FDA.reportPublic FDA data

Clobetasol Propionate

Product NDC
72162-1273
11-digit product format
721621273
Labeler code
72162
Product ID
72162-1273_0b71ad3e-c1eb-4fae-af8c-3b5317e3d9a1
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
Clobetasol Propionate Ointment USP, 0.05%
Dosage form
OINTMENT
Route
TOPICAL
Labeler
Bryant Ranch Prepack
Application
ANDA211295
Marketing category
ANDA
Marketing start
2019-11-18
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
72162-1273-2Clobetasol Propionate45 g in 1 TUBEOINTMENT45106
72162-1273-2Clobetasol Propionate1 in 1 CARTONOINTMENT1106
72162-1273-3Clobetasol Propionate1 in 1 CARTONOINTMENT1106
72162-1273-3Clobetasol Propionate30 g in 1 TUBEOINTMENT30106
72162-1273-4Clobetasol Propionate1 in 1 CARTONOINTMENT1106
72162-1273-4Clobetasol Propionate15 g in 1 TUBEOINTMENT15106
72162-1273-6Clobetasol Propionate1 in 1 CARTONOINTMENT1106
72162-1273-6Clobetasol Propionate60 g in 1 TUBEOINTMENT60106

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
72162-1273-2GM - Gram72162-127374491914-ae8e-47e2-81a6-e7c5774ae3c012023-12-05
72162-1273-3GM - Gram72162-1273f20a6ee4-5af9-4b2d-8e4b-9d127ef9128712024-01-04
72162-1273-4GM - Gram72162-1273749ec300-5634-44de-b52a-15c14976ac4012024-01-04
72162-1273-6GM - Gram72162-127323adc6d6-9f4e-4a0c-a1b4-05264efc187112024-01-04

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
72162-1273CLOBETASOL PROPIONATE (CLOBETASOL PROPIONATE OINTMENT USP, 0.05%) OINTMENT [BRYANT RANCH PREPACK]105Current NDC, 8 package rows20250522_60f65ee3-b972-4e58-97fe-0c0ab14b9b48.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
861448clobetasol propionate 0.05 % Topical OintmentPSN60f65ee3-b972-4e58-97fe-0c0ab14b9b48106
861448clobetasol propionate 0.0005 MG/MG Topical OintmentSCD60f65ee3-b972-4e58-97fe-0c0ab14b9b48106
861448clobetasol propionate 0.05 % Topical OintmentSY60f65ee3-b972-4e58-97fe-0c0ab14b9b48106

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startSampleExclude flagStatus
72162-1273-2721621273021 TUBE in 1 CARTON (72162-1273-2) / 45 g in 1 TUBE1 tube2023-09-26NoNoHistorical
72162-1273-3721621273031 TUBE in 1 CARTON (72162-1273-3) / 30 g in 1 TUBE1 tube2023-09-26NoNoHistorical
72162-1273-4721621273041 TUBE in 1 CARTON (72162-1273-4) / 15 g in 1 TUBE1 tube2023-09-26NoNoHistorical
72162-1273-6721621273061 TUBE in 1 CARTON (72162-1273-6) / 60 g in 1 TUBE1 tube2023-09-26NoNoHistorical