Halobetasol Propionate

Product NDC
63629-8664
11-digit product format
636298664
Labeler code
63629
Product ID
63629-8664_39b11937-eb49-4add-8b6b-d8800581b4aa
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
Halobetasol Propionate
Dosage form
OINTMENT
Route
TOPICAL
Labeler
Bryant Ranch Prepack
Application
ANDA076872
Marketing category
ANDA
Marketing start
2009-02-05
Substance
HALOBETASOL PROPIONATE
Active strength
.5 mg/g
Pharmacologic classes
Corticosteroid Hormone Receptor Agonists [MoA], Corticosteroid [EPC]
NDC exclude flag
No
Listing certified through
2026-12-31
Current FDA listing
Yes

Additional Listing Data#

Finished product
Yes
Brand name base
Halobetasol Propionate
Listing expiration
2026-12-31

Active Ingredients#

Ingredient, Strength table
IngredientStrength
HALOBETASOL PROPIONATE.5 mg/g

Harmonized Identifiers#

Field, Values table
FieldValues
Unii91A0K1TY3Z
Rxcui977978

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

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
63629-8664-1Halobetasol Propionate15 g in 1 TUBEOINTMENT15105
63629-8664-1Halobetasol Propionate1 in 1 CARTONOINTMENT1105

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
63629-8664-1GM - Gram63629-866461cef864-0452-43f4-8120-abeedce7205812023-08-08

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
63629-8664HALOBETASOL PROPIONATE OINTMENT [BRYANT RANCH PREPACK]105Current NDC, Legacy NDC, 2 package rows20240823_e78c7fc9-34ba-4162-a98e-78931dc31dab.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
977978halobetasol propionate 0.05 % Topical OintmentPSNe78c7fc9-34ba-4162-a98e-78931dc31dab105
977978halobetasol propionate 0.0005 MG/MG Topical OintmentSCDe78c7fc9-34ba-4162-a98e-78931dc31dab105
977978halobetasol propionate 0.05 % Topical OintmentSYe78c7fc9-34ba-4162-a98e-78931dc31dab105

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
63629-8664-1636298664011 TUBE in 1 CARTON (63629-8664-1) / 15 g in 1 TUBE1 tube2010-01-140000-00-00NoNoCurrent