FDA.reportPublic FDA data

Clobetasol Propionate

Product NDC
51672-1347
11-digit product format
516721347
Labeler code
51672
Product ID
51672-1347_3961da45-d1bf-c7c6-e063-6294a90aebea
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
Clobetasol Propionate
Dosage form
SHAMPOO
Route
TOPICAL
Labeler
Sun Pharmaceutical Industries, Inc.
Application
ANDA214867
Marketing category
ANDA
Marketing start
2021-03-25
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
Rxcui861490

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
3c386306-c48a-413e-bb69-70cb268496f3Product name120210727
1c87bbde-dd91-a122-db33-67ae814cb645Product name720210510
519b5875-7d7d-4aa6-9d3d-470fa1376595Product name420200227
7792dadb-52b6-46b6-8fdf-80b1171065b5Product name120180810
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
51672-1347-8Clobetasol Propionate1 in 1 CARTONSHAMPOO12
51672-1347-8Clobetasol Propionate118 mL in 1 BOTTLESHAMPOO1182

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
51672-1347-8ML - Milliliter51672-13472d589269-b174-4eee-a152-dcf6f35c1add12021-05-05

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
51672-1347CLOBETASOL PROPIONATE SHAMPOO [TARO PHARMACEUTICALS U.S.A., INC.]1Current NDC, Legacy NDC, 2 package rows20210330_04d7d65b-d7ed-4223-abab-5d0aed36a155.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
861490clobetasol propionate 0.05 % Medicated ShampooPSN04d7d65b-d7ed-4223-abab-5d0aed36a1552
861490clobetasol propionate 0.5 MG/ML Medicated ShampooSCD04d7d65b-d7ed-4223-abab-5d0aed36a1552
861490clobetasol propionate 0.05 % Medicated ShampooSY04d7d65b-d7ed-4223-abab-5d0aed36a1552

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
51672-1347-8516721347081 BOTTLE in 1 CARTON (51672-1347-8) / 118 mL in 1 BOTTLE1 bottle2021-03-250000-00-00NoNoCurrent