FDA.reportPublic FDA data

Betamethasone Dipropionate

Product NDC
51672-1274
11-digit product format
516721274
Labeler code
51672
Product ID
51672-1274_38f55e1e-dffd-ee76-e063-6394a90aee5e
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
Betamethasone Dipropionate
Dosage form
CREAM
Route
TOPICAL
Labeler
Sun Pharmaceutical Industries, Inc.
Application
ANDA073552
Marketing category
ANDA
Marketing start
1992-04-30
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
Rxcui238920

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
51672-1274-1Betamethasone Dipropionate15 g in 1 TUBECREAM157
51672-1274-1Betamethasone Dipropionate1 in 1 CARTONCREAM17
51672-1274-6Betamethasone Dipropionate1 in 1 CARTONCREAM17
51672-1274-6Betamethasone Dipropionate45 g in 1 TUBECREAM457

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
51672-1274-1GM - Gram51672-127496629d41-03df-48dc-8a6e-779d839e010712012-07-24
51672-1274-6GM - Gram51672-1274fc92771e-edb4-4374-aac8-0e44502979c612012-07-24

DailyMed Socrata Ingredients#

Ingredient, Type, UNII table
IngredientTypeUNIIDailyMed labelSPL versionUploaded
Betamethasone DipropionateACTIVE INGREDIENT826Y60901UBETAMETHASONE DIPROPIONATE CREAM [TARO PHARMACEUTICALS U.S.A., INC.]2
BetamethasoneACTIVE MOIETY9842X06Q6MBETAMETHASONE DIPROPIONATE CREAM [TARO PHARMACEUTICALS U.S.A., INC.]2
Ceteth-20INACTIVE INGREDIENTI835H2IHHXBETAMETHASONE DIPROPIONATE CREAM [TARO PHARMACEUTICALS U.S.A., INC.]2
cetostearyl alcoholINACTIVE INGREDIENT2DMT128M1SBETAMETHASONE DIPROPIONATE CREAM [TARO PHARMACEUTICALS U.S.A., INC.]2
chlorocresolINACTIVE INGREDIENT36W53O7109BETAMETHASONE DIPROPIONATE CREAM [TARO PHARMACEUTICALS U.S.A., INC.]2
mineral oilINACTIVE INGREDIENTT5L8T28FGPBETAMETHASONE DIPROPIONATE CREAM [TARO PHARMACEUTICALS U.S.A., INC.]2
petrolatumINACTIVE INGREDIENT4T6H12BN9UBETAMETHASONE DIPROPIONATE CREAM [TARO PHARMACEUTICALS U.S.A., INC.]2
phosphoric acidINACTIVE INGREDIENTE4GA8884NNBETAMETHASONE DIPROPIONATE CREAM [TARO PHARMACEUTICALS U.S.A., INC.]2
propylene glycolINACTIVE INGREDIENT6DC9Q167V3BETAMETHASONE DIPROPIONATE CREAM [TARO PHARMACEUTICALS U.S.A., INC.]2
sodium hydroxideINACTIVE INGREDIENT55X04QC32IBETAMETHASONE DIPROPIONATE CREAM [TARO PHARMACEUTICALS U.S.A., INC.]2
sodium phosphate, monobasicINACTIVE INGREDIENT3980JIH2SWBETAMETHASONE DIPROPIONATE CREAM [TARO PHARMACEUTICALS U.S.A., INC.]2
waterINACTIVE INGREDIENT059QF0KO0RBETAMETHASONE DIPROPIONATE CREAM [TARO PHARMACEUTICALS U.S.A., INC.]2

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
51672-1274BETAMETHASONE DIPROPIONATE CREAM [TARO PHARMACEUTICALS U.S.A., INC.]6Current NDC, Legacy NDC, 4 package rows20241222_bc12c828-54ba-411d-b752-9b735f7adf63.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
238920betamethasone 0.05 % Topical CreamPSN5137f94e-6818-440b-a33e-228aa27de61d8
238920betamethasone 0.5 MG/ML Topical CreamSCD5137f94e-6818-440b-a33e-228aa27de61d8
238920betamethasone 0.05 % Topical CreamSY5137f94e-6818-440b-a33e-228aa27de61d8
238920betamethasone 0.5 MG/GM (betamethasone dipropionate 0.64 MG/GM) Topical CreamSY5137f94e-6818-440b-a33e-228aa27de61d8
238920betamethasone 0.05 % Topical CreamPSNbc12c828-54ba-411d-b752-9b735f7adf637
238920betamethasone 0.5 MG/ML Topical CreamSCDbc12c828-54ba-411d-b752-9b735f7adf637
238920betamethasone 0.05 % Topical CreamSYbc12c828-54ba-411d-b752-9b735f7adf637
238920betamethasone 0.5 MG/GM (betamethasone dipropionate 0.64 MG/GM) Topical CreamSYbc12c828-54ba-411d-b752-9b735f7adf637

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
51672-1274-1516721274011 TUBE in 1 CARTON (51672-1274-1) / 15 g in 1 TUBE1 tube1992-04-300000-00-00NoNoCurrent
51672-1274-6516721274061 TUBE in 1 CARTON (51672-1274-6) / 45 g in 1 TUBE1 tube1992-04-300000-00-00NoNoCurrent