FDA.reportPublic FDA data

Clobetasol Propionate

Product NDC
51672-1297
11-digit product format
516721297
Labeler code
51672
Product ID
51672-1297_3cf4526e-e856-d065-e063-6394a90a12bc
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
Clobetasol Propionate
Dosage form
CREAM
Route
TOPICAL
Labeler
Sun Pharmaceutical Industries, Inc.
Application
ANDA075633
Marketing category
ANDA
Marketing start
2000-05-17
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
Rxcui1992281

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
51672-1297-1Clobetasol Propionate1 in 1 CARTONCREAM18
51672-1297-1Clobetasol Propionate15 g in 1 TUBECREAM158
51672-1297-2Clobetasol Propionate30 g in 1 TUBECREAM308
51672-1297-2Clobetasol Propionate1 in 1 CARTONCREAM18
51672-1297-3Clobetasol Propionate1 in 1 CARTONCREAM18
51672-1297-3Clobetasol Propionate60 g in 1 TUBECREAM608

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
51672-1297-1GM - Gram51672-129713c4a332-82bb-4378-8e47-07fa1531072412012-07-24
51672-1297-2GM - Gram51672-12978b73fd3a-5f27-42a6-b7a7-d890778268dc12012-07-24
51672-1297-3GM - Gram51672-129722738d19-9474-4df3-a835-4c697a57478e12012-07-24

DailyMed Socrata Ingredients#

Ingredient, Type, UNII table
IngredientTypeUNIIDailyMed labelSPL versionUploaded
Clobetasol PropionateACTIVE INGREDIENT779619577MCLOBETASOL PROPIONATE CREAM [TARO PHARMACEUTICALS U.S.A., INC.]3
ClobetasolACTIVE MOIETYADN79D536HCLOBETASOL PROPIONATE CREAM [TARO PHARMACEUTICALS U.S.A., INC.]3
ceteth-20INACTIVE INGREDIENTI835H2IHHXCLOBETASOL PROPIONATE CREAM [TARO PHARMACEUTICALS U.S.A., INC.]3
cetostearyl alcoholINACTIVE INGREDIENT2DMT128M1SCLOBETASOL PROPIONATE CREAM [TARO PHARMACEUTICALS U.S.A., INC.]3
citric acid monohydrateINACTIVE INGREDIENT2968PHW8QPCLOBETASOL PROPIONATE CREAM [TARO PHARMACEUTICALS U.S.A., INC.]3
dimethicone 350INACTIVE INGREDIENT2Y53S6ATLUCLOBETASOL PROPIONATE CREAM [TARO PHARMACEUTICALS U.S.A., INC.]3
imidureaINACTIVE INGREDIENTM629807ATLCLOBETASOL PROPIONATE CREAM [TARO PHARMACEUTICALS U.S.A., INC.]3
isopropyl myristateINACTIVE INGREDIENT0RE8K4LNJSCLOBETASOL PROPIONATE CREAM [TARO PHARMACEUTICALS U.S.A., INC.]3
propylene glycolINACTIVE INGREDIENT6DC9Q167V3CLOBETASOL PROPIONATE CREAM [TARO PHARMACEUTICALS U.S.A., INC.]3
sodium citrateINACTIVE INGREDIENT1Q73Q2JULRCLOBETASOL PROPIONATE CREAM [TARO PHARMACEUTICALS U.S.A., INC.]3
waterINACTIVE INGREDIENT059QF0KO0RCLOBETASOL PROPIONATE CREAM [TARO PHARMACEUTICALS U.S.A., INC.]3

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
51672-1297CLOBETASOL PROPIONATE CREAM [SUN PHARMACEUTICAL INDUSTRIES, INC.]7Current NDC, Legacy NDC, 6 package rows20250524_91571297-03ad-441e-8ec6-f78c21fbe5e8.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
1992281clobetasol propionate 0.05 % Emollient Base Topical CreamPSN91571297-03ad-441e-8ec6-f78c21fbe5e88
1992281Emollient clobetasol propionate 0.5 MG/ML Topical CreamSCD91571297-03ad-441e-8ec6-f78c21fbe5e88
1992281clobetasol propionate 0.05 % Emollient Base Topical CreamSY91571297-03ad-441e-8ec6-f78c21fbe5e88

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
51672-1297-1516721297011 TUBE in 1 CARTON (51672-1297-1) / 15 g in 1 TUBE1 tube2000-05-170000-00-00NoNoCurrent
51672-1297-2516721297021 TUBE in 1 CARTON (51672-1297-2) / 30 g in 1 TUBE1 tube2000-05-170000-00-00NoNoCurrent
51672-1297-3516721297031 TUBE in 1 CARTON (51672-1297-3) / 60 g in 1 TUBE1 tube2000-05-170000-00-00NoNoCurrent