FDA.reportPublic FDA data

Halobetasol Propionate

Product NDC
72162-1396
11-digit product format
721621396
Labeler code
72162
Product ID
72162-1396_fcb21245-f0e9-4ffc-82bb-2667e55586af
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
72162-1396-2Halobetasol Propionate15 g in 1 TUBEOINTMENT15103
72162-1396-2Halobetasol Propionate1 in 1 CARTONOINTMENT1103
72162-1396-4Halobetasol Propionate1 in 1 CARTONOINTMENT1103
72162-1396-4Halobetasol Propionate50 g in 1 TUBEOINTMENT50103

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
72162-1396-2GM - Gram72162-13969f76aa9b-a2a9-46dc-be3e-ab05d1b1647612024-04-05
72162-1396-4GM - Gram72162-13969b8f33fb-2fc9-4ae7-ba79-01199220e3e912024-04-05

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
72162-1396HALOBETASOL PROPIONATE OINTMENT [BRYANT RANCH PREPACK]100Current NDC, 4 package rows20240313_be683823-9c07-498c-8357-71cbb3a3964c.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
977978halobetasol propionate 0.05 % Topical OintmentPSNbe683823-9c07-498c-8357-71cbb3a3964c103
977978halobetasol propionate 0.0005 MG/MG Topical OintmentSCDbe683823-9c07-498c-8357-71cbb3a3964c103
977978halobetasol propionate 0.05 % Topical OintmentSYbe683823-9c07-498c-8357-71cbb3a3964c103

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startSampleExclude flagStatus
72162-1396-2721621396021 TUBE in 1 CARTON (72162-1396-2) / 15 g in 1 TUBE1 tube2024-03-11NoNoCurrent
72162-1396-4721621396041 TUBE in 1 CARTON (72162-1396-4) / 50 g in 1 TUBE1 tube2024-03-11NoNoCurrent