FDA.reportPublic FDA data

calcipotriene and betamethasone dipropionate

Product NDC
0713-0848
11-digit product format
007130848
Labeler code
0713
Product ID
0713-0848_1f935790-9208-96ae-e063-6294a90ae07c
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
calcipotriene and betamethasone dipropionate
Dosage form
SUSPENSION
Route
TOPICAL
Labeler
Cosette Pharmaceuticals, Inc.
Application
ANDA210765
Marketing category
ANDA
Marketing start
2024-08-02
Substance
BETAMETHASONE DIPROPIONATE; CALCIPOTRIENE
Active strength
.5; 50 mg/g; ug/g
Pharmacologic classes
Corticosteroid Hormone Receptor Agonists [MoA], Corticosteroid [EPC], Vitamin D Analog [EPC], Vitamin D [CS]
NDC exclude flag
No
Listing certified through
2026-12-31
Current FDA listing
Yes

Additional Listing Data#

Finished product
Yes
Brand name base
calcipotriene and betamethasone dipropionate
Listing expiration
2026-12-31

Active Ingredients#

Ingredient, Strength table
IngredientStrength
BETAMETHASONE DIPROPIONATE.5 mg/g
CALCIPOTRIENE50 ug/g

Harmonized Identifiers#

Field, Values table
FieldValues
Unii826Y60901U, 143NQ3779B
Rxcui833461

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
4d1338f1-f50a-5bb5-4946-11534fdee48fProduct name220210527
7fea2046-07a9-4bb6-9409-828ac6f1f6dfProduct name120210201
f059f1a2-0e64-4839-9a7f-42687c91a44bProduct name120201007
c148aeb5-688c-9b49-a40f-30a41e3595e4Product name220180419
4ea9e4b5-b452-48ad-9b25-b9a4d403405dProduct name120160310
f31c883b-7ebf-1c60-f3b6-4ba41e8ff7a6Product name220151106
07737a91-49bd-c707-82e4-7a6a1660aef6Product name220150616
4f07db9b-3707-3e2c-05b5-d7852ba808c4Product name120140508
6f16fc1e-e77d-460f-8810-a12ca121425cProduct name120140508

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
0713-0848-60calcipotriene and betamethasone dipropionate60 g in 1 BOTTLESUSPENSION602
0713-0848-60calcipotriene and betamethasone dipropionate1 in 1 CARTONSUSPENSION12
0713-0848-92calcipotriene and betamethasone dipropionate2 in 1 CARTONSUSPENSION22
0713-0848-92calcipotriene and betamethasone dipropionate60 g in 1 BOTTLESUSPENSION602

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
0713-0848-60GM - Gram0713-084899245751-b126-45d9-a02f-89579905b5f712024-08-12
0713-0848-92GM - Gram0713-0848357e7261-b38a-437b-8ad5-f642d518b15912024-08-12

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
0713-0848CALCIPOTRIENE AND BETAMETHASONE DIPROPIONATE SUSPENSION [COSETTE PHARMACEUTICALS, INC.]2Current NDC, 4 package rows20240815_1eba330b-ce18-6b12-e063-6294a90a8763.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
833461calcipotriene 0.005 % / betamethasone dipropionate 0.064 % Topical SuspensionPSN1eba330b-ce18-6b12-e063-6294a90a87632
833461betamethasone 0.5 MG/ML / calcipotriene 0.05 MG/ML Topical LotionSCD1eba330b-ce18-6b12-e063-6294a90a87632
833461betamethasone 0.05 % (betamethasone dipropionate 0.064 % ) / calcipotriene 0.005 % Topical SuspensionSY1eba330b-ce18-6b12-e063-6294a90a87632

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startSampleExclude flagStatus
0713-0848-60007130848601 BOTTLE in 1 CARTON (0713-0848-60) / 60 g in 1 BOTTLE1 bottle2024-08-02NoNoHistorical
0713-0848-92007130848922 BOTTLE in 1 CARTON (0713-0848-92) / 60 g in 1 BOTTLE2 bottle2024-08-02NoNoHistorical