Calcipotriene and Betamethasone Dipropionate

Product NDC
51672-1402
11-digit product format
516721402
Labeler code
51672
Product ID
51672-1402_38e5b828-cecd-c95b-e063-6394a90ae2e0
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
Calcipotriene and Betamethasone Dipropionate
Dosage form
SUSPENSION
Route
TOPICAL
Labeler
Sun Pharmaceutical Industries, Inc.
Application
ANDA213269
Marketing category
ANDA
Marketing start
2020-09-02
Substance
BETAMETHASONE DIPROPIONATE; CALCIPOTRIENE
Active strength
50; 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 DIPROPIONATE50 mg/g
CALCIPOTRIENE50 ug/g

Harmonized Identifiers#

Field, Values table
FieldValues
Unii826Y60901U, 143NQ3779B

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
51672-1402-4Calcipotriene and Betamethasone Dipropionate60 g in 1 BOTTLESUSPENSION602
51672-1402-4Calcipotriene and Betamethasone Dipropionate1 in 1 CARTONSUSPENSION12
51672-1402-8Calcipotriene and Betamethasone Dipropionate60 g in 1 BOTTLESUSPENSION602
51672-1402-8Calcipotriene and Betamethasone Dipropionate2 in 1 CARTONSUSPENSION22

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
51672-1402CALCIPOTRIENE AND BETAMETHASONE DIPROPIONATE SUSPENSION [TARO PHARMACEUTICALS U.S.A., INC.]1Current NDC, Legacy NDC, 4 package rows20200904_1d0ab2e6-1ab1-4d3e-ad55-7fa26446f191.zip

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
51672-1402-4516721402041 BOTTLE in 1 CARTON (51672-1402-4) / 60 g in 1 BOTTLE1 bottle2020-09-020000-00-00NoNoCurrent
51672-1402-8516721402082 BOTTLE in 1 CARTON (51672-1402-8) / 60 g in 1 BOTTLE2 bottle2020-09-020000-00-00NoNoCurrent