FDA.reportPublic FDA data

Calcipotriene and Betamethasone Dipropionate

Product NDC
63629-8617
11-digit product format
636298617
Labeler code
63629
Product ID
63629-8617_00b3f040-c085-db52-e063-6394a90aa60e
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
Calcipotriene, Betamethasone Dipropionate
Dosage form
OINTMENT
Route
TOPICAL
Labeler
Bryant Ranch Prepack
Application
ANDA200174
Marketing category
ANDA
Marketing start
2020-01-30
Substance
BETAMETHASONE DIPROPIONATE; CALCIPOTRIENE
Active strength
.643; 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.643 mg/g
CALCIPOTRIENE50 ug/g

Harmonized Identifiers#

Field, Values table
FieldValues
Unii826Y60901U, 143NQ3779B
Rxcui388525

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
63629-8617-1Calcipotriene and Betamethasone Dipropionate100 g in 1 TUBEOINTMENT100103
63629-8617-1Calcipotriene and Betamethasone Dipropionate1 in 1 CARTONOINTMENT1103

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
63629-8617-1GM - Gram63629-8617d9f32c00-c512-4386-b1b7-9ed10a9557df12023-08-08

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
63629-8617CALCIPOTRIENE AND BETAMETHASONE DIPROPIONATE (CALCIPOTRIENE, BETAMETHASONE DIPROPIONATE) OINTMENT [BRYANT RANCH PREPACK]103Current NDC, Legacy NDC, 2 package rows20230718_d4b301c5-704a-406d-9d9c-74f006334f8a.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
388525calcipotriene 0.005 % / betamethasone dipropionate 0.064 % Topical OintmentPSNd4b301c5-704a-406d-9d9c-74f006334f8a103
388525betamethasone 0.0005 MG/MG / calcipotriene 0.00005 MG/MG Topical OintmentSCDd4b301c5-704a-406d-9d9c-74f006334f8a103
388525betamethasone 0.05 % (betamethasone dipropionate 0.064 % ) / calcipotriene 0.005 % Topical OintmentSYd4b301c5-704a-406d-9d9c-74f006334f8a103
388525betamethasone 0.05 % / calcipotriene 0.005 % Topical OintmentSYd4b301c5-704a-406d-9d9c-74f006334f8a103
388525betamethasone 0.5 MG (betamethasone dipropionate 0.64 MG) / calcipotriene 0.05 MG per GM Topical OintmentSYd4b301c5-704a-406d-9d9c-74f006334f8a103

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
63629-8617-1636298617011 TUBE in 1 CARTON (63629-8617-1) / 100 g in 1 TUBE1 tube2020-01-300000-00-00NoNoCurrent