FDA.reportPublic FDA data

CLOBETASOL PROPIONATE

Product NDC
42571-362
11-digit product format
425710362
Labeler code
42571
Product ID
42571-362_4d29e0fe-60c7-9568-e063-6394a90a905e
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
clobetasol propionate
Dosage form
SOLUTION
Route
TOPICAL
Labeler
Micro Labs Limited
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
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

FDA-Initiated Inactive NDC Indexing#

NDC, Effective, Action table
NDCEffectiveActionDocumentIndexing SPLRelated label
42571-362-812026-01-29C16284748780-149896155-b371-586f-e063-e6dba90add90PRODUCT INFORMATION Clobetasol Propionate Topical Solution, USP Rx only FOR TOPICAL DERMATOLOGIC USE ONLY-NOT FOR OPHTHALMIC, ORAL, OR INTRAVAGINAL USE
42571-362-992026-01-29C16284748780-149896155-b371-586f-e063-e6dba90add90PRODUCT INFORMATION Clobetasol Propionate Topical Solution, USP Rx only FOR TOPICAL DERMATOLOGIC USE ONLY-NOT FOR OPHTHALMIC, ORAL, OR INTRAVAGINAL USE

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
42571-362-81CLOBETASOL PROPIONATE1 in 1 CARTONSOLUTION14
42571-362-81CLOBETASOL PROPIONATE25 mL in 1 BOTTLESOLUTION254
42571-362-99CLOBETASOL PROPIONATE1 in 1 CARTONSOLUTION14
42571-362-99CLOBETASOL PROPIONATE50 mL in 1 BOTTLESOLUTION504

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
42571-362-81ML - Milliliter42571-3621d4d3b89-5f29-443f-8b5e-d8672d72c9ef12020-02-13
42571-362-99ML - Milliliter42571-3621708cd4a-79a6-4f23-a269-a6beccca55df12020-02-13

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
42571-362CLOBETASOL PROPIONATE SOLUTION [MICRO LABS LIMITED]3Current NDC, Legacy NDC, 4 package rows20241228_85aea21d-c4ff-4558-b416-516fa93bea1f.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
861487clobetasol propionate 0.05 % Topical SolutionPSNc26e6e8f-9670-48c5-917b-e73e5589579a5
861487clobetasol propionate 0.5 MG/ML Topical SolutionSCDc26e6e8f-9670-48c5-917b-e73e5589579a5
861487clobetasol propionate 0.05 % Topical SolutionSYc26e6e8f-9670-48c5-917b-e73e5589579a5
861487clobetasol propionate 0.05 % Topical SolutionPSN85aea21d-c4ff-4558-b416-516fa93bea1f4
861487clobetasol propionate 0.5 MG/ML Topical SolutionSCD85aea21d-c4ff-4558-b416-516fa93bea1f4
861487clobetasol propionate 0.05 % Topical SolutionSY85aea21d-c4ff-4558-b416-516fa93bea1f4

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
42571-362-81425710362811 BOTTLE in 1 CARTON (42571-362-81) / 25 mL in 1 BOTTLE1 bottle2019-10-020000-00-00NoNoCurrent
42571-362-99425710362991 BOTTLE in 1 CARTON (42571-362-99) / 50 mL in 1 BOTTLE1 bottle2019-10-020000-00-00NoNoCurrent