FDA.reportPublic FDA data

Clobetasol Propionate

Product NDC
69238-1732
11-digit product format
692381732
Labeler code
69238
Product ID
69238-1732_f50085cc-bc01-4826-8582-0a557d5f0273
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
Clobetasol Propionate
Dosage form
SHAMPOO
Route
TOPICAL
Labeler
Amneal Pharmaceuticals NY LLC
Application
ANDA214895
Marketing category
ANDA
Marketing start
2021-06-15
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
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
d5e51f11-ad28-caa4-4b49-4143974782adProduct name120150831

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
69238-1732-8Clobetasol Propionate118 mL in 1 BOTTLESHAMPOO1188
69238-1732-8Clobetasol Propionate1 in 1 CARTONSHAMPOO18

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
69238-1732-8ML - Milliliter69238-17329c37dfed-2158-4f73-b434-705547def30012021-08-05

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
69238-1732CLOBETASOL PROPIONATE SHAMPOO [AMNEAL PHARMACEUTICALS NY LLC]8Current NDC, Legacy NDC, 2 package rows20230608_4363539b-d25e-4da3-911c-9ba142d7f4f4.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
861490clobetasol propionate 0.05 % Medicated ShampooPSN4363539b-d25e-4da3-911c-9ba142d7f4f48
861490clobetasol propionate 0.5 MG/ML Medicated ShampooSCD4363539b-d25e-4da3-911c-9ba142d7f4f48
861490clobetasol propionate 0.05 % Medicated ShampooSY4363539b-d25e-4da3-911c-9ba142d7f4f48

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
69238-1732-8692381732081 BOTTLE in 1 CARTON (69238-1732-8) / 118 mL in 1 BOTTLE1 bottle2021-06-150000-00-00NoNoCurrent