FDA.reportPublic FDA data

Clobetasol Propionate

Product NDC
68462-530
11-digit product format
684620530
Labeler code
68462
Product ID
68462-530_923024a2-fbce-4487-872f-98e4016183c3
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
Clobetasol Propionate
Dosage form
OINTMENT
Route
TOPICAL
Labeler
Glenmark Pharmaceuticals Inc., USA
Application
ANDA208933
Marketing category
ANDA
Marketing start
2017-03-20
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
Listing expiration
2026-12-31

Active Ingredients#

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

Harmonized Identifiers#

Field, Values table
FieldValues
Unii779619577M
Rxcui861448

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
68462-530-17Clobetasol Propionate15 g in 1 TUBEOINTMENT154
68462-530-17Clobetasol Propionate1 in 1 CARTONOINTMENT14
68462-530-35Clobetasol Propionate1 in 1 CARTONOINTMENT14
68462-530-35Clobetasol Propionate30 g in 1 TUBEOINTMENT304
68462-530-47Clobetasol Propionate45 g in 1 TUBEOINTMENT454
68462-530-47Clobetasol Propionate1 in 1 CARTONOINTMENT14
68462-530-65Clobetasol Propionate60 g in 1 TUBEOINTMENT604
68462-530-65Clobetasol Propionate1 in 1 CARTONOINTMENT14

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
68462-530-17GM - Gram68462-530f1d2e402-fdaf-4f42-bf0c-bab06b8548b512017-04-05
68462-530-35GM - Gram68462-5306ac2bc50-3897-4937-a406-77543427e87812017-04-05
68462-530-47GM - Gram68462-5303e58d522-b2b8-4b3b-8e28-6653a2db781c12018-02-20
68462-530-65GM - Gram68462-53017eabe08-d267-4003-85fd-8bd7caef739712018-02-20

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
68462-530CLOBETASOL PROPIONATE OINTMENT [GLENMARK PHARMACEUTICALS INC., USA]4Current NDC, Legacy NDC, 8 package rows20240104_420deed6-321f-4a2a-9042-1e61636621aa.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
861448clobetasol propionate 0.05 % Topical OintmentPSN420deed6-321f-4a2a-9042-1e61636621aa4
861448clobetasol propionate 0.0005 MG/MG Topical OintmentSCD420deed6-321f-4a2a-9042-1e61636621aa4
861448clobetasol propionate 0.05 % Topical OintmentSY420deed6-321f-4a2a-9042-1e61636621aa4

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
68462-530-17684620530171 TUBE in 1 CARTON (68462-530-17) / 15 g in 1 TUBE1 tube2017-03-200000-00-00NoNoCurrent
68462-530-35684620530351 TUBE in 1 CARTON (68462-530-35) / 30 g in 1 TUBE1 tube2017-03-200000-00-00NoNoCurrent
68462-530-47684620530471 TUBE in 1 CARTON (68462-530-47) / 45 g in 1 TUBE1 tube2017-03-200000-00-00NoNoCurrent
68462-530-65684620530651 TUBE in 1 CARTON (68462-530-65) / 60 g in 1 TUBE1 tube2017-03-200000-00-00NoNoCurrent