Hydrocortisone

Product NDC: 73352-455
11-digit product format: 733520455
Labeler code: 73352
Product ID: 73352-455_1c65bd29-4b72-4efc-8b4e-86b492a4b190
Type: HUMAN PRESCRIPTION DRUG
Nonproprietary name: Hydrocortisone
Dosage form: SOLUTION
Route: TOPICAL
Labeler: Trifluent Pharma LLC
Application: ANDA081271
Marketing category: ANDA
Marketing start: 2024-11-22
Substance: HYDROCORTISONE
Active strength: 25 mg/mL
Pharmacologic classes: Corticosteroid Hormone Receptor Agonists [MoA], Corticosteroid [EPC]
NDC exclude flag: No
Listing certified through: 2026-12-31
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 · 1 matching rows.

Application-product, Trade name, Ingredient table
Application-product	Trade name	Ingredient	Strength	Dosage form / route	TE codes	RLD / RS	Approval date
A081271-001	TEXACORT	HYDROCORTISONE	2.5%	SOLUTION / TOPICAL		RS	1992-04-17

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 · 41 observed states.

Captured, Edition, Application-product table
Captured	Edition	Application-product	Trade name	Strength	Dosage form / route	RLD / RS	Approval date	Source SHA-256
2026-02-19 14:30 UTC	2026-02	A081271-001	TEXACORT	2.5%	SOLUTION / TOPICAL	RS	1992-04-17	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A081271-001	TEXACORT	2.5%	SOLUTION / TOPICAL	RS	1992-04-17	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	A081271-001	TEXACORT	2.5%	SOLUTION / TOPICAL	RS	1992-04-17	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A081271-001	TEXACORT	2.5%	SOLUTION / TOPICAL	RS	1992-04-17	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A081271-001	TEXACORT	2.5%	SOLUTION / TOPICAL	RS	1992-04-17	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A081271-001	TEXACORT	2.5%	SOLUTION / TOPICAL	RS	1992-04-17	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A081271-001	TEXACORT	2.5%	SOLUTION / TOPICAL	RS	1992-04-17	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A081271-001	TEXACORT	2.5%	SOLUTION / TOPICAL	RS	1992-04-17	`5bbf6a4d5a75…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A081271-001	TEXACORT	2.5%	SOLUTION / TOPICAL	RS	1992-04-17	`d8e5a09893c0…`
2024-10-29 15:01 UTC	2024-10	A081271-001	TEXACORT	2.5%	SOLUTION / TOPICAL	RS	1992-04-17	`d06236e962d9…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A081271-001	TEXACORT	2.5%	SOLUTION / TOPICAL	RS	1992-04-17	`79d66fd596c7…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A081271-001	TEXACORT	2.5%	SOLUTION / TOPICAL	RS	1992-04-17	`301d65b070ca…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A081271-001	TEXACORT	2.5%	SOLUTION / TOPICAL	RS	1992-04-17	`1e350fbaab3a…`
2024-05-31 18:47 UTC	2024-05	A081271-001	TEXACORT	2.5%	SOLUTION / TOPICAL	RS	1992-04-17	`8072bd15b7f6…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	A081271-001	TEXACORT	2.5%	SOLUTION / TOPICAL	RS	1992-04-17	`5c6f7cd8ea54…`
2022-04-08 23:34 UTC	2022-04	A081271-001	TEXACORT	2.5%	SOLUTION / TOPICAL	RS	1992-04-17	`5d02ea3f76ae…`
2022-04-04 05:41 UTC	2022-04	A081271-001	TEXACORT	2.5%	SOLUTION / TOPICAL	RS	1992-04-17	`4b0b4de00fa7…`
2019-12-13 00:20 UTC	2019-12	A081271-001	TEXACORT	2.5%	SOLUTION / TOPICAL	RS	1992-04-17	`74a2ff9319b5…`
2022-03-09 01:35 UTC	2022-03	A081271-001	TEXACORT	2.5%	SOLUTION / TOPICAL	RS	1992-04-17	`bb7c543d1eb4…`
2021-12-28 21:50 UTC	2021-12	A081271-001	TEXACORT	2.5%	SOLUTION / TOPICAL	RS	1992-04-17	`782e0a99824c…`
2021-05-05 16:15 UTC · 3 captures of this ZIP	2021-05	A081271-001	TEXACORT	2.5%	SOLUTION / TOPICAL	RS	1992-04-17	`87673890dc5c…`
2021-03-12 10:30 UTC	2021-03	A081271-001	TEXACORT	2.5%	SOLUTION / TOPICAL	RS	1992-04-17	`5aa47cf7b7d7…`
2020-12-22 03:56 UTC	2020-12	A081271-001	TEXACORT	2.5%	SOLUTION / TOPICAL	RS	1992-04-17	`8869cabd3fbd…`
2020-11-12 02:37 UTC	2020-11	A081271-001	TEXACORT	2.5%	SOLUTION / TOPICAL	RS	1992-04-17	`c0c555d07b60…`
2019-12-14 00:12 UTC	2019-12	A081271-001	TEXACORT	2.5%	SOLUTION / TOPICAL	RS	1992-04-17	`3f01610625f2…`
2019-09-15 20:21 UTC	2019-09	A081271-001	TEXACORT	2.5%	SOLUTION / TOPICAL	RS	1992-04-17	`b00525d2431f…`
2019-07-19 19:46 UTC	2019-07	A081271-001	TEXACORT	2.5%	SOLUTION / TOPICAL	RS	1992-04-17	`ea99ee380514…`
2024-03-16 18:09 UTC · 4 captures of this ZIP	2024-03	A081271-001	TEXACORT	2.5%	SOLUTION / TOPICAL	RS	1992-04-17	`6a51e52b5d6a…`
2024-02-18 07:12 UTC	2024-02	A081271-001	TEXACORT	2.5%	SOLUTION / TOPICAL	RS	1992-04-17	`1c564ffb4f44…`
2023-12-20 04:57 UTC	2023-12	A081271-001	TEXACORT	2.5%	SOLUTION / TOPICAL	RS	1992-04-17	`ea1830bbd6c7…`
2023-11-28 05:40 UTC · 2 captures of this ZIP	2023-11	A081271-001	TEXACORT	2.5%	SOLUTION / TOPICAL	RS	1992-04-17	`a72a2bbeb626…`
2023-10-25 00:34 UTC · 2 captures of this ZIP	2023-10	A081271-001	TEXACORT	2.5%	SOLUTION / TOPICAL	RS	1992-04-17	`9b2671bbb829…`
2023-07-15 15:27 UTC · 2 captures of this ZIP	2023-07	A081271-001	TEXACORT	2.5%	SOLUTION / TOPICAL	RS	1992-04-17	`a67488948f0b…`
2023-06-13 01:57 UTC · 3 captures of this ZIP	2023-06	A081271-001	TEXACORT	2.5%	SOLUTION / TOPICAL	RS	1992-04-17	`3f0d92c62455…`
2023-05-13 08:27 UTC	2023-05	A081271-001	TEXACORT	2.5%	SOLUTION / TOPICAL	RS	1992-04-17	`053a50430f4f…`
2023-01-26 05:58 UTC	2023-01	A081271-001	TEXACORT	2.5%	SOLUTION / TOPICAL	RS	1992-04-17	`3bdfa0b2c4d7…`
2022-11-12 20:34 UTC · 5 captures of this ZIP	2022-11	A081271-001	TEXACORT	2.5%	SOLUTION / TOPICAL	RS	1992-04-17	`3a93d1ddd44b…`
2022-10-28 04:53 UTC	2022-10	A081271-001	TEXACORT	2.5%	SOLUTION / TOPICAL	RS	1992-04-17	`f41ea6bd6efb…`
2022-09-29 23:25 UTC	2022-09	A081271-001	TEXACORT	2.5%	SOLUTION / TOPICAL	RS	1992-04-17	`e64feba35796…`
2022-07-09 03:26 UTC · 3 captures of this ZIP	2022-07	A081271-001	TEXACORT	2.5%	SOLUTION / TOPICAL	RS	1992-04-17	`cb3db0bc1861…`

Additional Listing Data#

Finished product: Yes
Brand name base: Hydrocortisone
Listing expiration: 2026-12-31

Active Ingredients#

Ingredient, Strength table
Ingredient	Strength
HYDROCORTISONE	25 mg/mL

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
197786	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
20508a94-01bc-4f1d-a42b-122a31402aaf	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
73352-455-01	Hydrocortisone	1 in 1 CARTON	SOLUTION	1		3
73352-455-01	Hydrocortisone	30 mL in 1 BOTTLE, WITH APPLICATOR	SOLUTION	30		3

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDC	Billing unit	Product NDC	DailyMed indexing SPL	SPL version	Effective
73352-455-01	ML - Milliliter	73352-455	d837d572-6051-42ec-950f-5b55dbc94d1b	1	2025-01-14

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDC	Dashboard title	SPL version	Validation	Dashboard ZIP
73352-455	HYDROCORTISONE SOLUTION [TRIFLUENT PHARMA LLC]	1	Current NDC, 2 package rows	20241127_20508a94-01bc-4f1d-a42b-122a31402aaf.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 · 2 matching rows.

Brand, Generic, Manufacturer table
Brand	Generic	Manufacturer	SPL set ID	Effective date	Available safety fields	Join
Texacort	HYDROCORTISONE	Mission Pharmacal Company	25279d46-6bad-471f-8bd6-736d53cfd942	2026-01-08	Adverse reactions	Exact identifier application applno (ANDA): 081271 application number: ANDA081271
Hydrocortisone	HYDROCORTISONE	Trifluent Pharma LLC	20508a94-01bc-4f1d-a42b-122a31402aaf	2025-12-01	Adverse reactions	Exact identifier application applno (ANDA): 081271 application number: ANDA081271 ndc (product): 73352-455

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
197786	hydrocortisone 2.5 % Topical Solution	PSN	20508a94-01bc-4f1d-a42b-122a31402aaf	3
197786	hydrocortisone 25 MG/ML Topical Solution	SCD	20508a94-01bc-4f1d-a42b-122a31402aaf	3
197786	hydrocortisone 2.5 % Topical Solution	SY	20508a94-01bc-4f1d-a42b-122a31402aaf	3

Packages#

Package NDC, 11-digit format, Description table
Package NDC	11-digit format	Description	Marketing start	Sample	Exclude flag	Status
73352-455-01	73352045501	1 BOTTLE, WITH APPLICATOR in 1 CARTON (73352-455-01) / 30 mL in 1 BOTTLE, WITH APPLICATOR	2024-11-22	No	No	Current

Title, Manufacturer, Effective date table
Title	Manufacturer	Effective date	Type	Version
Hydrocortisone Topical Solution 2.5%	Trifluent Pharma LLC \| Mission Pharmacal Company	2025-12-01	HUMAN PRESCRIPTION DRUG LABEL	3