12 UTC	2024-02	N008697-002	CORTEF	20MG	TABLET / ORAL	AB	RLD, RS, Approved before 1982	`1c564ffb4f44…`
2024-02-18 07:12 UTC	2024-02	N008697-003	CORTEF	5MG	TABLET / ORAL	AB	RLD, Approved before 1982	`1c564ffb4f44…`
2023-12-20 04:57 UTC	2023-12	N008697-001	CORTEF	10MG	TABLET / ORAL	AB	RLD, Approved before 1982	`ea1830bbd6c7…`
2023-12-20 04:57 UTC	2023-12	N008697-002	CORTEF	20MG	TABLET / ORAL	AB	RLD, RS, Approved before 1982	`ea1830bbd6c7…`
2023-12-20 04:57 UTC	2023-12	N008697-003	CORTEF	5MG	TABLET / ORAL	AB	RLD, Approved before 1982	`ea1830bbd6c7…`
2023-11-28 05:40 UTC · 2 captures of this ZIP	2023-11	N008697-001	CORTEF	10MG	TABLET / ORAL	AB	RLD, Approved before 1982	`a72a2bbeb626…`
2023-11-28 05:40 UTC · 2 captures of this ZIP	2023-11	N008697-002	CORTEF	20MG	TABLET / ORAL	AB	RLD, RS, Approved before 1982	`a72a2bbeb626…`
2023-11-28 05:40 UTC · 2 captures of this ZIP	2023-11	N008697-003	CORTEF	5MG	TABLET / ORAL	AB	RLD, Approved before 1982	`a72a2bbeb626…`
2023-10-25 00:34 UTC · 2 captures of this ZIP	2023-10	N008697-001	CORTEF	10MG	TABLET / ORAL	AB	RLD, Approved before 1982	`9b2671bbb829…`
2023-10-25 00:34 UTC · 2 captures of this ZIP	2023-10	N008697-002	CORTEF	20MG	TABLET / ORAL	AB	RLD, RS, Approved before 1982	`9b2671bbb829…`
2023-10-25 00:34 UTC · 2 captures of this ZIP	2023-10	N008697-003	CORTEF	5MG	TABLET / ORAL	AB	RLD, Approved before 1982	`9b2671bbb829…`
2023-07-15 15:27 UTC · 2 captures of this ZIP	2023-07	N008697-001	CORTEF	10MG	TABLET / ORAL	AB	RLD, Approved before 1982	`a67488948f0b…`
2023-07-15 15:27 UTC · 2 captures of this ZIP	2023-07	N008697-002	CORTEF	20MG	TABLET / ORAL	AB	RLD, RS, Approved before 1982	`a67488948f0b…`
2023-07-15 15:27 UTC · 2 captures of this ZIP	2023-07	N008697-003	CORTEF	5MG	TABLET / ORAL	AB	RLD, Approved before 1982	`a67488948f0b…`
2023-06-13 01:57 UTC · 3 captures of this ZIP	2023-06	N008697-001	CORTEF	10MG	TABLET / ORAL	AB	RLD, Approved before 1982	`3f0d92c62455…`
2023-06-13 01:57 UTC · 3 captures of this ZIP	2023-06	N008697-002	CORTEF	20MG	TABLET / ORAL	AB	RLD, RS, Approved before 1982	`3f0d92c62455…`
2023-06-13 01:57 UTC · 3 captures of this ZIP	2023-06	N008697-003	CORTEF	5MG	TABLET / ORAL	AB	RLD, Approved before 1982	`3f0d92c62455…`
2023-05-13 08:27 UTC	2023-05	N008697-001	CORTEF	10MG	TABLET / ORAL	AB	RLD, Approved before 1982	`053a50430f4f…`
2023-05-13 08:27 UTC	2023-05	N008697-002	CORTEF	20MG	TABLET / ORAL	AB	RLD, RS, Approved before 1982	`053a50430f4f…`
2023-05-13 08:27 UTC	2023-05	N008697-003	CORTEF	5MG	TABLET / ORAL	AB	RLD, Approved before 1982	`053a50430f4f…`
2023-01-26 05:58 UTC	2023-01	N008697-001	CORTEF	10MG	TABLET / ORAL	AB	RLD, Approved before 1982	`3bdfa0b2c4d7…`
2023-01-26 05:58 UTC	2023-01	N008697-002	CORTEF	20MG	TABLET / ORAL	AB	RLD, RS, Approved before 1982	`3bdfa0b2c4d7…`
2023-01-26 05:58 UTC	2023-01	N008697-003	CORTEF	5MG	TABLET / ORAL	AB	RLD, Approved before 1982	`3bdfa0b2c4d7…`
2022-11-12 20:34 UTC · 5 captures of this ZIP	2022-11	N008697-001	CORTEF	10MG	TABLET / ORAL	AB	RLD, Approved before 1982	`3a93d1ddd44b…`
2022-11-12 20:34 UTC · 5 captures of this ZIP	2022-11	N008697-002	CORTEF	20MG	TABLET / ORAL	AB	RLD, RS, Approved before 1982	`3a93d1ddd44b…`
2022-11-12 20:34 UTC · 5 captures of this ZIP	2022-11	N008697-003	CORTEF	5MG	TABLET / ORAL	AB	RLD, Approved before 1982	`3a93d1ddd44b…`

Observed Orange Book normalized TE history#

Normalized TE history page 1 of 4 · 132 observed states.

Captured, Edition, Application-product table
Captured	Edition	Application-product	TE code	Order	Source SHA-256
2026-10-15 13:18:30	2026-09	N008697-001	AB	1	`c2088c7a36db…`
2026-10-15 13:18:30	2026-09	N008697-002	AB	1	`c2088c7a36db…`
2026-10-15 13:18:30	2026-09	N008697-003	AB	1	`c2088c7a36db…`
2026-09-14 22:38:34	2026-08	N008697-001	AB	1	`84e616aacf4f…`
2026-09-14 22:38:34	2026-08	N008697-002	AB	1	`84e616aacf4f…`
2026-09-14 22:38:34	2026-08	N008697-003	AB	1	`84e616aacf4f…`
2026-08-18 06:07:40	2026-07	N008697-001	AB	1	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	N008697-002	AB	1	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	N008697-003	AB	1	`caaa826d4ba7…`
2026-02-19 14:30 UTC	2026-02	N008697-001	AB	1	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	N008697-002	AB	1	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	N008697-003	AB	1	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	N008697-001	AB	1	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	N008697-002	AB	1	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	N008697-003	AB	1	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	N008697-001	AB	1	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	N008697-002	AB	1	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	N008697-003	AB	1	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	N008697-001	AB	1	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	N008697-002	AB	1	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	N008697-003	AB	1	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	N008697-001	AB	1	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	N008697-002	AB	1	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	N008697-003	AB	1	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	N008697-001	AB	1	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	N008697-002	AB	1	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	N008697-003	AB	1	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	N008697-001	AB	1	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	N008697-002	AB	1	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	N008697-003	AB	1	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	N008697-001	AB	1	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	N008697-002	AB	1	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	N008697-003	AB	1	`5bbf6a4d5a75…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	N008697-001	AB	1	`d8e5a09893c0…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	N008697-002	AB	1	`d8e5a09893c0…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	N008697-003	AB	1	`d8e5a09893c0…`
2024-10-29 15:01 UTC	2024-10	N008697-001	AB	1	`d06236e962d9…`
2024-10-29 15:01 UTC	2024-10	N008697-002	AB	1	`d06236e962d9…`
2024-10-29 15:01 UTC	2024-10	N008697-003	AB	1	`d06236e962d9…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	N008697-001	AB	1	`79d66fd596c7…`

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 · 3 matching rows.

Brand, Generic, Manufacturer table
Brand	Generic	Manufacturer	SPL set ID	Effective date	Available safety fields	Join
Hydrocortisone	HYDROCORTISONE	Mylan Pharmaceuticals Inc.	bc751403-94f2-4f9d-b533-cf6186a40ceb	2026-05-25	Warnings, Adverse reactions	Exact identifier application applno (NDA): 008697 application number: NDA008697 ndc (product): 59762-0075 ndc (product): 59762-0073 ndc (product): 59762-0074
CORTEF	HYDROCORTISONE	Pharmacia & Upjohn Company LLC	9ce19944-dd88-4a7b-84ca-b07f4ec23bad	2025-02-17	Warnings, Adverse reactions	Exact identifier application applno (NDA): 008697 application number: NDA008697 ndc (product): 0009-0044 ndc (product): 0009-0031 ndc (product): 0009-0012
Hydrocortisone	HYDROCORTISONE	Asclemed USA, Inc.	459a9907-1261-4a75-8388-f0e2f466939c	2022-10-12	Warnings, Adverse reactions	Exact identifier application applno (NDA): 008697 application number: NDA008697 ndc (product): 76420-028

Reported adverse events (FAERS/openFDA)#

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

NDC Listings For This Application#

NDC listings for this application page 1 of 1 · 21 matching rows.

NDC, Name, Nonproprietary name table
NDC	Name	Nonproprietary name	Labeler	Marketing category	Status
0009-0012	CORTEF	hydrocortisone	Pharmacia and Upjohn Company LLC	NDA	Current
0009-0012	CORTEF	hydrocortisone	Pharmacia & Upjohn Company LLC	NDA	Current
0009-0012	CORTEF	hydrocortisone	Pharmacia and Upjohn Company LLC	NDA	Current
0009-0031	CORTEF	hydrocortisone	Pharmacia and Upjohn Company LLC	NDA	Current
0009-0031	CORTEF	hydrocortisone	Pharmacia & Upjohn Company LLC	NDA	Current
0009-0031	CORTEF	hydrocortisone	Pharmacia and Upjohn Company LLC	NDA	Current
0009-0044	CORTEF	hydrocortisone	Pharmacia and Upjohn Company LLC	NDA	Current
0009-0044	CORTEF	hydrocortisone	Pharmacia & Upjohn Company LLC	NDA	Current
0009-0044	CORTEF	hydrocortisone	Pharmacia and Upjohn Company LLC	NDA	Current
59762-0073	Hydrocortisone	hydrocortisone	Greenstone LLC	NDA AUTHORIZED GENERIC	Current
59762-0073	Hydrocortisone	hydrocortisone	Greenstone LLC	NDA AUTHORIZED GENERIC	Current
59762-0073	Hydrocortisone	hydrocortisone	Greenstone LLC	NDA AUTHORIZED GENERIC	Current
59762-0074	Hydrocortisone	hydrocortisone	Greenstone LLC	NDA AUTHORIZED GENERIC	Current
59762-0074	Hydrocortisone	hydrocortisone	Greenstone LLC	NDA AUTHORIZED GENERIC	Current
59762-0074	Hydrocortisone	hydrocortisone	Greenstone LLC	NDA AUTHORIZED GENERIC	Current
59762-0075	Hydrocortisone	hydrocortisone	Greenstone LLC	NDA AUTHORIZED GENERIC	Current
59762-0075	Hydrocortisone	hydrocortisone	Greenstone LLC	NDA AUTHORIZED GENERIC	Current
59762-0075	Hydrocortisone	hydrocortisone	Greenstone LLC	NDA AUTHORIZED GENERIC	Current
70518-3275	CORTEF	hydrocortisone	REMEDYREPACK INC.	NDA	Current
76420-028	Hydrocortisone	hydrocortisone	Asclemed USA, Inc.	NDA AUTHORIZED GENERIC	Current
76420-028	Hydrocortisone	hydrocortisone	Asclemed USA, Inc.	NDA AUTHORIZED GENERIC	Current

Documents#

Document, Submission type, Date table
Document	Submission type	Date
78703	SUPPL	2024-06-07
78670	SUPPL	2024-06-06
77119	SUPPL	2023-12-22
77102	SUPPL	2023-12-21
61029	SUPPL	2019-11-22
61015	SUPPL	2019-11-22
45258	SUPPL	2016-09-09
45257	SUPPL	2016-09-09
45253	SUPPL	2016-09-09
45252	SUPPL	2016-09-09
32967	SUPPL	2015-04-15