Impoyz

Product NDC
68040-713
11-digit product format
680400713
Labeler code
68040
Product ID
68040-713_a5624741-36f8-4f2f-8e8b-b235571727ae
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
clobetasol propionate
Dosage form
CREAM
Route
TOPICAL
Labeler
Primus Pharmaceuticals, Inc.
Application
NDA209483
Marketing category
NDA
Marketing start
2021-12-01
Substance
CLOBETASOL PROPIONATE
Active strength
.25 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
N209483-001IMPOYZCLOBETASOL PROPIONATE0.025%CREAM / TOPICALRLD, RS2017-11-28

Orange Book patents#

Current patent rows page 1 of 1 · 14 matching rows.

Application-product, Patent, Expiration table
Application-productPatentExpirationUse codeCoverage / statusSubmission date
N209483-001100648752030-08-31U-1408Drug product2018-09-10
N209483-001100648752030-08-31U-1858Drug product2018-09-10
N209483-001100648752030-08-31U-193Drug product2018-09-10
N209483-001100648752030-08-31U-742Drug product2018-09-10
N209483-001100648752030-08-31U-88Drug product2018-09-10
N209483-001105889142030-08-31U-2771Drug product2020-04-08
N209483-001111794652030-08-31U-1858Drug product2026-03-03
N209483-00199562312030-08-31U-1408Drug product2018-05-21
N209483-00199562312030-08-31U-1761Drug product2018-05-21
N209483-00199562312030-08-31U-1858Drug product2018-05-21
N209483-00199562312030-08-31U-193Drug product2018-05-21
N209483-00199562312030-08-31U-742Drug product2018-05-21
N209483-00199562312030-08-31U-88Drug product2018-05-21
N209483-00198553342035-03-11Drug product2018-01-04

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 UTC2026-02N209483-001IMPOYZ0.025%CREAM / TOPICALRLD, RS2017-11-28011fe1cb6892…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12N209483-001IMPOYZ0.025%CREAM / TOPICALRLD, RS2017-11-2831067a03dcf5…
2025-08-23 18:47 UTC2025-08N209483-001IMPOYZ0.025%CREAM / TOPICALRLD, RS2017-11-286a471c1ec25d…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03N209483-001IMPOYZ0.025%CREAM / TOPICALRLD, RS2017-11-28fd3edfee7708…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02N209483-001IMPOYZ0.025%CREAM / TOPICALRLD, RS2017-11-28b8a1b40f171c…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01N209483-001IMPOYZ0.025%CREAM / TOPICALRLD, RS2017-11-2803ed91905a0d…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12N209483-001IMPOYZ0.025%CREAM / TOPICALRLD, RS2017-11-282680178bc6a6…
2024-09-14 05:58 UTC · 2 captures of this ZIP2024-09N209483-001IMPOYZ0.025%CREAM / TOPICALRLD, RS2017-11-285bbf6a4d5a75…
2024-11-08 22:44 UTC · 3 captures of this ZIP2024-11N209483-001IMPOYZ0.025%CREAM / TOPICALRLD, RS2017-11-28d8e5a09893c0…
2024-10-29 15:01 UTC2024-10N209483-001IMPOYZ0.025%CREAM / TOPICALRLD, RS2017-11-28d06236e962d9…
2024-08-13 05:28 UTC · 3 captures of this ZIP2024-08N209483-001IMPOYZ0.025%CREAM / TOPICALRLD, RS2017-11-2879d66fd596c7…
2024-07-13 05:37 UTC · 2 captures of this ZIP2024-07N209483-001IMPOYZ0.025%CREAM / TOPICALRLD, RS2017-11-28301d65b070ca…
2024-06-18 03:08 UTC · 5 captures of this ZIP2024-06N209483-001IMPOYZ0.025%CREAM / TOPICALRLD, RS2017-11-281e350fbaab3a…
2024-05-31 18:47 UTC2024-05N209483-001IMPOYZ0.025%CREAM / TOPICALRLD, RS2017-11-288072bd15b7f6…
2022-06-29 02:47 UTC · 2 captures of this ZIP2022-06N209483-001IMPOYZ0.025%CREAM / TOPICALRLD, RS2017-11-285c6f7cd8ea54…
2022-04-08 23:34 UTC2022-04N209483-001IMPOYZ0.025%CREAM / TOPICALRLD, RS2017-11-285d02ea3f76ae…
2022-04-04 05:41 UTC2022-04N209483-001IMPOYZ0.025%CREAM / TOPICALRLD, RS2017-11-284b0b4de00fa7…
2019-12-13 00:20 UTC2019-12N209483-001IMPOYZ0.025%CREAM / TOPICALRLD, RS2017-11-2874a2ff9319b5…
2022-03-09 01:35 UTC2022-03N209483-001IMPOYZ0.025%CREAM / TOPICALRLD, RS2017-11-28bb7c543d1eb4…
2021-12-28 21:50 UTC2021-12N209483-001IMPOYZ0.025%CREAM / TOPICALRLD, RS2017-11-28782e0a99824c…
2021-05-05 16:15 UTC · 3 captures of this ZIP2021-05N209483-001IMPOYZ0.025%CREAM / TOPICALRLD, RS2017-11-2887673890dc5c…
2021-03-12 10:30 UTC2021-03N209483-001IMPOYZ0.025%CREAM / TOPICALRLD, RS2017-11-285aa47cf7b7d7…
2020-12-22 03:56 UTC2020-12N209483-001IMPOYZ0.025%CREAM / TOPICALRLD, RS2017-11-288869cabd3fbd…
2020-11-12 02:37 UTC2020-11N209483-001IMPOYZ0.025%CREAM / TOPICALRLD, RS2017-11-28c0c555d07b60…
2019-12-14 00:12 UTC2019-12N209483-001IMPOYZ0.025%CREAM / TOPICALRLD, RS2017-11-283f01610625f2…
2019-09-15 20:21 UTC2019-09N209483-001IMPOYZ0.025%CREAM / TOPICALRLD, RS2017-11-28b00525d2431f…
2019-07-19 19:46 UTC2019-07N209483-001IMPOYZ0.025%CREAM / TOPICALRLD, RS2017-11-28ea99ee380514…
2024-03-16 18:09 UTC · 4 captures of this ZIP2024-03N209483-001IMPOYZ0.025%CREAM / TOPICALRLD, RS2017-11-286a51e52b5d6a…
2024-02-18 07:12 UTC2024-02N209483-001IMPOYZ0.025%CREAM / TOPICALRLD, RS2017-11-281c564ffb4f44…
2023-12-20 04:57 UTC2023-12N209483-001IMPOYZ0.025%CREAM / TOPICALRLD, RS2017-11-28ea1830bbd6c7…
2023-11-28 05:40 UTC · 2 captures of this ZIP2023-11N209483-001IMPOYZ0.025%CREAM / TOPICALRLD, RS2017-11-28a72a2bbeb626…
2023-10-25 00:34 UTC · 2 captures of this ZIP2023-10N209483-001IMPOYZ0.025%CREAM / TOPICALRLD, RS2017-11-289b2671bbb829…
2023-07-15 15:27 UTC · 2 captures of this ZIP2023-07N209483-001IMPOYZ0.025%CREAM / TOPICALRLD, RS2017-11-28a67488948f0b…
2023-06-13 01:57 UTC · 3 captures of this ZIP2023-06N209483-001IMPOYZ0.025%CREAM / TOPICALRLD, RS2017-11-283f0d92c62455…
2023-05-13 08:27 UTC2023-05N209483-001IMPOYZ0.025%CREAM / TOPICALRLD, RS2017-11-28053a50430f4f…
2023-01-26 05:58 UTC2023-01N209483-001IMPOYZ0.025%CREAM / TOPICALRLD, RS2017-11-283bdfa0b2c4d7…
2022-11-12 20:34 UTC · 5 captures of this ZIP2022-11N209483-001IMPOYZ0.025%CREAM / TOPICALRLD, RS2017-11-283a93d1ddd44b…
2022-10-28 04:53 UTC2022-10N209483-001IMPOYZ0.025%CREAM / TOPICALRLD, RS2017-11-28f41ea6bd6efb…
2022-09-29 23:25 UTC2022-09N209483-001IMPOYZ0.025%CREAM / TOPICALRLD, RS2017-11-28e64feba35796…
2022-07-09 03:26 UTC · 3 captures of this ZIP2022-07N209483-001IMPOYZ0.025%CREAM / TOPICALRLD, RS2017-11-28cb3db0bc1861…

Observed Orange Book patent history#

Patent history page 1 of 14 · 530 observed states.

Captured, Edition, Application-product table
CapturedEditionApplication-productPatentExpirationUse codeCoverage / statusSubmission dateSource SHA-256
2026-02-19 14:30 UTC2026-02N209483-001100648752030-08-31U-88Drug product2018-09-10011fe1cb6892…
2026-02-19 14:30 UTC2026-02N209483-001100648752030-08-31U-1858Drug product2018-09-10011fe1cb6892…
2026-02-19 14:30 UTC2026-02N209483-001100648752030-08-31U-193Drug product2018-09-10011fe1cb6892…
2026-02-19 14:30 UTC2026-02N209483-001100648752030-08-31U-1408Drug product2018-09-10011fe1cb6892…
2026-02-19 14:30 UTC2026-02N209483-001100648752030-08-31U-742Drug product2018-09-10011fe1cb6892…
2026-02-19 14:30 UTC2026-02N209483-001105889142030-08-31U-2771Drug product2020-04-08011fe1cb6892…
2026-02-19 14:30 UTC2026-02N209483-00199562312030-08-31U-88Drug product2018-05-21011fe1cb6892…
2026-02-19 14:30 UTC2026-02N209483-00199562312030-08-31U-1408Drug product2018-05-21011fe1cb6892…
2026-02-19 14:30 UTC2026-02N209483-00199562312030-08-31U-193Drug product2018-05-21011fe1cb6892…
2026-02-19 14:30 UTC2026-02N209483-00199562312030-08-31U-742Drug product2018-05-21011fe1cb6892…
2026-02-19 14:30 UTC2026-02N209483-00199562312030-08-31U-1858Drug product2018-05-21011fe1cb6892…
2026-02-19 14:30 UTC2026-02N209483-00199562312030-08-31U-1761Drug product2018-05-21011fe1cb6892…
2026-02-19 14:30 UTC2026-02N209483-00198553342035-03-11Drug product2018-01-04011fe1cb6892…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12N209483-001100648752030-08-31U-88Drug product2018-09-1031067a03dcf5…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12N209483-001100648752030-08-31U-1858Drug product2018-09-1031067a03dcf5…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12N209483-001100648752030-08-31U-193Drug product2018-09-1031067a03dcf5…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12N209483-001100648752030-08-31U-1408Drug product2018-09-1031067a03dcf5…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12N209483-001100648752030-08-31U-742Drug product2018-09-1031067a03dcf5…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12N209483-001105889142030-08-31U-2771Drug product2020-04-0831067a03dcf5…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12N209483-00199562312030-08-31U-88Drug product2018-05-2131067a03dcf5…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12N209483-00199562312030-08-31U-1408Drug product2018-05-2131067a03dcf5…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12N209483-00199562312030-08-31U-193Drug product2018-05-2131067a03dcf5…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12N209483-00199562312030-08-31U-742Drug product2018-05-2131067a03dcf5…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12N209483-00199562312030-08-31U-1858Drug product2018-05-2131067a03dcf5…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12N209483-00199562312030-08-31U-1761Drug product2018-05-2131067a03dcf5…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12N209483-00198553342035-03-11Drug product2018-01-0431067a03dcf5…
2025-08-23 18:47 UTC2025-08N209483-001100648752030-08-31U-88Drug product2018-09-106a471c1ec25d…
2025-08-23 18:47 UTC2025-08N209483-001100648752030-08-31U-1858Drug product2018-09-106a471c1ec25d…
2025-08-23 18:47 UTC2025-08N209483-001100648752030-08-31U-193Drug product2018-09-106a471c1ec25d…
2025-08-23 18:47 UTC2025-08N209483-001100648752030-08-31U-1408Drug product2018-09-106a471c1ec25d…
2025-08-23 18:47 UTC2025-08N209483-001100648752030-08-31U-742Drug product2018-09-106a471c1ec25d…
2025-08-23 18:47 UTC2025-08N209483-001105889142030-08-31U-2771Drug product2020-04-086a471c1ec25d…
2025-08-23 18:47 UTC2025-08N209483-00199562312030-08-31U-88Drug product2018-05-216a471c1ec25d…
2025-08-23 18:47 UTC2025-08N209483-00199562312030-08-31U-1408Drug product2018-05-216a471c1ec25d…
2025-08-23 18:47 UTC2025-08N209483-00199562312030-08-31U-193Drug product2018-05-216a471c1ec25d…
2025-08-23 18:47 UTC2025-08N209483-00199562312030-08-31U-742Drug product2018-05-216a471c1ec25d…
2025-08-23 18:47 UTC2025-08N209483-00199562312030-08-31U-1858Drug product2018-05-216a471c1ec25d…
2025-08-23 18:47 UTC2025-08N209483-00199562312030-08-31U-1761Drug product2018-05-216a471c1ec25d…
2025-08-23 18:47 UTC2025-08N209483-00198553342035-03-11Drug product2018-01-046a471c1ec25d…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03N209483-001100648752030-08-31U-88Drug product2018-09-10fd3edfee7708…

Observed Orange Book exclusivity history#

Captured, Edition, Application-product table
CapturedEditionApplication-productExclusivity codeExpirationSource SHA-256
2019-12-13 00:20 UTC2019-12N209483-001NP2020-11-2874a2ff9319b5…
2020-12-22 03:56 UTC2020-12N209483-001NP2020-11-288869cabd3fbd…
2020-11-12 02:37 UTC2020-11N209483-001NP2020-11-28c0c555d07b60…
2019-12-14 00:12 UTC2019-12N209483-001NP2020-11-283f01610625f2…
2019-09-15 20:21 UTC2019-09N209483-001NP2020-11-28b00525d2431f…
2019-07-19 19:46 UTC2019-07N209483-001NP2020-11-28ea99ee380514…

Additional Listing Data#

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

Active Ingredients#

Ingredient, Strength table
IngredientStrength
CLOBETASOL PROPIONATE.25 mg/g

Harmonized UNII identifiers#

UNII identifiers page 1 of 1 · 1 matching rows.

Identifier, FDA.report destination table
IdentifierFDA.report destination
779619577MInternal UNII lookup

Harmonized RxCUI identifiers#

RxCUI identifiers page 1 of 1 · 2 matching rows.

Identifier, FDA.report destination table
IdentifierFDA.report destination
1995455Internal RxNorm lookup
1995460Internal RxNorm lookup

Harmonized SPL set identifiers#

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

Identifier, FDA.report destination table
IdentifierFDA.report destination
40173654-334e-4618-847b-6a1e030cd2fdAvailable on FDA.report

DailyMed Product Concepts#

Product concept, Relation, Version table
Product conceptRelationVersionEffective
20abe2c3-3e80-d2b2-39eb-3156e4af4799Product name320250124
45ad92f8-d116-4c0c-851c-2e740b7d8e6fProduct name120250122
42be0ad5-6fd7-4f1b-8108-6d9dd7d571dfProduct name720250107
3813b789-94b9-edd6-f010-6b926dd462e5Product name520230113
30eee8a1-850e-41ed-b5ab-761301aeab49Product name620221206
18e5b6f7-c414-b1f1-b684-17fdd02c215eProduct name420210927
1c87bbde-dd91-a122-db33-67ae814cb645Product name720210510
519b5875-7d7d-4aa6-9d3d-470fa1376595Product name420200227
98669154-3e9c-47da-8a2c-656ab71848beProduct name220180607
8d4f8539-436f-453b-8b76-5322d403fc8eProduct name120180131
837ac3c6-ee71-c5a6-6eba-c4065f37e9f5Product name220171010

FDA-Initiated Inactive NDC Indexing#

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
68040-713-38Impoyz1 in 1 CARTONCREAM13
68040-713-38Impoyz100 g in 1 TUBECREAM1003
68040-713-44Impoyz20 in 1 CARTONCREAM203
68040-713-44Impoyz2.5 g in 1 TUBECREAM2.53

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
68040-713-38GM - Gram68040-7139f5548da-0a16-4fab-9127-7432f74a213512022-02-07

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
68040-713IMPOYZ (CLOBETASOL PROPIONATE) CREAM [PRIMUS PHARMACEUTICALS, INC.]3Current NDC, Legacy NDC, 4 package rows20240131_40173654-334e-4618-847b-6a1e030cd2fd.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
Clobetasol PropionateCLOBETASOL PROPIONATEINA Pharmaceutics Inc1b0e9eb5-71eb-44b4-894a-094a9f325dc82025-02-13Warnings, Adverse reactionsExact identifier
application applno (NDA): 209483
application number: NDA209483
ImpoyzCLOBETASOL PROPIONATEPrimus Pharmaceuticals, Inc.40173654-334e-4618-847b-6a1e030cd2fd2024-01-30Warnings, Adverse reactionsExact identifier
application applno (NDA): 209483
application number: NDA209483
ndc (product): 68040-713

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
1995455clobetasol propionate 0.025 % Topical CreamPSN40173654-334e-4618-847b-6a1e030cd2fd3
1995460impoyz 0.025 % Topical CreamPSN40173654-334e-4618-847b-6a1e030cd2fd3
1995460clobetasol propionate 0.25 MG/ML Topical Cream [Impoyz]SBD40173654-334e-4618-847b-6a1e030cd2fd3
1995455clobetasol propionate 0.25 MG/ML Topical CreamSCD40173654-334e-4618-847b-6a1e030cd2fd3
1995455clobetasol propionate 0.025 % Topical CreamSY40173654-334e-4618-847b-6a1e030cd2fd3
1995460Impoyz 0.025 % Topical CreamSY40173654-334e-4618-847b-6a1e030cd2fd3
1995460Impoyz 0.25 MG/ML Topical CreamSY40173654-334e-4618-847b-6a1e030cd2fd3

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
68040-713-38680400713381 TUBE in 1 CARTON (68040-713-38) / 100 g in 1 TUBE1 tube2021-12-010000-00-00NoNoCurrent
68040-713-446804007134420 TUBE in 1 CARTON (68040-713-44) / 2.5 g in 1 TUBE20 tube2021-12-01NoNoCurrent