Clobetasol Propionate

Product NDC
52565-051
11-digit product format
525650051
Labeler code
52565
Product ID
52565-051_2f77cb4f-4940-4b7d-8dac-a20fe8193b52
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
Clobetasol Propionate
Dosage form
CREAM
Route
TOPICAL
Labeler
Teligent Pharma, Inc.
Application
ANDA209974
Marketing category
ANDA
Marketing start
2018-04-17
Marketing end
0000-00-00
Substance
CLOBETASOL PROPIONATE
Active strength
1 mg/g
Pharmacologic classes
Corticosteroid [EPC],Corticosteroid Hormone Receptor Agonists [MoA]
NDC exclude flag
No
Listing certified through
2020-12-31
Current FDA listing
Historical FDA.report record

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

FDA-Initiated Inactive NDC Indexing#

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
52565-051-15Clobetasol Propionate1 in 1 CARTONCREAM14
52565-051-15Clobetasol Propionate15 g in 1 TUBECREAM154
52565-051-30Clobetasol Propionate30 g in 1 TUBECREAM304
52565-051-30Clobetasol Propionate1 in 1 CARTONCREAM14
52565-051-45Clobetasol Propionate45 g in 1 TUBECREAM454
52565-051-45Clobetasol Propionate1 in 1 CARTONCREAM14
52565-051-60Clobetasol Propionate60 g in 1 TUBECREAM604
52565-051-60Clobetasol Propionate1 in 1 CARTONCREAM14

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
52565-051-15GM - Gram52565-051dcb67bd0-638f-4392-ba4c-ba52f4cc518a12018-06-11
52565-051-30GM - Gram52565-051eec6a41e-5306-48c7-883d-043f2e856a5012018-06-11
52565-051-45GM - Gram52565-051ffa55d13-0bff-436f-b0db-dc7ecf243b2a12018-06-11
52565-051-60GM - Gram52565-051d4a74177-e0c3-451b-9123-9868c73f51a412018-06-11

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
52565-051CLOBETASOL PROPIONATE CREAM [TELIGENT PHARMA, INC.]4Legacy NDC, 8 package rows20190911_a84c85fb-05f6-1eb8-444e-c5613766e3e5.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
861495clobetasol propionate 0.05 % Topical CreamPSNbea723d5-3948-4c47-8719-c34369b186df5
861495clobetasol propionate 0.5 MG/ML Topical CreamSCDbea723d5-3948-4c47-8719-c34369b186df5
861495clobetasol propionate 0.05 % Topical CreamSYbea723d5-3948-4c47-8719-c34369b186df5
861495clobetasol propionate 0.05 % Topical CreamPSNa84c85fb-05f6-1eb8-444e-c5613766e3e54
861495clobetasol propionate 0.5 MG/ML Topical CreamSCDa84c85fb-05f6-1eb8-444e-c5613766e3e54
861495clobetasol propionate 0.05 % Topical CreamSYa84c85fb-05f6-1eb8-444e-c5613766e3e54

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
52565-051-15525650051151 TUBE in 1 CARTON (52565-051-15) > 15 g in 1 TUBE1 tube2018-04-170000-00-00NoNoCurrent
52565-051-30525650051301 TUBE in 1 CARTON (52565-051-30) > 30 g in 1 TUBE1 tube2018-04-170000-00-00NoNoCurrent
52565-051-45525650051451 TUBE in 1 CARTON (52565-051-45) > 45 g in 1 TUBE1 tube2018-04-170000-00-00NoNoCurrent
52565-051-60525650051601 TUBE in 1 CARTON (52565-051-60) > 60 g in 1 TUBE1 tube2018-04-170000-00-00NoNoCurrent