HYDROCORTISONE 2.5% / KETOCONAZOLE 2%

Product NDC
72934-2112
11-digit product format
729342112
Labeler code
72934
Product ID
72934-2112_89026ad5-ed04-5058-e053-2a95a90ad2b0
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
HYDROCORTISONE 2.5% / KETOCONAZOLE 2%
Dosage form
CREAM
Route
TOPICAL
Labeler
Sincerus Florida, LLC
Marketing category
UNAPPROVED DRUG OTHER
Marketing start
2019-05-17
Marketing end
0000-00-00
Substance
HYDROCORTISONE; KETOCONAZOLE
Active strength
3 g/100g; g/100g
Pharmacologic classes
Corticosteroid [EPC],Corticosteroid Hormone Receptor Agonists [MoA],Azole Antifungal [EPC],Azoles [CS],Cytochrome P450 3A4 Inhibitors [MoA],Cytochrome P450 3A5 Inhibitors [MoA],P-Glycoprotein Inhibitors [MoA]
NDC exclude flag
No
Listing certified through
2020-12-31
Current FDA listing
Historical FDA.report record

DailyMed Product Concepts#

Product concept, Relation, Version table
Product conceptRelationVersionEffective
15bd4439-874a-4934-9954-248e5455d460Product name120260310
9962b773-9f2e-22cc-0032-535e48ac417bProduct name320250724
fd9dd88b-5db8-6370-b47e-37f6c9b1c5d5Product name220250331
56bb0587-1bf2-48b2-9d93-fc9f59d1eeb2Product name120250325
4d56e8eb-d741-d4a5-de3f-2bab1af75a60Product name720220608
1e18fb2e-aeff-8efe-93be-5a5f7be8faa2Product name220211209
8bc3781f-20ed-678b-44a7-a981e693c65fProduct name220211209
626d7260-31b5-4412-84fd-579746adb6b3Product name120210513
8a011600-5e61-4c59-ab7b-54ab658a3b71Product name220181127
a919621a-248d-3c7a-1084-9f9ce286fdfdProduct name220181009
e7d5a174-836b-a0af-b014-cb0826c69ddcProduct name220181004
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fcce390d-6460-4701-87cf-940d8800a1c3Product name220180212
bf065fa6-1e3b-e4c3-0bde-2dc842ceeea1Product name220150218
02657a3f-1489-66ea-f740-5ab9524e57d7Product name120140508
152a96a4-36b6-f5b1-d4e6-9a500e06bbf3Product 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, Action table
NDCEffectiveActionDocumentIndexing SPLRelated label
72934-2112-22021-01-29C16284748780-1ba0f9c33-26bf-a910-e053-dadaa90a0b85HYDROCORTISONE 2.5% / KETOCONAZOLE 2%

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
72934-2112-2HYDROCORTISONE 2.5% / KETOCONAZOLE 2%30 g in 1 BOTTLE, PUMPCREAM301

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
72934-2112-2GM - Gram72934-21127e1a5df7-104e-481e-9721-79faab63916712020-03-10

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
72934-2112HYDROCORTISONE 2.5% / KETOCONAZOLE 2% CREAM [SINCERUS FLORIDA, LLC]1Legacy NDC, 1 package rows20190517_89026ad5-ed03-5058-e053-2a95a90ad2b0.zip

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsStatus
72934-2112-27293421120230 g in 1 BOTTLE, PUMP30 gHistorical