FDA.reportPublic FDA data

CLOBETASOL PROPIONATE

Product NDC
68462-532
11-digit product format
684620532
Labeler code
68462
Product ID
68462-532_8a5a06f3-bb61-4854-8c74-673747cbcfdd
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
CLOBETASOL PROPIONATE
Dosage form
SOLUTION
Route
TOPICAL
Labeler
Glenmark Pharmaceuticals Inc., USA
Application
ANDA210190
Marketing category
ANDA
Marketing start
2018-04-18
Substance
CLOBETASOL PROPIONATE
Active strength
.5 mg/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.5 mg/mL

Harmonized Identifiers#

Field, Values table
FieldValues
Unii779619577M
Rxcui861487

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
68462-532-28CLOBETASOL PROPIONATE25 mL in 1 BOTTLESOLUTION255
68462-532-28CLOBETASOL PROPIONATE1 in 1 CARTONSOLUTION15
68462-532-53CLOBETASOL PROPIONATE50 mL in 1 BOTTLESOLUTION505
68462-532-53CLOBETASOL PROPIONATE1 in 1 CARTONSOLUTION15

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
68462-532-28ML - Milliliter68462-532c0730222-08ce-4230-b253-a87ac2855ad312018-07-03
68462-532-53ML - Milliliter68462-532fabe498d-00b8-4652-b514-fc05e197eac512018-07-03

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
68462-532CLOBETASOL PROPIONATE SOLUTION [GLENMARK PHARMACEUTICALS INC., USA]5Current NDC, Legacy NDC, 4 package rows20240104_e37dd885-889a-4bfd-9813-bb7b9b96cee1.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
861487clobetasol propionate 0.05 % Topical SolutionPSNe37dd885-889a-4bfd-9813-bb7b9b96cee15
861487clobetasol propionate 0.5 MG/ML Topical SolutionSCDe37dd885-889a-4bfd-9813-bb7b9b96cee15
861487clobetasol propionate 0.05 % Topical SolutionSYe37dd885-889a-4bfd-9813-bb7b9b96cee15

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
68462-532-28684620532281 BOTTLE in 1 CARTON (68462-532-28) / 25 mL in 1 BOTTLE1 bottle2018-04-180000-00-00NoNoCurrent
68462-532-53684620532531 BOTTLE in 1 CARTON (68462-532-53) / 50 mL in 1 BOTTLE1 bottle2018-04-180000-00-00NoNoCurrent