FDA.reportPublic FDA data

Calcipotriene and Betamethasone Dipropionate

Product NDC
45802-816
11-digit product format
458020816
Labeler code
45802
Product ID
45802-816_9b7de25a-99a2-4123-b913-ba33289ff5be
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
Calcipotriene, Betamethasone Dipropionate
Dosage form
OINTMENT
Route
TOPICAL
Labeler
Padagis Israel Pharmaceuticals Ltd
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
45802-816-01Calcipotriene and Betamethasone Dipropionate100 g in 1 TUBEOINTMENT1007
45802-816-01Calcipotriene and Betamethasone Dipropionate1 in 1 CARTONOINTMENT17
45802-816-96Calcipotriene and Betamethasone Dipropionate60 g in 1 TUBEOINTMENT607
45802-816-96Calcipotriene and Betamethasone Dipropionate1 in 1 CARTONOINTMENT17

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
45802-816-01GM - Gram45802-816c25d95df-df73-4465-addb-612ce4688ef712020-02-13
45802-816-96GM - Gram45802-816838519b1-24cd-4dd6-8b18-9edb1d9df1e312020-02-13

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
45802-816CALCIPOTRIENE AND BETAMETHASONE DIPROPIONATE (CALCIPOTRIENE, BETAMETHASONE DIPROPIONATE) OINTMENT [PADAGIS ISRAEL PHARMACEUTICALS LTD]7Current NDC, Legacy NDC, 4 package rows20241222_ba55ff2b-9cfe-40dc-9dac-718cf141c171.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
388525calcipotriene 0.005 % / betamethasone dipropionate 0.064 % Topical OintmentPSN174c5378-f2b9-4e9e-931a-4123137be62d103
388525calcipotriene 0.005 % / betamethasone dipropionate 0.064 % Topical OintmentPSNd4b301c5-704a-406d-9d9c-74f006334f8a103
388525betamethasone 0.0005 MG/MG / calcipotriene 0.00005 MG/MG Topical OintmentSCD174c5378-f2b9-4e9e-931a-4123137be62d103
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 OintmentSY174c5378-f2b9-4e9e-931a-4123137be62d103
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 0.05 % / calcipotriene 0.005 % Topical OintmentSY174c5378-f2b9-4e9e-931a-4123137be62d103
388525betamethasone 0.5 MG (betamethasone dipropionate 0.64 MG) / calcipotriene 0.05 MG per GM Topical OintmentSYd4b301c5-704a-406d-9d9c-74f006334f8a103
388525betamethasone 0.5 MG (betamethasone dipropionate 0.64 MG) / calcipotriene 0.05 MG per GM Topical OintmentSY174c5378-f2b9-4e9e-931a-4123137be62d103
388525calcipotriene 0.005 % / betamethasone dipropionate 0.064 % Topical OintmentPSNd223e857-590e-48b9-b33e-1275537a508e101
388525betamethasone 0.0005 MG/MG / calcipotriene 0.00005 MG/MG Topical OintmentSCDd223e857-590e-48b9-b33e-1275537a508e101
388525betamethasone 0.05 % (betamethasone dipropionate 0.064 % ) / calcipotriene 0.005 % Topical OintmentSYd223e857-590e-48b9-b33e-1275537a508e101
388525betamethasone 0.05 % / calcipotriene 0.005 % Topical OintmentSYd223e857-590e-48b9-b33e-1275537a508e101
388525betamethasone 0.5 MG (betamethasone dipropionate 0.64 MG) / calcipotriene 0.05 MG per GM Topical OintmentSYd223e857-590e-48b9-b33e-1275537a508e101
388525calcipotriene 0.005 % / betamethasone dipropionate 0.064 % Topical OintmentPSNba55ff2b-9cfe-40dc-9dac-718cf141c1717
388525betamethasone 0.0005 MG/MG / calcipotriene 0.00005 MG/MG Topical OintmentSCDba55ff2b-9cfe-40dc-9dac-718cf141c1717
388525betamethasone 0.05 % (betamethasone dipropionate 0.064 % ) / calcipotriene 0.005 % Topical OintmentSYba55ff2b-9cfe-40dc-9dac-718cf141c1717
388525betamethasone 0.05 % / calcipotriene 0.005 % Topical OintmentSYba55ff2b-9cfe-40dc-9dac-718cf141c1717
388525betamethasone 0.5 MG (betamethasone dipropionate 0.64 MG) / calcipotriene 0.05 MG per GM Topical OintmentSYba55ff2b-9cfe-40dc-9dac-718cf141c1717

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
45802-816-01458020816011 TUBE in 1 CARTON (45802-816-01) / 100 g in 1 TUBE1 tube2020-01-300000-00-00NoNoCurrent
45802-816-96458020816961 TUBE in 1 CARTON (45802-816-96) / 60 g in 1 TUBE1 tube2020-01-300000-00-00NoNoCurrent