FDA.reportPublic FDA data

Betamethasone Dipropionate

Product NDC
51672-1340
11-digit product format
516721340
Labeler code
51672
Product ID
51672-1340_3961e128-73c9-c458-e063-6294a90a8a8f
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
Betamethasone Dipropionate
Dosage form
LOTION, AUGMENTED
Route
TOPICAL
Labeler
Sun Pharmaceutical Industries, Inc.
Application
ANDA077477
Marketing category
ANDA
Marketing start
2007-05-21
Substance
BETAMETHASONE DIPROPIONATE
Active strength
.5 mg/mL
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/mL

Harmonized Identifiers#

Field, Values table
FieldValues
Unii826Y60901U
Rxcui848178

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
6c13b22c-b3ba-4127-b768-0132dd5ab0d1Product name120230829
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

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
51672-1340-3Betamethasone Dipropionate30 mL in 1 BOTTLELOTION, AUGMENTED308
51672-1340-3Betamethasone Dipropionate1 in 1 CARTONLOTION, AUGMENTED18
51672-1340-4Betamethasone Dipropionate1 in 1 CARTONLOTION, AUGMENTED18
51672-1340-4Betamethasone Dipropionate60 mL in 1 BOTTLELOTION, AUGMENTED608

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
51672-1340-3ML - Milliliter51672-1340cc487549-b095-4df9-8679-b1a16e572c0112012-07-24
51672-1340-4ML - Milliliter51672-13400bfdc60b-602a-4151-813f-5fdb3d8b305d12012-07-24

DailyMed Socrata Ingredients#

Ingredient, Type, UNII table
IngredientTypeUNIIDailyMed labelSPL versionUploaded
Betamethasone DipropionateACTIVE INGREDIENT826Y60901UBETAMETHASONE DIPROPIONATE LOTION, AUGMENTED [TARO PHARMACEUTICALS U.S.A., INC.]4
BetamethasoneACTIVE MOIETY9842X06Q6MBETAMETHASONE DIPROPIONATE LOTION, AUGMENTED [TARO PHARMACEUTICALS U.S.A., INC.]4
hydroxypropyl cellulose (Type H)INACTIVE INGREDIENTRFW2ET671PBETAMETHASONE DIPROPIONATE LOTION, AUGMENTED [TARO PHARMACEUTICALS U.S.A., INC.]4
isopropyl alcoholINACTIVE INGREDIENTND2M416302BETAMETHASONE DIPROPIONATE LOTION, AUGMENTED [TARO PHARMACEUTICALS U.S.A., INC.]4
phosphoric acidINACTIVE INGREDIENTE4GA8884NNBETAMETHASONE DIPROPIONATE LOTION, AUGMENTED [TARO PHARMACEUTICALS U.S.A., INC.]4
propylene glycolINACTIVE INGREDIENT6DC9Q167V3BETAMETHASONE DIPROPIONATE LOTION, AUGMENTED [TARO PHARMACEUTICALS U.S.A., INC.]4
sodium phosphate, monobasic, monohydrateINACTIVE INGREDIENT593YOG76RNBETAMETHASONE DIPROPIONATE LOTION, AUGMENTED [TARO PHARMACEUTICALS U.S.A., INC.]4
waterINACTIVE INGREDIENT059QF0KO0RBETAMETHASONE DIPROPIONATE LOTION, AUGMENTED [TARO PHARMACEUTICALS U.S.A., INC.]4

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
51672-1340BETAMETHASONE DIPROPIONATE LOTION, AUGMENTED [TARO PHARMACEUTICALS U.S.A., INC.]7Current NDC, Legacy NDC, 4 package rows20241222_3b23a3c0-3306-4a2d-932d-25916d16dc68.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
848178betamethasone 0.05 % (betamethasone diproprionate 0.64 MG/ML) Augmented Topical LotionPSN3b23a3c0-3306-4a2d-932d-25916d16dc688
848178Augmented betamethasone 0.5 MG/ML Topical LotionSCD3b23a3c0-3306-4a2d-932d-25916d16dc688
848178augmented betamethasone 0.05 % Topical LotionSY3b23a3c0-3306-4a2d-932d-25916d16dc688
848178betamethasone 0.05 % (betamethasone diproprionate 0.64 MG/ML) Augmented Topical LotionSY3b23a3c0-3306-4a2d-932d-25916d16dc688

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
51672-1340-3516721340031 BOTTLE in 1 CARTON (51672-1340-3) / 30 mL in 1 BOTTLE1 bottle2007-05-210000-00-00NoNoCurrent
51672-1340-4516721340041 BOTTLE in 1 CARTON (51672-1340-4) / 60 mL in 1 BOTTLE1 bottle2007-05-210000-00-00NoNoCurrent