FDA.reportPublic FDA data

Clobetasol Propionate Cream, 0.05%

Product NDC
82804-133
11-digit product format
828040133
Labeler code
82804
Product ID
82804-133_6f52ac0f-4028-4733-9ef6-e5ce5468b384
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
Clobetasol Propionate Cream, 0.05%
Dosage form
CREAM
Route
TOPICAL
Labeler
Proficient Rx LP
Application
ANDA212982
Marketing category
ANDA
Marketing start
2020-10-01
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 Cream, 0.05%
Brand name suffix
Clobetasol Propionate Cream, 0.05%
Listing expiration
2026-12-31

Active Ingredients#

Ingredient, Strength table
IngredientStrength
CLOBETASOL PROPIONATE.5 mg/g

Harmonized Identifiers#

Field, Values table
FieldValues
Unii779619577M
Rxcui861495

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
82804-133-30Clobetasol Propionate Cream, 0.05%Clobetasol Propionate Cream, 0.05%30 g in 1 TUBECREAM301

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
82804-133-30GM - Gram82804-133f033ef00-1108-4fef-846b-a29b784d76b512024-12-10

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
82804-133CLOBETASOL PROPIONATE CREAM, 0.05% CLOBETASOL PROPIONATE CREAM, 0.05% (CLOBETASOL PROPIONATE CREAM, 0.05%) CREAM [PROFICIENT RX LP]1Current NDC, 1 package rows20240907_6f52ac0f-4028-4733-9ef6-e5ce5468b384.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
861495clobetasol propionate 0.05 % Topical CreamPSN6f52ac0f-4028-4733-9ef6-e5ce5468b3841
861495clobetasol propionate 0.5 MG/ML Topical CreamSCD6f52ac0f-4028-4733-9ef6-e5ce5468b3841
861495clobetasol propionate 0.05 % Topical CreamSY6f52ac0f-4028-4733-9ef6-e5ce5468b3841

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startSampleExclude flagStatus
82804-133-308280401333030 g in 1 TUBE (82804-133-30) 30 g2024-08-07NoNoCurrent