FDA.reportPublic FDA data

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

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 Identifiers#

Field, Values table
FieldValues
Unii779619577M
Rxcui1995455, 1995460

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#

NDC, Effective, Action table
NDCEffectiveActionDocumentIndexing SPLRelated label
68040-713-382023-11-20C16284748780-1f386c64a-17fe-0266-e053-dadaa90a7c1aThese highlights do not include all the information needed to use IMPOYZ ® Cream safely and effectively. See full prescribing information for IMPOYZ Cream. IMPOYZ (clobetasol propionate) Cream, 0.025%, for topical use Initial U.S. Approval: 1985
68040-713-382023-01-30C16284748780-1f386c64a-17fe-0266-e053-dadaa90a7c1aThese highlights do not include all the information needed to use IMPOYZ ® Cream safely and effectively. See full prescribing information for IMPOYZ Cream. IMPOYZ (clobetasol propionate) Cream, 0.025%, for topical use Initial U.S. Approval: 1985

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

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 tube2021-12-01NoNoHistorical