FDA.reportPublic FDA data

Betamethasone Dipropionate

Product NDC
0713-0807
11-digit product format
007130807
Labeler code
0713
Product ID
0713-0807_ed81406a-8c03-5c33-e053-2a95a90a941f
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
Betamethasone Dipropionate
Dosage form
LOTION
Route
TOPICAL
Labeler
Cosette Pharmaceuticals, Inc.
Application
ANDA071467
Marketing category
ANDA
Marketing start
2016-09-05
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
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
0713-0807-53Betamethasone Dipropionate60 mL in 1 BOTTLELOTION604
0713-0807-53Betamethasone Dipropionate1 in 1 CARTONLOTION14

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
0713-0807-53ML - Milliliter0713-08071ce8f16c-8c6e-4062-a677-5f97f16237e412016-10-06

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
0713-0807BETAMETHASONE DIPROPIONATE LOTION [COSETTE PHARMACEUTICALS, INC.]4Current NDC, Legacy NDC, 2 package rows20221116_c9839c0a-bee5-0ef7-8933-e6231c440407.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
240209betamethasone dipropionate 0.05 % Topical LotionPSNc9839c0a-bee5-0ef7-8933-e6231c4404074
240209betamethasone 0.5 MG/ML Topical LotionSCDc9839c0a-bee5-0ef7-8933-e6231c4404074
240209betamethasone 0.05 % Topical LotionSYc9839c0a-bee5-0ef7-8933-e6231c4404074
240209betamethasone 0.5 MG/ML (betamethasone dipropionate 0.64 MG/ML) Topical LotionSYc9839c0a-bee5-0ef7-8933-e6231c4404074

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
0713-0807-53007130807531 BOTTLE in 1 CARTON (0713-0807-53) / 60 mL in 1 BOTTLE1 bottle2016-09-050000-00-00NoNoCurrent