Hydrocortisone

Product NDC: 68788-8302
11-digit product format: 687888302
Labeler code: 68788
Product ID: 68788-8302_d215d533-f00c-46ca-8c92-ec925950e344
Type: HUMAN PRESCRIPTION DRUG
Nonproprietary name: Hydrocortisone
Dosage form: CREAM
Route: TOPICAL
Labeler: Preferred Pharmaceuticals, Inc.
Application: ANDA080706
Marketing category: ANDA
Marketing start: 2022-12-19
Substance: HYDROCORTISONE
Active strength: 25 mg/g
Pharmacologic classes: Corticosteroid Hormone Receptor Agonists [MoA], Corticosteroid [EPC]
NDC exclude flag: No
Listing certified through: 2027-12-31
Current FDA listing: Yes

Source provenance: Browse the complete Orange Book source catalog · source snapshot 1.

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
A080706-006	ALA-CORT	HYDROCORTISONE	1%	CREAM / TOPICAL	AT	Approved before 1982
A080706-007	ALA-CORT	HYDROCORTISONE	2.5%	CREAM / TOPICAL	AT		2016-01-05

Therapeutic equivalence codes#

Current TE-code rows page 1 of 1 · 2 matching rows.

Application-product, TE code table
Application-product	TE code
A080706-006	AT
A080706-007	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 3 · 82 observed states.

Captured, Edition, Application-product table
Captured	Edition	Application-product	Trade name	Strength	Dosage form / route	Product TE source text	RLD / RS	Approval date	Source SHA-256
2026-02-19 14:30 UTC	2026-02	A080706-006	ALA-CORT	1%	CREAM / TOPICAL	AT	Approved before 1982		`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A080706-007	ALA-CORT	2.5%	CREAM / TOPICAL	AT		2016-01-05	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A080706-006	ALA-CORT	1%	CREAM / TOPICAL	AT	Approved before 1982		`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A080706-007	ALA-CORT	2.5%	CREAM / TOPICAL	AT		2016-01-05	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	A080706-006	ALA-CORT	1%	CREAM / TOPICAL	AT	Approved before 1982		`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A080706-007	ALA-CORT	2.5%	CREAM / TOPICAL	AT		2016-01-05	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A080706-006	ALA-CORT	1%	CREAM / TOPICAL	AT	Approved before 1982		`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A080706-007	ALA-CORT	2.5%	CREAM / TOPICAL	AT		2016-01-05	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A080706-006	ALA-CORT	1%	CREAM / TOPICAL	AT	Approved before 1982		`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A080706-007	ALA-CORT	2.5%	CREAM / TOPICAL	AT		2016-01-05	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A080706-006	ALA-CORT	1%	CREAM / TOPICAL	AT	Approved before 1982		`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A080706-007	ALA-CORT	2.5%	CREAM / TOPICAL	AT		2016-01-05	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A080706-006	ALA-CORT	1%	CREAM / TOPICAL	AT	Approved before 1982		`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A080706-007	ALA-CORT	2.5%	CREAM / TOPICAL	AT		2016-01-05	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A080706-006	ALA-CORT	1%	CREAM / TOPICAL	AT	Approved before 1982		`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A080706-007	ALA-CORT	2.5%	CREAM / TOPICAL	AT		2016-01-05	`5bbf6a4d5a75…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A080706-006	ALA-CORT	1%	CREAM / TOPICAL	AT	Approved before 1982		`d8e5a09893c0…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A080706-007	ALA-CORT	2.5%	CREAM / TOPICAL	AT		2016-01-05	`d8e5a09893c0…`
2024-10-29 15:01 UTC	2024-10	A080706-006	ALA-CORT	1%	CREAM / TOPICAL	AT	Approved before 1982		`d06236e962d9…`
2024-10-29 15:01 UTC	2024-10	A080706-007	ALA-CORT	2.5%	CREAM / TOPICAL	AT		2016-01-05	`d06236e962d9…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A080706-006	ALA-CORT	1%	CREAM / TOPICAL	AT	Approved before 1982		`79d66fd596c7…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A080706-007	ALA-CORT	2.5%	CREAM / TOPICAL	AT		2016-01-05	`79d66fd596c7…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A080706-006	ALA-CORT	1%	CREAM / TOPICAL	AT	Approved before 1982		`301d65b070ca…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A080706-007	ALA-CORT	2.5%	CREAM / TOPICAL	AT		2016-01-05	`301d65b070ca…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A080706-006	ALA-CORT	1%	CREAM / TOPICAL	AT	Approved before 1982		`1e350fbaab3a…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A080706-007	ALA-CORT	2.5%	CREAM / TOPICAL	AT		2016-01-05	`1e350fbaab3a…`
2024-05-31 18:47 UTC	2024-05	A080706-006	ALA-CORT	1%	CREAM / TOPICAL	AT	Approved before 1982		`8072bd15b7f6…`
2024-05-31 18:47 UTC	2024-05	A080706-007	ALA-CORT	2.5%	CREAM / TOPICAL	AT		2016-01-05	`8072bd15b7f6…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	A080706-006	ALA-CORT	1%	CREAM / TOPICAL	AT	Approved before 1982		`5c6f7cd8ea54…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	A080706-007	ALA-CORT	2.5%	CREAM / TOPICAL	AT		2016-01-05	`5c6f7cd8ea54…`
2022-04-08 23:34 UTC	2022-04	A080706-006	ALA-CORT	1%	CREAM / TOPICAL	AT	Approved before 1982		`5d02ea3f76ae…`
2022-04-08 23:34 UTC	2022-04	A080706-007	ALA-CORT	2.5%	CREAM / TOPICAL	AT		2016-01-05	`5d02ea3f76ae…`
2022-04-04 05:41 UTC	2022-04	A080706-006	ALA-CORT	1%	CREAM / TOPICAL	AT	Approved before 1982		`4b0b4de00fa7…`
2022-04-04 05:41 UTC	2022-04	A080706-007	ALA-CORT	2.5%	CREAM / TOPICAL	AT		2016-01-05	`4b0b4de00fa7…`
2019-12-13 00:20 UTC	2019-12	A080706-006	ALA-CORT	1%	CREAM / TOPICAL	AT	Approved before 1982		`74a2ff9319b5…`
2019-12-13 00:20 UTC	2019-12	A080706-007	ALA-CORT	2.5%	CREAM / TOPICAL	AT		2016-01-05	`74a2ff9319b5…`
2022-03-09 01:35 UTC	2022-03	A080706-006	ALA-CORT	1%	CREAM / TOPICAL	AT	Approved before 1982		`bb7c543d1eb4…`
2022-03-09 01:35 UTC	2022-03	A080706-007	ALA-CORT	2.5%	CREAM / TOPICAL	AT		2016-01-05	`bb7c543d1eb4…`
2021-12-28 21:50 UTC	2021-12	A080706-006	ALA-CORT	1%	CREAM / TOPICAL	AT	Approved before 1982		`782e0a99824c…`
2021-12-28 21:50 UTC	2021-12	A080706-007	ALA-CORT	2.5%	CREAM / TOPICAL	AT		2016-01-05	`782e0a99824c…`

Observed Orange Book normalized TE history#

Normalized TE history page 1 of 3 · 82 observed states.

Captured, Edition, Application-product table
Captured	Edition	Application-product	TE code	Order	Source SHA-256
2026-02-19 14:30 UTC	2026-02	A080706-006	AT	1	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A080706-007	AT	1	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A080706-006	AT	1	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A080706-007	AT	1	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	A080706-006	AT	1	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A080706-007	AT	1	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A080706-006	AT	1	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A080706-007	AT	1	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A080706-006	AT	1	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A080706-007	AT	1	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A080706-006	AT	1	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A080706-007	AT	1	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A080706-006	AT	1	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A080706-007	AT	1	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A080706-006	AT	1	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A080706-007	AT	1	`5bbf6a4d5a75…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A080706-006	AT	1	`d8e5a09893c0…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A080706-007	AT	1	`d8e5a09893c0…`
2024-10-29 15:01 UTC	2024-10	A080706-006	AT	1	`d06236e962d9…`
2024-10-29 15:01 UTC	2024-10	A080706-007	AT	1	`d06236e962d9…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A080706-006	AT	1	`79d66fd596c7…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A080706-007	AT	1	`79d66fd596c7…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A080706-006	AT	1	`301d65b070ca…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A080706-007	AT	1	`301d65b070ca…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A080706-006	AT	1	`1e350fbaab3a…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A080706-007	AT	1	`1e350fbaab3a…`
2024-05-31 18:47 UTC	2024-05	A080706-006	AT	1	`8072bd15b7f6…`
2024-05-31 18:47 UTC	2024-05	A080706-007	AT	1	`8072bd15b7f6…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	A080706-006	AT	1	`5c6f7cd8ea54…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	A080706-007	AT	1	`5c6f7cd8ea54…`
2022-04-08 23:34 UTC	2022-04	A080706-006	AT	1	`5d02ea3f76ae…`
2022-04-08 23:34 UTC	2022-04	A080706-007	AT	1	`5d02ea3f76ae…`
2022-04-04 05:41 UTC	2022-04	A080706-006	AT	1	`4b0b4de00fa7…`
2022-04-04 05:41 UTC	2022-04	A080706-007	AT	1	`4b0b4de00fa7…`
2019-12-13 00:20 UTC	2019-12	A080706-006	AT	1	`74a2ff9319b5…`
2019-12-13 00:20 UTC	2019-12	A080706-007	AT	1	`74a2ff9319b5…`
2022-03-09 01:35 UTC	2022-03	A080706-006	AT	1	`bb7c543d1eb4…`
2022-03-09 01:35 UTC	2022-03	A080706-007	AT	1	`bb7c543d1eb4…`
2021-12-28 21:50 UTC	2021-12	A080706-006	AT	1	`782e0a99824c…`
2021-12-28 21:50 UTC	2021-12	A080706-007	AT	1	`782e0a99824c…`

openFDA label cross-check#

Cross-check layer: openFDA label JSON enriches search and identifies hydration gaps. The DailyMed Structured Product Label remains the canonical label presentation on FDA.report. Every label matching the complete exact-identifier union is deduplicated and paginated below.

Matched openFDA labels page 1 of 1 · 11 matching rows.

Brand, Generic, Manufacturer table
Brand	Generic	Manufacturer	SPL set ID	Effective date	Available safety fields	Join
Hydrocortisone	HYDROCORTISONE	Bryant Ranch Prepack	04758c46-0ca4-4852-acdc-1f8553ce2e6e	2026-05-21	Adverse reactions	Exact identifier application applno (ANDA): 080706 application number: ANDA080706
Hydrocortisone	HYDROCORTISONE	Preferred Pharmaceuticals, Inc.	026728d4-846b-4bd4-9183-ae6c4a714138	2026-05-11	Adverse reactions	Exact identifier application applno (ANDA): 080706 application number: ANDA080706 ndc (product): 68788-8302
Hydrocortisone	HYDROCORTISONE	Sportpharm LLC	78f43570-b6fd-42eb-bb9e-580abf79bf0d	2026-04-24	Adverse reactions	Exact identifier application applno (ANDA): 080706 application number: ANDA080706
Hydrocortisone	HYDROCORTISONE	Bryant Ranch Prepack	5e95eb82-40cd-411b-9006-c27b65db4b3f	2026-03-25	Adverse reactions	Exact identifier application applno (ANDA): 080706 application number: ANDA080706
Hydrocortisone	HYDROCORTISONE	Bryant Ranch Prepack	7f262fa3-4d2a-43f2-a4a7-f49f6034cf50	2026-03-25	Adverse reactions	Exact identifier application applno (ANDA): 080706 application number: ANDA080706
Hydrocortisone	HYDROCORTISONE	Bryant Ranch Prepack	3d17e73a-15f5-4881-baf2-47a0149585fd	2026-03-25	Adverse reactions	Exact identifier application applno (ANDA): 080706 application number: ANDA080706
Hydrocortisone	HYDROCORTISONE	A-S Medication Solutions	5c4c3e02-5272-4a28-a9c8-1c5fa3ae181c	2026-01-30	Adverse reactions	Exact identifier application applno (ANDA): 080706 application number: ANDA080706
Hydrocortisone	HYDROCORTISONE	Crown Laboratories	a84830ad-73dc-4a2e-b987-0a1103526535	2026-01-12	Adverse reactions	Exact identifier application applno (ANDA): 080706 application number: ANDA080706
Alacort	HYDROCORTISONE	Crown Laboratories	de000081-a245-4f6b-9e7c-e47d84b82338	2026-01-12	Adverse reactions	Exact identifier application applno (ANDA): 080706 application number: ANDA080706
Hydrocortisone	HYDROCORTISONE	ANI Pharmaceuticals, Inc.	b2918ac7-14b5-4372-9055-8caf6f4bcf37	2025-12-22	Adverse reactions	Exact identifier application applno (ANDA): 080706 application number: ANDA080706
Hydrocortisone	HYDROCORTISONE	Bryant Ranch Prepack	b6808d2d-192c-4d70-a2e8-bf13375c0280	2025-11-05	Adverse reactions	Exact identifier application applno (ANDA): 080706 application number: ANDA080706

Additional Listing Data#

Finished product: Yes
Brand name base: Hydrocortisone
Listing expiration: 2027-12-31

Active Ingredients#

Ingredient, Strength table
Ingredient	Strength
HYDROCORTISONE	25 mg/g

Harmonized UNII identifiers#

UNII identifiers page 1 of 1 · 1 matching rows.

Identifier, FDA.report destination table
Identifier	FDA.report destination
WI4X0X7BPJ	Internal UNII lookup

Harmonized RxCUI identifiers#

RxCUI identifiers page 1 of 1 · 1 matching rows.

Identifier, FDA.report destination table
Identifier	FDA.report destination
310891	Internal RxNorm lookup

Harmonized SPL set identifiers#

SPL set identifiers page 1 of 1 · 1 matching rows.

Identifier, FDA.report destination table
Identifier	FDA.report destination
026728d4-846b-4bd4-9183-ae6c4a714138	Available on FDA.report

DailyMed Product Concepts#

Product concept, Relation, Version table
Product concept	Relation	Version	Effective
15bd4439-874a-4934-9954-248e5455d460	Product name	1	20260310
9962b773-9f2e-22cc-0032-535e48ac417b	Product name	3	20250724
56bb0587-1bf2-48b2-9d93-fc9f59d1eeb2	Product name	1	20250325
4d56e8eb-d741-d4a5-de3f-2bab1af75a60	Product name	7	20220608
3c386306-c48a-413e-bb69-70cb268496f3	Product name	1	20210727
626d7260-31b5-4412-84fd-579746adb6b3	Product name	1	20210513
8a011600-5e61-4c59-ab7b-54ab658a3b71	Product name	2	20181127
a919621a-248d-3c7a-1084-9f9ce286fdfd	Product name	2	20181009
e7d5a174-836b-a0af-b014-cb0826c69ddc	Product name	2	20181004
fcce390d-6460-4701-87cf-940d8800a1c3	Product name	2	20180212
bf065fa6-1e3b-e4c3-0bde-2dc842ceeea1	Product name	2	20150218
02657a3f-1489-66ea-f740-5ab9524e57d7	Product name	1	20140508
26f3d783-2cc1-4327-e77d-71804cf675a2	Product name	1	20140508
36fdc54c-bbeb-981e-8a53-4d768e283892	Product name	1	20140508
58f3f9b7-3b9b-a9c1-1c9f-18ac777192b8	Product name	1	20140508
61e59a42-186b-9f4b-aec3-fb49a6debc31	Product name	1	20140508
705740e1-dee5-2610-c5a3-4c59cd9d62af	Product name	1	20140508
7bdc4804-3832-c0df-e519-72b6d47c9792	Product name	1	20140508
a7051cba-790b-a699-81f8-dbbbdbd9b5ac	Product name	1	20140508
abaf203f-619e-f265-559f-8c81af5cb1c2	Product name	1	20140508
acc4d8bb-0e29-e9f8-65f8-31e94184a9c0	Product name	1	20140508
b045ad64-0f28-9a02-2f9b-b34d94fb2278	Product name	1	20140508
bfd28ffb-d550-3fe9-f65b-10bcb7f971fd	Product name	1	20140508
da108d9e-edc8-17a3-8c28-3251c6a8accc	Product name	1	20140508
fe21f3fd-a378-0654-1972-db3c3b64470e	Product name	1	20140508

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDC	Product	Description	Form	Quantity	Strength	SPL version
68788-8302-3	Hydrocortisone	1 in 1 CARTON	CREAM	1		5
68788-8302-3	Hydrocortisone	30 g in 1 TUBE	CREAM	30		5

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDC	Billing unit	Product NDC	DailyMed indexing SPL	SPL version	Effective
68788-8302-3	GM - Gram	68788-8302	2a835951-bff9-4f52-a864-ee72ca8d7efc	1	2023-02-06

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDC	Dashboard title	SPL version	Validation	Dashboard ZIP
68788-8302	HYDROCORTISONE CREAM [PREFERRED PHARMACEUTICALS, INC.]	3	Current NDC, Legacy NDC, 2 package rows	20240522_026728d4-846b-4bd4-9183-ae6c4a714138.zip

UNII, Preferred term, Registry number table
UNII	Preferred term	Registry number	Matched term
WI4X0X7BPJ	HYDROCORTISONE	50-23-7	HYDROCORTISONE

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUI	RxNorm string	TTY	DailyMed	SPL version
310891	hydrocortisone 2.5 % Topical Cream	PSN	026728d4-846b-4bd4-9183-ae6c4a714138	5
310891	hydrocortisone 25 MG/ML Topical Cream	SCD	026728d4-846b-4bd4-9183-ae6c4a714138	5
310891	hydrocortisone 2.5 % Topical Cream	SY	026728d4-846b-4bd4-9183-ae6c4a714138	5

Packages#

Package NDC, 11-digit format, Description table
Package NDC	11-digit format	Description	Units	Marketing start	Marketing end	Sample	Exclude flag	Status
68788-8302-3	68788830203	1 TUBE in 1 CARTON (68788-8302-3) / 30 g in 1 TUBE	1 tube	2022-12-19	0000-00-00	No	No	Current

Title, Manufacturer, Effective date table
Title	Manufacturer	Effective date	Type	Version
Hydrocortisone Cream USP 1%, 2.5%	Preferred Pharmaceuticals, Inc.	2026-05-11	HUMAN PRESCRIPTION DRUG LABEL	5