FDA.reportPublic FDA data

Clobetasol Propionate (emollient)

Product NDC
52565-094
11-digit product format
525650094
Labeler code
52565
Product ID
52565-094_ead40d2f-5094-43d1-bcf0-bb8568dea064
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
clobetasol propionate
Dosage form
CREAM
Route
TOPICAL
Labeler
Teligent Pharma, Inc.
Application
ANDA209411
Marketing category
ANDA
Marketing start
2017-08-21
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#

NDC, Effective, Action table
NDCEffectiveActionDocumentIndexing SPLRelated label
52565-094-152023-01-30C16284748780-1f386c64a-20a8-0266-e053-dadaa90a7c1aThese highlights do not include all the information needed to use CLOBETASOL PROPIONATE CREAM (EMOLLIENT) safely and effectively. See full prescribing information for CLOBETASOL PROPIONATE CREAM (EMOLLIENT). CLOBETASOL PROPIONATE cream, for topical use Initial U.S. Approval: 1994
52565-094-302023-01-30C16284748780-1f386c64a-20a8-0266-e053-dadaa90a7c1aThese highlights do not include all the information needed to use CLOBETASOL PROPIONATE CREAM (EMOLLIENT) safely and effectively. See full prescribing information for CLOBETASOL PROPIONATE CREAM (EMOLLIENT). CLOBETASOL PROPIONATE cream, for topical use Initial U.S. Approval: 1994
52565-094-452023-01-30C16284748780-1f386c64a-20a8-0266-e053-dadaa90a7c1aThese highlights do not include all the information needed to use CLOBETASOL PROPIONATE CREAM (EMOLLIENT) safely and effectively. See full prescribing information for CLOBETASOL PROPIONATE CREAM (EMOLLIENT). CLOBETASOL PROPIONATE cream, for topical use Initial U.S. Approval: 1994
52565-094-602023-01-30C16284748780-1f386c64a-20a8-0266-e053-dadaa90a7c1aThese highlights do not include all the information needed to use CLOBETASOL PROPIONATE CREAM (EMOLLIENT) safely and effectively. See full prescribing information for CLOBETASOL PROPIONATE CREAM (EMOLLIENT). CLOBETASOL PROPIONATE cream, for topical use Initial U.S. Approval: 1994

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
52565-094-15Clobetasol Propionate (emollient)15 g in 1 TUBECREAM152
52565-094-15Clobetasol Propionate (emollient)1 in 1 CARTONCREAM12
52565-094-30Clobetasol Propionate (emollient)30 g in 1 TUBECREAM302
52565-094-30Clobetasol Propionate (emollient)1 in 1 CARTONCREAM12
52565-094-45Clobetasol Propionate (emollient)1 in 1 CARTONCREAM12
52565-094-45Clobetasol Propionate (emollient)45 g in 1 TUBECREAM452
52565-094-60Clobetasol Propionate (emollient)1 in 1 CARTONCREAM12
52565-094-60Clobetasol Propionate (emollient)60 g in 1 TUBECREAM602

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
52565-094-15GM - Gram52565-094e6b79ff4-c55e-40b1-a033-7824ba9227ad12017-11-06
52565-094-30GM - Gram52565-09425c9b26c-1664-4f10-895e-2adb04b8a14b12017-11-06
52565-094-45GM - Gram52565-09462255d49-07a6-4607-8766-401fe2411f3c12017-11-06
52565-094-60GM - Gram52565-0941244db96-89a9-459d-b308-3a759497895e12017-11-06

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
52565-094CLOBETASOL PROPIONATE (EMOLLIENT) (CLOBETASOL PROPIONATE) CREAM [TELIGENT PHARMA, INC.]2Legacy NDC, 8 package rows20190911_a175ba8a-a037-d62c-977a-96e2a776f7b1.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
1992281clobetasol propionate 0.05 % Emollient Base Topical CreamPSNa175ba8a-a037-d62c-977a-96e2a776f7b12
1992281Emollient clobetasol propionate 0.5 MG/ML Topical CreamSCDa175ba8a-a037-d62c-977a-96e2a776f7b12
1992281clobetasol propionate 0.05 % Emollient Base Topical CreamSYa175ba8a-a037-d62c-977a-96e2a776f7b12

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
52565-094-15525650094151 TUBE in 1 CARTON (52565-094-15) > 15 g in 1 TUBE1 tube2017-08-210000-00-00NoNoCurrent
52565-094-30525650094301 TUBE in 1 CARTON (52565-094-30) > 30 g in 1 TUBE1 tube2017-08-210000-00-00NoNoCurrent
52565-094-45525650094451 TUBE in 1 CARTON (52565-094-45) > 45 g in 1 TUBE1 tube2017-08-210000-00-00NoNoCurrent
52565-094-60525650094601 TUBE in 1 CARTON (52565-094-60) > 60 g in 1 TUBE1 tube2017-08-210000-00-00NoNoCurrent