FDA.reportPublic FDA data

clobetasol propionate

Product NDC
68462-625
11-digit product format
684620625
Labeler code
68462
Product ID
68462-625_5dad350f-062c-4799-9cdb-1272c56ccda7
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
clobetasol propionate
Dosage form
AEROSOL, FOAM
Route
TOPICAL
Labeler
Glenmark Pharmaceuticals Inc., USA
Application
ANDA211450
Marketing category
ANDA
Marketing start
2019-09-09
Substance
CLOBETASOL PROPIONATE
Active strength
.5 mg/g
Pharmacologic classes
Corticosteroid Hormone Receptor Agonists [MoA], Corticosteroid [EPC]
NDC exclude flag
No
Listing certified through
2027-12-31
Current FDA listing
Yes

Additional Listing Data#

Finished product
Yes
Brand name base
clobetasol propionate
Listing expiration
2027-12-31

Active Ingredients#

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

Harmonized Identifiers#

Field, Values table
FieldValues
Unii779619577M
Rxcui1992273

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
ce6d5c06-3ae0-18a6-d5b3-8cd3cc0f8906Product name720210625
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
68462-625-27clobetasol propionate50 g in 1 CANAEROSOL, FOAM504
68462-625-94clobetasol propionate100 g in 1 CANAEROSOL, FOAM1004

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
68462-625-27GM - Gram68462-625a5271fef-da44-49e0-9b28-a3dafa79f4ba12019-10-07
68462-625-94GM - Gram68462-625c6d66e97-9949-42c9-bb0b-993d15a1790d12019-10-07

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
68462-625CLOBETASOL PROPIONATE AEROSOL, FOAM [GLENMARK PHARMACEUTICALS INC., USA]3Current NDC, Legacy NDC, 2 package rows20240104_6a3ad15e-2874-40d0-9e69-105b369c8cfc.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
1992273clobetasol propionate 0.05 % Emollient Base Topical FoamPSN6a3ad15e-2874-40d0-9e69-105b369c8cfc4
1992273Emollient clobetasol propionate 0.5 MG/ML Topical FoamSCD6a3ad15e-2874-40d0-9e69-105b369c8cfc4
1992273clobetasol propionate 0.05 % Emollient Base Topical FoamSY6a3ad15e-2874-40d0-9e69-105b369c8cfc4

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
68462-625-276846206252750 g in 1 CAN (68462-625-27) 50 g2019-09-090000-00-00NoNoCurrent
68462-625-9468462062594100 g in 1 CAN (68462-625-94) 100 g2019-09-090000-00-00NoNoCurrent