FDA.reportPublic FDA data

Vanos

Product NDC
99207-525
11-digit product format
992070525
Labeler code
99207
Product ID
99207-525_679f7835-6495-4ea6-bd02-e5f62d462776
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
fluocinonide
Dosage form
CREAM
Route
TOPICAL
Labeler
Bausch Health US, LLC
Application
NDA021758
Marketing category
NDA
Marketing start
2006-03-13
Marketing end
2026-08-31
Substance
FLUOCINONIDE
Active strength
1 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
Vanos

Active Ingredients#

Ingredient, Strength table
IngredientStrength
FLUOCINONIDE1 mg/g

Harmonized Identifiers#

Field, Values table
FieldValues
Unii2W4A77YPAN
Rxcui485647, 543484

DailyMed Product Concepts#

Product concept, Relation, Version table
Product conceptRelationVersionEffective
a338afdd-91bc-4c45-5113-8b445b8e6cf2Product name520200618
f3bf4e6e-291f-4372-8e90-b4047949153aProduct name320200514
934e8c63-e34a-6dfb-4224-efad2d76fafcProduct name520190405
ac5b31c4-5bd3-4df8-8f07-dbc9d194cdfeProduct name120181219
ef1d202f-16bf-4f17-a390-087db27f5314Product name120181203
de14082b-1b4a-48ac-b75c-4ee3ff8a29beProduct name120180809

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
99207-525-02Vanos20 in 1 CARTONCREAM2023
99207-525-02Vanos1.5 g in 1 TUBECREAM1.523
99207-525-10Vanos120 g in 1 TUBECREAM12023
99207-525-10Vanos1 in 1 CARTONCREAM123
99207-525-30Vanos30 g in 1 TUBECREAM3023
99207-525-30Vanos1 in 1 CARTONCREAM123
99207-525-60Vanos60 g in 1 TUBECREAM6023
99207-525-60Vanos1 in 1 CARTONCREAM123

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
99207-525-10GM - Gram99207-5255f6e0317-4eec-45ea-9e3e-c9b18d16308c12012-07-24
99207-525-30GM - Gram99207-52538d9533f-58ba-4f8f-a0a5-54a2e498807812012-07-24
99207-525-60GM - Gram99207-525ffd07c0f-3f93-46de-99fb-77301da79a9812012-07-24

DailyMed Socrata Ingredients#

Ingredient, Type, UNII table
IngredientTypeUNIIDailyMed labelSPL versionUploaded
fluocinonideACTIVE INGREDIENT2W4A77YPANVANOS (FLUOCINONIDE) CREAM [MEDICIS PHARMACEUTICAL CORP]13
fluocinonideACTIVE MOIETY2W4A77YPANVANOS (FLUOCINONIDE) CREAM [MEDICIS PHARMACEUTICAL CORP]13
CARBOMER HOMOPOLYMER TYPE C (ALLYL PENTAERYTHRITOL CROSSLINKED)INACTIVE INGREDIENT4Q93RCW27EVANOS (FLUOCINONIDE) CREAM [MEDICIS PHARMACEUTICAL CORP]13
citric acid monohydrateINACTIVE INGREDIENT2968PHW8QPVANOS (FLUOCINONIDE) CREAM [MEDICIS PHARMACEUTICAL CORP]13
diisopropanolamineINACTIVE INGREDIENT0W44HYL8T5VANOS (FLUOCINONIDE) CREAM [MEDICIS PHARMACEUTICAL CORP]13
dimethyl isosorbideINACTIVE INGREDIENTSA6A6V432SVANOS (FLUOCINONIDE) CREAM [MEDICIS PHARMACEUTICAL CORP]13
glyceryl monostearateINACTIVE INGREDIENT230OU9XXE4VANOS (FLUOCINONIDE) CREAM [MEDICIS PHARMACEUTICAL CORP]13
peg-100 stearateINACTIVE INGREDIENTYD01N1999RVANOS (FLUOCINONIDE) CREAM [MEDICIS PHARMACEUTICAL CORP]13
propylene glycolINACTIVE INGREDIENT6DC9Q167V3VANOS (FLUOCINONIDE) CREAM [MEDICIS PHARMACEUTICAL CORP]13
waterINACTIVE INGREDIENT059QF0KO0RVANOS (FLUOCINONIDE) CREAM [MEDICIS PHARMACEUTICAL CORP]13
FLUOCINONIDEACTIVE INGREDIENT2W4A77YPANVANOS (FLUOCINONIDE) CREAM [PHYSICIANS TOTAL CARE, INC.]1
FLUOCINONIDEACTIVE MOIETY2W4A77YPANVANOS (FLUOCINONIDE) CREAM [PHYSICIANS TOTAL CARE, INC.]1
CARBOMER HOMOPOLYMER TYPE CINACTIVE INGREDIENT4Q93RCW27EVANOS (FLUOCINONIDE) CREAM [PHYSICIANS TOTAL CARE, INC.]1
CITRIC ACID MONOHYDRATEINACTIVE INGREDIENT2968PHW8QPVANOS (FLUOCINONIDE) CREAM [PHYSICIANS TOTAL CARE, INC.]1
DIISOPROPANOLAMINEINACTIVE INGREDIENT0W44HYL8T5VANOS (FLUOCINONIDE) CREAM [PHYSICIANS TOTAL CARE, INC.]1
DIMETHYL ISOSORBIDEINACTIVE INGREDIENTSA6A6V432SVANOS (FLUOCINONIDE) CREAM [PHYSICIANS TOTAL CARE, INC.]1
GLYCERYL MONOSTEARATEINACTIVE INGREDIENT230OU9XXE4VANOS (FLUOCINONIDE) CREAM [PHYSICIANS TOTAL CARE, INC.]1
POLYOXYL 100 STEARATEINACTIVE INGREDIENTYD01N1999RVANOS (FLUOCINONIDE) CREAM [PHYSICIANS TOTAL CARE, INC.]1
PROPYLENE GLYCOLINACTIVE INGREDIENT6DC9Q167V3VANOS (FLUOCINONIDE) CREAM [PHYSICIANS TOTAL CARE, INC.]1
WATERINACTIVE INGREDIENT059QF0KO0RVANOS (FLUOCINONIDE) CREAM [PHYSICIANS TOTAL CARE, INC.]1

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
99207-525VANOS (FLUOCINONIDE) CREAM [BAUSCH HEALTH US, LLC]22Current NDC, Legacy NDC, 8 package rows20240229_95cb19a0-4b71-4c66-92bd-901cfd223301.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
485647fluocinonide 0.1 % Topical CreamPSN95cb19a0-4b71-4c66-92bd-901cfd22330123
543484Vanos 0.1 % Topical CreamPSN95cb19a0-4b71-4c66-92bd-901cfd22330123
543484fluocinonide 1 MG/ML Topical Cream [Vanos]SBD95cb19a0-4b71-4c66-92bd-901cfd22330123
485647fluocinonide 1 MG/ML Topical CreamSCD95cb19a0-4b71-4c66-92bd-901cfd22330123
485647fluocinonide 0.1 % Topical CreamSY95cb19a0-4b71-4c66-92bd-901cfd22330123
485647fluocinonide 1 MG per 1 GM Topical CreamSY95cb19a0-4b71-4c66-92bd-901cfd22330123
543484Vanos 0.1 % Topical CreamSY95cb19a0-4b71-4c66-92bd-901cfd22330123
543484Vanos 1 MG/ML Topical CreamSY95cb19a0-4b71-4c66-92bd-901cfd22330123
485647fluocinonide 0.1 % Topical CreamPSN34b91547-31f6-4043-b91c-16c9ebd813491
543484Vanos 0.1 % Topical CreamPSN34b91547-31f6-4043-b91c-16c9ebd813491
543484fluocinonide 1 MG/ML Topical Cream [Vanos]SBD34b91547-31f6-4043-b91c-16c9ebd813491
485647fluocinonide 1 MG/ML Topical CreamSCD34b91547-31f6-4043-b91c-16c9ebd813491
485647fluocinonide 0.1 % Topical CreamSY34b91547-31f6-4043-b91c-16c9ebd813491
485647fluocinonide 1 MG per 1 GM Topical CreamSY34b91547-31f6-4043-b91c-16c9ebd813491
543484Vanos 0.1 % Topical CreamSY34b91547-31f6-4043-b91c-16c9ebd813491
543484Vanos 1 MG/ML Topical CreamSY34b91547-31f6-4043-b91c-16c9ebd813491

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
99207-525-029920705250220 TUBE in 1 CARTON (99207-525-02) > 1.5 g in 1 TUBE20 tube2006-03-130000-00-00NoNoCurrent
99207-525-10992070525101 TUBE in 1 CARTON (99207-525-10) / 120 g in 1 TUBE1 tube2006-03-132026-08-31NoNoCurrent
99207-525-30992070525301 TUBE in 1 CARTON (99207-525-30) / 30 g in 1 TUBE1 tube2006-03-132026-08-31NoNoCurrent
99207-525-60992070525601 TUBE in 1 CARTON (99207-525-60) / 60 g in 1 TUBE1 tube2006-03-132026-08-31NoNoCurrent