Home NDC 0187-0653 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 42 .
Orange Book products# Current product rows page 1 of 1 · 1 matching rows.
Application-product, Trade name, Ingredient table Application-product Trade name Ingredient Strength Dosage form / route TE codes RLD / RS Approval date N209354-001 DUOBRII HALOBETASOL PROPIONATE; TAZAROTENE 0.01%;0.045% LOTION / TOPICAL AB RLD, RS 2019-04-25
Therapeutic equivalence codes# Current TE-code rows page 1 of 1 · 1 matching rows.
Application-product, TE code table Application-product TE code N209354-001 AB
Orange Book patents# Current patent rows page 1 of 1 · 10 matching rows.
Application-product, Patent, Expiration table Application-product Patent Expiration Use code Coverage / status Submission date N209354-001 10478502 2031-11-02 U-2625 Drug product 2019-11-22 N209354-001 11839656 2031-11-02 U-2625 2024-01-05 N209354-001 11957753 2031-11-02 Drug product 2024-05-10 N209354-001 11986527 2031-11-02 U-2625 2024-06-13 N209354-001 12076403 2031-11-02 Drug product 2024-09-24 N209354-001 8809307 2031-11-02 Drug product 2019-04-30 N209354-001 10251895 2036-06-06 Drug product 2019-04-26 N209354-001 10426787 2036-06-06 U-2625 2019-10-09 N209354-001 11648256 2036-06-06 U-2625 Drug product 2023-06-13 N209354-001 11679115 2036-06-06 U-2625 Drug product 2023-07-13
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.
Product history page 1 of 2 · 42 observed states.
Captured, Edition, Application-product table Captured Edition Application-product Trade name Strength Dosage form / route Product TE source text RLD / RS Approval date Source SHA-256 2026-08-18 06:07:40 2026-07 N209354-001 DUOBRII 0.01%;0.045% LOTION / TOPICAL AB RLD, RS 2019-04-25 caaa826d4ba7…2026-02-19 14:30 UTC 2026-02 N209354-001 DUOBRII 0.01%;0.045% LOTION / TOPICAL AB RLD, RS 2019-04-25 011fe1cb6892…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 N209354-001 DUOBRII 0.01%;0.045% LOTION / TOPICAL AB RLD, RS 2019-04-25 31067a03dcf5…2025-08-23 18:47 UTC 2025-08 N209354-001 DUOBRII 0.01%;0.045% LOTION / TOPICAL AB RLD, RS 2019-04-25 6a471c1ec25d…2025-03-22 03:13 UTC · 3 captures of this ZIP 2025-03 N209354-001 DUOBRII 0.01%;0.045% LOTION / TOPICAL RLD, RS 2019-04-25 fd3edfee7708…2025-02-26 10:13 UTC · 3 captures of this ZIP 2025-02 N209354-001 DUOBRII 0.01%;0.045% LOTION / TOPICAL RLD, RS 2019-04-25 b8a1b40f171c…2025-01-19 17:59 UTC · 7 captures of this ZIP 2025-01 N209354-001 DUOBRII 0.01%;0.045% LOTION / TOPICAL RLD, RS 2019-04-25 03ed91905a0d…2024-12-13 21:23 UTC · 2 captures of this ZIP 2024-12 N209354-001 DUOBRII 0.01%;0.045% LOTION / TOPICAL RLD, RS 2019-04-25 2680178bc6a6…2024-09-14 05:58 UTC · 2 captures of this ZIP 2024-09 N209354-001 DUOBRII 0.01%;0.045% LOTION / TOPICAL RLD, RS 2019-04-25 5bbf6a4d5a75…2024-11-08 22:44 UTC · 3 captures of this ZIP 2024-11 N209354-001 DUOBRII 0.01%;0.045% LOTION / TOPICAL RLD, RS 2019-04-25 d8e5a09893c0…2024-10-29 15:01 UTC 2024-10 N209354-001 DUOBRII 0.01%;0.045% LOTION / TOPICAL RLD, RS 2019-04-25 d06236e962d9…2024-08-13 05:28 UTC · 3 captures of this ZIP 2024-08 N209354-001 DUOBRII 0.01%;0.045% LOTION / TOPICAL RLD, RS 2019-04-25 79d66fd596c7…2024-07-13 05:37 UTC · 2 captures of this ZIP 2024-07 N209354-001 DUOBRII 0.01%;0.045% LOTION / TOPICAL RLD, RS 2019-04-25 301d65b070ca…2024-06-18 03:08 UTC · 5 captures of this ZIP 2024-06 N209354-001 DUOBRII 0.01%;0.045% LOTION / TOPICAL RLD, RS 2019-04-25 1e350fbaab3a…2024-05-31 18:47 UTC 2024-05 N209354-001 DUOBRII 0.01%;0.045% LOTION / TOPICAL RLD, RS 2019-04-25 8072bd15b7f6…2022-06-29 02:47 UTC · 2 captures of this ZIP 2022-06 N209354-001 DUOBRII 0.01%;0.045% LOTION / TOPICAL RLD, RS 2019-04-25 5c6f7cd8ea54…2022-04-08 23:34 UTC 2022-04 N209354-001 DUOBRII 0.01%;0.045% LOTION / TOPICAL RLD, RS 2019-04-25 5d02ea3f76ae…2022-04-04 05:41 UTC 2022-04 N209354-001 DUOBRII 0.01%;0.045% LOTION / TOPICAL RLD, RS 2019-04-25 4b0b4de00fa7…2019-12-13 00:20 UTC 2019-12 N209354-001 DUOBRII 0.01%;0.045% LOTION / TOPICAL RLD, RS 2019-04-25 74a2ff9319b5…2022-03-09 01:35 UTC 2022-03 N209354-001 DUOBRII 0.01%;0.045% LOTION / TOPICAL RLD, RS 2019-04-25 bb7c543d1eb4…2021-12-28 21:50 UTC 2021-12 N209354-001 DUOBRII 0.01%;0.045% LOTION / TOPICAL RLD, RS 2019-04-25 782e0a99824c…2021-05-05 16:15 UTC · 3 captures of this ZIP 2021-05 N209354-001 DUOBRII 0.01%;0.045% LOTION / TOPICAL RLD, RS 2019-04-25 87673890dc5c…2021-03-12 10:30 UTC 2021-03 N209354-001 DUOBRII 0.01%;0.045% LOTION / TOPICAL RLD, RS 2019-04-25 5aa47cf7b7d7…2020-12-22 03:56 UTC 2020-12 N209354-001 DUOBRII 0.01%;0.045% LOTION / TOPICAL RLD, RS 2019-04-25 8869cabd3fbd…2020-11-12 02:37 UTC 2020-11 N209354-001 DUOBRII 0.01%;0.045% LOTION / TOPICAL RLD, RS 2019-04-25 c0c555d07b60…2019-12-14 00:12 UTC 2019-12 N209354-001 DUOBRII 0.01%;0.045% LOTION / TOPICAL RLD, RS 2019-04-25 3f01610625f2…2019-09-15 20:21 UTC 2019-09 N209354-001 DUOBRII 0.01%;0.045% LOTION / TOPICAL RLD, RS 2019-04-25 b00525d2431f…2019-07-19 19:46 UTC 2019-07 N209354-001 DUOBRII 0.01%;0.045% LOTION / TOPICAL RLD, RS 2019-04-25 ea99ee380514…2024-03-16 18:09 UTC · 4 captures of this ZIP 2024-03 N209354-001 DUOBRII 0.01%;0.045% LOTION / TOPICAL RLD, RS 2019-04-25 6a51e52b5d6a…2024-02-18 07:12 UTC 2024-02 N209354-001 DUOBRII 0.01%;0.045% LOTION / TOPICAL RLD, RS 2019-04-25 1c564ffb4f44…2023-12-20 04:57 UTC 2023-12 N209354-001 DUOBRII 0.01%;0.045% LOTION / TOPICAL RLD, RS 2019-04-25 ea1830bbd6c7…2023-11-28 05:40 UTC · 2 captures of this ZIP 2023-11 N209354-001 DUOBRII 0.01%;0.045% LOTION / TOPICAL RLD, RS 2019-04-25 a72a2bbeb626…2023-10-25 00:34 UTC · 2 captures of this ZIP 2023-10 N209354-001 DUOBRII 0.01%;0.045% LOTION / TOPICAL RLD, RS 2019-04-25 9b2671bbb829…2023-07-15 15:27 UTC · 2 captures of this ZIP 2023-07 N209354-001 DUOBRII 0.01%;0.045% LOTION / TOPICAL RLD, RS 2019-04-25 a67488948f0b…2023-06-13 01:57 UTC · 3 captures of this ZIP 2023-06 N209354-001 DUOBRII 0.01%;0.045% LOTION / TOPICAL RLD, RS 2019-04-25 3f0d92c62455…2023-05-13 08:27 UTC 2023-05 N209354-001 DUOBRII 0.01%;0.045% LOTION / TOPICAL RLD, RS 2019-04-25 053a50430f4f…2023-01-26 05:58 UTC 2023-01 N209354-001 DUOBRII 0.01%;0.045% LOTION / TOPICAL RLD, RS 2019-04-25 3bdfa0b2c4d7…2022-11-12 20:34 UTC · 5 captures of this ZIP 2022-11 N209354-001 DUOBRII 0.01%;0.045% LOTION / TOPICAL RLD, RS 2019-04-25 3a93d1ddd44b…2022-10-28 04:53 UTC 2022-10 N209354-001 DUOBRII 0.01%;0.045% LOTION / TOPICAL RLD, RS 2019-04-25 f41ea6bd6efb…2022-09-29 23:25 UTC 2022-09 N209354-001 DUOBRII 0.01%;0.045% LOTION / TOPICAL RLD, RS 2019-04-25 e64feba35796…
Observed Orange Book normalized TE history# Observed Orange Book patent history# Patent history page 1 of 7 · 271 observed states.
Captured, Edition, Application-product table Captured Edition Application-product Patent Expiration Use code Coverage / status Submission date Source SHA-256 2026-08-18 06:07:40 2026-07 N209354-001 10478502 2031-11-02 U-2625 Drug product 2019-11-22 caaa826d4ba7…2026-08-18 06:07:40 2026-07 N209354-001 11839656 2031-11-02 U-2625 2024-01-05 caaa826d4ba7…2026-08-18 06:07:40 2026-07 N209354-001 11957753 2031-11-02 Drug product 2024-05-10 caaa826d4ba7…2026-08-18 06:07:40 2026-07 N209354-001 11986527 2031-11-02 U-2625 2024-06-13 caaa826d4ba7…2026-08-18 06:07:40 2026-07 N209354-001 12076403 2031-11-02 Drug product 2024-09-24 caaa826d4ba7…2026-08-18 06:07:40 2026-07 N209354-001 8809307 2031-11-02 Drug product 2019-04-30 caaa826d4ba7…2026-08-18 06:07:40 2026-07 N209354-001 10251895 2036-06-06 Drug product 2019-04-26 caaa826d4ba7…2026-08-18 06:07:40 2026-07 N209354-001 10426787 2036-06-06 U-2625 2019-10-09 caaa826d4ba7…2026-08-18 06:07:40 2026-07 N209354-001 11648256 2036-06-06 U-2625 Drug product 2023-06-13 caaa826d4ba7…2026-08-18 06:07:40 2026-07 N209354-001 11679115 2036-06-06 U-2625 Drug product 2023-07-13 caaa826d4ba7…2026-02-19 14:30 UTC 2026-02 N209354-001 10478502 2031-11-02 U-2625 Drug product 2019-11-22 011fe1cb6892…2026-02-19 14:30 UTC 2026-02 N209354-001 11839656 2031-11-02 U-2625 2024-01-05 011fe1cb6892…2026-02-19 14:30 UTC 2026-02 N209354-001 11957753 2031-11-02 Drug product 2024-05-10 011fe1cb6892…2026-02-19 14:30 UTC 2026-02 N209354-001 11986527 2031-11-02 U-2625 2024-06-13 011fe1cb6892…2026-02-19 14:30 UTC 2026-02 N209354-001 12076403 2031-11-02 Drug product 2024-09-24 011fe1cb6892…2026-02-19 14:30 UTC 2026-02 N209354-001 8809307 2031-11-02 Drug product 2019-04-30 011fe1cb6892…2026-02-19 14:30 UTC 2026-02 N209354-001 10251895 2036-06-06 Drug product 2019-04-26 011fe1cb6892…2026-02-19 14:30 UTC 2026-02 N209354-001 10426787 2036-06-06 U-2625 2019-10-09 011fe1cb6892…2026-02-19 14:30 UTC 2026-02 N209354-001 11648256 2036-06-06 U-2625 Drug product 2023-06-13 011fe1cb6892…2026-02-19 14:30 UTC 2026-02 N209354-001 11679115 2036-06-06 U-2625 Drug product 2023-07-13 011fe1cb6892…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 N209354-001 10478502 2031-11-02 U-2625 Drug product 2019-11-22 31067a03dcf5…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 N209354-001 11839656 2031-11-02 U-2625 2024-01-05 31067a03dcf5…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 N209354-001 11957753 2031-11-02 Drug product 2024-05-10 31067a03dcf5…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 N209354-001 11986527 2031-11-02 U-2625 2024-06-13 31067a03dcf5…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 N209354-001 12076403 2031-11-02 Drug product 2024-09-24 31067a03dcf5…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 N209354-001 8809307 2031-11-02 Drug product 2019-04-30 31067a03dcf5…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 N209354-001 10251895 2036-06-06 Drug product 2019-04-26 31067a03dcf5…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 N209354-001 10426787 2036-06-06 U-2625 2019-10-09 31067a03dcf5…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 N209354-001 11648256 2036-06-06 U-2625 Drug product 2023-06-13 31067a03dcf5…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 N209354-001 11679115 2036-06-06 U-2625 Drug product 2023-07-13 31067a03dcf5…2025-08-23 18:47 UTC 2025-08 N209354-001 10478502 2031-11-02 U-2625 Drug product 2019-11-22 6a471c1ec25d…2025-08-23 18:47 UTC 2025-08 N209354-001 11839656 2031-11-02 U-2625 2024-01-05 6a471c1ec25d…2025-08-23 18:47 UTC 2025-08 N209354-001 11957753 2031-11-02 Drug product 2024-05-10 6a471c1ec25d…2025-08-23 18:47 UTC 2025-08 N209354-001 11986527 2031-11-02 U-2625 2024-06-13 6a471c1ec25d…2025-08-23 18:47 UTC 2025-08 N209354-001 12076403 2031-11-02 Drug product 2024-09-24 6a471c1ec25d…2025-08-23 18:47 UTC 2025-08 N209354-001 8809307 2031-11-02 Drug product 2019-04-30 6a471c1ec25d…2025-08-23 18:47 UTC 2025-08 N209354-001 10251895 2036-06-06 Drug product 2019-04-26 6a471c1ec25d…2025-08-23 18:47 UTC 2025-08 N209354-001 10426787 2036-06-06 U-2625 2019-10-09 6a471c1ec25d…2025-08-23 18:47 UTC 2025-08 N209354-001 11648256 2036-06-06 U-2625 Drug product 2023-06-13 6a471c1ec25d…2025-08-23 18:47 UTC 2025-08 N209354-001 11679115 2036-06-06 U-2625 Drug product 2023-07-13 6a471c1ec25d…
Observed Orange Book exclusivity history# Additional Listing Data#
Finished product Yes
Brand name base Duobrii
Listing expiration 2026-12-31 Active Ingredients# Ingredient, Strength table Ingredient Strength 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 Identifier FDA.report destination 91A0K1TY3Z Internal UNII lookup 81BDR9Y8PS Internal UNII lookup
Harmonized RxCUI identifiers# RxCUI identifiers page 1 of 1 · 2 matching rows.
Identifier, FDA.report destination table Identifier FDA.report destination 2166089 Internal RxNorm lookup 2166094 Internal RxNorm lookup
Harmonized SPL set identifiers# SPL set identifiers page 1 of 1 · 1 matching rows.
DailyMed Product Concepts# DailyMed Package Descriptions# Package NDC, Product, Description table Package NDC Product Description Form Quantity Strength SPL version 0187-0653-01 Duobrii 100 g in 1 TUBE LOTION 100 6 0187-0653-01 Duobrii 1 in 1 CARTON LOTION 1 6 0187-0653-03 Duobrii 3 g in 1 TUBE LOTION 3 6 0187-0653-03 Duobrii 6 in 1 CARTON LOTION 6 6
DailyMed Dashboard NDC Coverage# NDC, Dashboard title, SPL version table NDC Dashboard title SPL version Validation Dashboard ZIP 0187-0653 DUOBRII (HALOBETASOL PROPIONATE AND TAZAROTENE) LOTION [BAUSCH HEALTH US, LLC] 6 Current NDC, Legacy NDC, 4 package rows 20230425_b3f0cdc0-69fd-43d1-baf2-d776a3a20715.zip
openFDA label cross-check# OpenFDA label data provides additional search and identifier links. DailyMed’s Structured Product Label is the canonical label on FDA.report. Matching records are deduplicated before they are shown below.
Matched openFDA labels page 1 of 1 · 1 matching rows.
Brand, Generic, Manufacturer table Brand Generic Manufacturer SPL set ID Effective date Available safety fields Join Duobrii HALOBETASOL PROPIONATE AND TAZAROTENE Bausch Health US, LLC b3f0cdc0-69fd-43d1-baf2-d776a3a20715 2020-01-01 Warnings, Adverse reactions Exact identifier application applno (NDA): 209354 application number: NDA209354 ndc (product): 0187-0653
DailyMed RxNorm Mappings# Packages# Package NDC, 11-digit format, Description table Package NDC 11-digit format Description Units Marketing start Marketing end Sample Exclude flag Status 0187-0653-01 00187065301 1 TUBE in 1 CARTON (0187-0653-01) / 100 g in 1 TUBE 1 tube 2019-04-25 0000-00-00 No No Current 0187-0653-03 00187065303 6 TUBE in 1 CARTON (0187-0653-03) / 3 g in 1 TUBE 6 tube 2019-04-25 0000-00-00 Yes No Current