FDA.reportPublic FDA data

CLOBETASOL PROPIONATE

Product NDC
61919-329
11-digit product format
619190329
Labeler code
61919
Product ID
61919-329_a8eb8a82-e2ef-4b86-9bd1-e99bd945c0ed
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
clobetasol propionate gel
Dosage form
GEL
Route
TOPICAL
Labeler
Direct RX
Application
ANDA075027
Marketing category
ANDA
Marketing start
2015-01-01
Marketing end
0000-00-00
Substance
CLOBETASOL PROPIONATE
Active strength
0 mg/g
Pharmacologic classes
Corticosteroid [EPC],Corticosteroid Hormone Receptor Agonists [MoA]
NDC exclude flag
E
Listing certified through
2017-12-31
Current FDA listing
Historical FDA.report record

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
61919-329-152020-01-31C16284748780-19d75b9d0-9f28-f424-e053-dadaa90a57ceCLOBETASOL PROPIONATE- clobetasol propionate gel

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
61919-329-15CLOBETASOL PROPIONATE15 g in 1 TUBEGEL151

DailyMed Socrata Ingredients#

Ingredient, Type, UNII table
IngredientTypeUNIIDailyMed labelSPL versionUploaded
CLOBETASOL PROPIONATEACTIVE INGREDIENT779619577MCLOBETASOL PROPIONATE (CLOBETASOL PROPIONATE GEL) GEL [DIRECT RX]1
CLOBETASOLACTIVE MOIETYADN79D536HCLOBETASOL PROPIONATE (CLOBETASOL PROPIONATE GEL) GEL [DIRECT RX]1
CARBOMER COPOLYMER TYPE B (ALLYL PENTAERYTHRITOL CROSSLINKED)INACTIVE INGREDIENT809Y72KV36CLOBETASOL PROPIONATE (CLOBETASOL PROPIONATE GEL) GEL [DIRECT RX]1
PROPYLENE GLYCOLINACTIVE INGREDIENT6DC9Q167V3CLOBETASOL PROPIONATE (CLOBETASOL PROPIONATE GEL) GEL [DIRECT RX]1
SODIUM HYDROXIDEINACTIVE INGREDIENT55X04QC32ICLOBETASOL PROPIONATE (CLOBETASOL PROPIONATE GEL) GEL [DIRECT RX]1
WATERINACTIVE INGREDIENT059QF0KO0RCLOBETASOL PROPIONATE (CLOBETASOL PROPIONATE GEL) GEL [DIRECT RX]1

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
61919-329CLOBETASOL PROPIONATE (CLOBETASOL PROPIONATE GEL) GEL [DIRECT RX]1Legacy NDC, 1 package rows20150623_bb24bbe8-7522-4e99-ac42-bd3079e51107.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
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 formatDescriptionUnitsStatus
61919-329-156191903291515 g in 1 TUBE15 gHistorical