FDA.reportPublic FDA data

Clodan

Product NDC
43538-950
11-digit product format
435380950
Labeler code
43538
Product ID
43538-950_d9fb3d50-fdde-4dc7-af7c-c8c2c039fc51
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
clobetasol propionate
Dosage form
SHAMPOO
Route
TOPICAL
Labeler
Medimetriks Pharmaceuticals
Application
ANDA090974
Marketing category
ANDA
Marketing start
2014-06-22
Substance
CLOBETASOL PROPIONATE
Active strength
.5 mg/mL
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
Clodan
Listing expiration
2026-12-31

Active Ingredients#

Ingredient, Strength table
IngredientStrength
CLOBETASOL PROPIONATE.5 mg/mL

Harmonized Identifiers#

Field, Values table
FieldValues
Unii779619577M
Rxcui861490, 1541099

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
43538-950-04Clodan1 in 1 CARTONSHAMPOO15
43538-950-04Clodan118 mL in 1 BOTTLESHAMPOO1185

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
43538-950-04ML - Milliliter43538-950371f855c-b251-4440-8c2b-38d39be0a28912014-08-01

DailyMed Socrata Ingredients#

Ingredient, Type, UNII table
IngredientTypeUNIIDailyMed labelSPL versionUploaded
clobetasol propionateACTIVE INGREDIENT779619577MCLODAN (CLOBETASOL PROPIONATE) SHAMPOO [MEDIMETRIKS PHARMACEUTICALS]1
clobetasolACTIVE MOIETYADN79D536HCLODAN (CLOBETASOL PROPIONATE) SHAMPOO [MEDIMETRIKS PHARMACEUTICALS]1
alcoholINACTIVE INGREDIENT3K9958V90MCLODAN (CLOBETASOL PROPIONATE) SHAMPOO [MEDIMETRIKS PHARMACEUTICALS]1
citric acid monohydrateINACTIVE INGREDIENT2968PHW8QPCLODAN (CLOBETASOL PROPIONATE) SHAMPOO [MEDIMETRIKS PHARMACEUTICALS]1
coco-betaineINACTIVE INGREDIENT03DH2IZ3FYCLODAN (CLOBETASOL PROPIONATE) SHAMPOO [MEDIMETRIKS PHARMACEUTICALS]1
sodium citrateINACTIVE INGREDIENT1Q73Q2JULRCLODAN (CLOBETASOL PROPIONATE) SHAMPOO [MEDIMETRIKS PHARMACEUTICALS]1
sodium laureth-3 sulfateINACTIVE INGREDIENTBPV390UAP0CLODAN (CLOBETASOL PROPIONATE) SHAMPOO [MEDIMETRIKS PHARMACEUTICALS]1
waterINACTIVE INGREDIENT059QF0KO0RCLODAN (CLOBETASOL PROPIONATE) SHAMPOO [MEDIMETRIKS PHARMACEUTICALS]1

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
43538-950CLODAN (CLOBETASOL PROPIONATE) SHAMPOO [MEDIMETRIKS PHARMACEUTICALS]5Current NDC, Legacy NDC, 2 package rows20231121_b5d32546-65dc-4b0c-826e-ddbc2a50b152.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
861490clobetasol propionate 0.05 % Medicated ShampooPSNb5d32546-65dc-4b0c-826e-ddbc2a50b1525
1541099Clodan 0.05 % Medicated ShampooPSNb5d32546-65dc-4b0c-826e-ddbc2a50b1525
1541099clobetasol propionate 0.5 MG/ML Medicated Shampoo [Clodan]SBDb5d32546-65dc-4b0c-826e-ddbc2a50b1525
861490clobetasol propionate 0.5 MG/ML Medicated ShampooSCDb5d32546-65dc-4b0c-826e-ddbc2a50b1525
861490clobetasol propionate 0.05 % Medicated ShampooSYb5d32546-65dc-4b0c-826e-ddbc2a50b1525
1541099Clodan 0.05 % Medicated ShampooSYb5d32546-65dc-4b0c-826e-ddbc2a50b1525
1541099Clodan 0.5 MG/ML Medicated ShampooSYb5d32546-65dc-4b0c-826e-ddbc2a50b1525

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
43538-950-04435380950041 BOTTLE in 1 CARTON (43538-950-04) / 118 mL in 1 BOTTLE1 bottle2014-06-220000-00-00NoNoCurrent