calcipotriene and betamethasone dipropionate (45802-816)

Drug Facts

Product Profile

Brand Name calcipotriene and betamethasone dipropionate

Generic Name calcipotriene, betamethasone dipropionate

Labeler padagis israel pharmaceuticals ltd

Dosage Form OINTMENT

Routes

TOPICAL

Active Ingredients

betamethasone dipropionate .643 mg/g, calcipotriene 50 ug/g

Manufacturer

Padagis Israel Pharmaceuticals Ltd

Identifiers & Regulatory

Product NDC 45802-816

Product ID 45802-816_9b7de25a-99a2-4123-b913-ba33289ff5be

Product Type HUMAN PRESCRIPTION DRUG

Marketing Category ANDA

Application Number ANDA200174

Listing Expiration 2026-12-31

Marketing Start 2020-01-30

Pharmacologic Class

Established (EPC)

vitamin d analog [epc]

Chemical Structure

vitamin d [cs]

Normalized Code Variants

Searchable formats for this product NDC code

Digits Only 45802816

Hyphenated Format 45802-816

Supplemental Identifiers

RxCUI

388525

UNII

826Y60901U 143NQ3779B

NUI

M0022797 N0000175849

Packaging Origin

Original Packager

true

Resolved Product View

Precedence rule: structured NDC data is preferred, falling back to linked label metadata when unavailable. Source tags show the origin of each value.

Resolved Identity

Brand Name calcipotriene and betamethasone dipropionate (source: ndc)

Generic Name calcipotriene, betamethasone dipropionate (source: ndc)

Application Number ANDA200174 (source: ndc)

Routes

TOPICAL

source: ndc

Resolved Composition

Strengths

.643 mg/g
50 ug/g

source: ndc

Packaging

1 TUBE in 1 CARTON (45802-816-01) / 100 g in 1 TUBE
1 TUBE in 1 CARTON (45802-816-96) / 60 g in 1 TUBE

source: ndc

Packages (2)

45802-816-01 1 TUBE in 1 CARTON (45802-816-01) / 100 g in 1 TUBE 45802-816-96 1 TUBE in 1 CARTON (45802-816-96) / 60 g in 1 TUBE

Ingredients (2)

betamethasone dipropionate (.643 mg/g) calcipotriene (50 ug/g)

Linked Drug Pages (1)

Calcipotriene and Betamethasone Dipropionate ndc-match (0.9)

Raw FDA Data

View complete raw FDA NDC JSON payload

{"route": ["TOPICAL"], "spl_id": "9b7de25a-99a2-4123-b913-ba33289ff5be", "openfda": {"nui": ["M0022797", "N0000175849"], "unii": ["826Y60901U", "143NQ3779B"], "rxcui": ["388525"], "spl_set_id": ["ba55ff2b-9cfe-40dc-9dac-718cf141c171"], "pharm_class_cs": ["Vitamin D [CS]"], "pharm_class_epc": ["Vitamin D Analog [EPC]"], "manufacturer_name": ["Padagis Israel Pharmaceuticals Ltd"], "is_original_packager": [true]}, "finished": true, "packaging": [{"sample": false, "description": "1 TUBE in 1 CARTON (45802-816-01)  / 100 g in 1 TUBE", "package_ndc": "45802-816-01", "marketing_start_date": "20200130"}, {"sample": false, "description": "1 TUBE in 1 CARTON (45802-816-96)  / 60 g in 1 TUBE", "package_ndc": "45802-816-96", "marketing_start_date": "20200130"}], "brand_name": "Calcipotriene and Betamethasone Dipropionate", "product_id": "45802-816_9b7de25a-99a2-4123-b913-ba33289ff5be", "dosage_form": "OINTMENT", "pharm_class": ["Corticosteroid Hormone Receptor Agonists [MoA]", "Corticosteroid [EPC]", "Vitamin D Analog [EPC]", "Vitamin D [CS]"], "product_ndc": "45802-816", "generic_name": "Calcipotriene, Betamethasone Dipropionate", "labeler_name": "Padagis Israel Pharmaceuticals Ltd", "product_type": "HUMAN PRESCRIPTION DRUG", "brand_name_base": "Calcipotriene and Betamethasone Dipropionate", "active_ingredients": [{"name": "BETAMETHASONE DIPROPIONATE", "strength": ".643 mg/g"}, {"name": "CALCIPOTRIENE", "strength": "50 ug/g"}], "application_number": "ANDA200174", "marketing_category": "ANDA", "marketing_start_date": "20200130", "listing_expiration_date": "20261231"}