Hydrocortisone

Product NDC: 0603-3899
11-digit product format: 006033899
Labeler code: 0603
Product ID: 0603-3899_922778c7-7e86-4fe8-8a5b-5e4d0ad066ab
Type: HUMAN PRESCRIPTION DRUG
Nonproprietary name: hydrocortisone
Dosage form: TABLET
Route: ORAL
Labeler: Par Pharmaceutical
Application: ANDA040761
Marketing category: ANDA
Marketing start: 2007-07-16
Marketing end: 2019-09-30
Substance: HYDROCORTISONE
Active strength: 5 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 · 4 matching rows.

Dataset, Scope, Product NDC table
Dataset	Scope	Product NDC	Package NDC	Code	Status	Source date
excluded product	product	0603-3899		D	Discontinued by firm	2026-10-05
excluded package	package	0603-3899	0603-3899-19	D	Discontinued by firm	2026-10-05
excluded package	package	0603-3899	0603-3899-21	D	Discontinued by firm	2026-10-05
excluded package	package	0603-3899	0603-3899-28	D	Discontinued by firm	2026-10-05

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 · 48 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	0603-3899-28	`d630ba8d3edf…`	`732f749b63fb…`
2025-12-14 17:58 UTC · source 2025-12-05	excluded package	package	0603-3899-19	`d630ba8d3edf…`	`732f749b63fb…`
2025-12-14 17:58 UTC · source 2025-12-05	excluded package	package	0603-3899-21	`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	0603-3899-28	`f5e01cc5f278…`	`a2eaf40c39c3…`
2025-08-27 00:01 UTC · source 2025-08-26	excluded package	package	0603-3899-19	`f5e01cc5f278…`	`a2eaf40c39c3…`
2025-08-27 00:01 UTC · source 2025-08-26	excluded package	package	0603-3899-21	`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	0603-3899-28	`2ef7874e63bc…`	`57b86245f4fa…`
2025-04-01 02:39 UTC · source 2025-03-31	excluded package	package	0603-3899-19	`2ef7874e63bc…`	`57b86245f4fa…`
2025-04-01 02:39 UTC · source 2025-03-31	excluded package	package	0603-3899-21	`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	0603-3899-28	`a1b67e2a42f9…`	`c4cf2c586c0d…`
2025-03-28 20:22 UTC · source 2025-03-28	excluded package	package	0603-3899-19	`a1b67e2a42f9…`	`c4cf2c586c0d…`
2025-03-28 20:22 UTC · source 2025-03-28	excluded package	package	0603-3899-21	`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	0603-3899-28	`cfe11265f3b6…`	`090c488252e2…`
2025-03-22 03:12 UTC · source 2025-03-21	excluded package	package	0603-3899-19	`cfe11265f3b6…`	`090c488252e2…`
2025-03-22 03:12 UTC · source 2025-03-21	excluded package	package	0603-3899-21	`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	0603-3899-28	`cdf11ea48f46…`	`ba0047e9e063…`
2025-03-10 12:48 UTC · source 2025-03-10	excluded package	package	0603-3899-19	`cdf11ea48f46…`	`ba0047e9e063…`
2025-03-10 12:48 UTC · source 2025-03-10	excluded package	package	0603-3899-21	`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	0603-3899-28	`302b2466d912…`	`e7b80fea0513…`
2025-02-02 03:52 UTC · source 2025-01-31	excluded package	package	0603-3899-19	`302b2466d912…`	`e7b80fea0513…`
2025-02-02 03:52 UTC · source 2025-01-31	excluded package	package	0603-3899-21	`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	0603-3899-28	`ed331223b511…`	`672a5bd82f5f…`
2025-01-20 13:05 UTC · source 2025-01-20	excluded package	package	0603-3899-19	`ed331223b511…`	`672a5bd82f5f…`
2025-01-20 13:05 UTC · source 2025-01-20	excluded package	package	0603-3899-21	`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	0603-3899-28	`0efc9e666f02…`	`f202fb6c5f17…`
2025-01-11 03:41 UTC · source 2025-01-10	excluded package	package	0603-3899-19	`0efc9e666f02…`	`f202fb6c5f17…`
2025-01-11 03:41 UTC · source 2025-01-10	excluded package	package	0603-3899-21	`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	0603-3899-28	`ad56d346431e…`	`cc804d4bbf1e…`
2024-11-09 02:27 UTC · source 2024-11-08	excluded package	package	0603-3899-19	`ad56d346431e…`	`cc804d4bbf1e…`
2024-11-09 02:27 UTC · source 2024-11-08	excluded package	package	0603-3899-21	`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	0603-3899-28	`367a005e9d99…`	`383a685ebd0f…`
2024-10-04 04:10 UTC · source 2024-10-03	excluded package	package	0603-3899-19	`367a005e9d99…`	`383a685ebd0f…`
2024-10-04 04:10 UTC · source 2024-10-03	excluded package	package	0603-3899-21	`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	0603-3899-28	`557ba5c1ecfa…`	`9c80585c8c6e…`
2024-07-10 04:00 UTC · source 2024-07-09	excluded package	package	0603-3899-19	`557ba5c1ecfa…`	`9c80585c8c6e…`
2024-07-10 04:00 UTC · source 2024-07-09	excluded package	package	0603-3899-21	`557ba5c1ecfa…`	`9c80585c8c6e…`

Source provenance: Browse the complete Orange Book source catalog · source snapshot 43.

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	Approval date
A040761-001	HYDROCORTISONE	HYDROCORTISONE	5MG	TABLET / ORAL	2007-07-16
A040761-002	HYDROCORTISONE	HYDROCORTISONE	10MG	TABLET / ORAL	2007-07-16
A040761-003	HYDROCORTISONE	HYDROCORTISONE	20MG	TABLET / ORAL	2007-07-16

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 · 129 observed states.

Captured, Edition, Application-product table
Captured	Edition	Application-product	Trade name	Strength	Dosage form / route	Approval date	Source SHA-256
2026-09-14 22:38:34	2026-08	A040761-001	HYDROCORTISONE	5MG	TABLET / ORAL	2007-07-16	`84e616aacf4f…`
2026-09-14 22:38:34	2026-08	A040761-002	HYDROCORTISONE	10MG	TABLET / ORAL	2007-07-16	`84e616aacf4f…`
2026-09-14 22:38:34	2026-08	A040761-003	HYDROCORTISONE	20MG	TABLET / ORAL	2007-07-16	`84e616aacf4f…`
2026-08-18 06:07:40	2026-07	A040761-001	HYDROCORTISONE	5MG	TABLET / ORAL	2007-07-16	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	A040761-002	HYDROCORTISONE	10MG	TABLET / ORAL	2007-07-16	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	A040761-003	HYDROCORTISONE	20MG	TABLET / ORAL	2007-07-16	`caaa826d4ba7…`
2026-02-19 14:30 UTC	2026-02	A040761-001	HYDROCORTISONE	5MG	TABLET / ORAL	2007-07-16	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A040761-002	HYDROCORTISONE	10MG	TABLET / ORAL	2007-07-16	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A040761-003	HYDROCORTISONE	20MG	TABLET / ORAL	2007-07-16	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A040761-001	HYDROCORTISONE	5MG	TABLET / ORAL	2007-07-16	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A040761-002	HYDROCORTISONE	10MG	TABLET / ORAL	2007-07-16	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A040761-003	HYDROCORTISONE	20MG	TABLET / ORAL	2007-07-16	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	A040761-001	HYDROCORTISONE	5MG	TABLET / ORAL	2007-07-16	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A040761-002	HYDROCORTISONE	10MG	TABLET / ORAL	2007-07-16	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A040761-003	HYDROCORTISONE	20MG	TABLET / ORAL	2007-07-16	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A040761-001	HYDROCORTISONE	5MG	TABLET / ORAL	2007-07-16	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A040761-002	HYDROCORTISONE	10MG	TABLET / ORAL	2007-07-16	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A040761-003	HYDROCORTISONE	20MG	TABLET / ORAL	2007-07-16	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A040761-001	HYDROCORTISONE	5MG	TABLET / ORAL	2007-07-16	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A040761-002	HYDROCORTISONE	10MG	TABLET / ORAL	2007-07-16	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A040761-003	HYDROCORTISONE	20MG	TABLET / ORAL	2007-07-16	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A040761-001	HYDROCORTISONE	5MG	TABLET / ORAL	2007-07-16	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A040761-002	HYDROCORTISONE	10MG	TABLET / ORAL	2007-07-16	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A040761-003	HYDROCORTISONE	20MG	TABLET / ORAL	2007-07-16	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A040761-001	HYDROCORTISONE	5MG	TABLET / ORAL	2007-07-16	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A040761-002	HYDROCORTISONE	10MG	TABLET / ORAL	2007-07-16	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A040761-003	HYDROCORTISONE	20MG	TABLET / ORAL	2007-07-16	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A040761-001	HYDROCORTISONE	5MG	TABLET / ORAL	2007-07-16	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A040761-002	HYDROCORTISONE	10MG	TABLET / ORAL	2007-07-16	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A040761-003	HYDROCORTISONE	20MG	TABLET / ORAL	2007-07-16	`5bbf6a4d5a75…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A040761-001	HYDROCORTISONE	5MG	TABLET / ORAL	2007-07-16	`d8e5a09893c0…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A040761-002	HYDROCORTISONE	10MG	TABLET / ORAL	2007-07-16	`d8e5a09893c0…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A040761-003	HYDROCORTISONE	20MG	TABLET / ORAL	2007-07-16	`d8e5a09893c0…`
2024-10-29 15:01 UTC	2024-10	A040761-001	HYDROCORTISONE	5MG	TABLET / ORAL	2007-07-16	`d06236e962d9…`
2024-10-29 15:01 UTC	2024-10	A040761-002	HYDROCORTISONE	10MG	TABLET / ORAL	2007-07-16	`d06236e962d9…`
2024-10-29 15:01 UTC	2024-10	A040761-003	HYDROCORTISONE	20MG	TABLET / ORAL	2007-07-16	`d06236e962d9…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A040761-001	HYDROCORTISONE	5MG	TABLET / ORAL	2007-07-16	`79d66fd596c7…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A040761-002	HYDROCORTISONE	10MG	TABLET / ORAL	2007-07-16	`79d66fd596c7…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A040761-003	HYDROCORTISONE	20MG	TABLET / ORAL	2007-07-16	`79d66fd596c7…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A040761-001	HYDROCORTISONE	5MG	TABLET / ORAL	2007-07-16	`301d65b070ca…`

Observed Orange Book normalized TE history#

Captured, Edition, Application-product table
Captured	Edition	Application-product	TE code	Order	Source SHA-256
2019-12-13 00:20 UTC	2019-12	A040761-001	AB	1	`74a2ff9319b5…`
2019-12-13 00:20 UTC	2019-12	A040761-002	AB	1	`74a2ff9319b5…`
2019-12-13 00:20 UTC	2019-12	A040761-003	AB	1	`74a2ff9319b5…`
2019-12-14 00:12 UTC	2019-12	A040761-001	AB	1	`3f01610625f2…`
2019-12-14 00:12 UTC	2019-12	A040761-002	AB	1	`3f01610625f2…`
2019-12-14 00:12 UTC	2019-12	A040761-003	AB	1	`3f01610625f2…`
2019-09-15 20:21 UTC	2019-09	A040761-001	AB	1	`b00525d2431f…`
2019-09-15 20:21 UTC	2019-09	A040761-002	AB	1	`b00525d2431f…`
2019-09-15 20:21 UTC	2019-09	A040761-003	AB	1	`b00525d2431f…`
2019-07-19 19:46 UTC	2019-07	A040761-001	AB	1	`ea99ee380514…`
2019-07-19 19:46 UTC	2019-07	A040761-002	AB	1	`ea99ee380514…`
2019-07-19 19:46 UTC	2019-07	A040761-003	AB	1	`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 Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDC	Billing unit	Product NDC	DailyMed indexing SPL	SPL version	Effective
0603-3899-19	EA - Each	0603-3899	ba947c6a-38a9-4e56-947c-ab0aa8628963	1	2012-07-24

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
LACTOSE	INACTIVE INGREDIENT	J2B2A4N98G	HYDROCORTISONE TABLET [CARILION MATERIALS MANAGEMENT]	2
MAGNESIUM STEARATE	INACTIVE INGREDIENT	70097M6I30	HYDROCORTISONE TABLET [CARILION MATERIALS MANAGEMENT]	2
SILICON DIOXIDE	INACTIVE INGREDIENT	ETJ7Z6XBU4	HYDROCORTISONE TABLET [CARILION MATERIALS MANAGEMENT]	2
SODIUM LAURYL SULFATE	INACTIVE INGREDIENT	368GB5141J	HYDROCORTISONE TABLET [CARILION MATERIALS MANAGEMENT]	2
SODIUM STARCH GLYCOLATE TYPE A POTATO	INACTIVE INGREDIENT	5856J3G2A2	HYDROCORTISONE TABLET [CARILION MATERIALS MANAGEMENT]	2

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
197787	hydrocortisone 5 MG Oral Tablet	PSN	532dcc5d-9640-4300-a2f3-ae5655d6a0ba	3
197787	hydrocortisone 5 MG Oral Tablet	SCD	532dcc5d-9640-4300-a2f3-ae5655d6a0ba	3

Title, Manufacturer, Effective date table
Title	Manufacturer	Effective date	Type	Version
HYDROCORTISONE TABLETS, USP 5 mg, 10 mg and 20 mg	Carilion Materials Management	2016-08-06	HUMAN PRESCRIPTION DRUG LABEL	3