FDA.reportPublic FDA data

CLOBETASOL PROPIONATE

Product NDC
70752-153
11-digit product format
707520153
Labeler code
70752
Product ID
70752-153_b21464f4-6d72-4ecb-a3a8-5478fdd22aff
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
clobetasol propionate
Dosage form
SOLUTION
Route
TOPICAL
Labeler
Quagen Pharmaceuticals LLC
Application
ANDA211240
Marketing category
ANDA
Marketing start
2022-03-14
Substance
CLOBETASOL PROPIONATE
Active strength
.5 mg/mL
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/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

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
70752-153-04CLOBETASOL PROPIONATE1 in 1 CARTONSOLUTION16
70752-153-04CLOBETASOL PROPIONATE50 mL in 1 BOTTLESOLUTION506
70752-153-20CLOBETASOL PROPIONATE25 mL in 1 BOTTLESOLUTION256
70752-153-20CLOBETASOL PROPIONATE1 in 1 CARTONSOLUTION16

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
70752-153-04ML - Milliliter70752-153208a7346-26fb-4c46-929c-6bf2f004811812023-02-06
70752-153-20ML - Milliliter70752-1538cb6a6a4-1005-4ef2-9b06-2ebd212e557912023-02-06

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
70752-153CLOBETASOL PROPIONATE SOLUTION [QUAGEN PHARMACEUTICALS LLC]6Current NDC, Legacy NDC, 4 package rows20240113_5f6d2a57-92c9-4568-83d1-524de42182b4.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
861487clobetasol propionate 0.05 % Topical SolutionPSN5f6d2a57-92c9-4568-83d1-524de42182b46
861487clobetasol propionate 0.5 MG/ML Topical SolutionSCD5f6d2a57-92c9-4568-83d1-524de42182b46
861487clobetasol propionate 0.05 % Topical SolutionSY5f6d2a57-92c9-4568-83d1-524de42182b46

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
70752-153-04707520153041 BOTTLE in 1 CARTON (70752-153-04) / 50 mL in 1 BOTTLE1 bottle2022-03-140000-00-00NoNoCurrent
70752-153-20707520153201 BOTTLE in 1 CARTON (70752-153-20) / 25 mL in 1 BOTTLE1 bottle2022-03-140000-00-00NoNoCurrent