HYDROCORTISONE

Product NDC: 54505-333
11-digit product format: 545050333
Labeler code: 54505
Product ID: 54505-333_cf7e1e9e-371d-4f56-b26e-ff7d78617578
Type: HUMAN PRESCRIPTION DRUG
Nonproprietary name: hydrocortisone
Dosage form: TABLET
Route: ORAL
Labeler: Lineage Therapeutics Inc
Application: ANDA040646
Marketing category: ANDA
Marketing start: 2007-03-30
Marketing end: 2019-09-30
Substance: HYDROCORTISONE
Active strength: 20 mg/1
Pharmacologic classes: Corticosteroid [EPC],Corticosteroid Hormone Receptor Agonists [MoA]
NDC exclude flag: No
Listing certified through: 0000-00-00
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 · 2 matching rows.

Dataset, Scope, Product NDC table
Dataset	Scope	Product NDC	Package NDC	Code	Status	Reporting period	Source date
excluded product	product	54505-333		D	Discontinued by firm		2026-08-17
excluded package	package	54505-333	54505-333-10	D	Discontinued by firm		2026-08-17

Observed NDC auxiliary status history#

This history shows the information present in each captured FDA auxiliary file. It is not a continuous regulatory timeline, and a missing record does not establish a status.

Historic NDC status page 1 of 1 · 24 matching rows.

View current auxiliary records. · View the auxiliary file history.

Captured / source date, Dataset, Scope table
Captured / source date	Dataset	Scope	Package NDC	Snapshot	Source SHA-256
2025-12-14 17:58 UTC · source 2025-12-05	excluded product	product		`d630ba8d3edf…`	`732f749b63fb…`
2025-12-14 17:58 UTC · source 2025-12-05	excluded package	package	54505-333-10	`d630ba8d3edf…`	`732f749b63fb…`
2025-08-27 00:01 UTC · source 2025-08-26	excluded product	product		`f5e01cc5f278…`	`a2eaf40c39c3…`
2025-08-27 00:01 UTC · source 2025-08-26	excluded package	package	54505-333-10	`f5e01cc5f278…`	`a2eaf40c39c3…`
2025-04-01 02:39 UTC · source 2025-03-31	excluded product	product		`2ef7874e63bc…`	`57b86245f4fa…`
2025-04-01 02:39 UTC · source 2025-03-31	excluded package	package	54505-333-10	`2ef7874e63bc…`	`57b86245f4fa…`
2025-03-28 20:22 UTC · source 2025-03-28	excluded product	product		`a1b67e2a42f9…`	`c4cf2c586c0d…`
2025-03-28 20:22 UTC · source 2025-03-28	excluded package	package	54505-333-10	`a1b67e2a42f9…`	`c4cf2c586c0d…`
2025-03-22 03:12 UTC · source 2025-03-21	excluded product	product		`cfe11265f3b6…`	`090c488252e2…`
2025-03-22 03:12 UTC · source 2025-03-21	excluded package	package	54505-333-10	`cfe11265f3b6…`	`090c488252e2…`
2025-03-10 12:48 UTC · source 2025-03-10	excluded product	product		`cdf11ea48f46…`	`ba0047e9e063…`
2025-03-10 12:48 UTC · source 2025-03-10	excluded package	package	54505-333-10	`cdf11ea48f46…`	`ba0047e9e063…`
2025-02-02 03:52 UTC · source 2025-01-31	excluded product	product		`302b2466d912…`	`e7b80fea0513…`
2025-02-02 03:52 UTC · source 2025-01-31	excluded package	package	54505-333-10	`302b2466d912…`	`e7b80fea0513…`
2025-01-20 13:05 UTC · source 2025-01-20	excluded product	product		`ed331223b511…`	`672a5bd82f5f…`
2025-01-20 13:05 UTC · source 2025-01-20	excluded package	package	54505-333-10	`ed331223b511…`	`672a5bd82f5f…`
2025-01-11 03:41 UTC · source 2025-01-10	excluded product	product		`0efc9e666f02…`	`f202fb6c5f17…`
2025-01-11 03:41 UTC · source 2025-01-10	excluded package	package	54505-333-10	`0efc9e666f02…`	`f202fb6c5f17…`
2024-11-09 02:27 UTC · source 2024-11-08	excluded product	product		`ad56d346431e…`	`cc804d4bbf1e…`
2024-11-09 02:27 UTC · source 2024-11-08	excluded package	package	54505-333-10	`ad56d346431e…`	`cc804d4bbf1e…`
2024-10-04 04:10 UTC · source 2024-10-03	excluded product	product		`367a005e9d99…`	`383a685ebd0f…`
2024-10-04 04:10 UTC · source 2024-10-03	excluded package	package	54505-333-10	`367a005e9d99…`	`383a685ebd0f…`
2024-07-10 04:00 UTC · source 2024-07-09	excluded product	product		`557ba5c1ecfa…`	`9c80585c8c6e…`
2024-07-10 04:00 UTC · source 2024-07-09	excluded package	package	54505-333-10	`557ba5c1ecfa…`	`9c80585c8c6e…`

Source provenance: Browse the complete Orange Book source catalog · source snapshot 42.

Orange Book products#

Current product rows page 1 of 1 · 3 matching rows.

Application-product, Trade name, Ingredient table
Application-product	Trade name	Ingredient	Strength	Dosage form / route	TE codes	Approval date
A040646-001	HYDROCORTISONE	HYDROCORTISONE	5MG	TABLET / ORAL	AB	2007-03-30
A040646-002	HYDROCORTISONE	HYDROCORTISONE	10MG	TABLET / ORAL	AB	2007-03-30
A040646-003	HYDROCORTISONE	HYDROCORTISONE	20MG	TABLET / ORAL	AB	2007-03-30

Therapeutic equivalence codes#

Current TE-code rows page 1 of 1 · 3 matching rows.

Application-product, TE code table
Application-product	TE code
A040646-001	AB
A040646-002	AB
A040646-003	AB

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 4 · 126 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
2026-08-18 06:07:40	2026-07	A040646-001	HYDROCORTISONE	5MG	TABLET / ORAL	AB	2007-03-30	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	A040646-002	HYDROCORTISONE	10MG	TABLET / ORAL	AB	2007-03-30	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	A040646-003	HYDROCORTISONE	20MG	TABLET / ORAL	AB	2007-03-30	`caaa826d4ba7…`
2026-02-19 14:30 UTC	2026-02	A040646-001	HYDROCORTISONE	5MG	TABLET / ORAL	AB	2007-03-30	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A040646-002	HYDROCORTISONE	10MG	TABLET / ORAL	AB	2007-03-30	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A040646-003	HYDROCORTISONE	20MG	TABLET / ORAL	AB	2007-03-30	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A040646-001	HYDROCORTISONE	5MG	TABLET / ORAL	AB	2007-03-30	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A040646-002	HYDROCORTISONE	10MG	TABLET / ORAL	AB	2007-03-30	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A040646-003	HYDROCORTISONE	20MG	TABLET / ORAL	AB	2007-03-30	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	A040646-001	HYDROCORTISONE	5MG	TABLET / ORAL	AB	2007-03-30	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A040646-002	HYDROCORTISONE	10MG	TABLET / ORAL	AB	2007-03-30	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A040646-003	HYDROCORTISONE	20MG	TABLET / ORAL	AB	2007-03-30	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A040646-001	HYDROCORTISONE	5MG	TABLET / ORAL	AB	2007-03-30	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A040646-002	HYDROCORTISONE	10MG	TABLET / ORAL	AB	2007-03-30	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A040646-003	HYDROCORTISONE	20MG	TABLET / ORAL	AB	2007-03-30	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A040646-001	HYDROCORTISONE	5MG	TABLET / ORAL	AB	2007-03-30	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A040646-002	HYDROCORTISONE	10MG	TABLET / ORAL	AB	2007-03-30	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A040646-003	HYDROCORTISONE	20MG	TABLET / ORAL	AB	2007-03-30	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A040646-001	HYDROCORTISONE	5MG	TABLET / ORAL	AB	2007-03-30	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A040646-002	HYDROCORTISONE	10MG	TABLET / ORAL	AB	2007-03-30	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A040646-003	HYDROCORTISONE	20MG	TABLET / ORAL	AB	2007-03-30	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A040646-001	HYDROCORTISONE	5MG	TABLET / ORAL	AB	2007-03-30	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A040646-002	HYDROCORTISONE	10MG	TABLET / ORAL	AB	2007-03-30	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A040646-003	HYDROCORTISONE	20MG	TABLET / ORAL	AB	2007-03-30	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A040646-001	HYDROCORTISONE	5MG	TABLET / ORAL	AB	2007-03-30	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A040646-002	HYDROCORTISONE	10MG	TABLET / ORAL	AB	2007-03-30	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A040646-003	HYDROCORTISONE	20MG	TABLET / ORAL	AB	2007-03-30	`5bbf6a4d5a75…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A040646-001	HYDROCORTISONE	5MG	TABLET / ORAL	AB	2007-03-30	`d8e5a09893c0…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A040646-002	HYDROCORTISONE	10MG	TABLET / ORAL	AB	2007-03-30	`d8e5a09893c0…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A040646-003	HYDROCORTISONE	20MG	TABLET / ORAL	AB	2007-03-30	`d8e5a09893c0…`
2024-10-29 15:01 UTC	2024-10	A040646-001	HYDROCORTISONE	5MG	TABLET / ORAL	AB	2007-03-30	`d06236e962d9…`
2024-10-29 15:01 UTC	2024-10	A040646-002	HYDROCORTISONE	10MG	TABLET / ORAL	AB	2007-03-30	`d06236e962d9…`
2024-10-29 15:01 UTC	2024-10	A040646-003	HYDROCORTISONE	20MG	TABLET / ORAL	AB	2007-03-30	`d06236e962d9…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A040646-001	HYDROCORTISONE	5MG	TABLET / ORAL	AB	2007-03-30	`79d66fd596c7…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A040646-002	HYDROCORTISONE	10MG	TABLET / ORAL	AB	2007-03-30	`79d66fd596c7…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A040646-003	HYDROCORTISONE	20MG	TABLET / ORAL	AB	2007-03-30	`79d66fd596c7…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A040646-001	HYDROCORTISONE	5MG	TABLET / ORAL	AB	2007-03-30	`301d65b070ca…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A040646-002	HYDROCORTISONE	10MG	TABLET / ORAL	AB	2007-03-30	`301d65b070ca…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A040646-003	HYDROCORTISONE	20MG	TABLET / ORAL	AB	2007-03-30	`301d65b070ca…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A040646-001	HYDROCORTISONE	5MG	TABLET / ORAL	AB	2007-03-30	`1e350fbaab3a…`

Observed Orange Book normalized TE history#

Normalized TE history page 1 of 4 · 126 observed states.

Captured, Edition, Application-product table
Captured	Edition	Application-product	TE code	Order	Source SHA-256
2026-08-18 06:07:40	2026-07	A040646-001	AB	1	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	A040646-002	AB	1	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	A040646-003	AB	1	`caaa826d4ba7…`
2026-02-19 14:30 UTC	2026-02	A040646-001	AB	1	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A040646-002	AB	1	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A040646-003	AB	1	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A040646-001	AB	1	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A040646-002	AB	1	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A040646-003	AB	1	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	A040646-001	AB	1	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A040646-002	AB	1	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A040646-003	AB	1	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A040646-001	AB	1	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A040646-002	AB	1	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A040646-003	AB	1	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A040646-001	AB	1	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A040646-002	AB	1	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A040646-003	AB	1	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A040646-001	AB	1	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A040646-002	AB	1	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A040646-003	AB	1	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A040646-001	AB	1	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A040646-002	AB	1	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A040646-003	AB	1	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A040646-001	AB	1	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A040646-002	AB	1	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A040646-003	AB	1	`5bbf6a4d5a75…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A040646-001	AB	1	`d8e5a09893c0…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A040646-002	AB	1	`d8e5a09893c0…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A040646-003	AB	1	`d8e5a09893c0…`
2024-10-29 15:01 UTC	2024-10	A040646-001	AB	1	`d06236e962d9…`
2024-10-29 15:01 UTC	2024-10	A040646-002	AB	1	`d06236e962d9…`
2024-10-29 15:01 UTC	2024-10	A040646-003	AB	1	`d06236e962d9…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A040646-001	AB	1	`79d66fd596c7…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A040646-002	AB	1	`79d66fd596c7…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A040646-003	AB	1	`79d66fd596c7…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A040646-001	AB	1	`301d65b070ca…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A040646-002	AB	1	`301d65b070ca…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A040646-003	AB	1	`301d65b070ca…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A040646-001	AB	1	`1e350fbaab3a…`

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 Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDC	Billing unit	Product NDC	DailyMed indexing SPL	SPL version	Effective
54505-333-10	EA - Each	54505-333	d35d03d7-e8b8-45a8-916c-2c408d6defd7	1	2013-08-02

DailyMed Socrata Ingredients#

Ingredient, Type, UNII table
Ingredient	Type	UNII	DailyMed label	SPL version
HYDROCORTISONE	ACTIVE INGREDIENT	WI4X0X7BPJ	HYDROCORTISONE TABLET [CARILION MATERIALS MANAGEMENT]	2
HYDROCORTISONE	ACTIVE MOIETY	WI4X0X7BPJ	HYDROCORTISONE TABLET [CARILION MATERIALS MANAGEMENT]	2
CELLULOSE, MICROCRYSTALLINE	INACTIVE INGREDIENT	OP1R32D61U	HYDROCORTISONE TABLET [CARILION MATERIALS MANAGEMENT]	2
CROSCARMELLOSE SODIUM	INACTIVE INGREDIENT	M28OL1HH48	HYDROCORTISONE TABLET [CARILION MATERIALS MANAGEMENT]	2
LACTOSE	INACTIVE INGREDIENT	J2B2A4N98G	HYDROCORTISONE TABLET [CARILION MATERIALS MANAGEMENT]	2
MAGNESIUM STEARATE	INACTIVE INGREDIENT	70097M6I30	HYDROCORTISONE TABLET [CARILION MATERIALS MANAGEMENT]	2
SODIUM STARCH GLYCOLATE TYPE A POTATO	INACTIVE INGREDIENT	5856J3G2A2	HYDROCORTISONE TABLET [CARILION MATERIALS MANAGEMENT]	2
STARCH, CORN	INACTIVE INGREDIENT	O8232NY3SJ	HYDROCORTISONE TABLET [CARILION MATERIALS MANAGEMENT]	2
HYDROCORTISONE	ACTIVE INGREDIENT	WI4X0X7BPJ	HYDROCORTISONE TABLET [LINEAGE THERAPEUTICS INC]	1
HYDROCORTISONE	ACTIVE MOIETY	WI4X0X7BPJ	HYDROCORTISONE TABLET [LINEAGE THERAPEUTICS INC]	1
CELLULOSE, MICROCRYSTALLINE	INACTIVE INGREDIENT	OP1R32D61U	HYDROCORTISONE TABLET [LINEAGE THERAPEUTICS INC]	1
CROSCARMELLOSE SODIUM	INACTIVE INGREDIENT	M28OL1HH48	HYDROCORTISONE TABLET [LINEAGE THERAPEUTICS INC]	1
LACTOSE	INACTIVE INGREDIENT	J2B2A4N98G	HYDROCORTISONE TABLET [LINEAGE THERAPEUTICS INC]	1
MAGNESIUM STEARATE	INACTIVE INGREDIENT	70097M6I30	HYDROCORTISONE TABLET [LINEAGE THERAPEUTICS INC]	1
SODIUM STARCH GLYCOLATE TYPE A POTATO	INACTIVE INGREDIENT	5856J3G2A2	HYDROCORTISONE TABLET [LINEAGE THERAPEUTICS INC]	1
STARCH, CORN	INACTIVE INGREDIENT	O8232NY3SJ	HYDROCORTISONE TABLET [LINEAGE THERAPEUTICS INC]	1

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 · 7 matching rows.

Brand, Generic, Manufacturer table
Brand	Generic	Manufacturer	SPL set ID	Effective date	Available safety fields	Join
HYDROCORTISONE	HYDROCORTISONE	Preferred Pharmaceuticals Inc.	0bbb8a63-ae1d-41d7-b201-d1b171b31f46	2026-05-11	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 040646 application number: ANDA040646
HYDROCORTISONE	HYDROCORTISONE	Major Pharmaceuticals	91885fc8-876f-4a4d-8ae5-eb246a335808	2025-09-10	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 040646 application number: ANDA040646
HYDROCORTISONE	HYDROCORTISONE	AvPAK	f3956208-291c-7374-e053-2a95a90a4628	2025-01-09	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 040646 application number: ANDA040646
HYDROCORTISONE	HYDROCORTISONE	Bryant Ranch Prepack	47bfae62-bf25-413e-93fc-3c72c901f1a5	2024-07-18	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 040646 application number: ANDA040646
HYDROCORTISONE	HYDROCORTISONE	Bryant Ranch Prepack	6c676166-2471-478c-b662-f8c9c168977b	2024-07-17	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 040646 application number: ANDA040646
HYDROCORTISONE	HYDROCORTISONE	Bryant Ranch Prepack	134fae59-f928-4304-86ca-2271b593caf4	2024-07-15	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 040646 application number: ANDA040646
HYDROCORTISONE	HYDROCORTISONE	Amneal Pharmaceuticals of New York LLC	9fe627ad-4aba-4bd1-8590-6cc2d61674ba	2024-07-03	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 040646 application number: ANDA040646

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
197783	hydrocortisone 20 MG Oral Tablet	PSN	d4d2912e-d1e8-4b40-af88-59c87fa12318	2
197783	hydrocortisone 20 MG Oral Tablet	SCD	d4d2912e-d1e8-4b40-af88-59c87fa12318	2

Title, Manufacturer, Effective date table
Title	Manufacturer	Effective date	Type	Version
HYDROCORTISONE Tablets, USP Lineage Therapeutics Rx only	Lineage Therapeutics Inc	2018-12-10	HUMAN PRESCRIPTION DRUG LABEL	3
HYDROCORTISONE Tablets, USP Lineage Therapeutics Rx only	Carilion Materials Management	2013-06-24	HUMAN PRESCRIPTION DRUG LABEL	2