Bryhali

Product NDC
0187-0002
11-digit product format
001870002
Labeler code
0187
Product ID
0187-0002_e14757d5-86ff-41a8-8bde-14065af6899e
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
halobetasol propionate
Dosage form
LOTION
Route
TOPICAL
Labeler
Bausch Health US, LLC
Application
NDA209355
Marketing category
NDA
Marketing start
2018-11-06
Substance
HALOBETASOL PROPIONATE
Active strength
.1 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
Bryhali
Listing expiration
2026-12-31

Active Ingredients#

Ingredient, Strength table
IngredientStrength
HALOBETASOL PROPIONATE.1 mg/g

Harmonized Identifiers#

Field, Values table
FieldValues
Unii91A0K1TY3Z
Rxcui2101710, 2101715

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
0187-0002-01Bryhali100 g in 1 TUBELOTION1004
0187-0002-01Bryhali1 in 1 CARTONLOTION14
0187-0002-03Bryhali1 in 1 CARTONLOTION14
0187-0002-03Bryhali3 g in 1 TUBELOTION34
0187-0002-60Bryhali1 in 1 CARTONLOTION14
0187-0002-60Bryhali60 g in 1 TUBELOTION604

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
0187-0002-01GM - Gram0187-0002c3903580-5c02-4783-bbf6-38b65aae6aed12018-12-13
0187-0002-60GM - Gram0187-00028061991a-a378-4ec5-913c-f85bbd535c3012018-12-13

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
0187-0002BRYHALI (HALOBETASOL PROPIONATE) LOTION [BAUSCH HEALTH US, LLC]4Current NDC, Legacy NDC, 6 package rows20200805_d4bbb66a-3f9d-4091-b1b0-1cbc908432d3.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
2101715Bryhali 0.01 % Topical LotionPSNd4bbb66a-3f9d-4091-b1b0-1cbc908432d34
2101710halobetasol propionate 0.01 % Topical LotionPSNd4bbb66a-3f9d-4091-b1b0-1cbc908432d34
2101715halobetasol propionate 0.1 MG/ML Topical Lotion [Bryhali]SBDd4bbb66a-3f9d-4091-b1b0-1cbc908432d34
2101710halobetasol propionate 0.1 MG/ML Topical LotionSCDd4bbb66a-3f9d-4091-b1b0-1cbc908432d34
2101715Bryhali 0.01 % Topical LotionSYd4bbb66a-3f9d-4091-b1b0-1cbc908432d34
2101715Bryhali 0.1 MG/ML Topical LotionSYd4bbb66a-3f9d-4091-b1b0-1cbc908432d34
2101710halobetasol propionate 0.01 % Topical LotionSYd4bbb66a-3f9d-4091-b1b0-1cbc908432d34

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
0187-0002-01001870002011 TUBE in 1 CARTON (0187-0002-01) / 100 g in 1 TUBE1 tube2018-11-060000-00-00NoNoCurrent
0187-0002-03001870002031 TUBE in 1 CARTON (0187-0002-03) / 3 g in 1 TUBE1 tube2018-11-060000-00-00YesNoCurrent
0187-0002-60001870002601 TUBE in 1 CARTON (0187-0002-60) / 60 g in 1 TUBE1 tube2018-11-060000-00-00NoNoCurrent