FDA.reportPublic FDA data

Clobetasol Propionate

Product NDC
45802-925
11-digit product format
458020925
Labeler code
45802
Product ID
45802-925_596d1122-15bb-4b30-b175-457ba7933a6e
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
Clobetasol propionate
Dosage form
GEL
Route
TOPICAL
Labeler
Padagis Israel Pharmaceuticals Ltd
Application
ANDA075027
Marketing category
ANDA
Marketing start
2008-07-30
Substance
CLOBETASOL 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

Additional Listing Data#

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

Active Ingredients#

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

Harmonized Identifiers#

Field, Values table
FieldValues
Unii779619577M
Rxcui861434

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
45802-925-14Clobetasol Propionate15 g in 1 TUBEGEL158
45802-925-14Clobetasol Propionate1 in 1 CARTONGEL18
45802-925-94Clobetasol Propionate1 in 1 CARTONGEL18
45802-925-94Clobetasol Propionate30 g in 1 TUBEGEL308
45802-925-96Clobetasol Propionate1 in 1 CARTONGEL18
45802-925-96Clobetasol Propionate60 g in 1 TUBEGEL608

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
45802-925CLOBETASOL PROPIONATE GEL [PADAGIS ISRAEL PHARMACEUTICALS LTD]8Current NDC, Legacy NDC, 6 package rows20231117_f9df643a-015d-4101-ac8f-c1e05b052df5.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
861434clobetasol propionate 0.05 % Topical GelPSN1bdc1978-00d1-43f4-a127-a9d9c709644d104
861434clobetasol propionate 0.0005 MG/MG Topical GelSCD1bdc1978-00d1-43f4-a127-a9d9c709644d104
861434clobetasol propionate 0.05 % Topical GelSY1bdc1978-00d1-43f4-a127-a9d9c709644d104
861434clobetasol propionate 0.05 % Topical GelPSN695b2b8a-9d8c-4e94-bc78-2f535b8e2cbc103
861434clobetasol propionate 0.05 % Topical GelPSNf0ca99cd-6c54-44f8-a9b3-432e93fc5d59103
861434clobetasol propionate 0.05 % Topical GelPSNbc021c6c-43db-469c-b1c3-0166b18daea4103
861434clobetasol propionate 0.0005 MG/MG Topical GelSCD695b2b8a-9d8c-4e94-bc78-2f535b8e2cbc103
861434clobetasol propionate 0.0005 MG/MG Topical GelSCDf0ca99cd-6c54-44f8-a9b3-432e93fc5d59103
861434clobetasol propionate 0.0005 MG/MG Topical GelSCDbc021c6c-43db-469c-b1c3-0166b18daea4103
861434clobetasol propionate 0.05 % Topical GelSYbc021c6c-43db-469c-b1c3-0166b18daea4103
861434clobetasol propionate 0.05 % Topical GelSYf0ca99cd-6c54-44f8-a9b3-432e93fc5d59103
861434clobetasol propionate 0.05 % Topical GelSY695b2b8a-9d8c-4e94-bc78-2f535b8e2cbc103
861434clobetasol propionate 0.05 % Topical GelPSNf9df643a-015d-4101-ac8f-c1e05b052df58
861434clobetasol propionate 0.0005 MG/MG Topical GelSCDf9df643a-015d-4101-ac8f-c1e05b052df58
861434clobetasol propionate 0.05 % Topical GelSYf9df643a-015d-4101-ac8f-c1e05b052df58
861434clobetasol propionate 0.05 % Topical GelPSNbb24bbe8-7522-4e99-ac42-bd3079e511071
861434clobetasol propionate 0.0005 MG/MG Topical GelSCDbb24bbe8-7522-4e99-ac42-bd3079e511071
861434clobetasol propionate 0.05 % Topical GelSYbb24bbe8-7522-4e99-ac42-bd3079e511071

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
45802-925-14458020925141 TUBE in 1 CARTON (45802-925-14) / 15 g in 1 TUBE1 tube2008-07-300000-00-00NoNoCurrent
45802-925-94458020925941 TUBE in 1 CARTON (45802-925-94) / 30 g in 1 TUBE1 tube2008-11-110000-00-00NoNoCurrent
45802-925-96458020925961 TUBE in 1 CARTON (45802-925-96) / 60 g in 1 TUBE1 tube2008-07-310000-00-00NoNoCurrent