Hydrocortisone

Product NDC: 72162-2686
Requested package NDC: 72162-2686-1
11-digit product format: 721622686
Labeler code: 72162
Product ID: 72162-2686_bbdb58ad-a838-4c0e-81ff-f807274b201c
Type: HUMAN PRESCRIPTION DRUG
Nonproprietary name: Hydrocortisone
Dosage form: TABLET
Route: ORAL
Labeler: Bryant Ranch Prepack
Application: ANDA207029
Marketing category: ANDA
Marketing start: 2020-09-25
Substance: HYDROCORTISONE
Active strength: 10 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 1 of 4 · 132 observed states.

Captured, Edition, Application-product table
Captured	Edition	Application-product	TE code	Order	Source SHA-256
2026-10-15 13:18:30	2026-09	A207029-001	AB	1	`c2088c7a36db…`
2026-10-15 13:18:30	2026-09	A207029-002	AB	1	`c2088c7a36db…`
2026-10-15 13:18:30	2026-09	A207029-003	AB	1	`c2088c7a36db…`
2026-09-14 22:38:34	2026-08	A207029-001	AB	1	`84e616aacf4f…`
2026-09-14 22:38:34	2026-08	A207029-002	AB	1	`84e616aacf4f…`
2026-09-14 22:38:34	2026-08	A207029-003	AB	1	`84e616aacf4f…`
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…`

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	10 mg/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 · 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
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

Packages#

Package NDC, 11-digit format, Description table
Package NDC	11-digit format	Description	Units	Marketing start	Sample	Exclude flag	Status
72162-2686-1	72162268601	100 TABLET in 1 BOTTLE, PLASTIC (72162-2686-1)	100 tablet	2026-10-29	No	No	Current

Title, Manufacturer, Effective date table
Title	Manufacturer	Effective date	Type	Version
Hydrocortisone Tablets, USP 5 mg, 10 mg and 20 mg	Bryant Ranch Prepack	2026-10-29	HUMAN PRESCRIPTION DRUG LABEL	100