Clobetasol Propionate

Product NDC
68071-1596
11-digit product format
680711596
Labeler code
68071
Product ID
68071-1596_bf8d39bc-3626-5375-e053-2a95a90a2976
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
Clobetasol Propionate Cream
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 [EPC],Corticosteroid Hormone Receptor Agonists [MoA]
NDC exclude flag
No
Listing certified through
2022-12-31
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
68071-1596-42023-01-30C16284748780-1f386c64a-2c9c-0266-e053-dadaa90a7c1aRx only FOR TOPICAL DERMATOLOGIC USE ONLY. NOT FOR OPHTHALMIC, ORAL, OR INTRAVAGINAL USE.

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
68071-1596-4Clobetasol Propionate45 g in 1 TUBECREAM451

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
68071-1596CLOBETASOL PROPIONATE (CLOBETASOL PROPIONATE CREAM) CREAM [NUCARE PHARMACEUTICALS,INC.]1Legacy NDC, 1 package rows20210410_bf8d2ec8-cc35-2dfd-e053-2995a90aa0bb.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
861495clobetasol propionate 0.05 % Topical CreamPSNbf8d2ec8-cc35-2dfd-e053-2995a90aa0bb1
861495clobetasol propionate 0.5 MG/ML Topical CreamSCDbf8d2ec8-cc35-2dfd-e053-2995a90aa0bb1
861495clobetasol propionate 0.05 % Topical CreamSYbf8d2ec8-cc35-2dfd-e053-2995a90aa0bb1

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
68071-1596-46807115960445 g in 1 TUBE (68071-1596-4) 45 g2021-04-090000-00-00NoNoCurrent