FDA.reportPublic FDA data

Clobetasol Propionate (emollient)

Product NDC
83148-064
11-digit product format
831480064
Labeler code
83148
Product ID
83148-064_40290b7e-9b7d-6810-e063-6394a90a2d5d
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
clobetasol propionate
Dosage form
CREAM
Route
TOPICAL
Labeler
The J. Molner Company LLC
Application
ANDA209411
Marketing category
ANDA
Marketing start
2025-09-29
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 (emollient)
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
d5e51f11-ad28-caa4-4b49-4143974782adProduct name120150831

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
83148-064-15Clobetasol Propionate (emollient)1 in 1 CARTONCREAM16
83148-064-15Clobetasol Propionate (emollient)15 g in 1 TUBECREAM156
83148-064-30Clobetasol Propionate (emollient)30 g in 1 TUBECREAM306
83148-064-30Clobetasol Propionate (emollient)1 in 1 CARTONCREAM16
83148-064-60Clobetasol Propionate (emollient)1 in 1 CARTONCREAM16
83148-064-60Clobetasol Propionate (emollient)60 g in 1 TUBECREAM606

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
83148-064-15GM - Gram83148-064ac15e067-b249-4197-936a-1a0126d78a1812025-10-14
83148-064-30GM - Gram83148-064c916453a-bdc1-48b9-8970-84172605207e12025-10-14
83148-064-60GM - Gram83148-06434ca906f-a3aa-44b1-82f4-5559edef206112025-10-14

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
1992281clobetasol propionate 0.05 % Emollient Base Topical CreamPSNcb0bc057-d6ab-4eea-af7a-01661ae9b517100
1992281Emollient clobetasol propionate 0.5 MG/ML Topical CreamSCDcb0bc057-d6ab-4eea-af7a-01661ae9b517100
1992281clobetasol propionate 0.05 % Emollient Base Topical CreamSYcb0bc057-d6ab-4eea-af7a-01661ae9b517100
1992281clobetasol propionate 0.05 % Emollient Base Topical CreamPSN26ccb1d8-c466-e238-e063-6394a90a00696
1992281Emollient clobetasol propionate 0.5 MG/ML Topical CreamSCD26ccb1d8-c466-e238-e063-6394a90a00696
1992281clobetasol propionate 0.05 % Emollient Base Topical CreamSY26ccb1d8-c466-e238-e063-6394a90a00696

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startSampleExclude flagStatus
83148-064-15831480064151 TUBE in 1 CARTON (83148-064-15) / 15 g in 1 TUBE1 tube2025-09-29NoNoCurrent
83148-064-30831480064301 TUBE in 1 CARTON (83148-064-30) / 30 g in 1 TUBE1 tube2025-10-01NoNoCurrent
83148-064-60831480064601 TUBE in 1 CARTON (83148-064-60) / 60 g in 1 TUBE1 tube2025-09-29NoNoCurrent