FDA.reportPublic FDA data

Clobetasol Propionate

Product NDC
69238-1532
11-digit product format
692381532
Labeler code
69238
Product ID
69238-1532_df6ce06d-306e-47db-8130-24bc017bcf6e
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
Clobetasol Propionate
Dosage form
CREAM
Route
TOPICAL
Labeler
Amneal Pharmaceuticals NY LLC
Application
ANDA211256
Marketing category
ANDA
Marketing start
2018-12-28
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
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
d5e51f11-ad28-caa4-4b49-4143974782adProduct name120150831

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
69238-1532-3Clobetasol Propionate30 g in 1 TUBECREAM3010
69238-1532-3Clobetasol Propionate1 in 1 CARTONCREAM110
69238-1532-4Clobetasol Propionate1 in 1 CARTONCREAM110
69238-1532-4Clobetasol Propionate45 g in 1 TUBECREAM4510
69238-1532-5Clobetasol Propionate1 in 1 CARTONCREAM110
69238-1532-5Clobetasol Propionate15 g in 1 TUBECREAM1510
69238-1532-6Clobetasol Propionate60 g in 1 TUBECREAM6010
69238-1532-6Clobetasol Propionate1 in 1 CARTONCREAM110

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
69238-1532-3GM - Gram69238-1532351c985e-9a0b-484e-8f91-22b001e7a64112020-04-20
69238-1532-4GM - Gram69238-1532ac4be92c-3359-474e-a13b-a61636f3649412020-04-20
69238-1532-5GM - Gram69238-15325ad72de6-5518-4ab8-b922-b0756381f0ae12020-04-20
69238-1532-6GM - Gram69238-1532d5a61d4c-3962-44ea-a96c-45bd7602c95b12020-04-20

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
69238-1532CLOBETASOL PROPIONATE CREAM [AMNEAL PHARMACEUTICALS NY LLC]10Current NDC, Legacy NDC, 8 package rows20231230_53871de0-30cc-4446-b2a0-7a10caa965e0.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
861495clobetasol propionate 0.05 % Topical CreamPSN53871de0-30cc-4446-b2a0-7a10caa965e010
861495clobetasol propionate 0.5 MG/ML Topical CreamSCD53871de0-30cc-4446-b2a0-7a10caa965e010
861495clobetasol propionate 0.05 % Topical CreamSY53871de0-30cc-4446-b2a0-7a10caa965e010
861495clobetasol propionate 0.05 % Topical CreamPSNe1854cfc-9b3b-5fad-e053-2a95a90a73e81
861495clobetasol propionate 0.05 % Topical CreamPSNe223598e-3cf8-4362-b963-a23ea05072ba1
861495clobetasol propionate 0.5 MG/ML Topical CreamSCDe1854cfc-9b3b-5fad-e053-2a95a90a73e81
861495clobetasol propionate 0.5 MG/ML Topical CreamSCDe223598e-3cf8-4362-b963-a23ea05072ba1
861495clobetasol propionate 0.05 % Topical CreamSYe1854cfc-9b3b-5fad-e053-2a95a90a73e81
861495clobetasol propionate 0.05 % Topical CreamSYe223598e-3cf8-4362-b963-a23ea05072ba1

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
69238-1532-3692381532031 TUBE in 1 CARTON (69238-1532-3) / 30 g in 1 TUBE1 tube2018-12-280000-00-00NoNoCurrent
69238-1532-4692381532041 TUBE in 1 CARTON (69238-1532-4) / 45 g in 1 TUBE1 tube2018-12-280000-00-00NoNoCurrent
69238-1532-5692381532051 TUBE in 1 CARTON (69238-1532-5) / 15 g in 1 TUBE1 tube2018-12-280000-00-00NoNoCurrent
69238-1532-6692381532061 TUBE in 1 CARTON (69238-1532-6) / 60 g in 1 TUBE1 tube2018-12-280000-00-00NoNoCurrent