calcitriol

Generic: calcitriol

Labeler: padagis israel pharmaceuticals ltd
NDC Directory HUMAN PRESCRIPTION DRUG NDA AUTHORIZED GENERIC Inactive Finished

Drug Facts

Product Profile

Brand Name calcitriol
Generic Name calcitriol
Labeler padagis israel pharmaceuticals ltd
Dosage Form OINTMENT
Routes
TOPICAL
Active Ingredients

calcitriol 3 ug/g

Manufacturer
Padagis Israel Pharmaceuticals Ltd

Identifiers & Regulatory

Product NDC 45802-608
Product ID 45802-608_d1600f2d-9c61-486e-9ef0-54160ef6adc3
Product Type HUMAN PRESCRIPTION DRUG
Marketing Category NDA AUTHORIZED GENERIC
Application Number NDA022087
Listing Expiration 2026-12-31
Marketing Start 2012-03-08

Pharmacologic Class

Established (EPC)
vitamin d3 analog [epc]
Chemical Structure
cholecalciferol [cs]

Normalized Code Variants

Searchable formats for this product NDC code

Digits Only 45802608
Hyphenated Format 45802-608

Supplemental Identifiers

RxCUI
388517
UNII
FXC9231JVH
NUI
M0004229 N0000175908

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 calcitriol (source: ndc)
Generic Name calcitriol (source: ndc)
Application Number NDA022087 (source: ndc)
Routes
TOPICAL
source: ndc

Resolved Composition

Strengths
  • 3 ug/g
source: ndc
Packaging
  • 1 TUBE in 1 CARTON (45802-608-01) / 100 g in 1 TUBE
source: ndc

Packages (1)

45802-608-01 1 TUBE in 1 CARTON (45802-608-01) / 100 g in 1 TUBE

Ingredients (1)

calcitriol (3 ug/g)

Linked Drug Pages (1)

calcitriol ndc-match (0.9)

Raw FDA Data

View complete raw FDA NDC JSON payload 
{"route": ["TOPICAL"], "spl_id": "d1600f2d-9c61-486e-9ef0-54160ef6adc3", "openfda": {"nui": ["M0004229", "N0000175908"], "unii": ["FXC9231JVH"], "rxcui": ["388517"], "spl_set_id": ["7fa4ab07-3d8e-4300-91f3-b1e17cba8691"], "pharm_class_cs": ["Cholecalciferol [CS]"], "pharm_class_epc": ["Vitamin D3 Analog [EPC]"], "manufacturer_name": ["Padagis Israel Pharmaceuticals Ltd"], "is_original_packager": [true]}, "finished": true, "packaging": [{"sample": false, "description": "1 TUBE in 1 CARTON (45802-608-01)  / 100 g in 1 TUBE", "package_ndc": "45802-608-01", "marketing_start_date": "20120308"}], "brand_name": "calcitriol", "product_id": "45802-608_d1600f2d-9c61-486e-9ef0-54160ef6adc3", "dosage_form": "OINTMENT", "pharm_class": ["Cholecalciferol [CS]", "Vitamin D3 Analog [EPC]"], "product_ndc": "45802-608", "generic_name": "calcitriol", "labeler_name": "Padagis Israel Pharmaceuticals Ltd", "product_type": "HUMAN PRESCRIPTION DRUG", "brand_name_base": "calcitriol", "active_ingredients": [{"name": "CALCITRIOL", "strength": "3 ug/g"}], "application_number": "NDA022087", "marketing_category": "NDA AUTHORIZED GENERIC", "marketing_start_date": "20120308", "listing_expiration_date": "20261231"}