Application 040879

Type: ANDA
Sponsor: RISING

Application Products#

Product, Drug, Ingredient table
Product	Drug	Ingredient	Form	Strength	Reference drug	Reference standard
001	HYDROCORTISONE	HYDROCORTISONE	CREAM;TOPICAL	2.5%	No	No

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

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
A040879-001	HYDROCORTISONE	HYDROCORTISONE	2.5%	CREAM / TOPICAL	AT		2010-08-20

Therapeutic equivalence codes#

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

Application-product, TE code table
Application-product	TE code
A040879-001	AT

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 · 43 observed states.

Captured, Edition, Application-product table
Captured	Edition	Application-product	Trade name	Strength	Dosage form / route	Product TE source text	Approval date	Source SHA-256
2026-09-14 22:38:34	2026-08	A040879-001	HYDROCORTISONE	2.5%	CREAM / TOPICAL	AT	2010-08-20	`84e616aacf4f…`
2026-08-18 06:07:40	2026-07	A040879-001	HYDROCORTISONE	2.5%	CREAM / TOPICAL	AT	2010-08-20	`caaa826d4ba7…`
2026-02-19 14:30 UTC	2026-02	A040879-001	HYDROCORTISONE	2.5%	CREAM / TOPICAL	AT	2010-08-20	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A040879-001	HYDROCORTISONE	2.5%	CREAM / TOPICAL	AT	2010-08-20	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	A040879-001	HYDROCORTISONE	2.5%	CREAM / TOPICAL	AT	2010-08-20	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A040879-001	HYDROCORTISONE	2.5%	CREAM / TOPICAL	AT	2010-08-20	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A040879-001	HYDROCORTISONE	2.5%	CREAM / TOPICAL	AT	2010-08-20	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A040879-001	HYDROCORTISONE	2.5%	CREAM / TOPICAL	AT	2010-08-20	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A040879-001	HYDROCORTISONE	2.5%	CREAM / TOPICAL	AT	2010-08-20	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A040879-001	HYDROCORTISONE	2.5%	CREAM / TOPICAL	AT	2010-08-20	`5bbf6a4d5a75…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A040879-001	HYDROCORTISONE	2.5%	CREAM / TOPICAL	AT	2010-08-20	`d8e5a09893c0…`
2024-10-29 15:01 UTC	2024-10	A040879-001	HYDROCORTISONE	2.5%	CREAM / TOPICAL	AT	2010-08-20	`d06236e962d9…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A040879-001	HYDROCORTISONE	2.5%	CREAM / TOPICAL	AT	2010-08-20	`79d66fd596c7…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A040879-001	HYDROCORTISONE	2.5%	CREAM / TOPICAL	AT	2010-08-20	`301d65b070ca…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A040879-001	HYDROCORTISONE	2.5%	CREAM / TOPICAL	AT	2010-08-20	`1e350fbaab3a…`
2024-05-31 18:47 UTC	2024-05	A040879-001	HYDROCORTISONE	2.5%	CREAM / TOPICAL	AT	2010-08-20	`8072bd15b7f6…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	A040879-001	HYDROCORTISONE	2.5%	CREAM / TOPICAL	AT	2010-08-20	`5c6f7cd8ea54…`
2022-04-08 23:34 UTC	2022-04	A040879-001	HYDROCORTISONE	2.5%	CREAM / TOPICAL	AT	2010-08-20	`5d02ea3f76ae…`
2022-04-04 05:41 UTC	2022-04	A040879-001	HYDROCORTISONE	2.5%	CREAM / TOPICAL	AT	2010-08-20	`4b0b4de00fa7…`
2019-12-13 00:20 UTC	2019-12	A040879-001	HYDROCORTISONE	2.5%	CREAM / TOPICAL	AT	2010-08-20	`74a2ff9319b5…`
2022-03-09 01:35 UTC	2022-03	A040879-001	HYDROCORTISONE	2.5%	CREAM / TOPICAL	AT	2010-08-20	`bb7c543d1eb4…`
2021-12-28 21:50 UTC	2021-12	A040879-001	HYDROCORTISONE	2.5%	CREAM / TOPICAL	AT	2010-08-20	`782e0a99824c…`
2021-05-05 16:15 UTC · 3 captures of this ZIP	2021-05	A040879-001	HYDROCORTISONE	2.5%	CREAM / TOPICAL	AT	2010-08-20	`87673890dc5c…`
2021-03-12 10:30 UTC	2021-03	A040879-001	HYDROCORTISONE	2.5%	CREAM / TOPICAL	AT	2010-08-20	`5aa47cf7b7d7…`
2020-12-22 03:56 UTC	2020-12	A040879-001	HYDROCORTISONE	2.5%	CREAM / TOPICAL	AT	2010-08-20	`8869cabd3fbd…`
2020-11-12 02:37 UTC	2020-11	A040879-001	HYDROCORTISONE	2.5%	CREAM / TOPICAL	AT	2010-08-20	`c0c555d07b60…`
2019-12-14 00:12 UTC	2019-12	A040879-001	HYDROCORTISONE	2.5%	CREAM / TOPICAL	AT	2010-08-20	`3f01610625f2…`
2019-09-15 20:21 UTC	2019-09	A040879-001	HYDROCORTISONE	2.5%	CREAM / TOPICAL	AT	2010-08-20	`b00525d2431f…`
2019-07-19 19:46 UTC	2019-07	A040879-001	HYDROCORTISONE	2.5%	CREAM / TOPICAL	AT	2010-08-20	`ea99ee380514…`
2024-03-16 18:09 UTC · 4 captures of this ZIP	2024-03	A040879-001	HYDROCORTISONE	2.5%	CREAM / TOPICAL	AT	2010-08-20	`6a51e52b5d6a…`
2024-02-18 07:12 UTC	2024-02	A040879-001	HYDROCORTISONE	2.5%	CREAM / TOPICAL	AT	2010-08-20	`1c564ffb4f44…`
2023-12-20 04:57 UTC	2023-12	A040879-001	HYDROCORTISONE	2.5%	CREAM / TOPICAL	AT	2010-08-20	`ea1830bbd6c7…`
2023-11-28 05:40 UTC · 2 captures of this ZIP	2023-11	A040879-001	HYDROCORTISONE	2.5%	CREAM / TOPICAL	AT	2010-08-20	`a72a2bbeb626…`
2023-10-25 00:34 UTC · 2 captures of this ZIP	2023-10	A040879-001	HYDROCORTISONE	2.5%	CREAM / TOPICAL	AT	2010-08-20	`9b2671bbb829…`
2023-07-15 15:27 UTC · 2 captures of this ZIP	2023-07	A040879-001	HYDROCORTISONE	2.5%	CREAM / TOPICAL	AT	2010-08-20	`a67488948f0b…`
2023-06-13 01:57 UTC · 3 captures of this ZIP	2023-06	A040879-001	HYDROCORTISONE	2.5%	CREAM / TOPICAL	AT	2010-08-20	`3f0d92c62455…`
2023-05-13 08:27 UTC	2023-05	A040879-001	HYDROCORTISONE	2.5%	CREAM / TOPICAL	AT	2010-08-20	`053a50430f4f…`
2023-01-26 05:58 UTC	2023-01	A040879-001	HYDROCORTISONE	2.5%	CREAM / TOPICAL	AT	2010-08-20	`3bdfa0b2c4d7…`
2022-11-12 20:34 UTC · 5 captures of this ZIP	2022-11	A040879-001	HYDROCORTISONE	2.5%	CREAM / TOPICAL	AT	2010-08-20	`3a93d1ddd44b…`
2022-10-28 04:53 UTC	2022-10	A040879-001	HYDROCORTISONE	2.5%	CREAM / TOPICAL	AT	2010-08-20	`f41ea6bd6efb…`

Observed Orange Book normalized TE history#

Normalized TE history page 1 of 2 · 43 observed states.

Captured, Edition, Application-product table
Captured	Edition	Application-product	TE code	Order	Source SHA-256
2026-09-14 22:38:34	2026-08	A040879-001	AT	1	`84e616aacf4f…`
2026-08-18 06:07:40	2026-07	A040879-001	AT	1	`caaa826d4ba7…`
2026-02-19 14:30 UTC	2026-02	A040879-001	AT	1	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A040879-001	AT	1	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	A040879-001	AT	1	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A040879-001	AT	1	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A040879-001	AT	1	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A040879-001	AT	1	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A040879-001	AT	1	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A040879-001	AT	1	`5bbf6a4d5a75…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A040879-001	AT	1	`d8e5a09893c0…`
2024-10-29 15:01 UTC	2024-10	A040879-001	AT	1	`d06236e962d9…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A040879-001	AT	1	`79d66fd596c7…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A040879-001	AT	1	`301d65b070ca…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A040879-001	AT	1	`1e350fbaab3a…`
2024-05-31 18:47 UTC	2024-05	A040879-001	AT	1	`8072bd15b7f6…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	A040879-001	AT	1	`5c6f7cd8ea54…`
2022-04-08 23:34 UTC	2022-04	A040879-001	AT	1	`5d02ea3f76ae…`
2022-04-04 05:41 UTC	2022-04	A040879-001	AT	1	`4b0b4de00fa7…`
2019-12-13 00:20 UTC	2019-12	A040879-001	AT	1	`74a2ff9319b5…`
2022-03-09 01:35 UTC	2022-03	A040879-001	AT	1	`bb7c543d1eb4…`
2021-12-28 21:50 UTC	2021-12	A040879-001	AT	1	`782e0a99824c…`
2021-05-05 16:15 UTC · 3 captures of this ZIP	2021-05	A040879-001	AT	1	`87673890dc5c…`
2021-03-12 10:30 UTC	2021-03	A040879-001	AT	1	`5aa47cf7b7d7…`
2020-12-22 03:56 UTC	2020-12	A040879-001	AT	1	`8869cabd3fbd…`
2020-11-12 02:37 UTC	2020-11	A040879-001	AT	1	`c0c555d07b60…`
2019-12-14 00:12 UTC	2019-12	A040879-001	AT	1	`3f01610625f2…`
2019-09-15 20:21 UTC	2019-09	A040879-001	AT	1	`b00525d2431f…`
2019-07-19 19:46 UTC	2019-07	A040879-001	AT	1	`ea99ee380514…`
2024-03-16 18:09 UTC · 4 captures of this ZIP	2024-03	A040879-001	AT	1	`6a51e52b5d6a…`
2024-02-18 07:12 UTC	2024-02	A040879-001	AT	1	`1c564ffb4f44…`
2023-12-20 04:57 UTC	2023-12	A040879-001	AT	1	`ea1830bbd6c7…`
2023-11-28 05:40 UTC · 2 captures of this ZIP	2023-11	A040879-001	AT	1	`a72a2bbeb626…`
2023-10-25 00:34 UTC · 2 captures of this ZIP	2023-10	A040879-001	AT	1	`9b2671bbb829…`
2023-07-15 15:27 UTC · 2 captures of this ZIP	2023-07	A040879-001	AT	1	`a67488948f0b…`
2023-06-13 01:57 UTC · 3 captures of this ZIP	2023-06	A040879-001	AT	1	`3f0d92c62455…`
2023-05-13 08:27 UTC	2023-05	A040879-001	AT	1	`053a50430f4f…`
2023-01-26 05:58 UTC	2023-01	A040879-001	AT	1	`3bdfa0b2c4d7…`
2022-11-12 20:34 UTC · 5 captures of this ZIP	2022-11	A040879-001	AT	1	`3a93d1ddd44b…`
2022-10-28 04:53 UTC	2022-10	A040879-001	AT	1	`f41ea6bd6efb…`

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 · 5 matching rows.

Brand, Generic, Manufacturer table
Brand	Generic	Manufacturer	SPL set ID	Effective date	Available safety fields	Join
PROCTOZONE-HC	HYDROCORTISONE 2.5%	Preferred Pharmaceuticals, Inc.	5f055f94-b213-431b-897e-1c439660f158	2026-08-21	Adverse reactions	Exact identifier application applno (ANDA): 040879 application number: ANDA040879 ndc (product): 68788-7091
PROCTOZONE-HC	HYDROCORTISONE 2.5%	Bryant Ranch Prepack	1cf056c4-01c6-424a-a436-779417eb8244	2024-08-06	Adverse reactions	Exact identifier application applno (ANDA): 040879 application number: ANDA040879 ndc (product): 63629-8847
PROCTOZONE-HC	HYDROCORTISONE 2.5%	Bryant Ranch Prepack	bfafb095-6dd1-4a38-88a7-16f6e0aa8de5	2023-12-08	Adverse reactions	Exact identifier application applno (ANDA): 040879 application number: ANDA040879 ndc (product): 63629-2396
PROCTOZONE-HC	HYDROCORTISONE 2.5%	Bryant Ranch Prepack	d1917a67-9735-46e2-9065-8f9f64ebefb9	2023-10-04	Adverse reactions	Exact identifier application applno (ANDA): 040879 application number: ANDA040879
PROCTOZONE-HC	HYDROCORTISONE 2.5%	Rising Pharma Holdings, Inc.	fb5746ff-3ff1-4874-a827-4694133641b9	2023-05-07	Adverse reactions	Exact identifier application applno (ANDA): 040879 application number: ANDA040879 ndc (product): 64980-324

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 · 14 matching rows.

NDC, Name, Nonproprietary name table
NDC	Name	Nonproprietary name	Labeler	Marketing category	Status
63629-2396	PROCTOZONE-HC	hydrocortisone 2.5%	Bryant Ranch Prepack	ANDA	Current
63629-2396	PROCTOZONE-HC	hydrocortisone 2.5%	Bryant Ranch Prepack	ANDA	Current
63629-2396	PROCTOZONE-HC	hydrocortisone 2.5%	Bryant Ranch Prepack	ANDA	Current
63629-2396	PROCTOZONE-HC	hydrocortisone 2.5%	Bryant Ranch Prepack	ANDA	Current
63629-8847	PROCTOZONE-HC	hydrocortisone 2.5%	Bryant Ranch Prepack	ANDA	Current
63629-8847	PROCTOZONE-HC	hydrocortisone 2.5%	Bryant Ranch Prepack	ANDA	Current
63629-8847	PROCTOZONE-HC	hydrocortisone 2.5%	Bryant Ranch Prepack	ANDA	Current
64980-324	PROCTOZONE-HC	hydrocortisone 2.5%	Rising Pharmaceuticals, Inc.	ANDA	Current
64980-324	PROCTOZONE-HC	hydrocortisone 2.5%	Rising Pharmaceuticals, Inc.	ANDA	Current
68071-2807	PROCTOZONE-HC	hydrocortisone 2.5%	NuCare Pharmaceuticals,Inc.	ANDA	Current
68788-7091	PROCTOZONE-HC	Hydrocortisone 2.5%	Preferred Pharmaceuticals, Inc.	ANDA	Current
68788-7091	PROCTOZONE-HC	Hydrocortisone 2.5%	Preferred Pharmaceuticals, Inc.	ANDA	Current
68788-7091	PROCTOZONE-HC	Hydrocortisone 2.5%	Preferred Pharmaceuticals, Inc.	ANDA	Current
68788-7091	PROCTOZONE-HC	Hydrocortisone 2.5%	Preferred Pharmaceuticals, Inc.	ANDA	Current