Hydrocortisone Acetate

Product NDC: 68788-4190
11-digit product format: 687884190
Labeler code: 68788
Product ID: 68788-4190_247bb729-f0b6-4325-a9f8-4b46d5cda300
Type: HUMAN PRESCRIPTION DRUG
Nonproprietary name: Hydrocortisone Acetate
Dosage form: SUPPOSITORY
Route: RECTAL
Labeler: Preferred Pharmaceuticals, Inc.
Marketing category: UNAPPROVED DRUG OTHER
Marketing start: 2026-08-28
Substance: HYDROCORTISONE ACETATE
Active strength: 25 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

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 Acetate
Listing expiration: 2027-12-31

Active Ingredients#

Ingredient, Strength table
Ingredient	Strength
HYDROCORTISONE ACETATE	25 mg/1

Harmonized UNII identifiers#

UNII identifiers page 1 of 1 · 1 matching rows.

Identifier, FDA.report destination table
Identifier	FDA.report destination
3X7931PO74	Internal UNII lookup

Harmonized RxCUI identifiers#

RxCUI identifiers page 1 of 1 · 1 matching rows.

Identifier, FDA.report destination table
Identifier	FDA.report destination
1291082	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
247bb729-f0b6-4325-a9f8-4b46d5cda300	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 Acetate	HYDROCORTISONE ACETATE	Preferred Pharmaceuticals, Inc.	247bb729-f0b6-4325-a9f8-4b46d5cda300	2026-08-28	Adverse reactions	Exact identifier ndc (product): 68788-4190

UNII, Preferred term, Registry number table
UNII	Preferred term	Registry number	Matched term
3X7931PO74	HYDROCORTISONE ACETATE	50-03-3	HYDROCORTISONE ACETATE

Packages#

Package NDC, 11-digit format, Description table
Package NDC	11-digit format	Description	Units	Marketing start	Sample	Exclude flag	Status
68788-4190-1	68788419001	12 SUPPOSITORY in 1 CARTON (68788-4190-1)	12 suppository	2026-08-28	No	No	Current
68788-4190-2	68788419002	24 SUPPOSITORY in 1 CARTON (68788-4190-2)	24 suppository	2026-08-28	No	No	Current

Title, Manufacturer, Effective date table
Title	Manufacturer	Effective date	Type	Version
Hydrocortisone Acetate Suppositories 25mg and 30mg	Preferred Pharmaceuticals, Inc.	2026-08-28	HUMAN PRESCRIPTION DRUG LABEL	1