FDA.reportPublic FDA data

Calcipotriene and Betamethasone Dipropionate

Product NDC
66993-938
11-digit product format
669930938
Labeler code
66993
Product ID
66993-938_aad74639-2667-44ea-9d2b-32a5dd5ea596
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
Calcipotriene and Betamethasone Dipropionate
Dosage form
OINTMENT
Route
TOPICAL
Labeler
Prasco Laboratories
Application
NDA021852
Marketing category
NDA AUTHORIZED GENERIC
Marketing start
2020-01-28
Substance
BETAMETHASONE DIPROPIONATE; CALCIPOTRIENE MONOHYDRATE
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
CALCIPOTRIENE MONOHYDRATE50 ug/g

Harmonized Identifiers#

Field, Values table
FieldValues
Unii826Y60901U, S7499TYY6G
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
66993-938-61Calcipotriene and Betamethasone Dipropionate60 g in 1 TUBEOINTMENT605
66993-938-61Calcipotriene and Betamethasone Dipropionate1 in 1 CARTONOINTMENT15
66993-938-65Calcipotriene and Betamethasone Dipropionate1 in 1 CARTONOINTMENT15
66993-938-65Calcipotriene and Betamethasone Dipropionate100 g in 1 TUBEOINTMENT1005

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
66993-938-61GM - Gram66993-938bd6d9fe1-cae4-41ff-b9f6-ff6cad17aaa412020-02-13
66993-938-65GM - Gram66993-9386d47553a-03f4-44d1-ada5-82435e49429d12020-02-13

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
66993-938CALCIPOTRIENE AND BETAMETHASONE DIPROPIONATE OINTMENT [PRASCO LABORATORIES]5Current NDC, Legacy NDC, 4 package rows20221213_d9493e66-251c-426c-90a8-1bf1e526ab85.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
388525calcipotriene 0.005 % / betamethasone dipropionate 0.064 % Topical OintmentPSNd9493e66-251c-426c-90a8-1bf1e526ab855
388525betamethasone 0.0005 MG/MG / calcipotriene 0.00005 MG/MG Topical OintmentSCDd9493e66-251c-426c-90a8-1bf1e526ab855
388525betamethasone 0.05 % (betamethasone dipropionate 0.064 % ) / calcipotriene 0.005 % Topical OintmentSYd9493e66-251c-426c-90a8-1bf1e526ab855
388525betamethasone 0.05 % / calcipotriene 0.005 % Topical OintmentSYd9493e66-251c-426c-90a8-1bf1e526ab855
388525betamethasone 0.5 MG (betamethasone dipropionate 0.64 MG) / calcipotriene 0.05 MG per GM Topical OintmentSYd9493e66-251c-426c-90a8-1bf1e526ab855

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
66993-938-61669930938611 TUBE in 1 CARTON (66993-938-61) / 60 g in 1 TUBE1 tube2020-01-280000-00-00NoNoCurrent
66993-938-65669930938651 TUBE in 1 CARTON (66993-938-65) / 100 g in 1 TUBE1 tube2020-01-280000-00-00NoNoCurrent