Hydrocortisone Acetate

Product NDC: 42494-301
Requested package NDC: 42494-301-12
11-digit product format: 424940301
Labeler code: 42494
Product ID: 42494-301_8688e642-1cb9-499d-bd65-6288fce36e73
Type: HUMAN PRESCRIPTION DRUG
Nonproprietary name: HYDROCORTISONE ACETATE
Dosage form: SUPPOSITORY
Route: RECTAL
Labeler: Cameron Pharmaceuticals, LLC
Marketing category: UNAPPROVED DRUG OTHER
Marketing start: 2017-05-01
Marketing end: 0000-00-00
Substance: HYDROCORTISONE ACETATE
Active strength: 25 mg/1
Pharmacologic classes: Corticosteroid [EPC],Corticosteroid Hormone Receptor Agonists [MoA]
NDC exclude flag: No
Listing certified through: 2022-12-31
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	42494-301	42494-301-12	D	Discontinued by firm		2026-08-11

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 · 15 matching rows.

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

Captured / source date, Code, Status table
Captured / source date	Code	Status	Snapshot	Source SHA-256
2025-12-14 17:58 UTC · source 2025-12-05	D	Discontinued by firm	`d630ba8d3edf…`	`732f749b63fb…`
2025-08-27 00:01 UTC · source 2025-08-26	I	Inactivated by FDA	`f5e01cc5f278…`	`a2eaf40c39c3…`
2025-04-01 02:39 UTC · source 2025-03-31	I	Inactivated by FDA	`2ef7874e63bc…`	`57b86245f4fa…`
2025-03-28 20:22 UTC · source 2025-03-28	I	Inactivated by FDA	`a1b67e2a42f9…`	`c4cf2c586c0d…`
2025-03-22 03:12 UTC · source 2025-03-21	I	Inactivated by FDA	`cfe11265f3b6…`	`090c488252e2…`
2025-03-10 12:48 UTC · source 2025-03-10	I	Inactivated by FDA	`cdf11ea48f46…`	`ba0047e9e063…`
2025-02-02 03:52 UTC · source 2025-01-31	I	Inactivated by FDA	`302b2466d912…`	`e7b80fea0513…`
2025-01-20 13:05 UTC · source 2025-01-20	I	Inactivated by FDA	`ed331223b511…`	`672a5bd82f5f…`
2025-01-11 03:41 UTC · source 2025-01-10	I	Inactivated by FDA	`0efc9e666f02…`	`f202fb6c5f17…`
2024-11-09 02:27 UTC · source 2024-11-08	I	Inactivated by FDA	`ad56d346431e…`	`cc804d4bbf1e…`
2024-10-04 04:10 UTC · source 2024-10-03	I	Inactivated by FDA	`367a005e9d99…`	`383a685ebd0f…`
2024-07-10 04:00 UTC · source 2024-07-09	I	Inactivated by FDA	`557ba5c1ecfa…`	`9c80585c8c6e…`
2024-05-28 21:12 UTC · source 2024-05-28	I	Inactivated by FDA	`8af77b9d5b6f…`	`d9bbb34c5368…`
2024-05-15 03:39 UTC · source 2024-05-14	I	Inactivated by FDA	`834df4deac94…`	`adcc014656a3…`
2024-03-11 06:39 UTC · source 2024-03-08	I	Inactivated by FDA	`1332a3947898…`	`d4bfe170f9cd…`

DailyMed Product Concepts#

Product concept, Relation, Version table
Product concept	Relation	Version	Effective
15bd4439-874a-4934-9954-248e5455d460	Product name	1	20260310
9962b773-9f2e-22cc-0032-535e48ac417b	Product name	3	20250724
56bb0587-1bf2-48b2-9d93-fc9f59d1eeb2	Product name	1	20250325
4d56e8eb-d741-d4a5-de3f-2bab1af75a60	Product name	7	20220608
626d7260-31b5-4412-84fd-579746adb6b3	Product name	1	20210513
8a011600-5e61-4c59-ab7b-54ab658a3b71	Product name	2	20181127
a919621a-248d-3c7a-1084-9f9ce286fdfd	Product name	2	20181009
e7d5a174-836b-a0af-b014-cb0826c69ddc	Product name	2	20181004
fcce390d-6460-4701-87cf-940d8800a1c3	Product name	2	20180212
bf065fa6-1e3b-e4c3-0bde-2dc842ceeea1	Product name	2	20150218
02657a3f-1489-66ea-f740-5ab9524e57d7	Product name	1	20140508
26f3d783-2cc1-4327-e77d-71804cf675a2	Product name	1	20140508
36fdc54c-bbeb-981e-8a53-4d768e283892	Product name	1	20140508
58f3f9b7-3b9b-a9c1-1c9f-18ac777192b8	Product name	1	20140508
61e59a42-186b-9f4b-aec3-fb49a6debc31	Product name	1	20140508
705740e1-dee5-2610-c5a3-4c59cd9d62af	Product name	1	20140508
7bdc4804-3832-c0df-e519-72b6d47c9792	Product name	1	20140508
a7051cba-790b-a699-81f8-dbbbdbd9b5ac	Product name	1	20140508
abaf203f-619e-f265-559f-8c81af5cb1c2	Product name	1	20140508
acc4d8bb-0e29-e9f8-65f8-31e94184a9c0	Product name	1	20140508
b045ad64-0f28-9a02-2f9b-b34d94fb2278	Product name	1	20140508
bfd28ffb-d550-3fe9-f65b-10bcb7f971fd	Product name	1	20140508
da108d9e-edc8-17a3-8c28-3251c6a8accc	Product name	1	20140508
fe21f3fd-a378-0654-1972-db3c3b64470e	Product name	1	20140508

FDA-Initiated Inactive NDC Indexing#

NDC, Effective, Action table
NDC	Effective	Action	Document	Indexing SPL	Related label
42494-301-01	2023-01-30	C162847	48780-1	f386c649-a212-0266-e053-dadaa90a7c1a	Hydrocortisone Acetate Suppositories, 25 mg For Rectal Administration Rx only
42494-301-12	2023-01-30	C162847	48780-1	f386c649-a212-0266-e053-dadaa90a7c1a	Hydrocortisone Acetate Suppositories, 25 mg For Rectal Administration Rx only
42494-301-24	2023-01-30	C162847	48780-1	f386c649-a212-0266-e053-dadaa90a7c1a	Hydrocortisone Acetate Suppositories, 25 mg For Rectal Administration Rx only

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDC	Billing unit	Product NDC	DailyMed indexing SPL	SPL version	Effective
42494-301-12	EA - Each	42494-301	206ec2fb-a59b-47ae-b2de-5627b7d8b695	1	2017-06-15
42494-301-24	EA - Each	42494-301	c5bc0ac0-263e-4fae-a1e7-823ab734ff8d	1	2017-06-15

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDC	Dashboard title	SPL version	Validation	Dashboard ZIP
42494-301	HYDROCORTISONE ACETATE SUPPOSITORY [CAMERON PHARMACEUTICALS, LLC]	3	Legacy NDC	20211021_b9efefd3-76a6-4450-b770-641c3585b3e6.zip

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

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUI	RxNorm string	TTY	DailyMed	SPL version
1291082	hydrocortisone acetate 25 MG Rectal Suppository	PSN	97552edd-c419-427f-a46a-5ce3ad413dc4	5
1291082	hydrocortisone acetate 25 MG Rectal Suppository	SCD	97552edd-c419-427f-a46a-5ce3ad413dc4	5
1291082	hydrocortisone acetate 25 MG Rectal Suppository	PSN	bbbcf584-315d-43aa-b429-60505a4bf373	1
1291082	hydrocortisone acetate 25 MG Rectal Suppository	SCD	bbbcf584-315d-43aa-b429-60505a4bf373	1

Packages#

Package NDC, 11-digit format, Description table
Package NDC	11-digit format	Description	Units	Marketing start	Marketing end	Sample	Exclude flag	Status
42494-301-12	42494030112	12 SUPPOSITORY in 1 BOX (42494-301-12)	12 suppository	2017-05-01	0000-00-00	No	No	Current

Title, Manufacturer, Effective date table
Title	Manufacturer	Effective date	Type	Version
Hydrocortisone Acetate Suppositories, 25 mg For Rectal Administration Rx only	RPK Pharmaceuticals, Inc.	2023-06-07	HUMAN PRESCRIPTION DRUG LABEL	5
Hydrocortisone Acetate Suppositories, 25 mg For Rectal Administration Rx only	Bryant Ranch Prepack	2023-02-07	HUMAN PRESCRIPTION DRUG LABEL	103
Hydrocortisone Acetate Suppositories, 25 mg For Rectal Administration Rx only	Bryant Ranch Prepack	2023-02-02	HUMAN PRESCRIPTION DRUG LABEL	103
Hydrocortisone Acetate Suppositories, 25 mg For Rectal Administration Rx only	Bryant Ranch Prepack	2022-04-15	HUMAN PRESCRIPTION DRUG LABEL	102
Hydrocortisone Acetate Suppositories, 25 mg For Rectal Administration Rx only	Cameron Pharmaceuticals, LLC	2021-10-19	HUMAN PRESCRIPTION DRUG LABEL	3
Hydrocortisone Acetate Suppositories, 25 mg For Rectal Administration Rx only	A-S Medication Solutions	2021-09-03	HUMAN PRESCRIPTION DRUG LABEL	1
Hydrocortisone Acetate Suppositories, 25 mg For Rectal Administration Rx only	NuCare Pharmaceuticals,Inc.	2021-02-17	HUMAN PRESCRIPTION DRUG LABEL	3