Clobetasol Propionate

Product NDC
0713-0656
11-digit product format
007130656
Labeler code
0713
Product ID
0713-0656_0b383db5-a99b-f222-e063-6294a90adc09
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
Clobetasol Propionate
Dosage form
OINTMENT
Route
TOPICAL
Labeler
Cosette Pharmaceuticals, Inc.
Application
ANDA074089
Marketing category
ANDA
Marketing start
2016-01-04
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
0713-0656-15Clobetasol Propionate1 in 1 CARTONOINTMENT19
0713-0656-15Clobetasol Propionate15 g in 1 TUBEOINTMENT159
0713-0656-31Clobetasol Propionate30 g in 1 TUBEOINTMENT309
0713-0656-31Clobetasol Propionate1 in 1 CARTONOINTMENT19
0713-0656-37Clobetasol Propionate45 g in 1 TUBEOINTMENT459
0713-0656-37Clobetasol Propionate1 in 1 CARTONOINTMENT19
0713-0656-60Clobetasol Propionate60 g in 1 TUBEOINTMENT609
0713-0656-60Clobetasol Propionate1 in 1 CARTONOINTMENT19

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
0713-0656CLOBETASOL PROPIONATE OINTMENT [COSETTE PHARMACEUTICALS, INC.]9Current NDC, Legacy NDC, 8 package rows20231129_807d6a1a-4eca-9cf4-f514-bb1cd7b10d0f.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
861448clobetasol propionate 0.05 % Topical OintmentPSN807d6a1a-4eca-9cf4-f514-bb1cd7b10d0f9
861448clobetasol propionate 0.0005 MG/MG Topical OintmentSCD807d6a1a-4eca-9cf4-f514-bb1cd7b10d0f9
861448clobetasol propionate 0.05 % Topical OintmentSY807d6a1a-4eca-9cf4-f514-bb1cd7b10d0f9

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
0713-0656-15007130656151 TUBE in 1 CARTON (0713-0656-15) / 15 g in 1 TUBE1 tube2016-04-140000-00-00NoNoCurrent
0713-0656-31007130656311 TUBE in 1 CARTON (0713-0656-31) / 30 g in 1 TUBE1 tube2016-04-140000-00-00NoNoCurrent
0713-0656-37007130656371 TUBE in 1 CARTON (0713-0656-37) / 45 g in 1 TUBE1 tube2016-04-140000-00-00NoNoCurrent
0713-0656-60007130656601 TUBE in 1 CARTON (0713-0656-60) / 60 g in 1 TUBE1 tube2016-04-140000-00-00NoNoCurrent