Halobetasol propionate

Product NDC
68308-769
11-digit product format
683080769
Labeler code
68308
Product ID
68308-769_096144f6-b603-41a6-b2a6-760e3a5c43c5
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
Halobetasol propionate
Dosage form
AEROSOL, FOAM
Route
TOPICAL
Labeler
Mayne Pharma
Application
ANDA215266
Marketing category
ANDA
Marketing start
2023-11-27
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
Rxcui2047646

DailyMed Product Concepts#

Product concept, Relation, Version table
Product conceptRelationVersionEffective
a107c35c-2cb4-4734-a92b-e9ed5cfc34d6Product name220260220
9314f950-fe47-4276-b1f9-66d9d4a64eaeProduct name120220217
c6f86816-7da6-43ea-8c25-ac9758311cc5Product name120220118
0bc08e12-b8ed-4802-abab-926d5509afb3Product name120210513
608e9379-3a63-4bf4-b035-b393ae8faa97Product name120190214
252e11b6-1a9a-4283-a242-df2c129c496dProduct name320170717
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
68308-769-50Halobetasol propionate1 in 1 CARTONAEROSOL, FOAM13
68308-769-50Halobetasol propionate50 g in 1 CANISTERAEROSOL, FOAM503

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
68308-769-50GM - Gram68308-769ece42990-3d1f-4503-89be-1233d7eb6fff12024-01-04

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
68308-769HALOBETASOL PROPIONATE AEROSOL, FOAM [MAYNE PHARMA]2Current NDC, 2 package rows20231205_24c41e6d-a314-4984-b45f-e5aa1fffa9b6.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
2047646halobetasol propionate 0.05 % Topical FoamPSN24c41e6d-a314-4984-b45f-e5aa1fffa9b63
2047646halobetasol propionate 0.5 MG/ML Topical FoamSCD24c41e6d-a314-4984-b45f-e5aa1fffa9b63
2047646halobetasol propionate 0.05 % Topical FoamSY24c41e6d-a314-4984-b45f-e5aa1fffa9b63

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startSampleExclude flagStatus
68308-769-50683080769501 CANISTER in 1 CARTON (68308-769-50) / 50 g in 1 CANISTER1 canister2023-12-01NoNoHistorical