FDA.reportPublic FDA data

Halobetasol Propionate

Product NDC
0713-0339
11-digit product format
007130339
Labeler code
0713
Product ID
0713-0339_163af771-5ae8-ac38-e063-6294a90ae5bd
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
Halobetasol Propionate
Dosage form
OINTMENT
Route
TOPICAL
Labeler
Cosette Pharmaceuticals, Inc.
Application
ANDA077109
Marketing category
ANDA
Marketing start
2005-06-14
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
0713-0339-15Halobetasol Propionate1 in 1 CARTONOINTMENT16
0713-0339-15Halobetasol Propionate15 g in 1 TUBEOINTMENT156
0713-0339-86Halobetasol Propionate50 g in 1 TUBEOINTMENT506
0713-0339-86Halobetasol Propionate1 in 1 CARTONOINTMENT16

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
0713-0339-15GM - Gram0713-03399e5408b9-77c9-4685-914b-d8b07ba8d09712018-03-08
0713-0339-86GM - Gram0713-03395333d3a5-47a2-493a-bb96-fde493b6443a12018-03-08

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
0713-0339HALOBETASOL PROPIONATE OINTMENT [COSETTE PHARMACEUTICALS, INC.]6Current NDC, Legacy NDC, 4 package rows20240418_f12ff257-dd77-4f9c-97c4-339784772d9f.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
977978halobetasol propionate 0.05 % Topical OintmentPSN14766ad1-d61d-4838-92e1-849a929f4dbd101
977978halobetasol propionate 0.0005 MG/MG Topical OintmentSCD14766ad1-d61d-4838-92e1-849a929f4dbd101
977978halobetasol propionate 0.05 % Topical OintmentSY14766ad1-d61d-4838-92e1-849a929f4dbd101
977978halobetasol propionate 0.05 % Topical OintmentPSNf12ff257-dd77-4f9c-97c4-339784772d9f6
977978halobetasol propionate 0.0005 MG/MG Topical OintmentSCDf12ff257-dd77-4f9c-97c4-339784772d9f6
977978halobetasol propionate 0.05 % Topical OintmentSYf12ff257-dd77-4f9c-97c4-339784772d9f6

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
0713-0339-15007130339151 TUBE in 1 CARTON (0713-0339-15) / 15 g in 1 TUBE1 tube2018-02-210000-00-00NoNoCurrent
0713-0339-86007130339861 TUBE in 1 CARTON (0713-0339-86) / 50 g in 1 TUBE1 tube2018-02-210000-00-00NoNoCurrent