calcitrol

Generic: calcitriol

Labeler: mayne pharma commercial llc.
NDC Directory HUMAN PRESCRIPTION DRUG NDA AUTHORIZED GENERIC Inactive Finished

Drug Facts

Product Profile

Brand Name calcitrol
Generic Name calcitriol
Labeler mayne pharma commercial llc.
Dosage Form OINTMENT
Routes
TOPICAL
Active Ingredients

calcitriol 3 ug/g

Manufacturer
Mayne Pharma Commercial LLC.

Identifiers & Regulatory

Product NDC 68308-665
Product ID 68308-665_1a9de7b9-1855-4fef-8095-2590498f49f8
Product Type HUMAN PRESCRIPTION DRUG
Marketing Category NDA AUTHORIZED GENERIC
Application Number NDA022087
Listing Expiration 2026-12-31
Marketing Start 2023-07-21

Pharmacologic Class

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

Normalized Code Variants

Searchable formats for this product NDC code

Digits Only 68308665
Hyphenated Format 68308-665

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 calcitrol (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 (68308-665-10) / 100 g in 1 TUBE
source: ndc

Packages (1)

68308-665-10 1 TUBE in 1 CARTON (68308-665-10) / 100 g in 1 TUBE

Ingredients (1)

calcitriol (3 ug/g)

Linked Drug Pages (1)

Calcitrol ndc-match (0.9)

Raw FDA Data

View complete raw FDA NDC JSON payload 
{"route": ["TOPICAL"], "spl_id": "1a9de7b9-1855-4fef-8095-2590498f49f8", "openfda": {"nui": ["M0004229", "N0000175908"], "unii": ["FXC9231JVH"], "rxcui": ["388517"], "spl_set_id": ["cc344944-7dad-403e-bfd2-8c649e2fbfb0"], "pharm_class_cs": ["Cholecalciferol [CS]"], "pharm_class_epc": ["Vitamin D3 Analog [EPC]"], "manufacturer_name": ["Mayne Pharma Commercial LLC."], "is_original_packager": [true]}, "finished": true, "packaging": [{"sample": false, "description": "1 TUBE in 1 CARTON (68308-665-10)  / 100 g in 1 TUBE", "package_ndc": "68308-665-10", "marketing_start_date": "20230721"}], "brand_name": "Calcitrol", "product_id": "68308-665_1a9de7b9-1855-4fef-8095-2590498f49f8", "dosage_form": "OINTMENT", "pharm_class": ["Cholecalciferol [CS]", "Vitamin D3 Analog [EPC]"], "product_ndc": "68308-665", "generic_name": "calcitriol", "labeler_name": "Mayne Pharma Commercial LLC.", "product_type": "HUMAN PRESCRIPTION DRUG", "brand_name_base": "Calcitrol", "active_ingredients": [{"name": "CALCITRIOL", "strength": "3 ug/g"}], "application_number": "NDA022087", "marketing_category": "NDA AUTHORIZED GENERIC", "marketing_start_date": "20230721", "listing_expiration_date": "20261231"}