Hydrocortisone Valerate

Product NDC: 68462-836
Requested package NDC: 68462-836-17
11-digit product format: 684620836
Labeler code: 68462
Product ID: 68462-836_18db91a0-fe67-4740-8a37-d656707356f1
Type: HUMAN PRESCRIPTION DRUG
Nonproprietary name: HYDROCORTISONE VALERATE
Dosage form: OINTMENT
Route: TOPICAL
Labeler: Glenmark Pharmaceuticals Inc., USA
Application: ANDA211750
Marketing category: ANDA
Marketing start: 2019-03-05
Marketing end: 0000-00-00
Substance: HYDROCORTISONE VALERATE
Active strength: 2 mg/g
Pharmacologic classes: Corticosteroid [EPC],Corticosteroid Hormone Receptor Agonists [MoA]
NDC exclude flag: No
Listing certified through: 2020-12-31
Current FDA listing: Historical FDA.report record

NDC auxiliary status#

These records are reproduced from FDA’s unfinished, excluded, and compounder listings. They describe what appeared in the source files; a missing record does not establish a regulatory status. View all current auxiliary records, including entries without an NDC. · View the auxiliary file history.

Current NDC status page 1 of 1 · 1 matching rows.

Dataset, Scope, Product NDC table
Dataset	Scope	Product NDC	Package NDC	Code	Status	Reporting period	Source date
excluded package	package	68462-836	68462-836-17	D	Discontinued by firm		2026-11-03

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

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
A211750-001	HYDROCORTISONE VALERATE	HYDROCORTISONE VALERATE	0.2%	OINTMENT / TOPICAL			2018-12-14

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 · 44 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
2026-10-15 13:18:30	2026-09	A211750-001	HYDROCORTISONE VALERATE	0.2%	OINTMENT / TOPICAL		2018-12-14	`c2088c7a36db…`
2026-09-14 22:38:34	2026-08	A211750-001	HYDROCORTISONE VALERATE	0.2%	OINTMENT / TOPICAL		2018-12-14	`84e616aacf4f…`
2026-08-18 06:07:40	2026-07	A211750-001	HYDROCORTISONE VALERATE	0.2%	OINTMENT / TOPICAL		2018-12-14	`caaa826d4ba7…`
2026-02-19 14:30 UTC	2026-02	A211750-001	HYDROCORTISONE VALERATE	0.2%	OINTMENT / TOPICAL		2018-12-14	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A211750-001	HYDROCORTISONE VALERATE	0.2%	OINTMENT / TOPICAL		2018-12-14	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	A211750-001	HYDROCORTISONE VALERATE	0.2%	OINTMENT / TOPICAL	AB	2018-12-14	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A211750-001	HYDROCORTISONE VALERATE	0.2%	OINTMENT / TOPICAL	AB	2018-12-14	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A211750-001	HYDROCORTISONE VALERATE	0.2%	OINTMENT / TOPICAL	AB	2018-12-14	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A211750-001	HYDROCORTISONE VALERATE	0.2%	OINTMENT / TOPICAL	AB	2018-12-14	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A211750-001	HYDROCORTISONE VALERATE	0.2%	OINTMENT / TOPICAL	AB	2018-12-14	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A211750-001	HYDROCORTISONE VALERATE	0.2%	OINTMENT / TOPICAL	AB	2018-12-14	`5bbf6a4d5a75…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A211750-001	HYDROCORTISONE VALERATE	0.2%	OINTMENT / TOPICAL	AB	2018-12-14	`d8e5a09893c0…`
2024-10-29 15:01 UTC	2024-10	A211750-001	HYDROCORTISONE VALERATE	0.2%	OINTMENT / TOPICAL	AB	2018-12-14	`d06236e962d9…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A211750-001	HYDROCORTISONE VALERATE	0.2%	OINTMENT / TOPICAL	AB	2018-12-14	`79d66fd596c7…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A211750-001	HYDROCORTISONE VALERATE	0.2%	OINTMENT / TOPICAL	AB	2018-12-14	`301d65b070ca…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A211750-001	HYDROCORTISONE VALERATE	0.2%	OINTMENT / TOPICAL	AB	2018-12-14	`1e350fbaab3a…`
2024-05-31 18:47 UTC	2024-05	A211750-001	HYDROCORTISONE VALERATE	0.2%	OINTMENT / TOPICAL	AB	2018-12-14	`8072bd15b7f6…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	A211750-001	HYDROCORTISONE VALERATE	0.2%	OINTMENT / TOPICAL	AB	2018-12-14	`5c6f7cd8ea54…`
2022-04-08 23:34 UTC	2022-04	A211750-001	HYDROCORTISONE VALERATE	0.2%	OINTMENT / TOPICAL	AB	2018-12-14	`5d02ea3f76ae…`
2022-04-04 05:41 UTC	2022-04	A211750-001	HYDROCORTISONE VALERATE	0.2%	OINTMENT / TOPICAL	AB	2018-12-14	`4b0b4de00fa7…`
2019-12-13 00:20 UTC	2019-12	A211750-001	HYDROCORTISONE VALERATE	0.2%	OINTMENT / TOPICAL	AB	2018-12-14	`74a2ff9319b5…`
2022-03-09 01:35 UTC	2022-03	A211750-001	HYDROCORTISONE VALERATE	0.2%	OINTMENT / TOPICAL	AB	2018-12-14	`bb7c543d1eb4…`
2021-12-28 21:50 UTC	2021-12	A211750-001	HYDROCORTISONE VALERATE	0.2%	OINTMENT / TOPICAL	AB	2018-12-14	`782e0a99824c…`
2021-05-05 16:15 UTC · 3 captures of this ZIP	2021-05	A211750-001	HYDROCORTISONE VALERATE	0.2%	OINTMENT / TOPICAL	AB	2018-12-14	`87673890dc5c…`
2021-03-12 10:30 UTC	2021-03	A211750-001	HYDROCORTISONE VALERATE	0.2%	OINTMENT / TOPICAL	AB	2018-12-14	`5aa47cf7b7d7…`
2020-12-22 03:56 UTC	2020-12	A211750-001	HYDROCORTISONE VALERATE	0.2%	OINTMENT / TOPICAL	AB	2018-12-14	`8869cabd3fbd…`
2020-11-12 02:37 UTC	2020-11	A211750-001	HYDROCORTISONE VALERATE	0.2%	OINTMENT / TOPICAL	AB	2018-12-14	`c0c555d07b60…`
2019-12-14 00:12 UTC	2019-12	A211750-001	HYDROCORTISONE VALERATE	0.2%	OINTMENT / TOPICAL	AB	2018-12-14	`3f01610625f2…`
2019-09-15 20:21 UTC	2019-09	A211750-001	HYDROCORTISONE VALERATE	0.2%	OINTMENT / TOPICAL	AB	2018-12-14	`b00525d2431f…`
2019-07-19 19:46 UTC	2019-07	A211750-001	HYDROCORTISONE VALERATE	0.2%	OINTMENT / TOPICAL	AB	2018-12-14	`ea99ee380514…`
2024-03-16 18:09 UTC · 4 captures of this ZIP	2024-03	A211750-001	HYDROCORTISONE VALERATE	0.2%	OINTMENT / TOPICAL	AB	2018-12-14	`6a51e52b5d6a…`
2024-02-18 07:12 UTC	2024-02	A211750-001	HYDROCORTISONE VALERATE	0.2%	OINTMENT / TOPICAL	AB	2018-12-14	`1c564ffb4f44…`
2023-12-20 04:57 UTC	2023-12	A211750-001	HYDROCORTISONE VALERATE	0.2%	OINTMENT / TOPICAL	AB	2018-12-14	`ea1830bbd6c7…`
2023-11-28 05:40 UTC · 2 captures of this ZIP	2023-11	A211750-001	HYDROCORTISONE VALERATE	0.2%	OINTMENT / TOPICAL	AB	2018-12-14	`a72a2bbeb626…`
2023-10-25 00:34 UTC · 2 captures of this ZIP	2023-10	A211750-001	HYDROCORTISONE VALERATE	0.2%	OINTMENT / TOPICAL	AB	2018-12-14	`9b2671bbb829…`
2023-07-15 15:27 UTC · 2 captures of this ZIP	2023-07	A211750-001	HYDROCORTISONE VALERATE	0.2%	OINTMENT / TOPICAL	AB	2018-12-14	`a67488948f0b…`
2023-06-13 01:57 UTC · 3 captures of this ZIP	2023-06	A211750-001	HYDROCORTISONE VALERATE	0.2%	OINTMENT / TOPICAL	AB	2018-12-14	`3f0d92c62455…`
2023-05-13 08:27 UTC	2023-05	A211750-001	HYDROCORTISONE VALERATE	0.2%	OINTMENT / TOPICAL	AB	2018-12-14	`053a50430f4f…`
2023-01-26 05:58 UTC	2023-01	A211750-001	HYDROCORTISONE VALERATE	0.2%	OINTMENT / TOPICAL	AB	2018-12-14	`3bdfa0b2c4d7…`
2022-11-12 20:34 UTC · 5 captures of this ZIP	2022-11	A211750-001	HYDROCORTISONE VALERATE	0.2%	OINTMENT / TOPICAL	AB	2018-12-14	`3a93d1ddd44b…`

Observed Orange Book normalized TE history#

Captured, Edition, Application-product table
Captured	Edition	Application-product	TE code	Order	Source SHA-256
2025-08-23 18:47 UTC	2025-08	A211750-001	AB	1	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A211750-001	AB	1	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A211750-001	AB	1	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A211750-001	AB	1	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A211750-001	AB	1	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A211750-001	AB	1	`5bbf6a4d5a75…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A211750-001	AB	1	`d8e5a09893c0…`
2024-10-29 15:01 UTC	2024-10	A211750-001	AB	1	`d06236e962d9…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A211750-001	AB	1	`79d66fd596c7…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A211750-001	AB	1	`301d65b070ca…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A211750-001	AB	1	`1e350fbaab3a…`
2024-05-31 18:47 UTC	2024-05	A211750-001	AB	1	`8072bd15b7f6…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	A211750-001	AB	1	`5c6f7cd8ea54…`
2022-04-08 23:34 UTC	2022-04	A211750-001	AB	1	`5d02ea3f76ae…`
2022-04-04 05:41 UTC	2022-04	A211750-001	AB	1	`4b0b4de00fa7…`
2019-12-13 00:20 UTC	2019-12	A211750-001	AB	1	`74a2ff9319b5…`
2022-03-09 01:35 UTC	2022-03	A211750-001	AB	1	`bb7c543d1eb4…`
2021-12-28 21:50 UTC	2021-12	A211750-001	AB	1	`782e0a99824c…`
2021-05-05 16:15 UTC · 3 captures of this ZIP	2021-05	A211750-001	AB	1	`87673890dc5c…`
2021-03-12 10:30 UTC	2021-03	A211750-001	AB	1	`5aa47cf7b7d7…`
2020-12-22 03:56 UTC	2020-12	A211750-001	AB	1	`8869cabd3fbd…`
2020-11-12 02:37 UTC	2020-11	A211750-001	AB	1	`c0c555d07b60…`
2019-12-14 00:12 UTC	2019-12	A211750-001	AB	1	`3f01610625f2…`
2019-09-15 20:21 UTC	2019-09	A211750-001	AB	1	`b00525d2431f…`
2019-07-19 19:46 UTC	2019-07	A211750-001	AB	1	`ea99ee380514…`
2024-03-16 18:09 UTC · 4 captures of this ZIP	2024-03	A211750-001	AB	1	`6a51e52b5d6a…`
2024-02-18 07:12 UTC	2024-02	A211750-001	AB	1	`1c564ffb4f44…`
2023-12-20 04:57 UTC	2023-12	A211750-001	AB	1	`ea1830bbd6c7…`
2023-11-28 05:40 UTC · 2 captures of this ZIP	2023-11	A211750-001	AB	1	`a72a2bbeb626…`
2023-10-25 00:34 UTC · 2 captures of this ZIP	2023-10	A211750-001	AB	1	`9b2671bbb829…`
2023-07-15 15:27 UTC · 2 captures of this ZIP	2023-07	A211750-001	AB	1	`a67488948f0b…`
2023-06-13 01:57 UTC · 3 captures of this ZIP	2023-06	A211750-001	AB	1	`3f0d92c62455…`
2023-05-13 08:27 UTC	2023-05	A211750-001	AB	1	`053a50430f4f…`
2023-01-26 05:58 UTC	2023-01	A211750-001	AB	1	`3bdfa0b2c4d7…`
2022-11-12 20:34 UTC · 5 captures of this ZIP	2022-11	A211750-001	AB	1	`3a93d1ddd44b…`
2022-10-28 04:53 UTC	2022-10	A211750-001	AB	1	`f41ea6bd6efb…`
2022-09-29 23:25 UTC	2022-09	A211750-001	AB	1	`e64feba35796…`
2022-07-09 03:26 UTC · 3 captures of this ZIP	2022-07	A211750-001	AB	1	`cb3db0bc1861…`

Observed Orange Book exclusivity history#

Captured, Edition, Application-product table
Captured	Edition	Application-product	Exclusivity code	Expiration	Source SHA-256
2019-12-13 00:20 UTC	2019-12	A211750-001	CGT	2019-07-16	`74a2ff9319b5…`
2019-12-14 00:12 UTC	2019-12	A211750-001	CGT	2019-07-16	`3f01610625f2…`
2019-09-15 20:21 UTC	2019-09	A211750-001	CGT	2019-07-16	`b00525d2431f…`
2019-07-19 19:46 UTC	2019-07	A211750-001	CGT	2019-07-16	`ea99ee380514…`

Reported adverse events (FAERS/openFDA)#

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

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	SPL version
68462-836-17	Hydrocortisone Valerate	15 g in 1 TUBE	OINTMENT	15	2
68462-836-17	Hydrocortisone Valerate	1 in 1 CARTON	OINTMENT	1	2
68462-836-47	Hydrocortisone Valerate	45 g in 1 TUBE	OINTMENT	45	2
68462-836-47	Hydrocortisone Valerate	1 in 1 CARTON	OINTMENT	1	2
68462-836-65	Hydrocortisone Valerate	60 g in 1 TUBE	OINTMENT	60	2
68462-836-65	Hydrocortisone Valerate	1 in 1 CARTON	OINTMENT	1	2

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDC	Billing unit	Product NDC	DailyMed indexing SPL	SPL version	Effective
68462-836-17	GM - Gram	68462-836	31dabad9-6ba4-493f-a730-76a892c7548e	1	2019-04-11
68462-836-47	GM - Gram	68462-836	c2632ee7-5818-4def-9b6b-604befcda1ae	1	2019-04-11
68462-836-65	GM - Gram	68462-836	dc0c8de8-05b0-444c-8c63-04213ddc7f9a	1	2019-04-11

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDC	Dashboard title	SPL version	Validation	Dashboard ZIP
68462-836	HYDROCORTISONE VALERATE OINTMENT [GLENMARK PHARMACEUTICALS INC., USA]	2	Legacy NDC, 6 package rows	20240104_18db91a0-fe67-4740-8a37-d656707356f1.zip

UNII, Preferred term, Registry number table
UNII	Preferred term	Registry number	Matched term
68717P8FUZ	HYDROCORTISONE VALERATE	57524-89-7	HYDROCORTISONE VALERATE

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUI	RxNorm string	TTY	DailyMed	SPL version
1370750	hydrocortisone valerate 0.2 % Topical Ointment	PSN	18db91a0-fe67-4740-8a37-d656707356f1	2
1370750	hydrocortisone valerate 0.002 MG/MG Topical Ointment	SCD	18db91a0-fe67-4740-8a37-d656707356f1	2
1370750	hydrocortisone valerate 0.2 % Topical Ointment	SY	18db91a0-fe67-4740-8a37-d656707356f1	2

Packages#

Package NDC, 11-digit format, Description table
Package NDC	11-digit format	Description	Units	Marketing start	Marketing end	Sample	Exclude flag	Status
68462-836-17	68462083617	1 TUBE in 1 CARTON (68462-836-17) > 15 g in 1 TUBE	1 tube	2019-03-05	0000-00-00	No	No	Current

Title, Manufacturer, Effective date table
Title	Manufacturer	Effective date	Type	Version
Hydrocortisone Valerate Ointment USP, 0.2%	Glenmark Pharmaceuticals Inc., USA \| Glenmark Pharmaceuticals Limited	2019-03-05	HUMAN PRESCRIPTION DRUG LABEL	2