FDA.reportPublic FDA data

Betamethasone Dipropionate

Product NDC
51672-1309
11-digit product format
516721309
Labeler code
51672
Product ID
51672-1309_38f65f63-5416-f33d-e063-6294a90a4238
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
Betamethasone Dipropionate
Dosage form
GEL
Route
TOPICAL
Labeler
Sun Pharmaceutical Industries, Inc.
Application
ANDA076508
Marketing category
ANDA
Marketing start
2003-12-02
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
Rxcui848208

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
51672-1309-1Betamethasone Dipropionate15 g in 1 TUBEGEL156
51672-1309-1Betamethasone Dipropionate1 in 1 CARTONGEL16
51672-1309-3Betamethasone Dipropionate1 in 1 CARTONGEL16
51672-1309-3Betamethasone Dipropionate50 g in 1 TUBEGEL506

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
51672-1309-1GM - Gram51672-13098f10039b-85a5-4ecd-bcea-3bab503cd15712012-07-24
51672-1309-3GM - Gram51672-1309aaa573ed-58dc-4041-9cbf-2a97c4d5b37612012-07-24

DailyMed Socrata Ingredients#

Ingredient, Type, UNII table
IngredientTypeUNIIDailyMed labelSPL versionUploaded
Betamethasone DipropionateACTIVE INGREDIENT826Y60901UBETAMETHASONE DIPROPIONATE GEL [TARO PHARMACEUTICALS U.S.A., INC.]2
BetamethasoneACTIVE MOIETY9842X06Q6MBETAMETHASONE DIPROPIONATE GEL [TARO PHARMACEUTICALS U.S.A., INC.]2

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
51672-1309BETAMETHASONE DIPROPIONATE GEL [TARO PHARMACEUTICALS U.S.A., INC.]5Current NDC, Legacy NDC, 4 package rows20241222_e041ceb2-8bda-4703-b663-804e7b462e32.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
848208betamethasone dipropionate 0.05 % Augmented Topical GelPSNe041ceb2-8bda-4703-b663-804e7b462e326
848208Augmented betamethasone 0.0005 MG/MG Topical GelSCDe041ceb2-8bda-4703-b663-804e7b462e326
848208augmented betamethasone 0.05 % Topical GelSYe041ceb2-8bda-4703-b663-804e7b462e326
848208betamethasone 0.05 % (betamethasone dipropionate 0.064 % ) Augmented Topical GelSYe041ceb2-8bda-4703-b663-804e7b462e326

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
51672-1309-1516721309011 TUBE in 1 CARTON (51672-1309-1) / 15 g in 1 TUBE1 tube2003-12-020000-00-00NoNoCurrent
51672-1309-3516721309031 TUBE in 1 CARTON (51672-1309-3) / 50 g in 1 TUBE1 tube2003-12-020000-00-00NoNoCurrent