FDA.reportPublic FDA data

Clobetasol Propionate

Product NDC
46708-465
11-digit product format
467080465
Labeler code
46708
Product ID
46708-465_987aebad-866d-4204-823e-71578800d598
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
Clobetasol Propionate
Dosage form
OINTMENT
Route
TOPICAL
Labeler
Alembic Pharmaceuticals Limited
Application
ANDA211800
Marketing category
ANDA
Marketing start
2025-02-12
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
46708-465-15Clobetasol Propionate1 in 1 CARTONOINTMENT11
46708-465-15Clobetasol Propionate15 g in 1 TUBEOINTMENT151
46708-465-30Clobetasol Propionate1 in 1 CARTONOINTMENT11
46708-465-30Clobetasol Propionate30 g in 1 TUBEOINTMENT301
46708-465-45Clobetasol Propionate1 in 1 CARTONOINTMENT11
46708-465-45Clobetasol Propionate45 g in 1 TUBEOINTMENT451
46708-465-60Clobetasol Propionate60 g in 1 TUBEOINTMENT601
46708-465-60Clobetasol Propionate1 in 1 CARTONOINTMENT11

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
46708-465CLOBETASOL PROPIONATE OINTMENT [ALEMBIC PHARMACEUTICALS LIMITED]1Current NDC, 8 package rows20250214_1a4331e1-5c79-44c3-a691-4b808a3bde97.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
861448clobetasol propionate 0.05 % Topical OintmentPSN1a4331e1-5c79-44c3-a691-4b808a3bde971
861448clobetasol propionate 0.0005 MG/MG Topical OintmentSCD1a4331e1-5c79-44c3-a691-4b808a3bde971
861448clobetasol propionate 0.05 % Topical OintmentSY1a4331e1-5c79-44c3-a691-4b808a3bde971

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startSampleExclude flagStatus
46708-465-15467080465151 TUBE in 1 CARTON (46708-465-15) / 15 g in 1 TUBE1 tube2025-02-12NoNoCurrent
46708-465-30467080465301 TUBE in 1 CARTON (46708-465-30) / 30 g in 1 TUBE1 tube2025-02-12NoNoCurrent
46708-465-45467080465451 TUBE in 1 CARTON (46708-465-45) / 45 g in 1 TUBE1 tube2025-02-12NoNoCurrent
46708-465-60467080465601 TUBE in 1 CARTON (46708-465-60) / 60 g in 1 TUBE1 tube2025-12-02NoNoCurrent