FDA.reportPublic FDA data

Clobetasol Propionate

Product NDC
68462-529
11-digit product format
684620529
Labeler code
68462
Product ID
68462-529_044676e5-96b4-40d4-82db-f87e2abf31a2
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
Clobetasol Propionate
Dosage form
CREAM
Route
TOPICAL
Labeler
Glenmark Pharmaceutcials Inc., USA
Application
ANDA209095
Marketing category
ANDA
Marketing start
2018-05-10
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
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
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
68462-529-17Clobetasol Propionate1 in 1 CARTONCREAM17
68462-529-17Clobetasol Propionate15 g in 1 TUBECREAM157
68462-529-35Clobetasol Propionate30 g in 1 TUBECREAM307
68462-529-35Clobetasol Propionate1 in 1 CARTONCREAM17
68462-529-47Clobetasol Propionate1 in 1 CARTONCREAM17
68462-529-47Clobetasol Propionate45 g in 1 TUBECREAM457
68462-529-65Clobetasol Propionate60 g in 1 TUBECREAM607
68462-529-65Clobetasol Propionate1 in 1 CARTONCREAM17

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
68462-529-17GM - Gram68462-5299f534169-b839-4b1d-b0f0-99307f12e23f12018-11-06
68462-529-35GM - Gram68462-52938f065be-ec14-4182-886f-7f1501b8e51c12018-09-05
68462-529-47GM - Gram68462-529a1c036ec-4d9a-489b-b145-5dabbbb9dfc712018-11-06
68462-529-65GM - Gram68462-529f25be517-1eaa-47f1-906d-d426e7d49ba412018-09-05

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
68462-529CLOBETASOL PROPIONATE CREAM [GLENMARK PHARMACEUTCIALS INC., USA]6Current NDC, Legacy NDC, 8 package rows20240104_69794e0b-2a79-419e-844f-ed051be62249.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
861495clobetasol propionate 0.05 % Topical CreamPSN69794e0b-2a79-419e-844f-ed051be622497
861495clobetasol propionate 0.5 MG/ML Topical CreamSCD69794e0b-2a79-419e-844f-ed051be622497
861495clobetasol propionate 0.05 % Topical CreamSY69794e0b-2a79-419e-844f-ed051be622497

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
68462-529-17684620529171 TUBE in 1 CARTON (68462-529-17) / 15 g in 1 TUBE1 tube2018-07-190000-00-00NoNoCurrent
68462-529-35684620529351 TUBE in 1 CARTON (68462-529-35) / 30 g in 1 TUBE1 tube2018-05-100000-00-00NoNoCurrent
68462-529-47684620529471 TUBE in 1 CARTON (68462-529-47) / 45 g in 1 TUBE1 tube2018-07-190000-00-00NoNoCurrent
68462-529-65684620529651 TUBE in 1 CARTON (68462-529-65) / 60 g in 1 TUBE1 tube2018-05-100000-00-00NoNoCurrent