FDA.reportPublic FDA data

CLOBETASOL PROPIONATE

Product NDC
62332-547
11-digit product format
623320547
Labeler code
62332
Product ID
62332-547_38759a63-edf0-4435-9333-d8c87eae8475
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
CLOBETASOL PROPIONATE
Dosage form
CREAM
Route
TOPICAL
Labeler
Alembic Pharmaceuticals Inc.
Application
ANDA213291
Marketing category
ANDA
Marketing start
2020-01-31
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
Rxcui861495

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
e2db08c6-133f-4f4f-afb4-e90a2418d6f6Product name120230320
3813b789-94b9-edd6-f010-6b926dd462e5Product name520230113
30eee8a1-850e-41ed-b5ab-761301aeab49Product name620221206
18e5b6f7-c414-b1f1-b684-17fdd02c215eProduct name420210927
ce6d5c06-3ae0-18a6-d5b3-8cd3cc0f8906Product name720210625
1c87bbde-dd91-a122-db33-67ae814cb645Product name720210510
f52be47f-7aa7-46c0-b1fa-50c18dd50206Product name120201029
519b5875-7d7d-4aa6-9d3d-470fa1376595Product name420200227
11ed6f83-cdd2-4637-8379-b1a1d3ae3cdeProduct name120181101
98669154-3e9c-47da-8a2c-656ab71848beProduct name220180607
8d4f8539-436f-453b-8b76-5322d403fc8eProduct name120180131
86c45a79-b9f0-4476-a27c-6e10db098497Product name120180125
837ac3c6-ee71-c5a6-6eba-c4065f37e9f5Product name220171010
d5e51f11-ad28-caa4-4b49-4143974782adProduct name120150831

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
62332-547-15CLOBETASOL PROPIONATE1 in 1 CARTONCREAM110
62332-547-15CLOBETASOL PROPIONATE15 g in 1 TUBECREAM1510
62332-547-30CLOBETASOL PROPIONATE1 in 1 CARTONCREAM110
62332-547-30CLOBETASOL PROPIONATE30 g in 1 TUBECREAM3010
62332-547-45CLOBETASOL PROPIONATE45 g in 1 TUBECREAM4510
62332-547-45CLOBETASOL PROPIONATE1 in 1 CARTONCREAM110
62332-547-60CLOBETASOL PROPIONATE60 g in 1 TUBECREAM6010
62332-547-60CLOBETASOL PROPIONATE1 in 1 CARTONCREAM110

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
62332-547-15GM - Gram62332-5479a7441cc-ce04-4680-8778-9c4a285995ff12020-07-13
62332-547-30GM - Gram62332-5472758720e-16cc-4c1f-a925-e58e20c2d2cb12020-07-13
62332-547-45GM - Gram62332-547a247d53a-5ce9-4084-a0c5-fb6ce7eee09f12020-07-13
62332-547-60GM - Gram62332-547aebc9ba8-d8aa-4bb6-9118-d783baab237512020-07-13

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
62332-547CLOBETASOL PROPIONATE CREAM [ALEMBIC PHARMACEUTICALS INC.]10Current NDC, Legacy NDC, 8 package rows20240327_0ccf8ddd-5fd8-48c7-97c9-5450a39c1bcb.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
861495clobetasol propionate 0.05 % Topical CreamPSN0ccf8ddd-5fd8-48c7-97c9-5450a39c1bcb10
861495clobetasol propionate 0.5 MG/ML Topical CreamSCD0ccf8ddd-5fd8-48c7-97c9-5450a39c1bcb10
861495clobetasol propionate 0.05 % Topical CreamSY0ccf8ddd-5fd8-48c7-97c9-5450a39c1bcb10

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
62332-547-15623320547151 TUBE in 1 CARTON (62332-547-15) / 15 g in 1 TUBE1 tube2020-01-310000-00-00NoNoCurrent
62332-547-30623320547301 TUBE in 1 CARTON (62332-547-30) / 30 g in 1 TUBE1 tube2020-01-310000-00-00NoNoCurrent
62332-547-45623320547451 TUBE in 1 CARTON (62332-547-45) / 45 g in 1 TUBE1 tube2020-01-310000-00-00NoNoCurrent
62332-547-60623320547601 TUBE in 1 CARTON (62332-547-60) / 60 g in 1 TUBE1 tube2020-01-310000-00-00NoNoCurrent