FDA.reportPublic FDA data

Clobetasol Propionate

Product NDC
72578-085
11-digit product format
725780085
Labeler code
72578
Product ID
72578-085_7885e4e8-e37e-4eaf-b632-f09f28f825cf
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
Clobetasol Propionate
Dosage form
LOTION
Route
TOPICAL
Labeler
Viona Pharmaceuticals Inc
Application
ANDA205249
Marketing category
ANDA
Marketing start
2020-04-30
Substance
CLOBETASOL PROPIONATE
Active strength
.05 g/100mL
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
Clobetasol Propionate
Listing expiration
2026-12-31

Active Ingredients#

Ingredient, Strength table
IngredientStrength
CLOBETASOL PROPIONATE.05 g/100mL

Harmonized Identifiers#

Field, Values table
FieldValues
Unii779619577M
Rxcui861505

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

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
72578-085-01Clobetasol Propionate1 in 1 CARTONLOTION13
72578-085-01Clobetasol Propionate59 mL in 1 BOTTLELOTION593
72578-085-02Clobetasol Propionate118 mL in 1 BOTTLELOTION1183
72578-085-02Clobetasol Propionate1 in 1 CARTONLOTION13

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
72578-085-01ML - Milliliter72578-08515035778-cff9-44a1-abfe-c18f2a12458612022-11-07
72578-085-02ML - Milliliter72578-085d0fc54d2-39ac-4c60-857a-f223753df8ee12022-11-07

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
72578-085CLOBETASOL PROPIONATE LOTION [VIONA PHARMACEUTICALS INC]3Current NDC, Legacy NDC, 4 package rows20240821_2fc7de5f-094f-400c-b87e-750b16046f46.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
861505clobetasol propionate 0.05 % Topical LotionPSN2fc7de5f-094f-400c-b87e-750b16046f463
861505clobetasol propionate 0.5 MG/ML Topical LotionSCD2fc7de5f-094f-400c-b87e-750b16046f463
861505clobetasol propionate 0.05 % Topical LotionSY2fc7de5f-094f-400c-b87e-750b16046f463

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
72578-085-01725780085011 BOTTLE in 1 CARTON (72578-085-01) / 59 mL in 1 BOTTLE1 bottle2020-04-300000-00-00NoNoCurrent
72578-085-02725780085021 BOTTLE in 1 CARTON (72578-085-02) / 118 mL in 1 BOTTLE1 bottle2020-04-300000-00-00NoNoCurrent