FDA.reportPublic FDA data

Betamethasone Dipropionate

Product NDC
45802-376
11-digit product format
458020376
Labeler code
45802
Product ID
45802-376_cf2f0a68-6788-47a1-b7de-aaceeb385301
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
Betamethasone Dipropionate
Dosage form
CREAM
Route
TOPICAL
Labeler
Padagis Israel Pharmaceuticals Ltd
Application
ANDA076592
Marketing category
ANDA
Marketing start
2006-09-28
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
Rxcui848176

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
3c386306-c48a-413e-bb69-70cb268496f3Product name120210727
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
6084a4f4-5437-c9a5-caec-5361ee075a59Product name120140508
90c5639a-61b0-88d6-ddcf-21888e94869aProduct name120140508
9514609b-a2a9-f8ec-6ba6-3f8e5ee89877Product name120140508

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
45802-376-32Betamethasone Dipropionate1 in 1 CARTONCREAM113
45802-376-32Betamethasone Dipropionate50 g in 1 TUBECREAM5013
45802-376-35Betamethasone Dipropionate1 in 1 CARTONCREAM113
45802-376-35Betamethasone Dipropionate15 g in 1 TUBECREAM1513

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
45802-376-32GM - Gram45802-376704ea348-1fba-4c7b-a09a-4b98d98d3ee712012-07-24
45802-376-35GM - Gram45802-376d80b53da-ee35-49d2-82bd-f6876fb2a94812012-07-24

DailyMed Socrata Ingredients#

Ingredient, Type, UNII table
IngredientTypeUNIIDailyMed labelSPL versionUploaded
Betamethasone DipropionateACTIVE INGREDIENT826Y60901UBETAMETHASONE DIPROPIONATE CREAM [PERRIGO NEW YORK INC]6
BetamethasoneACTIVE MOIETY9842X06Q6MBETAMETHASONE DIPROPIONATE CREAM [PERRIGO NEW YORK INC]6
CARBOMER HOMOPOLYMER TYPE C (ALLYL PENTAERYTHRITOL CROSSLINKED)INACTIVE INGREDIENT4Q93RCW27EBETAMETHASONE DIPROPIONATE CREAM [PERRIGO NEW YORK INC]6
CETEARETH-30INACTIVE INGREDIENT1R9DCZ5FOXBETAMETHASONE DIPROPIONATE CREAM [PERRIGO NEW YORK INC]6
CHLOROCRESOLINACTIVE INGREDIENT36W53O7109BETAMETHASONE DIPROPIONATE CREAM [PERRIGO NEW YORK INC]6
CYCLOMETHICONEINACTIVE INGREDIENTNMQ347994ZBETAMETHASONE DIPROPIONATE CREAM [PERRIGO NEW YORK INC]6
PETROLATUMINACTIVE INGREDIENT4T6H12BN9UBETAMETHASONE DIPROPIONATE CREAM [PERRIGO NEW YORK INC]6
PROPYLENE GLYCOLINACTIVE INGREDIENT6DC9Q167V3BETAMETHASONE DIPROPIONATE CREAM [PERRIGO NEW YORK INC]6
SODIUM HYDROXIDEINACTIVE INGREDIENT55X04QC32IBETAMETHASONE DIPROPIONATE CREAM [PERRIGO NEW YORK INC]6
SORBITOLINACTIVE INGREDIENT506T60A25RBETAMETHASONE DIPROPIONATE CREAM [PERRIGO NEW YORK INC]6
WATERINACTIVE INGREDIENT059QF0KO0RBETAMETHASONE DIPROPIONATE CREAM [PERRIGO NEW YORK INC]6
WHITE WAXINACTIVE INGREDIENT7G1J5DA97FBETAMETHASONE DIPROPIONATE CREAM [PERRIGO NEW YORK INC]6
Betamethasone DipropionateACTIVE INGREDIENT826Y60901UBETAMETHASONE DIPROPIONATE CREAM [PREFERRED PHARMACEUTICALS, INC.]1
BetamethasoneACTIVE MOIETY9842X06Q6MBETAMETHASONE DIPROPIONATE CREAM [PREFERRED PHARMACEUTICALS, INC.]1
CARBOMER HOMOPOLYMER TYPE C (ALLYL PENTAERYTHRITOL CROSSLINKED)INACTIVE INGREDIENT4Q93RCW27EBETAMETHASONE DIPROPIONATE CREAM [PREFERRED PHARMACEUTICALS, INC.]1
CETEARETH-30INACTIVE INGREDIENT1R9DCZ5FOXBETAMETHASONE DIPROPIONATE CREAM [PREFERRED PHARMACEUTICALS, INC.]1
CHLOROCRESOLINACTIVE INGREDIENT36W53O7109BETAMETHASONE DIPROPIONATE CREAM [PREFERRED PHARMACEUTICALS, INC.]1
CYCLOMETHICONEINACTIVE INGREDIENTNMQ347994ZBETAMETHASONE DIPROPIONATE CREAM [PREFERRED PHARMACEUTICALS, INC.]1
PETROLATUMINACTIVE INGREDIENT4T6H12BN9UBETAMETHASONE DIPROPIONATE CREAM [PREFERRED PHARMACEUTICALS, INC.]1
PROPYLENE GLYCOLINACTIVE INGREDIENT6DC9Q167V3BETAMETHASONE DIPROPIONATE CREAM [PREFERRED PHARMACEUTICALS, INC.]1
SODIUM HYDROXIDEINACTIVE INGREDIENT55X04QC32IBETAMETHASONE DIPROPIONATE CREAM [PREFERRED PHARMACEUTICALS, INC.]1
SORBITOLINACTIVE INGREDIENT506T60A25RBETAMETHASONE DIPROPIONATE CREAM [PREFERRED PHARMACEUTICALS, INC.]1
WATERINACTIVE INGREDIENT059QF0KO0RBETAMETHASONE DIPROPIONATE CREAM [PREFERRED PHARMACEUTICALS, INC.]1
WHITE WAXINACTIVE INGREDIENT7G1J5DA97FBETAMETHASONE DIPROPIONATE CREAM [PREFERRED PHARMACEUTICALS, INC.]1

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
45802-376BETAMETHASONE DIPROPIONATE CREAM [PADAGIS ISRAEL PHARMACEUTICALS LTD]13Current NDC, Legacy NDC, 4 package rows20250108_7bd2646c-f34a-4824-8f66-c41e77db19d2.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
848176betamethasone 0.05 % (betamethasone dipropionate 0.064 % ) Augmented Topical CreamPSN0481ac0d-9220-472b-b3f2-af6e0bb6962d105
848176Augmented betamethasone 0.5 MG/ML Topical CreamSCD0481ac0d-9220-472b-b3f2-af6e0bb6962d105
848176augmented betamethasone 0.05 % Topical CreamSY0481ac0d-9220-472b-b3f2-af6e0bb6962d105
848176betamethasone 0.05 % (betamethasone dipropionate 0.064 % ) Augmented Topical CreamSY0481ac0d-9220-472b-b3f2-af6e0bb6962d105
848176betamethasone 0.05 % (betamethasone dipropionate 0.064 % ) Augmented Topical CreamPSN79256f36-adff-4628-abc5-cb25bdfdc19d103
848176Augmented betamethasone 0.5 MG/ML Topical CreamSCD79256f36-adff-4628-abc5-cb25bdfdc19d103
848176augmented betamethasone 0.05 % Topical CreamSY79256f36-adff-4628-abc5-cb25bdfdc19d103
848176betamethasone 0.05 % (betamethasone dipropionate 0.064 % ) Augmented Topical CreamSY79256f36-adff-4628-abc5-cb25bdfdc19d103
848176betamethasone 0.05 % (betamethasone dipropionate 0.064 % ) Augmented Topical CreamPSNf2c557ea-275b-4ab4-90f4-4003e022214d102
848176Augmented betamethasone 0.5 MG/ML Topical CreamSCDf2c557ea-275b-4ab4-90f4-4003e022214d102
848176augmented betamethasone 0.05 % Topical CreamSYf2c557ea-275b-4ab4-90f4-4003e022214d102
848176betamethasone 0.05 % (betamethasone dipropionate 0.064 % ) Augmented Topical CreamSYf2c557ea-275b-4ab4-90f4-4003e022214d102
848176betamethasone 0.05 % (betamethasone dipropionate 0.064 % ) Augmented Topical CreamPSN7bd2646c-f34a-4824-8f66-c41e77db19d213
848176Augmented betamethasone 0.5 MG/ML Topical CreamSCD7bd2646c-f34a-4824-8f66-c41e77db19d213
848176augmented betamethasone 0.05 % Topical CreamSY7bd2646c-f34a-4824-8f66-c41e77db19d213
848176betamethasone 0.05 % (betamethasone dipropionate 0.064 % ) Augmented Topical CreamSY7bd2646c-f34a-4824-8f66-c41e77db19d213
848176betamethasone 0.05 % (betamethasone dipropionate 0.064 % ) Augmented Topical CreamPSN5683885d-461c-4e7e-bbe8-dc231d70619212
848176Augmented betamethasone 0.5 MG/ML Topical CreamSCD5683885d-461c-4e7e-bbe8-dc231d70619212
848176augmented betamethasone 0.05 % Topical CreamSY5683885d-461c-4e7e-bbe8-dc231d70619212
848176betamethasone 0.05 % (betamethasone dipropionate 0.064 % ) Augmented Topical CreamSY5683885d-461c-4e7e-bbe8-dc231d70619212
848176betamethasone 0.05 % (betamethasone dipropionate 0.064 % ) Augmented Topical CreamPSN13c20c58-3911-4d96-be09-7184ee1f7d4f5
848176betamethasone 0.05 % (betamethasone dipropionate 0.064 % ) Augmented Topical CreamPSN3f98fde7-0b1c-40a5-9372-a149dd6c6fd85
848176Augmented betamethasone 0.5 MG/ML Topical CreamSCD3f98fde7-0b1c-40a5-9372-a149dd6c6fd85
848176Augmented betamethasone 0.5 MG/ML Topical CreamSCD13c20c58-3911-4d96-be09-7184ee1f7d4f5
848176augmented betamethasone 0.05 % Topical CreamSY3f98fde7-0b1c-40a5-9372-a149dd6c6fd85
848176augmented betamethasone 0.05 % Topical CreamSY13c20c58-3911-4d96-be09-7184ee1f7d4f5
848176betamethasone 0.05 % (betamethasone dipropionate 0.064 % ) Augmented Topical CreamSY13c20c58-3911-4d96-be09-7184ee1f7d4f5
848176betamethasone 0.05 % (betamethasone dipropionate 0.064 % ) Augmented Topical CreamSY3f98fde7-0b1c-40a5-9372-a149dd6c6fd85
848176betamethasone 0.05 % (betamethasone dipropionate 0.064 % ) Augmented Topical CreamPSNf1be7c91-5408-4d31-8673-b691089aadce4
848176Augmented betamethasone 0.5 MG/ML Topical CreamSCDf1be7c91-5408-4d31-8673-b691089aadce4
848176augmented betamethasone 0.05 % Topical CreamSYf1be7c91-5408-4d31-8673-b691089aadce4
848176betamethasone 0.05 % (betamethasone dipropionate 0.064 % ) Augmented Topical CreamSYf1be7c91-5408-4d31-8673-b691089aadce4
848176betamethasone 0.05 % (betamethasone dipropionate 0.064 % ) Augmented Topical CreamPSN84b37e6a-779e-5d43-e053-2a91aa0a16b73
848176Augmented betamethasone 0.5 MG/ML Topical CreamSCD84b37e6a-779e-5d43-e053-2a91aa0a16b73
848176augmented betamethasone 0.05 % Topical CreamSY84b37e6a-779e-5d43-e053-2a91aa0a16b73
848176betamethasone 0.05 % (betamethasone dipropionate 0.064 % ) Augmented Topical CreamSY84b37e6a-779e-5d43-e053-2a91aa0a16b73
848176betamethasone 0.05 % (betamethasone dipropionate 0.064 % ) Augmented Topical CreamPSNebca0d24-0e59-3609-e053-2a95a90aa3db1
848176Augmented betamethasone 0.5 MG/ML Topical CreamSCDebca0d24-0e59-3609-e053-2a95a90aa3db1
848176augmented betamethasone 0.05 % Topical CreamSYebca0d24-0e59-3609-e053-2a95a90aa3db1
848176betamethasone 0.05 % (betamethasone dipropionate 0.064 % ) Augmented Topical CreamSYebca0d24-0e59-3609-e053-2a95a90aa3db1

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
45802-376-32458020376321 TUBE in 1 CARTON (45802-376-32) / 50 g in 1 TUBE1 tube2006-09-280000-00-00NoNoCurrent
45802-376-35458020376351 TUBE in 1 CARTON (45802-376-35) / 15 g in 1 TUBE1 tube2006-11-060000-00-00NoNoCurrent