calcitriol

Generic: calcitriol

Labeler: gland pharma limited
NDC Directory HUMAN PRESCRIPTION DRUG ANDA Inactive Finished

Drug Facts

Product Profile

Brand Name calcitriol
Generic Name calcitriol
Labeler gland pharma limited
Dosage Form INJECTION
Routes
INTRAVENOUS
Active Ingredients

calcitriol 1 ug/mL

Manufacturer
Gland Pharma Limited

Identifiers & Regulatory

Product NDC 68083-316
Product ID 68083-316_7e6d4205-3332-4f96-b258-8ffde9119ed4
Product Type HUMAN PRESCRIPTION DRUG
Marketing Category ANDA
Application Number ANDA211030
Listing Expiration 2026-12-31
Marketing Start 2020-02-03

Pharmacologic Class

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

Normalized Code Variants

Searchable formats for this product NDC code

Digits Only 68083316
Hyphenated Format 68083-316

Supplemental Identifiers

RxCUI
308869
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 ANDA211030 (source: ndc)
Routes
INTRAVENOUS
source: ndc

Resolved Composition

Strengths
  • 1 ug/mL
source: ndc
Packaging
  • 10 VIAL in 1 CARTON (68083-316-10) / 1 mL in 1 VIAL
source: ndc

Packages (1)

68083-316-10 10 VIAL in 1 CARTON (68083-316-10) / 1 mL in 1 VIAL

Ingredients (1)

calcitriol (1 ug/mL)

Linked Drug Pages (1)

Calcitriol ndc-match (0.9)

Raw FDA Data

View complete raw FDA NDC JSON payload 
{"route": ["INTRAVENOUS"], "spl_id": "7e6d4205-3332-4f96-b258-8ffde9119ed4", "openfda": {"nui": ["M0004229", "N0000175908"], "unii": ["FXC9231JVH"], "rxcui": ["308869"], "spl_set_id": ["d9ba544c-6ca8-410d-a306-51482a8c6848"], "pharm_class_cs": ["Cholecalciferol [CS]"], "pharm_class_epc": ["Vitamin D3 Analog [EPC]"], "manufacturer_name": ["Gland Pharma Limited"], "is_original_packager": [true]}, "finished": true, "packaging": [{"sample": false, "description": "10 VIAL in 1 CARTON (68083-316-10)  / 1 mL in 1 VIAL", "package_ndc": "68083-316-10", "marketing_start_date": "20200203"}], "brand_name": "Calcitriol", "product_id": "68083-316_7e6d4205-3332-4f96-b258-8ffde9119ed4", "dosage_form": "INJECTION", "pharm_class": ["Cholecalciferol [CS]", "Vitamin D3 Analog [EPC]"], "product_ndc": "68083-316", "generic_name": "Calcitriol", "labeler_name": "Gland Pharma Limited", "product_type": "HUMAN PRESCRIPTION DRUG", "brand_name_base": "Calcitriol", "active_ingredients": [{"name": "CALCITRIOL", "strength": "1 ug/mL"}], "application_number": "ANDA211030", "marketing_category": "ANDA", "marketing_start_date": "20200203", "listing_expiration_date": "20261231"}