FDA.reportPublic FDA data

CLOBETASOL PROPIONATE

Product NDC
68462-480
11-digit product format
684620480
Labeler code
68462
Product ID
68462-480_a827f327-e5a8-4162-9f5a-1215bcb449ec
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
CLOBETASOL PROPIONATE
Dosage form
SPRAY
Route
TOPICAL
Labeler
Glenmark Pharmaceuticals Inc., USA
Application
ANDA209004
Marketing category
ANDA
Marketing start
2018-03-26
Substance
CLOBETASOL PROPIONATE
Active strength
.05 g/mL
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/mL

Harmonized Identifiers#

Field, Values table
FieldValues
Unii779619577M
Rxcui861512

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
68462-480-39CLOBETASOL PROPIONATE59 mL in 1 BOTTLESPRAY594
68462-480-39CLOBETASOL PROPIONATE1 in 1 CARTONSPRAY14
68462-480-56CLOBETASOL PROPIONATE1 in 1 CARTONSPRAY14
68462-480-56CLOBETASOL PROPIONATE125 mL in 1 BOTTLESPRAY1254

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
68462-480-39ML - Milliliter68462-4800257d8cc-b31d-4a0f-865c-7b335c7c0a5d12018-06-11
68462-480-56ML - Milliliter68462-48042018bd9-9b72-4914-b504-20f2231fa74112018-06-11

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
68462-480CLOBETASOL PROPIONATE SPRAY [GLENMARK PHARMACEUTICALS INC., USA]4Current NDC, Legacy NDC, 4 package rows20240104_dfc58f73-e892-4fc3-8726-4e8d1546ebd3.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
861512clobetasol propionate 0.05 % Topical SprayPSNdfc58f73-e892-4fc3-8726-4e8d1546ebd34
861512clobetasol propionate 0.5 MG/ML Topical SpraySCDdfc58f73-e892-4fc3-8726-4e8d1546ebd34
861512clobetasol propionate 0.05 % Topical SpraySYdfc58f73-e892-4fc3-8726-4e8d1546ebd34

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
68462-480-39684620480391 BOTTLE in 1 CARTON (68462-480-39) / 59 mL in 1 BOTTLE1 bottle2018-03-260000-00-00NoNoCurrent
68462-480-56684620480561 BOTTLE in 1 CARTON (68462-480-56) / 125 mL in 1 BOTTLE1 bottle2018-03-260000-00-00NoNoCurrent