Halobetasol Propionate

Product NDC
85437-008
11-digit product format
854370008
Labeler code
85437
Product ID
85437-008_4d3f3b6d-7f22-1f5c-e063-6294a90a45b3
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
Halobetasol propionate
Dosage form
LOTION
Route
TOPICAL
Labeler
Coral Way Pharma, LLC
Application
NDA208183
Marketing category
NDA AUTHORIZED GENERIC
Marketing start
2026-03-10
Substance
HALOBETASOL PROPIONATE
Active strength
.5 mg/g
Pharmacologic classes
Corticosteroid Hormone Receptor Agonists [MoA], Corticosteroid [EPC]
NDC exclude flag
No
Listing certified through
2027-12-31
Current FDA listing
Yes

Additional Listing Data#

Finished product
Yes
Brand name base
Halobetasol Propionate
Listing expiration
2027-12-31

Active Ingredients#

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

Harmonized Identifiers#

Field, Values table
FieldValues
Unii91A0K1TY3Z
Rxcui1789962

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
85437-008-60Halobetasol Propionate59 g in 1 BOTTLELOTION594
85437-008-60Halobetasol Propionate1 in 1 CARTONLOTION14

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
85437-008-60ML - Milliliter85437-008fa9fa110-e560-4f61-b6ac-49e4c65ef06c12026-04-20

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
1789962halobetasol propionate 0.05 % Topical LotionPSN4cb1f7b3-c412-6fc7-e063-6394a90a63c94
1789962halobetasol propionate 0.5 MG/ML Topical LotionSCD4cb1f7b3-c412-6fc7-e063-6394a90a63c94
1789962halobetasol propionate 0.05 % Topical LotionSY4cb1f7b3-c412-6fc7-e063-6394a90a63c94

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startSampleExclude flagStatus
85437-008-60854370008601 BOTTLE in 1 CARTON (85437-008-60) / 59 g in 1 BOTTLE1 bottle2026-03-10NoNoHistorical