FDA.reportPublic FDA data

CLOBETASOL PROPIONATE

Product NDC
59651-732
11-digit product format
596510732
Labeler code
59651
Product ID
59651-732_51e53193-523e-4367-a405-8ab44df55358
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
CLOBETASOL PROPIONATE
Dosage form
OINTMENT
Route
TOPICAL
Labeler
Aurobindo Pharma Limited
Application
ANDA075057
Marketing category
ANDA
Marketing start
2023-09-28
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
59651-732-14CLOBETASOL PROPIONATE15 g in 1 TUBEOINTMENT154
59651-732-14CLOBETASOL PROPIONATE1 in 1 CARTONOINTMENT14
59651-732-30CLOBETASOL PROPIONATE30 g in 1 TUBEOINTMENT304
59651-732-30CLOBETASOL PROPIONATE1 in 1 CARTONOINTMENT14
59651-732-46CLOBETASOL PROPIONATE1 in 1 CARTONOINTMENT14
59651-732-46CLOBETASOL PROPIONATE45 g in 1 TUBEOINTMENT454
59651-732-60CLOBETASOL PROPIONATE60 g in 1 TUBEOINTMENT604
59651-732-60CLOBETASOL PROPIONATE1 in 1 CARTONOINTMENT14

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
59651-732CLOBETASOL PROPIONATE OINTMENT [AUROBINDO PHARMA LIMITED]4Current NDC, 8 package rows20240301_e238bf90-f5fd-446d-9799-e8f8fed2f0a9.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
861448clobetasol propionate 0.05 % Topical OintmentPSNe238bf90-f5fd-446d-9799-e8f8fed2f0a94
861448clobetasol propionate 0.0005 MG/MG Topical OintmentSCDe238bf90-f5fd-446d-9799-e8f8fed2f0a94
861448clobetasol propionate 0.05 % Topical OintmentSYe238bf90-f5fd-446d-9799-e8f8fed2f0a94

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startSampleExclude flagStatus
59651-732-14596510732141 TUBE in 1 CARTON (59651-732-14) / 15 g in 1 TUBE1 tube2023-09-28NoNoCurrent
59651-732-30596510732301 TUBE in 1 CARTON (59651-732-30) / 30 g in 1 TUBE1 tube2023-09-28NoNoCurrent
59651-732-46596510732461 TUBE in 1 CARTON (59651-732-46) / 45 g in 1 TUBE1 tube2023-09-28NoNoCurrent
59651-732-60596510732601 TUBE in 1 CARTON (59651-732-60) / 60 g in 1 TUBE1 tube2023-09-28NoNoCurrent