FDA.reportPublic FDA data

Vytone

Product NDC
44118-704
11-digit product format
441180704
Labeler code
44118
Product ID
44118-704_261d0f59-4215-9cb4-e063-6294a90ac111
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
HYDROCORTISONE ACETATE, IODOQUINOL
Dosage form
CREAM
Route
TOPICAL
Labeler
Eckson Labs LLC
Marketing category
UNAPPROVED DRUG OTHER
Marketing start
2022-03-30
Marketing end
2027-08-31
Substance
HYDROCORTISONE ACETATE; IODOQUINOL
Active strength
19; 10 mg/g; mg/g
Pharmacologic classes
Corticosteroid Hormone Receptor Agonists [MoA], Corticosteroid [EPC]
NDC exclude flag
No
Current FDA listing
Yes

Additional Listing Data#

Finished product
Yes
Brand name base
Vytone

Active Ingredients#

Ingredient, Strength table
IngredientStrength
HYDROCORTISONE ACETATE19 mg/g
IODOQUINOL10 mg/g

Harmonized Identifiers#

Field, Values table
FieldValues
Unii3X7931PO74, 63W7IE88K8
Rxcui1436947, 1436949

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

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
44118-704-01Vytone2 g in 1 PACKETCREAM22
44118-704-30Vytone30 in 1 CARTONCREAM302

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
44118-704-01GM - Gram44118-70436400332-a486-4161-8f84-1eedbebc604a12022-05-04
44118-704-30GM - Gram44118-704317049b9-cf2c-4bed-ae2f-cba9f24a6ac912022-05-04

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
44118-704VYTONE (HYDROCORTISONE ACETATE, IODOQUINOL) CREAM [ECKSON LABS LLC]2Current NDC, Legacy NDC, 2 package rows20241105_db751fea-59d7-314c-e053-2a95a90ae382.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
1436947hydrocortisone acetate 1.9 % / iodoquinol 1 % Topical CreamPSNdb751fea-59d7-314c-e053-2a95a90ae3822
1436949Vytone 1.9 % / 1 % Topical CreamPSNdb751fea-59d7-314c-e053-2a95a90ae3822
1436949hydrocortisone acetate 19 MG/ML / iodoquinol 10 MG/ML Topical Cream [Vytone]SBDdb751fea-59d7-314c-e053-2a95a90ae3822
1436947hydrocortisone acetate 19 MG/ML / iodoquinol 10 MG/ML Topical CreamSCDdb751fea-59d7-314c-e053-2a95a90ae3822
1436947hydrocortisone acetate 1.9 % / iodoquinol 1 % Topical CreamSYdb751fea-59d7-314c-e053-2a95a90ae3822
1436949Vytone (hydrocortisone acetate 1.9 % / iodoquinol 1 % ) Topical CreamSYdb751fea-59d7-314c-e053-2a95a90ae3822

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
44118-704-01441180704012 g in 1 PACKET2 gHistorical
44118-704-304411807043030 PACKET in 1 CARTON (44118-704-30) / 2 g in 1 PACKET (44118-704-01) 30 packet2022-03-302027-08-31NoNoCurrent