FDA.reportPublic FDA data

Betamethasone dipropionate

Product NDC
51672-1390
11-digit product format
516721390
Labeler code
51672
Product ID
51672-1390_39628349-b360-4030-e063-6394a90a6ce9
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
Betamethasone dipropionate
Dosage form
SPRAY
Route
TOPICAL
Labeler
Sun Pharmaceutical Industries, Inc.
Application
ANDA211722
Marketing category
ANDA
Marketing start
2020-06-17
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
Rxcui1738536

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
51672-1390-4Betamethasone dipropionate60 g in 1 BOTTLESPRAY602
51672-1390-4Betamethasone dipropionate1 in 1 CARTONSPRAY12
51672-1390-8Betamethasone dipropionate1 in 1 CARTONSPRAY12
51672-1390-8Betamethasone dipropionate120 g in 1 BOTTLESPRAY1202

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
51672-1390BETAMETHASONE DIPROPIONATE SPRAY [TARO PHARMACEUTICALS U.S.A., INC.]1Current NDC, Legacy NDC, 4 package rows20200701_dc3dd2f7-38ad-4c4c-8602-29b33cc6af90.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
1738536betamethasone 0.05 % Topical SprayPSNdc3dd2f7-38ad-4c4c-8602-29b33cc6af902
1738536betamethasone 0.5 MG/ML Topical SpraySCDdc3dd2f7-38ad-4c4c-8602-29b33cc6af902
1738536betamethasone (as dipropionate) 0.05 % Topical SpraySYdc3dd2f7-38ad-4c4c-8602-29b33cc6af902
1738536betamethasone dipropionate 0.064 % Topical SpraySYdc3dd2f7-38ad-4c4c-8602-29b33cc6af902

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
51672-1390-4516721390041 BOTTLE in 1 CARTON (51672-1390-4) / 60 g in 1 BOTTLE1 bottle2020-06-170000-00-00NoNoCurrent
51672-1390-8516721390081 BOTTLE in 1 CARTON (51672-1390-8) / 120 g in 1 BOTTLE1 bottle2020-06-170000-00-00NoNoCurrent