Hydrocortisone

Product NDC: 63629-1951
11-digit product format: 636291951
Labeler code: 63629
Product ID: 63629-1951_4de1e1ac-9169-4e68-e063-6394a90a8bbf
Type: HUMAN PRESCRIPTION DRUG
Nonproprietary name: Hydrocortisone
Dosage form: CREAM
Route: TOPICAL
Labeler: Bryant Ranch Prepack
Application: ANDA080706
Marketing category: ANDA
Marketing start: 2016-04-01
Substance: HYDROCORTISONE
Active strength: 10 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…`

Additional Listing Data#

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

Active Ingredients#

Ingredient, Strength table
Ingredient	Strength
HYDROCORTISONE	10 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
106258	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
7f262fa3-4d2a-43f2-a4a7-f49f6034cf50	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
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
63629-1951-1	Hydrocortisone	1 in 1 CARTON	CREAM	1		104
63629-1951-1	Hydrocortisone	28.4 g in 1 TUBE	CREAM	28.4		104

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDC	Billing unit	Product NDC	DailyMed indexing SPL	SPL version	Effective
63629-1951-1	GM - Gram	63629-1951	95d86908-589d-4d9b-a332-632b5b4a89aa	1	2021-04-08

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDC	Dashboard title	SPL version	Validation	Dashboard ZIP
63629-1951	HYDROCORTISONE CREAM [BRYANT RANCH PREPACK]	103	Current NDC, Legacy NDC, 2 package rows	20240602_7f262fa3-4d2a-43f2-a4a7-f49f6034cf50.zip

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 · 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
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 ndc (product): 63629-1951
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

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
106258	hydrocortisone 1 % Topical Cream	PSN	7f262fa3-4d2a-43f2-a4a7-f49f6034cf50	104
106258	hydrocortisone 10 MG/ML Topical Cream	SCD	7f262fa3-4d2a-43f2-a4a7-f49f6034cf50	104
106258	hydrocortisone 1 % (as hydrocortisone acetate 1.2 % ) Topical Cream	SY	7f262fa3-4d2a-43f2-a4a7-f49f6034cf50	104
106258	hydrocortisone 1 % Topical Cream	SY	7f262fa3-4d2a-43f2-a4a7-f49f6034cf50	104
106258	hydrocortisone 1 GM per 100 GM Topical Cream	SY	7f262fa3-4d2a-43f2-a4a7-f49f6034cf50	104

Packages#

Package NDC, 11-digit format, Description table
Package NDC	11-digit format	Description	Units	Marketing start	Marketing end	Sample	Exclude flag	Status
63629-1951-1	63629195101	1 TUBE in 1 CARTON (63629-1951-1) / 28.4 g in 1 TUBE	1 tube	2021-03-01	0000-00-00	No	No	Current

Title, Manufacturer, Effective date table
Title	Manufacturer	Effective date	Type	Version
Hydrocortisone Cream USP 1%, 2.5%	Bryant Ranch Prepack	2026-03-25	HUMAN PRESCRIPTION DRUG LABEL	104