Clobetasol Propionate Cream USP, 0.05%

Product NDC
68071-2671
11-digit product format
680712671
Labeler code
68071
Product ID
68071-2671_dbfe7b1d-6794-a6d8-e053-2a95a90a8e53
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
Clobetasol Propionate Cream USP, 0.05%
Dosage form
CREAM
Route
TOPICAL
Labeler
NuCare Pharmaceuticals,Inc.
Application
ANDA212982
Marketing category
ANDA
Marketing start
2020-10-01
Marketing end
0000-00-00
Substance
CLOBETASOL PROPIONATE
Active strength
1 mg/g
Pharmacologic classes
Corticosteroid Hormone Receptor Agonists [MoA], Corticosteroid [EPC]
NDC exclude flag
No
Listing certified through
2023-12-31
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
68071-2671-32025-01-30C16284748780-12cef2736-814d-d83d-e063-dadaa90ab31fRx only FOR TOPICAL DERMATOLOGIC USE ONLY. NOT FOR OPHTHALMIC, ORAL, OR INTRAVAGINAL USE.

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
68071-2671-3Clobetasol Propionate Cream USP, 0.05%Clobetasol Propionate Cream USP, 0.05%30 g in 1 TUBECREAM302

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
68071-2671CLOBETASOL PROPIONATE CREAM USP, 0.05% CLOBETASOL PROPIONATE CREAM USP, 0.05% (CLOBETASOL PROPIONATE CREAM USP, 0.05%) CREAM [NUCARE PHARMACEUTICALS,INC.]2Legacy NDC, 1 package rows20220407_dbfe408a-ceb1-241a-e053-2a95a90a4d90.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
861495clobetasol propionate 0.05 % Topical CreamPSNdbfe408a-ceb1-241a-e053-2a95a90a4d902
861495clobetasol propionate 0.5 MG/ML Topical CreamSCDdbfe408a-ceb1-241a-e053-2a95a90a4d902
861495clobetasol propionate 0.05 % Topical CreamSYdbfe408a-ceb1-241a-e053-2a95a90a4d902

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
68071-2671-36807126710330 g in 1 TUBE (68071-2671-3) 30 g2022-04-060000-00-00NoNoCurrent