Hydrocortisone

Product NDC: 43547-894
11-digit product format: 435470894
Labeler code: 43547
Product ID: 43547-894_04f112e5-ec88-46c8-b675-8b4e38a86ab4
Type: HUMAN PRESCRIPTION DRUG
Nonproprietary name: Hydrocortisone
Dosage form: TABLET
Route: ORAL
Labeler: Solco Healthcare LLC
Application: ANDA220329
Marketing category: ANDA
Marketing start: 2026-08-17
Substance: HYDROCORTISONE
Active strength: 20 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 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	TE codes	Approval date
A220329-001	HYDROCORTISONE	HYDROCORTISONE	5MG	TABLET / ORAL	AB	2026-02-25
A220329-002	HYDROCORTISONE	HYDROCORTISONE	10MG	TABLET / ORAL	AB	2026-02-25
A220329-003	HYDROCORTISONE	HYDROCORTISONE	20MG	TABLET / ORAL	AB	2026-02-25

Therapeutic equivalence codes#

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

Application-product, TE code table
Application-product	TE code
A220329-001	AB
A220329-002	AB
A220329-003	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.

Captured, Edition, Application-product table
Captured	Edition	Application-product	Trade name	Strength	Dosage form / route	Product TE source text	Approval date	Source SHA-256
2026-09-14 22:38:34	2026-08	A220329-001	HYDROCORTISONE	5MG	TABLET / ORAL	AB	2026-02-25	`84e616aacf4f…`
2026-09-14 22:38:34	2026-08	A220329-002	HYDROCORTISONE	10MG	TABLET / ORAL	AB	2026-02-25	`84e616aacf4f…`
2026-09-14 22:38:34	2026-08	A220329-003	HYDROCORTISONE	20MG	TABLET / ORAL	AB	2026-02-25	`84e616aacf4f…`
2026-08-18 06:07:40	2026-07	A220329-001	HYDROCORTISONE	5MG	TABLET / ORAL	AB	2026-02-25	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	A220329-002	HYDROCORTISONE	10MG	TABLET / ORAL	AB	2026-02-25	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	A220329-003	HYDROCORTISONE	20MG	TABLET / ORAL	AB	2026-02-25	`caaa826d4ba7…`
2026-07-26 02:55 UTC · 3 captures of this ZIP	2026-06	A220329-001	HYDROCORTISONE	5MG	TABLET / ORAL	AB	2026-02-25	`a50c72e98297…`
2026-07-26 02:55 UTC · 3 captures of this ZIP	2026-06	A220329-002	HYDROCORTISONE	10MG	TABLET / ORAL	AB	2026-02-25	`a50c72e98297…`
2026-07-26 02:55 UTC · 3 captures of this ZIP	2026-06	A220329-003	HYDROCORTISONE	20MG	TABLET / ORAL	AB	2026-02-25	`a50c72e98297…`

Observed Orange Book normalized TE history#

Captured, Edition, Application-product table
Captured	Edition	Application-product	TE code	Order	Source SHA-256
2026-09-14 22:38:34	2026-08	A220329-001	AB	1	`84e616aacf4f…`
2026-09-14 22:38:34	2026-08	A220329-002	AB	1	`84e616aacf4f…`
2026-09-14 22:38:34	2026-08	A220329-003	AB	1	`84e616aacf4f…`
2026-08-18 06:07:40	2026-07	A220329-001	AB	1	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	A220329-002	AB	1	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	A220329-003	AB	1	`caaa826d4ba7…`
2026-07-26 02:55 UTC · 3 captures of this ZIP	2026-06	A220329-001	AB	1	`a50c72e98297…`
2026-07-26 02:55 UTC · 3 captures of this ZIP	2026-06	A220329-002	AB	1	`a50c72e98297…`
2026-07-26 02:55 UTC · 3 captures of this ZIP	2026-06	A220329-003	AB	1	`a50c72e98297…`

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	20 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
04f112e5-ec88-46c8-b675-8b4e38a86ab4	Available on FDA.report

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 · 1 matching rows.

Brand, Generic, Manufacturer table
Brand	Generic	Manufacturer	SPL set ID	Effective date	Available safety fields	Join
Hydrocortisone	HYDROCORTISONE	Solco Healthcare LLC	04f112e5-ec88-46c8-b675-8b4e38a86ab4	2026-08-11	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 220329 application number: ANDA220329 ndc (product): 43547-894

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
43547-894-10	43547089410	100 TABLET in 1 BOTTLE (43547-894-10)	100 tablet	2026-08-17	No	No	Current

Title, Manufacturer, Effective date table
Title	Manufacturer	Effective date	Type	Version
Hydrocortisone Tablets, USP	Solco Healthcare LLC \| Appco Pharma LLC \| Steril-Gene Life Sciences (P) Ltd	2026-08-11	Human Prescription Drug Label	1