Clobetasol Propionate

Product NDC
68462-608
11-digit product format
684620608
Labeler code
68462
Product ID
68462-608_f995c5e9-6e42-423f-b475-ec0347aeca97
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
clobetasol propionate
Dosage form
AEROSOL, FOAM
Route
TOPICAL
Labeler
Glenmark Pharmaceuticals Inc., USA
Application
ANDA210809
Marketing category
ANDA
Marketing start
2019-02-16
Substance
CLOBETASOL PROPIONATE
Active strength
.5 mg/g
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/g

Harmonized Identifiers#

Field, Values table
FieldValues
Unii779619577M
Rxcui861353

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
ce6d5c06-3ae0-18a6-d5b3-8cd3cc0f8906Product name720210625
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
68462-608-27Clobetasol Propionate50 g in 1 CANAEROSOL, FOAM509
68462-608-94Clobetasol Propionate100 g in 1 CANAEROSOL, FOAM1009

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
68462-608-27GM - Gram68462-608bbc2de89-c9f1-4500-89c9-872afd8914c712019-05-02
68462-608-94GM - Gram68462-60865bd8c5d-5c28-4eeb-bfc4-51e11e6f973e12019-05-02

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
68462-608CLOBETASOL PROPIONATE AEROSOL, FOAM [GLENMARK PHARMACEUTICALS INC., USA]8Current NDC, Legacy NDC, 2 package rows20230706_db8c7a36-e950-44b9-b2ff-7fede2e87407.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
861353clobetasol propionate 0.05 % Topical FoamPSNdb8c7a36-e950-44b9-b2ff-7fede2e874079
861353clobetasol propionate 0.5 MG/ML Topical FoamSCDdb8c7a36-e950-44b9-b2ff-7fede2e874079
861353clobetasol propionate 0.05 % Topical FoamSYdb8c7a36-e950-44b9-b2ff-7fede2e874079

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
68462-608-276846206082750 g in 1 CAN (68462-608-27) 50 g2019-02-160000-00-00NoNoCurrent
68462-608-9468462060894100 g in 1 CAN (68462-608-94) 100 g2019-02-160000-00-00NoNoCurrent