ULTRAVATE

Product NDC
73159-008
11-digit product format
731590008
Labeler code
73159
Product ID
73159-008_32225bd7-54bb-93da-e063-6394a90aadc5
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
Halobetasol propionate
Dosage form
LOTION
Route
TOPICAL
Labeler
Lacer Pharma, LLC
Application
NDA208183
Marketing category
NDA
Marketing start
2025-04-06
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

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
N208183-001ULTRAVATEHALOBETASOL PROPIONATE0.05%LOTION / TOPICALRLD, RS2015-11-06

Orange Book patents#

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

Application-product, Patent, Expiration table
Application-productPatentExpirationUse codeCoverage / statusSubmission date
N208183-00189620282033-06-19U-1775Drug product2015-12-03

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 · 41 observed states.

Captured, Edition, Application-product table
CapturedEditionApplication-productTrade nameStrengthDosage form / routeProduct TE source textRLD / RSApproval dateSource SHA-256
2026-02-19 14:30 UTC2026-02N208183-001ULTRAVATE0.05%LOTION / TOPICALRLD, RS2015-11-06011fe1cb6892…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12N208183-001ULTRAVATE0.05%LOTION / TOPICALRLD, RS2015-11-0631067a03dcf5…
2025-08-23 18:47 UTC2025-08N208183-001ULTRAVATE0.05%LOTION / TOPICALRLD, RS2015-11-066a471c1ec25d…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03N208183-001ULTRAVATE0.05%LOTION / TOPICALRLD2015-11-06fd3edfee7708…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02N208183-001ULTRAVATE0.05%LOTION / TOPICALRLD2015-11-06b8a1b40f171c…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01N208183-001ULTRAVATE0.05%LOTION / TOPICALRLD2015-11-0603ed91905a0d…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12N208183-001ULTRAVATE0.05%LOTION / TOPICALRLD2015-11-062680178bc6a6…
2024-09-14 05:58 UTC · 2 captures of this ZIP2024-09N208183-001ULTRAVATE0.05%LOTION / TOPICALRLD2015-11-065bbf6a4d5a75…
2024-11-08 22:44 UTC · 3 captures of this ZIP2024-11N208183-001ULTRAVATE0.05%LOTION / TOPICALRLD2015-11-06d8e5a09893c0…
2024-10-29 15:01 UTC2024-10N208183-001ULTRAVATE0.05%LOTION / TOPICALRLD2015-11-06d06236e962d9…
2024-08-13 05:28 UTC · 3 captures of this ZIP2024-08N208183-001ULTRAVATE0.05%LOTION / TOPICALRLD2015-11-0679d66fd596c7…
2024-07-13 05:37 UTC · 2 captures of this ZIP2024-07N208183-001ULTRAVATE0.05%LOTION / TOPICALRLD2015-11-06301d65b070ca…
2024-06-18 03:08 UTC · 5 captures of this ZIP2024-06N208183-001ULTRAVATE0.05%LOTION / TOPICALRLD2015-11-061e350fbaab3a…
2024-05-31 18:47 UTC2024-05N208183-001ULTRAVATE0.05%LOTION / TOPICALRLD, RS2015-11-068072bd15b7f6…
2022-06-29 02:47 UTC · 2 captures of this ZIP2022-06N208183-001ULTRAVATE0.05%LOTION / TOPICALRLD, RS2015-11-065c6f7cd8ea54…
2022-04-08 23:34 UTC2022-04N208183-001ULTRAVATE0.05%LOTION / TOPICALRLD, RS2015-11-065d02ea3f76ae…
2022-04-04 05:41 UTC2022-04N208183-001ULTRAVATE0.05%LOTION / TOPICALRLD, RS2015-11-064b0b4de00fa7…
2019-12-13 00:20 UTC2019-12N208183-001ULTRAVATE0.05%LOTION / TOPICALRLD, RS2015-11-0674a2ff9319b5…
2022-03-09 01:35 UTC2022-03N208183-001ULTRAVATE0.05%LOTION / TOPICALRLD, RS2015-11-06bb7c543d1eb4…
2021-12-28 21:50 UTC2021-12N208183-001ULTRAVATE0.05%LOTION / TOPICALRLD, RS2015-11-06782e0a99824c…
2021-05-05 16:15 UTC · 3 captures of this ZIP2021-05N208183-001ULTRAVATE0.05%LOTION / TOPICALRLD, RS2015-11-0687673890dc5c…
2021-03-12 10:30 UTC2021-03N208183-001ULTRAVATE0.05%LOTION / TOPICALRLD, RS2015-11-065aa47cf7b7d7…
2020-12-22 03:56 UTC2020-12N208183-001ULTRAVATE0.05%LOTION / TOPICALRLD, RS2015-11-068869cabd3fbd…
2020-11-12 02:37 UTC2020-11N208183-001ULTRAVATE0.05%LOTION / TOPICALRLD, RS2015-11-06c0c555d07b60…
2019-12-14 00:12 UTC2019-12N208183-001ULTRAVATE0.05%LOTION / TOPICALRLD, RS2015-11-063f01610625f2…
2019-09-15 20:21 UTC2019-09N208183-001ULTRAVATE0.05%LOTION / TOPICALRLD, RS2015-11-06b00525d2431f…
2019-07-19 19:46 UTC2019-07N208183-001ULTRAVATE0.05%LOTION / TOPICALRLD, RS2015-11-06ea99ee380514…
2024-03-16 18:09 UTC · 4 captures of this ZIP2024-03N208183-001ULTRAVATE0.05%LOTION / TOPICALRLD, RS2015-11-066a51e52b5d6a…
2024-02-18 07:12 UTC2024-02N208183-001ULTRAVATE0.05%LOTION / TOPICALRLD, RS2015-11-061c564ffb4f44…
2023-12-20 04:57 UTC2023-12N208183-001ULTRAVATE0.05%LOTION / TOPICALRLD, RS2015-11-06ea1830bbd6c7…
2023-11-28 05:40 UTC · 2 captures of this ZIP2023-11N208183-001ULTRAVATE0.05%LOTION / TOPICALRLD, RS2015-11-06a72a2bbeb626…
2023-10-25 00:34 UTC · 2 captures of this ZIP2023-10N208183-001ULTRAVATE0.05%LOTION / TOPICALRLD, RS2015-11-069b2671bbb829…
2023-07-15 15:27 UTC · 2 captures of this ZIP2023-07N208183-001ULTRAVATE0.05%LOTION / TOPICALRLD, RS2015-11-06a67488948f0b…
2023-06-13 01:57 UTC · 3 captures of this ZIP2023-06N208183-001ULTRAVATE0.05%LOTION / TOPICALRLD, RS2015-11-063f0d92c62455…
2023-05-13 08:27 UTC2023-05N208183-001ULTRAVATE0.05%LOTION / TOPICALRLD, RS2015-11-06053a50430f4f…
2023-01-26 05:58 UTC2023-01N208183-001ULTRAVATE0.05%LOTION / TOPICALRLD, RS2015-11-063bdfa0b2c4d7…
2022-11-12 20:34 UTC · 5 captures of this ZIP2022-11N208183-001ULTRAVATE0.05%LOTION / TOPICALRLD, RS2015-11-063a93d1ddd44b…
2022-10-28 04:53 UTC2022-10N208183-001ULTRAVATE0.05%LOTION / TOPICALRLD, RS2015-11-06f41ea6bd6efb…
2022-09-29 23:25 UTC2022-09N208183-001ULTRAVATE0.05%LOTION / TOPICALRLD, RS2015-11-06e64feba35796…
2022-07-09 03:26 UTC · 3 captures of this ZIP2022-07N208183-001ULTRAVATE0.05%LOTION / TOPICALRLD, RS2015-11-06cb3db0bc1861…

Observed Orange Book patent history#

Patent history page 1 of 2 · 41 observed states.

Captured, Edition, Application-product table
CapturedEditionApplication-productPatentExpirationUse codeCoverage / statusSubmission dateSource SHA-256
2026-02-19 14:30 UTC2026-02N208183-00189620282033-06-19U-1775Drug product2015-12-03011fe1cb6892…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12N208183-00189620282033-06-19U-1775Drug product2015-12-0331067a03dcf5…
2025-08-23 18:47 UTC2025-08N208183-00189620282033-06-19U-1775Drug product2015-12-036a471c1ec25d…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03N208183-00189620282033-06-19U-1775Drug product2015-12-03fd3edfee7708…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02N208183-00189620282033-06-19U-1775Drug product2015-12-03b8a1b40f171c…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01N208183-00189620282033-06-19U-1775Drug product2015-12-0303ed91905a0d…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12N208183-00189620282033-06-19U-1775Drug product2015-12-032680178bc6a6…
2024-09-14 05:58 UTC · 2 captures of this ZIP2024-09N208183-00189620282033-06-19U-1775Drug product2015-12-035bbf6a4d5a75…
2024-11-08 22:44 UTC · 3 captures of this ZIP2024-11N208183-00189620282033-06-19U-1775Drug product2015-12-03d8e5a09893c0…
2024-10-29 15:01 UTC2024-10N208183-00189620282033-06-19U-1775Drug product2015-12-03d06236e962d9…
2024-08-13 05:28 UTC · 3 captures of this ZIP2024-08N208183-00189620282033-06-19U-1775Drug product2015-12-0379d66fd596c7…
2024-07-13 05:37 UTC · 2 captures of this ZIP2024-07N208183-00189620282033-06-19U-1775Drug product2015-12-03301d65b070ca…
2024-06-18 03:08 UTC · 5 captures of this ZIP2024-06N208183-00189620282033-06-19U-1775Drug product2015-12-031e350fbaab3a…
2024-05-31 18:47 UTC2024-05N208183-00189620282033-06-19U-1775Drug product2015-12-038072bd15b7f6…
2022-06-29 02:47 UTC · 2 captures of this ZIP2022-06N208183-00189620282033-06-19U-1775Drug product2015-12-035c6f7cd8ea54…
2022-04-08 23:34 UTC2022-04N208183-00189620282033-06-19U-1775Drug product2015-12-035d02ea3f76ae…
2022-04-04 05:41 UTC2022-04N208183-00189620282033-06-19U-1775Drug product2015-12-034b0b4de00fa7…
2019-12-13 00:20 UTC2019-12N208183-00189620282033-06-19U-1775Drug product2015-12-0374a2ff9319b5…
2022-03-09 01:35 UTC2022-03N208183-00189620282033-06-19U-1775Drug product2015-12-03bb7c543d1eb4…
2021-12-28 21:50 UTC2021-12N208183-00189620282033-06-19U-1775Drug product2015-12-03782e0a99824c…
2021-05-05 16:15 UTC · 3 captures of this ZIP2021-05N208183-00189620282033-06-19U-1775Drug product2015-12-0387673890dc5c…
2021-03-12 10:30 UTC2021-03N208183-00189620282033-06-19U-1775Drug product2015-12-035aa47cf7b7d7…
2020-12-22 03:56 UTC2020-12N208183-00189620282033-06-19U-1775Drug product2015-12-038869cabd3fbd…
2020-11-12 02:37 UTC2020-11N208183-00189620282033-06-19U-1775Drug product2015-12-03c0c555d07b60…
2019-12-14 00:12 UTC2019-12N208183-00189620282033-06-19U-1775Drug product2015-12-033f01610625f2…
2019-09-15 20:21 UTC2019-09N208183-00189620282033-06-19U-1775Drug product2015-12-03b00525d2431f…
2019-07-19 19:46 UTC2019-07N208183-00189620282033-06-19U-1775Drug product2015-12-03ea99ee380514…
2024-03-16 18:09 UTC · 4 captures of this ZIP2024-03N208183-00189620282033-06-19U-1775Drug product2015-12-036a51e52b5d6a…
2024-02-18 07:12 UTC2024-02N208183-00189620282033-06-19U-1775Drug product2015-12-031c564ffb4f44…
2023-12-20 04:57 UTC2023-12N208183-00189620282033-06-19U-1775Drug product2015-12-03ea1830bbd6c7…
2023-11-28 05:40 UTC · 2 captures of this ZIP2023-11N208183-00189620282033-06-19U-1775Drug product2015-12-03a72a2bbeb626…
2023-10-25 00:34 UTC · 2 captures of this ZIP2023-10N208183-00189620282033-06-19U-1775Drug product2015-12-039b2671bbb829…
2023-07-15 15:27 UTC · 2 captures of this ZIP2023-07N208183-00189620282033-06-19U-1775Drug product2015-12-03a67488948f0b…
2023-06-13 01:57 UTC · 3 captures of this ZIP2023-06N208183-00189620282033-06-19U-1775Drug product2015-12-033f0d92c62455…
2023-05-13 08:27 UTC2023-05N208183-00189620282033-06-19U-1775Drug product2015-12-03053a50430f4f…
2023-01-26 05:58 UTC2023-01N208183-00189620282033-06-19U-1775Drug product2015-12-033bdfa0b2c4d7…
2022-11-12 20:34 UTC · 5 captures of this ZIP2022-11N208183-00189620282033-06-19U-1775Drug product2015-12-033a93d1ddd44b…
2022-10-28 04:53 UTC2022-10N208183-00189620282033-06-19U-1775Drug product2015-12-03f41ea6bd6efb…
2022-09-29 23:25 UTC2022-09N208183-00189620282033-06-19U-1775Drug product2015-12-03e64feba35796…
2022-07-09 03:26 UTC · 3 captures of this ZIP2022-07N208183-00189620282033-06-19U-1775Drug product2015-12-03cb3db0bc1861…

Observed Orange Book exclusivity history#

Captured, Edition, Application-product table
CapturedEditionApplication-productExclusivity codeExpirationSource SHA-256
2022-06-29 02:47 UTC · 2 captures of this ZIP2022-06N208183-001NPP2023-08-315c6f7cd8ea54…
2022-04-08 23:34 UTC2022-04N208183-001NPP2023-08-315d02ea3f76ae…
2022-04-04 05:41 UTC2022-04N208183-001NPP2023-08-314b0b4de00fa7…
2022-03-09 01:35 UTC2022-03N208183-001NPP2023-08-31bb7c543d1eb4…
2021-12-28 21:50 UTC2021-12N208183-001NPP2023-08-31782e0a99824c…
2021-05-05 16:15 UTC · 3 captures of this ZIP2021-05N208183-001NPP2023-08-3187673890dc5c…
2021-03-12 10:30 UTC2021-03N208183-001NPP2023-08-315aa47cf7b7d7…
2020-12-22 03:56 UTC2020-12N208183-001NPP2023-08-318869cabd3fbd…
2020-11-12 02:37 UTC2020-11N208183-001NPP2023-08-31c0c555d07b60…
2023-12-20 04:57 UTC2023-12N208183-001NPP2023-08-31ea1830bbd6c7…
2023-11-28 05:40 UTC · 2 captures of this ZIP2023-11N208183-001NPP2023-08-31a72a2bbeb626…
2023-10-25 00:34 UTC · 2 captures of this ZIP2023-10N208183-001NPP2023-08-319b2671bbb829…
2023-07-15 15:27 UTC · 2 captures of this ZIP2023-07N208183-001NPP2023-08-31a67488948f0b…
2023-06-13 01:57 UTC · 3 captures of this ZIP2023-06N208183-001NPP2023-08-313f0d92c62455…
2023-05-13 08:27 UTC2023-05N208183-001NPP2023-08-31053a50430f4f…
2023-01-26 05:58 UTC2023-01N208183-001NPP2023-08-313bdfa0b2c4d7…
2022-11-12 20:34 UTC · 5 captures of this ZIP2022-11N208183-001NPP2023-08-313a93d1ddd44b…
2022-10-28 04:53 UTC2022-10N208183-001NPP2023-08-31f41ea6bd6efb…
2022-09-29 23:25 UTC2022-09N208183-001NPP2023-08-31e64feba35796…
2022-07-09 03:26 UTC · 3 captures of this ZIP2022-07N208183-001NPP2023-08-31cb3db0bc1861…

Additional Listing Data#

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

Active Ingredients#

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

Harmonized UNII identifiers#

UNII identifiers page 1 of 1 · 1 matching rows.

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

Harmonized RxCUI identifiers#

RxCUI identifiers page 1 of 1 · 2 matching rows.

Identifier, FDA.report destination table
IdentifierFDA.report destination
1789962Internal RxNorm lookup
1790329Internal RxNorm lookup

Harmonized SPL set identifiers#

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

Identifier, FDA.report destination table
IdentifierFDA.report destination
74e899db-1c1f-48b2-9913-5d32a14906aeAvailable on FDA.report

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
73159-008-60ULTRAVATE1 in 1 CARTONLOTION11
73159-008-60ULTRAVATE59 g in 1 BOTTLELOTION591

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
73159-008-60ML - Milliliter73159-00841156c44-0205-481e-b444-bfec1b8ccf4212025-06-13

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
73159-008ULTRAVATE (HALOBETASOL PROPIONATE) LOTION [LACER PHARMA, LLC]1Current NDC, 2 package rows20250430_74e899db-1c1f-48b2-9913-5d32a14906ae.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 · 2 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
Halobetasol PropionateHALOBETASOL PROPIONATECoral Way Pharma, LLC4cb1f7b3-c412-6fc7-e063-6394a90a63c92026-06-29Warnings, Adverse reactionsExact identifier
application applno (NDA): 208183
application number: NDA208183
ULTRAVATEHALOBETASOL PROPIONATELacer Pharma, LLC74e899db-1c1f-48b2-9913-5d32a14906ae2025-04-06Warnings, Adverse reactionsExact identifier
application applno (NDA): 208183
application number: NDA208183
ndc (product): 73159-008

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
1789962halobetasol propionate 0.05 % Topical LotionPSN74e899db-1c1f-48b2-9913-5d32a14906ae1
1790329Ultravate 0.05 % Topical LotionPSN74e899db-1c1f-48b2-9913-5d32a14906ae1
1790329halobetasol propionate 0.5 MG/ML Topical Lotion [Ultravate]SBD74e899db-1c1f-48b2-9913-5d32a14906ae1
1789962halobetasol propionate 0.5 MG/ML Topical LotionSCD74e899db-1c1f-48b2-9913-5d32a14906ae1
1789962halobetasol propionate 0.05 % Topical LotionSY74e899db-1c1f-48b2-9913-5d32a14906ae1
1790329Ultravate 0.05 % Topical LotionSY74e899db-1c1f-48b2-9913-5d32a14906ae1

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startSampleExclude flagStatus
73159-008-60731590008601 BOTTLE in 1 CARTON (73159-008-60) / 59 g in 1 BOTTLE1 bottle2025-04-06NoNoCurrent