FDA.reportPublic FDA data

Duobrii

Product NDC
0187-0653
11-digit product format
001870653
Labeler code
0187
Product ID
0187-0653_dbee276a-6a2e-4565-a106-09a5bcca8778
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
halobetasol propionate and tazarotene
Dosage form
LOTION
Route
TOPICAL
Labeler
Bausch Health US, LLC
Application
NDA209354
Marketing category
NDA
Marketing start
2019-04-25
Substance
HALOBETASOL PROPIONATE; TAZAROTENE
Active strength
.1; .45 mg/g; mg/g
Pharmacologic classes
Corticosteroid Hormone Receptor Agonists [MoA], Corticosteroid [EPC], Retinoid [EPC], Retinoids [CS]
NDC exclude flag
No
Listing certified through
2026-12-31
Current FDA listing
Yes

Source provenance: Browse the complete Orange Book source catalog · source snapshot 1.

Orange Book products#

Current product rows page 1 of 1 · 1 matching rows.

Application-product, Trade name, Ingredient table
Application-productTrade nameIngredientStrengthDosage form / routeTE codesRLD / RSApproval date
N209354-001DUOBRIIHALOBETASOL PROPIONATE; TAZAROTENE0.01%;0.045%LOTION / TOPICALABRLD, RS2019-04-25

Therapeutic equivalence codes#

Current TE-code rows page 1 of 1 · 1 matching rows.

Application-product, TE code table
Application-productTE code
N209354-001AB

Orange Book patents#

Current patent rows page 1 of 1 · 10 matching rows.

Application-product, Patent, Expiration table
Application-productPatentExpirationUse codeCoverage / statusSubmission date
N209354-001104785022031-11-02U-2625Drug product2019-11-22
N209354-001118396562031-11-02U-26252024-01-05
N209354-001119577532031-11-02Drug product2024-05-10
N209354-001119865272031-11-02U-26252024-06-13
N209354-001120764032031-11-02Drug product2024-09-24
N209354-00188093072031-11-02Drug product2019-04-30
N209354-001102518952036-06-06Drug product2019-04-26
N209354-001104267872036-06-06U-26252019-10-09
N209354-001116482562036-06-06U-2625Drug product2023-06-13
N209354-001116791152036-06-06U-2625Drug product2023-07-13

Observed Orange Book product history#

Observed FDA ZIP history: Each table is queried independently by exact application/product key from successfully parsed Orange Book snapshots. Capture times identify archived source observations; absence or a change between snapshots is not inferred. FDA publication files that were not recoverable as structured ZIP data are not represented as states.

Captured, Edition, Application-product table
CapturedEditionApplication-productTrade nameStrengthDosage form / routeProduct TE source textRLD / RSApproval dateSource SHA-256
2026-08-01 22:54:322026-06N209354-001DUOBRII0.01%;0.045%LOTION / TOPICALABRLD, RS2019-04-25a50c72e98297…

Observed Orange Book normalized TE history#

Captured, Edition, Application-product table
CapturedEditionApplication-productTE codeOrderSource SHA-256
2026-08-01 22:54:322026-06N209354-001AB1a50c72e98297…

Observed Orange Book patent history#

Captured, Edition, Application-product table
CapturedEditionApplication-productPatentExpirationUse codeCoverage / statusSubmission dateSource SHA-256
2026-08-01 22:54:322026-06N209354-001104785022031-11-02U-2625Drug product2019-11-22a50c72e98297…
2026-08-01 22:54:322026-06N209354-001118396562031-11-02U-26252024-01-05a50c72e98297…
2026-08-01 22:54:322026-06N209354-001119577532031-11-02Drug product2024-05-10a50c72e98297…
2026-08-01 22:54:322026-06N209354-001119865272031-11-02U-26252024-06-13a50c72e98297…
2026-08-01 22:54:322026-06N209354-001120764032031-11-02Drug product2024-09-24a50c72e98297…
2026-08-01 22:54:322026-06N209354-00188093072031-11-02Drug product2019-04-30a50c72e98297…
2026-08-01 22:54:322026-06N209354-001102518952036-06-06Drug product2019-04-26a50c72e98297…
2026-08-01 22:54:322026-06N209354-001104267872036-06-06U-26252019-10-09a50c72e98297…
2026-08-01 22:54:322026-06N209354-001116482562036-06-06U-2625Drug product2023-06-13a50c72e98297…
2026-08-01 22:54:322026-06N209354-001116791152036-06-06U-2625Drug product2023-07-13a50c72e98297…

openFDA label cross-check#

Cross-check layer: openFDA label JSON enriches search and identifies hydration gaps. The DailyMed Structured Product Label remains the canonical label presentation on FDA.report. Every label matching the complete exact-identifier union is deduplicated and paginated below.

Matched openFDA labels page 1 of 1 · 1 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
DuobriiHALOBETASOL PROPIONATE AND TAZAROTENEBausch Health US, LLCb3f0cdc0-69fd-43d1-baf2-d776a3a207152020-01-01Warnings, Adverse reactionsExact identifier
application applno (NDA): 209354
application number: NDA209354
ndc (product): 0187-0653

Additional Listing Data#

Finished product
Yes
Brand name base
Duobrii
Listing expiration
2026-12-31

Active Ingredients#

Ingredient, Strength table
IngredientStrength
HALOBETASOL PROPIONATE.1 mg/g
TAZAROTENE.45 mg/g

Harmonized UNII identifiers#

UNII identifiers page 1 of 1 · 2 matching rows.

Identifier, FDA.report destination table
IdentifierFDA.report destination
91A0K1TY3ZInternal UNII lookup
81BDR9Y8PSInternal UNII lookup

Harmonized RxCUI identifiers#

RxCUI identifiers page 1 of 1 · 2 matching rows.

Identifier, FDA.report destination table
IdentifierFDA.report destination
2166089Internal RxNorm lookup
2166094Internal RxNorm lookup

Harmonized SPL set identifiers#

SPL set identifiers page 1 of 1 · 1 matching rows.

Identifier, FDA.report destination table
IdentifierFDA.report destination
b3f0cdc0-69fd-43d1-baf2-d776a3a20715Available on FDA.report

DailyMed Product Concepts#

Product concept, Relation, Version table
Product conceptRelationVersionEffective
a107c35c-2cb4-4734-a92b-e9ed5cfc34d6Product name220260220
5993ea1b-833d-fa4b-caad-a0d477537538Product name520250305
c24b0f4e-b27e-8e2b-a129-1b5a6d72c459Product name220231128
9314f950-fe47-4276-b1f9-66d9d4a64eaeProduct name120220217
0bc08e12-b8ed-4802-abab-926d5509afb3Product name120210513
18da2240-e326-4d63-90cd-d6bb15f662a0Product name120200604
608e9379-3a63-4bf4-b035-b393ae8faa97Product name120190214
83c1408d-b2bb-43b6-84ca-4f3e3e6f11d3Product name120151123
9badac54-f0c2-d87e-de70-c4ea0b9cf6a2Product name120140508
a32b252c-8cd2-cc4a-c64c-4b9d3916df9eProduct name120140508
ee2f33ab-1561-3107-e994-434cb17b4d06Product name120140508

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
0187-0653-01Duobrii100 g in 1 TUBELOTION1006
0187-0653-01Duobrii1 in 1 CARTONLOTION16
0187-0653-03Duobrii3 g in 1 TUBELOTION36
0187-0653-03Duobrii6 in 1 CARTONLOTION66

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
0187-0653-01GM - Gram0187-06537b4dde3a-5bab-45d9-b36d-bba27292056512019-05-02

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
0187-0653DUOBRII (HALOBETASOL PROPIONATE AND TAZAROTENE) LOTION [BAUSCH HEALTH US, LLC]6Current NDC, Legacy NDC, 4 package rows20230425_b3f0cdc0-69fd-43d1-baf2-d776a3a20715.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
2166094Duobrii 0.01 % / 0.045 % Topical LotionPSNb3f0cdc0-69fd-43d1-baf2-d776a3a207156
2166089halobetasol propionate 0.01 % / tazarotene 0.045 % Topical LotionPSNb3f0cdc0-69fd-43d1-baf2-d776a3a207156
2166094halobetasol propionate 0.1 MG/ML / tazarotene 0.45 MG/ML Topical Lotion [Duobrii]SBDb3f0cdc0-69fd-43d1-baf2-d776a3a207156
2166089halobetasol propionate 0.1 MG/ML / tazarotene 0.45 MG/ML Topical LotionSCDb3f0cdc0-69fd-43d1-baf2-d776a3a207156
2166094Duobrii 0.01 % / 0.045 % Topical LotionSYb3f0cdc0-69fd-43d1-baf2-d776a3a207156
2166089halobetasol propionate 0.01 % / tazarotene 0.045 % Topical LotionSYb3f0cdc0-69fd-43d1-baf2-d776a3a207156

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
0187-0653-01001870653011 TUBE in 1 CARTON (0187-0653-01) / 100 g in 1 TUBE1 tube2019-04-250000-00-00NoNoCurrent
0187-0653-03001870653036 TUBE in 1 CARTON (0187-0653-03) / 3 g in 1 TUBE6 tube2019-04-250000-00-00YesNoCurrent