FDA.reportPublic FDA data

Betamethasone Dipropionate

Product NDC
52959-721
11-digit product format
529590721
Labeler code
52959
Product ID
52959-721_ca18345d-d08a-4be6-a006-49ecdd06ab30
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
Betamethasone Dipropionate
Dosage form
CREAM
Route
TOPICAL
Labeler
H.J. Harkins Company, Inc.
Application
ANDA019137
Marketing category
ANDA
Marketing start
1984-02-26
Marketing end
0000-00-00
Substance
BETAMETHASONE DIPROPIONATE
Active strength
1 mg/g
Pharmacologic classes
Corticosteroid [EPC],Corticosteroid Hormone Receptor Agonists [MoA]
NDC exclude flag
E
Listing certified through
2018-12-31
Current FDA listing
Historical FDA.report record

DailyMed Product Concepts#

Product concept, Relation, Version table
Product conceptRelationVersionEffective
dde7b902-54a1-627e-12f1-9e6d244ab88cProduct name420250317
726062af-1135-4707-a1d7-57256991bbf9Product name220250226
69b49899-11cf-4f7e-bd0a-7dc93b27311bProduct name320250130
bbdc14c7-d940-43b5-a2f7-36c425991f3cProduct name120240320
0a2fcc35-464b-9ec2-a622-753662cdd48cProduct name320240216
6f762601-17ef-4321-8f47-77783d3c4d8bProduct name320231116
1dbefad7-ab34-69c3-e51a-e7148aa38f70Product name520220921
7fea2046-07a9-4bb6-9409-828ac6f1f6dfProduct name120210201
f059f1a2-0e64-4839-9a7f-42687c91a44bProduct name120201007
4ea9e4b5-b452-48ad-9b25-b9a4d403405dProduct name120160310
f31c883b-7ebf-1c60-f3b6-4ba41e8ff7a6Product name220151106
19c71a3d-ed9c-166b-a7e5-38c250c35631Product name120140508
4f07db9b-3707-3e2c-05b5-d7852ba808c4Product name120140508

FDA-Initiated Inactive NDC Indexing#

NDC, Effective, Action table
NDCEffectiveActionDocumentIndexing SPLRelated label
52959-721-152020-01-31C16284748780-19d75b9d0-2bed-f424-e053-dadaa90a57ceBETAMETHASONE DIPROPIONATE CREAM USP, 0.05% BETAMETHASONE DIPROPIONATE OINTMENT USP, 0.05% BETAMETHASONE DIPROPIONATE LOTION USP, 0.05%
52959-721-452020-01-31C16284748780-19d75b9d0-2bed-f424-e053-dadaa90a57ceBETAMETHASONE DIPROPIONATE CREAM USP, 0.05% BETAMETHASONE DIPROPIONATE OINTMENT USP, 0.05% BETAMETHASONE DIPROPIONATE LOTION USP, 0.05%

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
52959-721-15Betamethasone Dipropionate15 g in 1 TUBECREAM153
52959-721-45Betamethasone Dipropionate45 g in 1 TUBECREAM453

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
52959-721-15GM - Gram52959-7218738d289-576a-4e3a-b6a2-d97e3a300cef12012-07-24
52959-721-45GM - Gram52959-721b3bd1d19-531a-4b91-9a7f-e6be3843502c12012-07-24

DailyMed Socrata Ingredients#

Ingredient, Type, UNII table
IngredientTypeUNIIDailyMed labelSPL versionUploaded
betamethasone dipropionateACTIVE INGREDIENT826Y60901UBETAMETHASONE DIPROPIONATE CREAM [H.J. HARKINS COMPANY, INC.]3
betamethasoneACTIVE MOIETY9842X06Q6MBETAMETHASONE DIPROPIONATE CREAM [H.J. HARKINS COMPANY, INC.]3

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
52959-721BETAMETHASONE DIPROPIONATE CREAM [H.J. HARKINS COMPANY, INC.]3Legacy NDC, 2 package rows20111223_668279da-ff19-47c9-84f7-267d27ad34f8.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
238920betamethasone 0.05 % Topical CreamPSN668279da-ff19-47c9-84f7-267d27ad34f83
238920betamethasone 0.5 MG/ML Topical CreamSCD668279da-ff19-47c9-84f7-267d27ad34f83
238920betamethasone 0.05 % Topical CreamSY668279da-ff19-47c9-84f7-267d27ad34f83
238920betamethasone 0.5 MG/GM (betamethasone dipropionate 0.64 MG/GM) Topical CreamSY668279da-ff19-47c9-84f7-267d27ad34f83

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsStatus
52959-721-155295907211515 g in 1 TUBE15 gHistorical
52959-721-455295907214545 g in 1 TUBE45 gHistorical