FDA.reportPublic FDA data

Calcipotriene and Betamethasone Dipropionate

Product NDC
63629-2520
11-digit product format
636292520
Labeler code
63629
Product ID
63629-2520_ea65f651-7e10-4b2e-af33-fd75351b3b8c
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

Source provenance: Browse the complete Orange Book source catalog · source snapshot 1.

Orange Book products#

Current product rows page 1 of 1 · 1 matching rows.

Application-product, Trade name, Ingredient table
Application-productTrade nameIngredientStrengthDosage form / routeTE codesRLD / RSApproval date
A200174-001CALCIPOTRIENE AND BETAMETHASONE DIPROPIONATEBETAMETHASONE DIPROPIONATE; CALCIPOTRIENE0.064%;0.005%OINTMENT / TOPICALAB2014-12-12

Therapeutic equivalence codes#

Current TE-code rows page 1 of 1 · 1 matching rows.

Application-product, TE code table
Application-productTE code
A200174-001AB

Observed Orange Book product history#

Observed FDA ZIP history: Each table is queried independently by exact application/product key from successfully parsed Orange Book snapshots. Capture times identify archived source observations; absence or a change between snapshots is not inferred. FDA publication files that were not recoverable as structured ZIP data are not represented as states.

Captured, Edition, Application-product table
CapturedEditionApplication-productTrade nameStrengthDosage form / routeProduct TE source textRLD / RSApproval dateSource SHA-256
2026-08-01 22:54:322026-06A200174-001CALCIPOTRIENE AND BETAMETHASONE DIPROPIONATE0.064%;0.005%OINTMENT / TOPICALAB2014-12-12a50c72e98297…

Observed Orange Book normalized TE history#

Captured, Edition, Application-product table
CapturedEditionApplication-productTE codeOrderSource SHA-256
2026-08-01 22:54:322026-06A200174-001AB1a50c72e98297…

openFDA label cross-check#

Cross-check layer: openFDA label JSON enriches search and identifies hydration gaps. The DailyMed Structured Product Label remains the canonical label presentation on FDA.report. Every label matching the complete exact-identifier union is deduplicated and paginated below.

Matched openFDA labels page 1 of 1 · 4 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
Calcipotriene and Betamethasone DipropionateCALCIPOTRIENE, BETAMETHASONE DIPROPIONATEPadagis Israel Pharmaceuticals Ltdba55ff2b-9cfe-40dc-9dac-718cf141c1712024-04-30Warnings, Adverse reactionsExact identifier
application applno (ANDA): 200174
application number: ANDA200174
Calcipotriene and Betamethasone DipropionateCALCIPOTRIENE, BETAMETHASONE DIPROPIONATEBryant Ranch Prepackd223e857-590e-48b9-b33e-1275537a508e2024-02-08Warnings, Adverse reactionsExact identifier
application applno (ANDA): 200174
application number: ANDA200174
Calcipotriene and Betamethasone DipropionateCALCIPOTRIENE, BETAMETHASONE DIPROPIONATEBryant Ranch Prepack174c5378-f2b9-4e9e-931a-4123137be62d2023-12-07Warnings, Adverse reactionsExact identifier
application applno (ANDA): 200174
application number: ANDA200174
ndc (product): 63629-2520
Calcipotriene and Betamethasone DipropionateCALCIPOTRIENE, BETAMETHASONE DIPROPIONATEBryant Ranch Prepackd4b301c5-704a-406d-9d9c-74f006334f8a2023-07-17Warnings, Adverse reactionsExact identifier
application applno (ANDA): 200174
application number: ANDA200174

Additional Listing Data#

Finished product
Yes
Brand name base
Calcipotriene and Betamethasone Dipropionate
Listing expiration
2026-12-31

Active Ingredients#

Ingredient, Strength table
IngredientStrength
CALCIPOTRIENE.643 mg/g
BETAMETHASONE DIPROPIONATE50 ug/g

Harmonized UNII identifiers#

UNII identifiers page 1 of 1 · 2 matching rows.

Identifier, FDA.report destination table
IdentifierFDA.report destination
143NQ3779BInternal UNII lookup
826Y60901UInternal UNII lookup

Harmonized RxCUI identifiers#

RxCUI identifiers page 1 of 1 · 1 matching rows.

Identifier, FDA.report destination table
IdentifierFDA.report destination
388525Internal RxNorm lookup

Harmonized SPL set identifiers#

SPL set identifiers page 1 of 1 · 1 matching rows.

Identifier, FDA.report destination table
IdentifierFDA.report destination
174c5378-f2b9-4e9e-931a-4123137be62dAvailable on FDA.report

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
63629-2520-1Calcipotriene and Betamethasone Dipropionate1 in 1 CARTONOINTMENT1103
63629-2520-1Calcipotriene and Betamethasone Dipropionate60 g in 1 TUBEOINTMENT60103

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
63629-2520-1GM - Gram63629-2520f57b4e13-f76d-42ac-80af-7cb573b6b5ae12021-07-15

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
63629-2520CALCIPOTRIENE AND BETAMETHASONE DIPROPIONATE (CALCIPOTRIENE, BETAMETHASONE DIPROPIONATE) OINTMENT [BRYANT RANCH PREPACK]103Current NDC, Legacy NDC, 2 package rows20231208_174c5378-f2b9-4e9e-931a-4123137be62d.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
388525betamethasone 0.0005 MG/MG / calcipotriene 0.00005 MG/MG Topical OintmentSCD174c5378-f2b9-4e9e-931a-4123137be62d103
388525betamethasone 0.05 % (betamethasone dipropionate 0.064 % ) / calcipotriene 0.005 % Topical OintmentSY174c5378-f2b9-4e9e-931a-4123137be62d103
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 OintmentSY174c5378-f2b9-4e9e-931a-4123137be62d103

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
63629-2520-1636292520011 TUBE in 1 CARTON (63629-2520-1) / 60 g in 1 TUBE1 tube2020-01-300000-00-00NoNoCurrent