Hydrocortisone

Product NDC: 72789-062
Requested package NDC: 72789-062-01
11-digit product format: 727890062
Labeler code: 72789
Product ID: 72789-062_e610588f-b288-1596-e053-2995a90a6a7a
Type: HUMAN PRESCRIPTION DRUG
Nonproprietary name: Hydrocortisone
Dosage form: TABLET
Route: ORAL
Labeler: PD-Rx Pharmaceuticals, Inc.
Application: ANDA207029
Marketing category: ANDA
Marketing start: 2017-07-07
Marketing end: 0000-00-00
Substance: HYDROCORTISONE
Active strength: 20 mg/1
Pharmacologic classes: Corticosteroid Hormone Receptor Agonists [MoA], Corticosteroid [EPC]
NDC exclude flag: No
Listing certified through: 2023-12-31
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	72789-062	72789-062-01	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 · 12 matching rows.

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

Captured / source date, Snapshot, Source SHA-256 table
Captured / source date	Snapshot	Source SHA-256
2025-12-14 17:58 UTC · source 2025-12-05	`d630ba8d3edf…`	`732f749b63fb…`
2025-08-27 00:01 UTC · source 2025-08-26	`f5e01cc5f278…`	`a2eaf40c39c3…`
2025-04-01 02:39 UTC · source 2025-03-31	`2ef7874e63bc…`	`57b86245f4fa…`
2025-03-28 20:22 UTC · source 2025-03-28	`a1b67e2a42f9…`	`c4cf2c586c0d…`
2025-03-22 03:12 UTC · source 2025-03-21	`cfe11265f3b6…`	`090c488252e2…`
2025-03-10 12:48 UTC · source 2025-03-10	`cdf11ea48f46…`	`ba0047e9e063…`
2025-02-02 03:52 UTC · source 2025-01-31	`302b2466d912…`	`e7b80fea0513…`
2025-01-20 13:05 UTC · source 2025-01-20	`ed331223b511…`	`672a5bd82f5f…`
2025-01-11 03:41 UTC · source 2025-01-10	`0efc9e666f02…`	`f202fb6c5f17…`
2024-11-09 02:27 UTC · source 2024-11-08	`ad56d346431e…`	`cc804d4bbf1e…`
2024-10-04 04:10 UTC · source 2024-10-03	`367a005e9d99…`	`383a685ebd0f…`
2024-07-10 04:00 UTC · source 2024-07-09	`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
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 · 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	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…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A207029-002	HYDROCORTISONE	10MG	TABLET / ORAL	AB	2017-04-27	`79d66fd596c7…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A207029-003	HYDROCORTISONE	20MG	TABLET / ORAL	AB	2017-04-27	`79d66fd596c7…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A207029-001	HYDROCORTISONE	5MG	TABLET / ORAL	AB	2017-04-27	`301d65b070ca…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A207029-002	HYDROCORTISONE	10MG	TABLET / ORAL	AB	2017-04-27	`301d65b070ca…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A207029-003	HYDROCORTISONE	20MG	TABLET / ORAL	AB	2017-04-27	`301d65b070ca…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A207029-001	HYDROCORTISONE	5MG	TABLET / ORAL	AB	2017-04-27	`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	A207029-001	AB	1	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	A207029-002	AB	1	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	A207029-003	AB	1	`caaa826d4ba7…`
2026-02-19 14:30 UTC	2026-02	A207029-001	AB	1	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A207029-002	AB	1	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A207029-003	AB	1	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A207029-001	AB	1	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A207029-002	AB	1	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A207029-003	AB	1	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	A207029-001	AB	1	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A207029-002	AB	1	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A207029-003	AB	1	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A207029-001	AB	1	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A207029-002	AB	1	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A207029-003	AB	1	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A207029-001	AB	1	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A207029-002	AB	1	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A207029-003	AB	1	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A207029-001	AB	1	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A207029-002	AB	1	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A207029-003	AB	1	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A207029-001	AB	1	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A207029-002	AB	1	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A207029-003	AB	1	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A207029-001	AB	1	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A207029-002	AB	1	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A207029-003	AB	1	`5bbf6a4d5a75…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A207029-001	AB	1	`d8e5a09893c0…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A207029-002	AB	1	`d8e5a09893c0…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A207029-003	AB	1	`d8e5a09893c0…`
2024-10-29 15:01 UTC	2024-10	A207029-001	AB	1	`d06236e962d9…`
2024-10-29 15:01 UTC	2024-10	A207029-002	AB	1	`d06236e962d9…`
2024-10-29 15:01 UTC	2024-10	A207029-003	AB	1	`d06236e962d9…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A207029-001	AB	1	`79d66fd596c7…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A207029-002	AB	1	`79d66fd596c7…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A207029-003	AB	1	`79d66fd596c7…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A207029-001	AB	1	`301d65b070ca…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A207029-002	AB	1	`301d65b070ca…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A207029-003	AB	1	`301d65b070ca…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A207029-001	AB	1	`1e350fbaab3a…`

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDC	Billing unit	Product NDC	DailyMed indexing SPL	SPL version	Effective
72789-062-01	EA - Each	72789-062	040583ee-84c0-47ec-a8e9-a6ce08b6ad7c	1	2020-05-08

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	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
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	American Health Packaging	506aab0d-9308-4d60-90b3-7d64952fff36	2025-05-25	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

Packages#

Package NDC, 11-digit format, Description table
Package NDC	11-digit format	Description	Units	Marketing start	Marketing end	Sample	Exclude flag	Status
72789-062-01	72789006201	100 TABLET in 1 BOTTLE, PLASTIC (72789-062-01)	100 tablet	2020-03-30	0000-00-00	No	No	Current

Title, Manufacturer, Effective date table
Title	Manufacturer	Effective date	Type	Version
Hydrocortisone Tablets, USP 20 mg	PD-Rx Pharmaceuticals, Inc.	2022-08-12	HUMAN PRESCRIPTION DRUG LABEL	9