FDA.reportPublic FDA data

betamethasone dipropionate

Product NDC
72578-093
11-digit product format
725780093
Labeler code
72578
Product ID
72578-093_48e480f9-2c41-4fd3-909b-a2490d7a1509
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
betamethasone dipropionate
Dosage form
OINTMENT
Route
TOPICAL
Labeler
Viona Pharmaceuticals Inc
Application
ANDA214048
Marketing category
ANDA
Marketing start
2020-07-20
Substance
BETAMETHASONE DIPROPIONATE
Active strength
.5 mg/g
Pharmacologic classes
Corticosteroid Hormone Receptor Agonists [MoA], Corticosteroid [EPC]
NDC exclude flag
No
Listing certified through
2026-12-31
Current FDA listing
Yes

Additional Listing Data#

Finished product
Yes
Brand name base
betamethasone dipropionate
Listing expiration
2026-12-31

Active Ingredients#

Ingredient, Strength table
IngredientStrength
BETAMETHASONE DIPROPIONATE.5 mg/g

Harmonized Identifiers#

Field, Values table
FieldValues
Unii826Y60901U
Rxcui197405

DailyMed Product Concepts#

Product concept, Relation, Version table
Product conceptRelationVersionEffective
dde7b902-54a1-627e-12f1-9e6d244ab88cProduct name420250317
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
4f07db9b-3707-3e2c-05b5-d7852ba808c4Product name120140508

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
72578-093-01betamethasone dipropionate15 g in 1 TUBEOINTMENT154
72578-093-01betamethasone dipropionate1 in 1 CARTONOINTMENT14
72578-093-06betamethasone dipropionate1 in 1 CARTONOINTMENT14
72578-093-06betamethasone dipropionate45 g in 1 TUBEOINTMENT454

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
72578-093BETAMETHASONE DIPROPIONATE OINTMENT [VIONA PHARMACEUTICALS INC]4Current NDC, Legacy NDC, 4 package rows20230818_9adfb030-17c3-46eb-bf85-a90cabafd367.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
197405betamethasone dipropionate 0.05 % Topical OintmentPSN9adfb030-17c3-46eb-bf85-a90cabafd3674
197405betamethasone 0.0005 MG/MG Topical OintmentSCD9adfb030-17c3-46eb-bf85-a90cabafd3674
197405betamethasone 0.05 % Topical OintmentSY9adfb030-17c3-46eb-bf85-a90cabafd3674
197405betamethasone 0.5 MG/GM (betamethasone dipropionate 0.64 MG/GM) Topical OintmentSY9adfb030-17c3-46eb-bf85-a90cabafd3674

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
72578-093-01725780093011 TUBE in 1 CARTON (72578-093-01) / 15 g in 1 TUBE1 tube2020-07-200000-00-00NoNoCurrent
72578-093-06725780093061 TUBE in 1 CARTON (72578-093-06) / 45 g in 1 TUBE1 tube2020-07-200000-00-00NoNoCurrent