FDA.reportPublic FDA data

Betamethasone Dipropionate

Product NDC
45802-021
11-digit product format
458020021
Labeler code
45802
Product ID
45802-021_2957986c-340c-4ef1-b78d-08b119fa703b
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
Betamethasone Dipropionate
Dosage form
LOTION
Route
TOPICAL
Labeler
Padagis Israel Pharmaceuticals Ltd
Application
ANDA072538
Marketing category
ANDA
Marketing start
2006-06-30
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
Rxcui240209

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
45802-021-46Betamethasone Dipropionate56.2 g in 1 BOTTLE, PLASTICLOTION56.212

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
45802-021-46ML - Milliliter45802-021297765e5-b7f8-4d49-80f3-c193a5b9be4712012-07-24

DailyMed Socrata Ingredients#

Ingredient, Type, UNII table
IngredientTypeUNIIDailyMed labelSPL versionUploaded
BETAMETHASONE DIPROPIONATEACTIVE INGREDIENT826Y60901UBETAMETHASONE DIPROPIONATE LOTION [PERRIGO NEW YORK INC]6
BETAMETHASONEACTIVE MOIETY9842X06Q6MBETAMETHASONE DIPROPIONATE LOTION [PERRIGO NEW YORK INC]6
CARBOMER HOMOPOLYMER TYPE B (ALLYL PENTAERYTHRITOL CROSSLINKED)INACTIVE INGREDIENTHHT01ZNK31BETAMETHASONE DIPROPIONATE LOTION [PERRIGO NEW YORK INC]6
ISOPROPYL ALCOHOLINACTIVE INGREDIENTND2M416302BETAMETHASONE DIPROPIONATE LOTION [PERRIGO NEW YORK INC]6
SODIUM HYDROXIDEINACTIVE INGREDIENT55X04QC32IBETAMETHASONE DIPROPIONATE LOTION [PERRIGO NEW YORK INC]6
WATERINACTIVE INGREDIENT059QF0KO0RBETAMETHASONE DIPROPIONATE LOTION [PERRIGO NEW YORK INC]6

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
45802-021BETAMETHASONE DIPROPIONATE LOTION [PADAGIS ISRAEL PHARMACEUTICALS LTD]11Current NDC, Legacy NDC, 1 package rows20230126_e6018480-7788-472d-a2d1-ccccffcd258e.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
240209betamethasone dipropionate 0.05 % Topical LotionPSNe6018480-7788-472d-a2d1-ccccffcd258e12
240209betamethasone 0.5 MG/ML Topical LotionSCDe6018480-7788-472d-a2d1-ccccffcd258e12
240209betamethasone 0.05 % Topical LotionSYe6018480-7788-472d-a2d1-ccccffcd258e12
240209betamethasone 0.5 MG/ML (betamethasone dipropionate 0.64 MG/ML) Topical LotionSYe6018480-7788-472d-a2d1-ccccffcd258e12

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
45802-021-464580200214656.2 g in 1 BOTTLE, PLASTIC (45802-021-46) 56.2 g2006-06-300000-00-00NoNoCurrent