FDA.reportPublic FDA data

Hydrocortisone Acetate

Product NDC
42494-341
Requested package NDC
42494-341-12
11-digit product format
424940341
Labeler code
42494
Product ID
42494-341_b9ed6ad3-0833-45c8-8f10-2e7675675b3f
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
Hydrocortisone Acetate
Dosage form
SUPPOSITORY
Route
RECTAL
Labeler
Cameron Pharmaceuticals, Limited Liability Company
Marketing category
UNAPPROVED DRUG OTHER
Marketing start
2022-04-01
Marketing end
0000-00-00
Substance
HYDROCORTISONE ACETATE
Active strength
25 mg/1
Pharmacologic classes
Corticosteroid Hormone Receptor Agonists [MoA], Corticosteroid [EPC]
NDC exclude flag
No
Listing certified through
2023-12-31
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
DatasetScopeProduct NDCPackage NDCCodeStatusReporting periodSource date
excluded packagepackage42494-34142494-341-12DDiscontinued by firm2026-08-10

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 · 3 matching rows.

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

Captured / source date, Dataset, Scope table
Captured / source dateDatasetScopeProduct NDCPackage NDCCodeStatusReporting periodArchiveSnapshotSource SHA-256
2025-02-02 03:52 UTC · source 2025-01-31excluded packagepackage42494-34142494-341-12UExcluded because listing certification expiredexcluded / ndc_excluded.zip302b2466d912…e7b80fea0513…
2025-01-20 13:05 UTC · source 2025-01-20excluded packagepackage42494-34142494-341-12UExcluded because listing certification expiredexcluded / ndc_excluded.ziped331223b511…672a5bd82f5f…
2025-01-11 03:41 UTC · source 2025-01-10excluded packagepackage42494-34142494-341-12UExcluded because listing certification expiredexcluded / ndc_excluded.zip0efc9e666f02…f202fb6c5f17…

DailyMed Product Concepts#

Product concept, Relation, Version table
Product conceptRelationVersionEffective
15bd4439-874a-4934-9954-248e5455d460Product name120260310
9962b773-9f2e-22cc-0032-535e48ac417bProduct name320250724
56bb0587-1bf2-48b2-9d93-fc9f59d1eeb2Product name120250325
4d56e8eb-d741-d4a5-de3f-2bab1af75a60Product name720220608
626d7260-31b5-4412-84fd-579746adb6b3Product name120210513
8a011600-5e61-4c59-ab7b-54ab658a3b71Product name220181127
a919621a-248d-3c7a-1084-9f9ce286fdfdProduct name220181009
e7d5a174-836b-a0af-b014-cb0826c69ddcProduct name220181004
fcce390d-6460-4701-87cf-940d8800a1c3Product name220180212
bf065fa6-1e3b-e4c3-0bde-2dc842ceeea1Product name220150218
02657a3f-1489-66ea-f740-5ab9524e57d7Product name120140508
26f3d783-2cc1-4327-e77d-71804cf675a2Product name120140508
36fdc54c-bbeb-981e-8a53-4d768e283892Product name120140508
58f3f9b7-3b9b-a9c1-1c9f-18ac777192b8Product name120140508
61e59a42-186b-9f4b-aec3-fb49a6debc31Product name120140508
705740e1-dee5-2610-c5a3-4c59cd9d62afProduct name120140508
7bdc4804-3832-c0df-e519-72b6d47c9792Product name120140508
a7051cba-790b-a699-81f8-dbbbdbd9b5acProduct name120140508
abaf203f-619e-f265-559f-8c81af5cb1c2Product name120140508
acc4d8bb-0e29-e9f8-65f8-31e94184a9c0Product name120140508
b045ad64-0f28-9a02-2f9b-b34d94fb2278Product name120140508
bfd28ffb-d550-3fe9-f65b-10bcb7f971fdProduct name120140508
da108d9e-edc8-17a3-8c28-3251c6a8acccProduct name120140508
fe21f3fd-a378-0654-1972-db3c3b64470eProduct name120140508

FDA-Initiated Inactive NDC Indexing#

NDC, Effective, Related label table
NDCEffectiveRelated label
42494-341-122025-02-14Hydrocortisone Acetate Suppositories, 25 mg
42494-341-242025-02-14Hydrocortisone Acetate Suppositories, 25 mg
42494-341-122025-01-30Hydrocortisone Acetate Suppositories, 25 mg
42494-341-242025-01-30Hydrocortisone Acetate Suppositories, 25 mg

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
42494-341-12EA - Each42494-3417cda3dcb-2be4-4573-8a5e-b3f621099bd212022-08-04
42494-341-24EA - Each42494-341aca00a95-4afb-415b-9ba7-06a00f00ed2512022-08-04

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
42494-341HYDROCORTISONE ACETATE SUPPOSITORY [CAMERON PHARMACEUTICALS, LIMITED LIABILITY COMPANY]2Legacy NDC20250216_df6203a0-25ec-472e-a117-58bc0842b698.zip

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
42494-341-12424940341121 BLISTER PACK in 1 BOX (42494-341-12) > 12 SUPPOSITORY in 1 BLISTER PACK1 blister pack2022-04-010000-00-00NoNoCurrent