Wynzora

Product NDC
73499-001
11-digit product format
734990001
Labeler code
73499
Product ID
73499-001_22617d3b-9736-472b-bc08-1ce53fe151aa
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
Calcipotriene and Betamethasone dipropionate
Dosage form
CREAM
Route
TOPICAL
Labeler
MC2 Therapeutics Ltd
Application
NDA213422
Marketing category
NDA
Marketing start
2021-06-30
Substance
BETAMETHASONE DIPROPIONATE; CALCIPOTRIENE
Active strength
64; 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
Wynzora
Listing expiration
2026-12-31

Active Ingredients#

Ingredient, Strength table
IngredientStrength
BETAMETHASONE DIPROPIONATE64 mg/g
CALCIPOTRIENE50 ug/g

Harmonized Identifiers#

Field, Values table
FieldValues
Unii826Y60901U, 143NQ3779B
Rxcui2471873, 2471878

DailyMed Product Concepts#

Product concept, Relation, Version table
Product conceptRelationVersionEffective
dde7b902-54a1-627e-12f1-9e6d244ab88cProduct name420250317
726062af-1135-4707-a1d7-57256991bbf9Product name220250226
69b49899-11cf-4f7e-bd0a-7dc93b27311bProduct name320250130
bbdc14c7-d940-43b5-a2f7-36c425991f3cProduct name120240320
0a2fcc35-464b-9ec2-a622-753662cdd48cProduct name320240216
6f762601-17ef-4321-8f47-77783d3c4d8bProduct name320231116
6c13b22c-b3ba-4127-b768-0132dd5ab0d1Product name120230829
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
19c71a3d-ed9c-166b-a7e5-38c250c35631Product name120140508
4f07db9b-3707-3e2c-05b5-d7852ba808c4Product name120140508
6f16fc1e-e77d-460f-8810-a12ca121425cProduct name120140508

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
73499-001-01Wynzora60 g in 1 TUBECREAM606
73499-001-01Wynzora1 in 1 CARTONCREAM16
73499-001-03Wynzora5 g in 1 TUBECREAM56
73499-001-03Wynzora10 in 1 CARTONCREAM106

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
73499-001-01GM - Gram73499-00102c5c798-dabe-4ee4-8cc4-98c75bf96f3512021-01-08
73499-001-03GM - Gram73499-0010234aa21-6e87-4374-acf4-b2f47686ab5f12023-12-05

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
73499-001WYNZORA (CALCIPOTRIENE AND BETAMETHASONE DIPROPIONATE) CREAM [MC2 THERAPEUTICS LTD]6Current NDC, Legacy NDC, 4 package rows20231207_36c5c818-0d40-445e-a3c0-0f46723a25e2.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
2471873betamethasone dipropionate 0.064 % / calcipotriene 0.005 % Topical CreamPSN36c5c818-0d40-445e-a3c0-0f46723a25e26
2471878Wynzora 0.005 % / 0.064 % Topical CreamPSN36c5c818-0d40-445e-a3c0-0f46723a25e26
2471878betamethasone dipropionate 0.64 MG/ML / calcipotriene 0.05 MG/ML Topical Cream [Wynzora]SBD36c5c818-0d40-445e-a3c0-0f46723a25e26
2471873betamethasone dipropionate 0.64 MG/ML / calcipotriene 0.05 MG/ML Topical CreamSCD36c5c818-0d40-445e-a3c0-0f46723a25e26
2471873betamethasone dipropionate 0.064 % / calcipotriene 0.005 % Topical CreamSY36c5c818-0d40-445e-a3c0-0f46723a25e26
2471878Wynzora (calcipotriene 0.005 % / betamethasone dipropionate 0.064 % ) Topical CreamSY36c5c818-0d40-445e-a3c0-0f46723a25e26

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
73499-001-01734990001011 TUBE in 1 CARTON (73499-001-01) / 60 g in 1 TUBE1 tube2021-06-300000-00-00NoNoCurrent
73499-001-037349900010310 TUBE in 1 CARTON (73499-001-03) / 5 g in 1 TUBE10 tube2021-06-300000-00-00YesNoCurrent