FDA.reportPublic FDA data

Halobetasol Propionate

Product NDC
52959-961
11-digit product format
529590961
Labeler code
52959
Product ID
52959-961_d9ec869c-720d-49a2-8d4c-f13a5c972e1f
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
Halobetasol Propionate
Dosage form
OINTMENT
Route
TOPICAL
Labeler
H.J. Harkins Company, Inc.
Application
ANDA076872
Marketing category
ANDA
Marketing start
2009-02-05
Marketing end
0000-00-00
Substance
HALOBETASOL PROPIONATE
Active strength
1 mg/g
Pharmacologic classes
Corticosteroid [EPC],Corticosteroid Hormone Receptor Agonists [MoA]
NDC exclude flag
E
Listing certified through
2018-12-31
Current FDA listing
Historical FDA.report record

DailyMed Product Concepts#

Product concept, Relation, Version table
Product conceptRelationVersionEffective
a107c35c-2cb4-4734-a92b-e9ed5cfc34d6Product name220260220
9314f950-fe47-4276-b1f9-66d9d4a64eaeProduct name120220217
0bc08e12-b8ed-4802-abab-926d5509afb3Product name120210513
608e9379-3a63-4bf4-b035-b393ae8faa97Product name120190214
83c1408d-b2bb-43b6-84ca-4f3e3e6f11d3Product name120151123
9badac54-f0c2-d87e-de70-c4ea0b9cf6a2Product name120140508
ee2f33ab-1561-3107-e994-434cb17b4d06Product name120140508

FDA-Initiated Inactive NDC Indexing#

NDC, Effective, Action table
NDCEffectiveActionDocumentIndexing SPLRelated label
52959-961-502020-01-31C16284748780-19d75b9d0-1399-f424-e053-dadaa90a57ceHALOBETASOL PROPIONATE OINTMENT, 0.05%

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
52959-961-50Halobetasol Propionate1 in 1 CARTONOINTMENT12
52959-961-50Halobetasol Propionate50 g in 1 TUBEOINTMENT502

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
52959-961-50GM - Gram52959-96125b2f915-b30f-4260-94ef-35dbfa7ee15b12015-10-02

DailyMed Socrata Ingredients#

Ingredient, Type, UNII table
IngredientTypeUNIIDailyMed labelSPL versionUploaded
Halobetasol PropionateACTIVE INGREDIENT91A0K1TY3ZHALOBETASOL PROPIONATE OINTMENT [H.J. HARKINS COMPANY, INC.]2
HalobetasolACTIVE MOIETY9P6159HM7THALOBETASOL PROPIONATE OINTMENT [H.J. HARKINS COMPANY, INC.]2
ALUMINUM STEARATEINACTIVE INGREDIENTU6XF9NP8HMHALOBETASOL PROPIONATE OINTMENT [H.J. HARKINS COMPANY, INC.]2
PETROLATUMINACTIVE INGREDIENT4T6H12BN9UHALOBETASOL PROPIONATE OINTMENT [H.J. HARKINS COMPANY, INC.]2
PROPYLENE GLYCOLINACTIVE INGREDIENT6DC9Q167V3HALOBETASOL PROPIONATE OINTMENT [H.J. HARKINS COMPANY, INC.]2
SORBITAN SESQUIOLEATEINACTIVE INGREDIENT0W8RRI5W5AHALOBETASOL PROPIONATE OINTMENT [H.J. HARKINS COMPANY, INC.]2
YELLOW WAXINACTIVE INGREDIENT2ZA36H0S2VHALOBETASOL PROPIONATE OINTMENT [H.J. HARKINS COMPANY, INC.]2

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
52959-961HALOBETASOL PROPIONATE OINTMENT [H.J. HARKINS COMPANY, INC.]2Legacy NDC, 2 package rows20111205_b840b012-ef8e-4637-8e48-b1c867e7a050.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
977978halobetasol propionate 0.05 % Topical OintmentPSNb840b012-ef8e-4637-8e48-b1c867e7a0502
977978halobetasol propionate 0.0005 MG/MG Topical OintmentSCDb840b012-ef8e-4637-8e48-b1c867e7a0502
977978halobetasol propionate 0.05 % Topical OintmentSYb840b012-ef8e-4637-8e48-b1c867e7a0502

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionStatus
52959-961-50529590961501 in 1 CARTONHistorical