FDA.reportPublic FDA data

CLOBETASOL PROPIONATE

Product NDC
51407-737
11-digit product format
514070737
Labeler code
51407
Product ID
51407-737_502865f7-6be4-e587-e063-6294a90acc8a
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
clobetasol propionate
Dosage form
SOLUTION
Route
TOPICAL
Labeler
Golden State Medical Supply, Inc.
Application
ANDA211494
Marketing category
ANDA
Marketing start
2019-10-02
Substance
CLOBETASOL PROPIONATE
Active strength
.5 mg/mL
Pharmacologic classes
Corticosteroid Hormone Receptor Agonists [MoA], Corticosteroid [EPC]
NDC exclude flag
No
Listing certified through
2027-12-31
Current FDA listing
Yes

Additional Listing Data#

Finished product
Yes
Brand name base
CLOBETASOL PROPIONATE
Listing expiration
2027-12-31

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
6c13b22c-b3ba-4127-b768-0132dd5ab0d1Product name120230829
3813b789-94b9-edd6-f010-6b926dd462e5Product name520230113
30eee8a1-850e-41ed-b5ab-761301aeab49Product name620221206
18e5b6f7-c414-b1f1-b684-17fdd02c215eProduct name420210927
3c386306-c48a-413e-bb69-70cb268496f3Product name120210727
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
51407-737-25CLOBETASOL PROPIONATE25 mL in 1 BOTTLESOLUTION255
51407-737-25CLOBETASOL PROPIONATE1 in 1 CARTONSOLUTION15
51407-737-50CLOBETASOL PROPIONATE50 mL in 1 BOTTLESOLUTION505
51407-737-50CLOBETASOL PROPIONATE1 in 1 CARTONSOLUTION15

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
51407-737-25ML - Milliliter51407-737331e2124-5c8f-48c0-a2ba-076ed346279912023-10-16
51407-737-50ML - Milliliter51407-73722b2b3b5-65a2-487d-b31a-eea66a3357c112023-10-16

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
51407-737CLOBETASOL PROPIONATE SOLUTION [GOLDEN STATE MEDICAL SUPPLY, INC.]4Current NDC, 4 package rows20250412_04180cdf-c63a-d524-e063-6394a90a2d06.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
861487clobetasol propionate 0.05 % Topical SolutionPSN04180cdf-c63a-d524-e063-6394a90a2d065
861487clobetasol propionate 0.5 MG/ML Topical SolutionSCD04180cdf-c63a-d524-e063-6394a90a2d065
861487clobetasol propionate 0.05 % Topical SolutionSY04180cdf-c63a-d524-e063-6394a90a2d065

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startSampleExclude flagStatus
51407-737-25514070737251 BOTTLE in 1 CARTON (51407-737-25) / 25 mL in 1 BOTTLE1 bottle2023-08-29NoNoCurrent
51407-737-50514070737501 BOTTLE in 1 CARTON (51407-737-50) / 50 mL in 1 BOTTLE1 bottle2023-08-29NoNoCurrent