FDA.reportPublic FDA data

Halobetasol Propionate

Product NDC
45802-129
11-digit product format
458020129
Labeler code
45802
Product ID
45802-129_4f3d068f-2393-41c4-9d14-47106cd5c6a0
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
Halobetasol Propionate
Dosage form
CREAM
Route
TOPICAL
Labeler
Padagis Israel Pharmaceuticals Ltd
Application
ANDA077123
Marketing category
ANDA
Marketing start
2008-08-04
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
Rxcui977990

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
45802-129-32Halobetasol Propionate50 g in 1 TUBECREAM506
45802-129-32Halobetasol Propionate1 in 1 CARTONCREAM16
45802-129-35Halobetasol Propionate1 in 1 CARTONCREAM16
45802-129-35Halobetasol Propionate15 g in 1 TUBECREAM156

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
45802-129-32GM - Gram45802-1293eb322d9-aaa3-422e-959b-12f4b22b15c712012-07-24
45802-129-35GM - Gram45802-12945fc8da3-b040-47b8-b33f-686cd30fc96a12012-07-24

DailyMed Socrata Ingredients#

Ingredient, Type, UNII table
IngredientTypeUNIIDailyMed labelSPL versionUploaded
HALOBETASOL PROPIONATEACTIVE INGREDIENT91A0K1TY3ZHALOBETASOL PROPIONATE CREAM [PERRIGO NEW YORK INC]2
HalobetasolACTIVE MOIETY9P6159HM7THALOBETASOL PROPIONATE CREAM [PERRIGO NEW YORK INC]2
CETYL ALCOHOLINACTIVE INGREDIENT936JST6JCNHALOBETASOL PROPIONATE CREAM [PERRIGO NEW YORK INC]2
DIAZOLIDINYL UREAINACTIVE INGREDIENTH5RIZ3MPW4HALOBETASOL PROPIONATE CREAM [PERRIGO NEW YORK INC]2
GLYCERININACTIVE INGREDIENTPDC6A3C0OXHALOBETASOL PROPIONATE CREAM [PERRIGO NEW YORK INC]2
ISOPROPYL PALMITATEINACTIVE INGREDIENT8CRQ2TH63MHALOBETASOL PROPIONATE CREAM [PERRIGO NEW YORK INC]2
METHYLCHLOROISOTHIAZOLINONEINACTIVE INGREDIENTDEL7T5QRPNHALOBETASOL PROPIONATE CREAM [PERRIGO NEW YORK INC]2
METHYLISOTHIAZOLINONEINACTIVE INGREDIENT229D0E1QFAHALOBETASOL PROPIONATE CREAM [PERRIGO NEW YORK INC]2
STEARETH-21INACTIVE INGREDIENT53J3F32P58HALOBETASOL PROPIONATE CREAM [PERRIGO NEW YORK INC]2
WATERINACTIVE INGREDIENT059QF0KO0RHALOBETASOL PROPIONATE CREAM [PERRIGO NEW YORK INC]2
HALOBETASOL PROPIONATEACTIVE INGREDIENT91A0K1TY3ZHALOBETASOL PROPIONATE CREAM [PHYSICIANS TOTAL CARE, INC.]1
HALOBETASOLACTIVE MOIETY9P6159HM7THALOBETASOL PROPIONATE CREAM [PHYSICIANS TOTAL CARE, INC.]1
CETYL ALCOHOLINACTIVE INGREDIENT936JST6JCNHALOBETASOL PROPIONATE CREAM [PHYSICIANS TOTAL CARE, INC.]1
DIAZOLIDINYL UREAINACTIVE INGREDIENTH5RIZ3MPW4HALOBETASOL PROPIONATE CREAM [PHYSICIANS TOTAL CARE, INC.]1
GLYCERININACTIVE INGREDIENTPDC6A3C0OXHALOBETASOL PROPIONATE CREAM [PHYSICIANS TOTAL CARE, INC.]1
ISOPROPYL PALMITATEINACTIVE INGREDIENT8CRQ2TH63MHALOBETASOL PROPIONATE CREAM [PHYSICIANS TOTAL CARE, INC.]1
METHYLCHLOROISOTHIAZOLINONEINACTIVE INGREDIENTDEL7T5QRPNHALOBETASOL PROPIONATE CREAM [PHYSICIANS TOTAL CARE, INC.]1
METHYLISOTHIAZOLINONEINACTIVE INGREDIENT229D0E1QFAHALOBETASOL PROPIONATE CREAM [PHYSICIANS TOTAL CARE, INC.]1
STEARETH-21INACTIVE INGREDIENT53J3F32P58HALOBETASOL PROPIONATE CREAM [PHYSICIANS TOTAL CARE, INC.]1
WATERINACTIVE INGREDIENT059QF0KO0RHALOBETASOL PROPIONATE CREAM [PHYSICIANS TOTAL CARE, INC.]1

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
45802-129HALOBETASOL PROPIONATE CREAM [PADAGIS ISRAEL PHARMACEUTICALS LTD]6Current NDC, Legacy NDC, 4 package rows20240111_df26430c-8182-4d03-a254-06d913de4c95.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
977990halobetasol propionate 0.05 % Topical CreamPSNdf26430c-8182-4d03-a254-06d913de4c956
977990halobetasol propionate 0.5 MG/ML Topical CreamSCDdf26430c-8182-4d03-a254-06d913de4c956
977990halobetasol propionate 0.05 % Topical CreamSYdf26430c-8182-4d03-a254-06d913de4c956
977990halobetasol propionate 0.05 % Topical CreamPSNe408184b-0545-4728-9f95-90d8cdec544a2
977990halobetasol propionate 0.5 MG/ML Topical CreamSCDe408184b-0545-4728-9f95-90d8cdec544a2
977990halobetasol propionate 0.05 % Topical CreamSYe408184b-0545-4728-9f95-90d8cdec544a2
977990halobetasol propionate 0.05 % Topical CreamPSNc40b91aa-cf2b-4774-a737-f2c4d5b6673f1
977990halobetasol propionate 0.5 MG/ML Topical CreamSCDc40b91aa-cf2b-4774-a737-f2c4d5b6673f1
977990halobetasol propionate 0.05 % Topical CreamSYc40b91aa-cf2b-4774-a737-f2c4d5b6673f1

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
45802-129-32458020129321 TUBE in 1 CARTON (45802-129-32) / 50 g in 1 TUBE1 tube2008-08-040000-00-00NoNoCurrent
45802-129-35458020129351 TUBE in 1 CARTON (45802-129-35) / 15 g in 1 TUBE1 tube2008-08-040000-00-00NoNoCurrent