Hydrocortisone

Product NDC: 66267-966
11-digit product format: 662670966
Labeler code: 66267
Product ID: 66267-966_9cae12dc-49db-2247-e053-2995a90a7599
Type: HUMAN PRESCRIPTION DRUG
Nonproprietary name: Hydrocortisone
Dosage form: CREAM
Route: TOPICAL
Labeler: NuCare Pharmaceuticals,Inc.
Application: ANDA089682
Marketing category: ANDA
Marketing start: 2002-09-30
Marketing end: 0000-00-00
Substance: HYDROCORTISONE
Active strength: 25 mg/g
Pharmacologic classes: Corticosteroid [EPC],Corticosteroid Hormone Receptor Agonists [MoA]
NDC exclude flag: No
Listing certified through: 2021-12-31
Current FDA listing: Historical FDA.report record

NDC auxiliary status#

Explicit status records from FDA unfinished, excluded, and compounder auxiliary files. Absence of a row is not itself a regulatory status.

Dataset, Scope, Product NDC table
Dataset	Scope	Product NDC	Package NDC	Code	Status	Reporting period	Source date
excluded product	product	66267-966		D	Discontinued by firm		2026-07-31
excluded package	package	66267-966	66267-966-20	D	Discontinued by firm		2026-07-31

Orange Book products#

Application-product, Trade name, Ingredient table
Application-product	Trade name	Ingredient	Strength	Dosage form / route	TE codes	RLD / RS	Approval date
A089682-001	HYDROCORTISONE	HYDROCORTISONE	2.5%	CREAM / TOPICAL			1988-03-10

openFDA label cross-check#

Cross-check layer: openFDA label JSON enriches search and identifies hydration gaps. The DailyMed Structured Product Label remains the canonical label presentation on FDA.report.

Brand, Generic, Manufacturer table
Brand	Generic	Manufacturer	SPL set ID	Effective date	Available safety fields	Join
Hydrocortisone	HYDROCORTISONE	NuCare Pharmaceuticals,Inc.	720357e2-6f01-737d-e053-2a95a90ae54b	2024-06-10	Adverse reactions	Exact identifier
Hydrocortisone	HYDROCORTISONE	A-S Medication Solutions	5ee2f62a-d8d5-4efd-bf6f-f79c10855631	2023-11-22	Adverse reactions	Exact identifier
Hydrocortisone	HYDROCORTISONE	Proficient Rx LP	d50240db-f630-4008-a272-55ba5c991304	2022-07-01	Adverse reactions	Exact identifier

Adverse reactions cross-check#

openFDA text is shown for search and cross-checking; DailyMed SPL is canonical.

adverse reactions

ADVERSE REACTIONS The following local adverse reactions are reported infrequently with topical corticosteroids, but may occur more frequently with the use of occlusive dressings. These reactions are listed in approximate decreasing order of occurrence: burning, itching, irritation, dryness, folliculitis, hypertrichosis, acneiform eruptions, hypopigmentation, perioral dermatitis, allergic contact dermatitis, maceration of the skin, secondary infection, skin atrophy, striae and miliaria. To report SUSPECTED ADVERSE EVENTS, contact the FDA at 1-800-FDA-1088 or http://www.fda.gov/ for voluntary reporting of adverse reactions.

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDC	Billing unit	Product NDC	DailyMed indexing SPL	SPL version	Effective
66267-966-20	GM - Gram	66267-966	9f117415-a6b7-439a-92bf-5a267c910ab3	1	2018-01-12

UNII, Preferred term, Registry number table
UNII	Preferred term	Registry number	Matched term
WI4X0X7BPJ	HYDROCORTISONE	50-23-7	HYDROCORTISONE

Title, Manufacturer, Effective date table
Title	Manufacturer	Effective date	Type	Version
HYDROCORTISONE CREAM USP, 2.5%	NuCare Pharmaceuticals,Inc.	2020-01-21	HUMAN PRESCRIPTION DRUG LABEL	2