Hydrocortisone

Product NDC: 42543-970
11-digit product format: 425430970
Labeler code: 42543
Product ID: 42543-970_4fea0f23-dfda-444b-8206-ea7e5a078338
Type: HUMAN PRESCRIPTION DRUG
Nonproprietary name: Hydrocortisone
Dosage form: TABLET
Route: ORAL
Labeler: Strides Pharma Inc.
Application: ANDA207029
Marketing category: ANDA
Marketing start: 2021-12-22
Substance: HYDROCORTISONE
Active strength: 5 mg/1
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 44.

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
A207029-001	HYDROCORTISONE	HYDROCORTISONE	5MG	TABLET / ORAL	AB	2017-04-27
A207029-002	HYDROCORTISONE	HYDROCORTISONE	10MG	TABLET / ORAL	AB	2017-04-27
A207029-003	HYDROCORTISONE	HYDROCORTISONE	20MG	TABLET / ORAL	AB	2017-04-27

Therapeutic equivalence codes#

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

Application-product, TE code table
Application-product	TE code
A207029-001	AB
A207029-002	AB
A207029-003	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 · 132 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	A207029-001	HYDROCORTISONE	5MG	TABLET / ORAL	AB	2017-04-27	`c2088c7a36db…`
2026-10-15 13:18:30	2026-09	A207029-002	HYDROCORTISONE	10MG	TABLET / ORAL	AB	2017-04-27	`c2088c7a36db…`
2026-10-15 13:18:30	2026-09	A207029-003	HYDROCORTISONE	20MG	TABLET / ORAL	AB	2017-04-27	`c2088c7a36db…`
2026-09-14 22:38:34	2026-08	A207029-001	HYDROCORTISONE	5MG	TABLET / ORAL	AB	2017-04-27	`84e616aacf4f…`
2026-09-14 22:38:34	2026-08	A207029-002	HYDROCORTISONE	10MG	TABLET / ORAL	AB	2017-04-27	`84e616aacf4f…`
2026-09-14 22:38:34	2026-08	A207029-003	HYDROCORTISONE	20MG	TABLET / ORAL	AB	2017-04-27	`84e616aacf4f…`
2026-08-18 06:07:40	2026-07	A207029-001	HYDROCORTISONE	5MG	TABLET / ORAL	AB	2017-04-27	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	A207029-002	HYDROCORTISONE	10MG	TABLET / ORAL	AB	2017-04-27	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	A207029-003	HYDROCORTISONE	20MG	TABLET / ORAL	AB	2017-04-27	`caaa826d4ba7…`
2026-02-19 14:30 UTC	2026-02	A207029-001	HYDROCORTISONE	5MG	TABLET / ORAL	AB	2017-04-27	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A207029-002	HYDROCORTISONE	10MG	TABLET / ORAL	AB	2017-04-27	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A207029-003	HYDROCORTISONE	20MG	TABLET / ORAL	AB	2017-04-27	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A207029-001	HYDROCORTISONE	5MG	TABLET / ORAL	AB	2017-04-27	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A207029-002	HYDROCORTISONE	10MG	TABLET / ORAL	AB	2017-04-27	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A207029-003	HYDROCORTISONE	20MG	TABLET / ORAL	AB	2017-04-27	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	A207029-001	HYDROCORTISONE	5MG	TABLET / ORAL	AB	2017-04-27	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A207029-002	HYDROCORTISONE	10MG	TABLET / ORAL	AB	2017-04-27	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A207029-003	HYDROCORTISONE	20MG	TABLET / ORAL	AB	2017-04-27	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A207029-001	HYDROCORTISONE	5MG	TABLET / ORAL	AB	2017-04-27	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A207029-002	HYDROCORTISONE	10MG	TABLET / ORAL	AB	2017-04-27	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A207029-003	HYDROCORTISONE	20MG	TABLET / ORAL	AB	2017-04-27	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A207029-001	HYDROCORTISONE	5MG	TABLET / ORAL	AB	2017-04-27	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A207029-002	HYDROCORTISONE	10MG	TABLET / ORAL	AB	2017-04-27	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A207029-003	HYDROCORTISONE	20MG	TABLET / ORAL	AB	2017-04-27	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A207029-001	HYDROCORTISONE	5MG	TABLET / ORAL	AB	2017-04-27	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A207029-002	HYDROCORTISONE	10MG	TABLET / ORAL	AB	2017-04-27	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A207029-003	HYDROCORTISONE	20MG	TABLET / ORAL	AB	2017-04-27	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A207029-001	HYDROCORTISONE	5MG	TABLET / ORAL	AB	2017-04-27	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A207029-002	HYDROCORTISONE	10MG	TABLET / ORAL	AB	2017-04-27	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A207029-003	HYDROCORTISONE	20MG	TABLET / ORAL	AB	2017-04-27	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A207029-001	HYDROCORTISONE	5MG	TABLET / ORAL	AB	2017-04-27	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A207029-002	HYDROCORTISONE	10MG	TABLET / ORAL	AB	2017-04-27	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A207029-003	HYDROCORTISONE	20MG	TABLET / ORAL	AB	2017-04-27	`5bbf6a4d5a75…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A207029-001	HYDROCORTISONE	5MG	TABLET / ORAL	AB	2017-04-27	`d8e5a09893c0…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A207029-002	HYDROCORTISONE	10MG	TABLET / ORAL	AB	2017-04-27	`d8e5a09893c0…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A207029-003	HYDROCORTISONE	20MG	TABLET / ORAL	AB	2017-04-27	`d8e5a09893c0…`
2024-10-29 15:01 UTC	2024-10	A207029-001	HYDROCORTISONE	5MG	TABLET / ORAL	AB	2017-04-27	`d06236e962d9…`
2024-10-29 15:01 UTC	2024-10	A207029-002	HYDROCORTISONE	10MG	TABLET / ORAL	AB	2017-04-27	`d06236e962d9…`
2024-10-29 15:01 UTC	2024-10	A207029-003	HYDROCORTISONE	20MG	TABLET / ORAL	AB	2017-04-27	`d06236e962d9…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A207029-001	HYDROCORTISONE	5MG	TABLET / ORAL	AB	2017-04-27	`79d66fd596c7…`

Observed Orange Book normalized TE history#

Normalized TE history page 3 of 4 · 132 observed states.

Captured, Edition, Application-product table
Captured	Edition	Application-product	TE code	Order	Source SHA-256
2020-11-12 02:37 UTC	2020-11	A207029-003	AB	1	`c0c555d07b60…`
2019-12-14 00:12 UTC	2019-12	A207029-001	AB	1	`3f01610625f2…`
2019-12-14 00:12 UTC	2019-12	A207029-002	AB	1	`3f01610625f2…`
2019-12-14 00:12 UTC	2019-12	A207029-003	AB	1	`3f01610625f2…`
2019-09-15 20:21 UTC	2019-09	A207029-001	AB	1	`b00525d2431f…`
2019-09-15 20:21 UTC	2019-09	A207029-002	AB	1	`b00525d2431f…`
2019-09-15 20:21 UTC	2019-09	A207029-003	AB	1	`b00525d2431f…`
2019-07-19 19:46 UTC	2019-07	A207029-001	AB	1	`ea99ee380514…`
2019-07-19 19:46 UTC	2019-07	A207029-002	AB	1	`ea99ee380514…`
2019-07-19 19:46 UTC	2019-07	A207029-003	AB	1	`ea99ee380514…`
2024-03-16 18:09 UTC · 4 captures of this ZIP	2024-03	A207029-001	AB	1	`6a51e52b5d6a…`
2024-03-16 18:09 UTC · 4 captures of this ZIP	2024-03	A207029-002	AB	1	`6a51e52b5d6a…`
2024-03-16 18:09 UTC · 4 captures of this ZIP	2024-03	A207029-003	AB	1	`6a51e52b5d6a…`
2024-02-18 07:12 UTC	2024-02	A207029-001	AB	1	`1c564ffb4f44…`
2024-02-18 07:12 UTC	2024-02	A207029-002	AB	1	`1c564ffb4f44…`
2024-02-18 07:12 UTC	2024-02	A207029-003	AB	1	`1c564ffb4f44…`
2023-12-20 04:57 UTC	2023-12	A207029-001	AB	1	`ea1830bbd6c7…`
2023-12-20 04:57 UTC	2023-12	A207029-002	AB	1	`ea1830bbd6c7…`
2023-12-20 04:57 UTC	2023-12	A207029-003	AB	1	`ea1830bbd6c7…`
2023-11-28 05:40 UTC · 2 captures of this ZIP	2023-11	A207029-001	AB	1	`a72a2bbeb626…`
2023-11-28 05:40 UTC · 2 captures of this ZIP	2023-11	A207029-002	AB	1	`a72a2bbeb626…`
2023-11-28 05:40 UTC · 2 captures of this ZIP	2023-11	A207029-003	AB	1	`a72a2bbeb626…`
2023-10-25 00:34 UTC · 2 captures of this ZIP	2023-10	A207029-001	AB	1	`9b2671bbb829…`
2023-10-25 00:34 UTC · 2 captures of this ZIP	2023-10	A207029-002	AB	1	`9b2671bbb829…`
2023-10-25 00:34 UTC · 2 captures of this ZIP	2023-10	A207029-003	AB	1	`9b2671bbb829…`
2023-07-15 15:27 UTC · 2 captures of this ZIP	2023-07	A207029-001	AB	1	`a67488948f0b…`
2023-07-15 15:27 UTC · 2 captures of this ZIP	2023-07	A207029-002	AB	1	`a67488948f0b…`
2023-07-15 15:27 UTC · 2 captures of this ZIP	2023-07	A207029-003	AB	1	`a67488948f0b…`
2023-06-13 01:57 UTC · 3 captures of this ZIP	2023-06	A207029-001	AB	1	`3f0d92c62455…`
2023-06-13 01:57 UTC · 3 captures of this ZIP	2023-06	A207029-002	AB	1	`3f0d92c62455…`
2023-06-13 01:57 UTC · 3 captures of this ZIP	2023-06	A207029-003	AB	1	`3f0d92c62455…`
2023-05-13 08:27 UTC	2023-05	A207029-001	AB	1	`053a50430f4f…`
2023-05-13 08:27 UTC	2023-05	A207029-002	AB	1	`053a50430f4f…`
2023-05-13 08:27 UTC	2023-05	A207029-003	AB	1	`053a50430f4f…`
2023-01-26 05:58 UTC	2023-01	A207029-001	AB	1	`3bdfa0b2c4d7…`
2023-01-26 05:58 UTC	2023-01	A207029-002	AB	1	`3bdfa0b2c4d7…`
2023-01-26 05:58 UTC	2023-01	A207029-003	AB	1	`3bdfa0b2c4d7…`
2022-11-12 20:34 UTC · 5 captures of this ZIP	2022-11	A207029-001	AB	1	`3a93d1ddd44b…`
2022-11-12 20:34 UTC · 5 captures of this ZIP	2022-11	A207029-002	AB	1	`3a93d1ddd44b…`
2022-11-12 20:34 UTC · 5 captures of this ZIP	2022-11	A207029-003	AB	1	`3a93d1ddd44b…`

Reported adverse events (FAERS/openFDA)#

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

Additional Listing Data#

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

Active Ingredients#

Ingredient, Strength table
Ingredient	Strength
HYDROCORTISONE	5 mg/1

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 · 3 matching rows.

Identifier, FDA.report destination table
Identifier	FDA.report destination
197782	Internal RxNorm lookup
197783	Internal RxNorm lookup
197787	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
c58dfac3-a131-4b6b-bf75-ba46e5bc6ba6	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
42543-970-25	Hydrocortisone	50 in 1 BOTTLE, PLASTIC	TABLET	50		6

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDC	Billing unit	Product NDC	DailyMed indexing SPL	SPL version	Effective
42543-970-25	EA - Each	42543-970	0b0ad861-b320-4755-9210-1d79b78c3b7f	1	2022-01-06

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDC	Dashboard title	SPL version	Validation	Dashboard ZIP
42543-970	HYDROCORTISONE TABLET [STRIDES PHARMA INC.]	5	Current NDC, Legacy NDC, 1 package rows	20241205_c58dfac3-a131-4b6b-bf75-ba46e5bc6ba6.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 · 6 matching rows.

Brand, Generic, Manufacturer table
Brand	Generic	Manufacturer	SPL set ID	Effective date	Available safety fields	Join
Hydrocortisone	HYDROCORTISONE	American Health Packaging	506aab0d-9308-4d60-90b3-7d64952fff36	2026-08-31	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 207029 application number: ANDA207029
Hydrocortisone	HYDROCORTISONE	Strides Pharma Science Limited	90a46849-5b75-467b-9bc5-8f192d4d20d2	2026-03-11	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 207029 application number: ANDA207029
Hydrocortisone	HYDROCORTISONE	PD-Rx Pharmaceuticals, Inc.	931ed426-89a1-4877-a4a5-cb963d51e717	2026-02-25	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 207029 application number: ANDA207029
Hydrocortisone	HYDROCORTISONE	Strides Pharma Inc.	c58dfac3-a131-4b6b-bf75-ba46e5bc6ba6	2026-01-08	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 207029 application number: ANDA207029 ndc (product): 42543-970
Hydrocortisone	HYDROCORTISONE	Chartwell RX, LLC.	4b6edbc4-7afb-4fb5-a16e-66ce70916f09	2025-12-10	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 207029 application number: ANDA207029
Hydrocortisone	HYDROCORTISONE	Asclemed USA, Inc.	b8437441-a4a6-4fb5-82eb-e49af69704f4	2021-04-10	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 207029 application number: ANDA207029

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
197782	hydrocortisone 10 MG Oral Tablet	PSN	931ed426-89a1-4877-a4a5-cb963d51e717	8
197783	hydrocortisone 20 MG Oral Tablet	PSN	931ed426-89a1-4877-a4a5-cb963d51e717	8
197787	hydrocortisone 5 MG Oral Tablet	PSN	931ed426-89a1-4877-a4a5-cb963d51e717	8
197782	hydrocortisone 10 MG Oral Tablet	SCD	931ed426-89a1-4877-a4a5-cb963d51e717	8
197783	hydrocortisone 20 MG Oral Tablet	SCD	931ed426-89a1-4877-a4a5-cb963d51e717	8
197787	hydrocortisone 5 MG Oral Tablet	SCD	931ed426-89a1-4877-a4a5-cb963d51e717	8
197782	hydrocortisone 10 MG Oral Tablet	PSN	c58dfac3-a131-4b6b-bf75-ba46e5bc6ba6	6
197783	hydrocortisone 20 MG Oral Tablet	PSN	c58dfac3-a131-4b6b-bf75-ba46e5bc6ba6	6
197787	hydrocortisone 5 MG Oral Tablet	PSN	c58dfac3-a131-4b6b-bf75-ba46e5bc6ba6	6
197782	hydrocortisone 10 MG Oral Tablet	SCD	c58dfac3-a131-4b6b-bf75-ba46e5bc6ba6	6
197783	hydrocortisone 20 MG Oral Tablet	SCD	c58dfac3-a131-4b6b-bf75-ba46e5bc6ba6	6
197787	hydrocortisone 5 MG Oral Tablet	SCD	c58dfac3-a131-4b6b-bf75-ba46e5bc6ba6	6

Packages#

Package NDC, 11-digit format, Description table
Package NDC	11-digit format	Description	Units	Marketing start	Marketing end	Sample	Exclude flag	Status
42543-970-25	42543097025	50 TABLET in 1 BOTTLE, PLASTIC (42543-970-25)	50 tablet	2021-12-22	0000-00-00	No	No	Current

Title, Manufacturer, Effective date table
Title	Manufacturer	Effective date	Type	Version
Hydrocortisone Tablets, USP 5mg, 10mg and 20mg	PD-Rx Pharmaceuticals, Inc.	2026-02-25	HUMAN PRESCRIPTION DRUG LABEL	8
Hydrocortisone Tablets, USP 5mg, 10mg and 20mg	Strides Pharma Inc.	2026-01-08	HUMAN PRESCRIPTION DRUG LABEL	6
Hydrocortisone Tablets, USP 5mg, 10mg and 20mg	Preferred Pharmaceuticals Inc.	2024-05-21	HUMAN PRESCRIPTION DRUG LABEL	2