calcitriol

Generic: calcitriol

Labeler: aphena pharma solutions - tennessee, llc
NDC Directory HUMAN PRESCRIPTION DRUG ANDA Inactive Finished

Drug Facts

Product Profile

Brand Name calcitriol
Generic Name calcitriol
Labeler aphena pharma solutions - tennessee, llc
Dosage Form CAPSULE, LIQUID FILLED
Routes
ORAL
Active Ingredients

calcitriol .25 ug/1

Manufacturer
Aphena Pharma Solutions - Tennessee, LLC

Identifiers & Regulatory

Product NDC 71610-468
Product ID 71610-468_e4a50edb-a1aa-436f-9379-63010ae70dae
Product Type HUMAN PRESCRIPTION DRUG
Marketing Category ANDA
Application Number ANDA091174
Listing Expiration 2026-12-31
Marketing Start 2013-05-24

Pharmacologic Class

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

Normalized Code Variants

Searchable formats for this product NDC code

Digits Only 71610468
Hyphenated Format 71610-468

Supplemental Identifiers

RxCUI
308867
UNII
FXC9231JVH
NUI
M0004229 N0000175908

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 ANDA091174 (source: ndc)
Routes
ORAL
source: ndc

Resolved Composition

Strengths
  • .25 ug/1
source: ndc
Packaging
  • 9000 CAPSULE, LIQUID FILLED in 1 BOTTLE, PLASTIC (71610-468-09)
  • 30 CAPSULE, LIQUID FILLED in 1 BOTTLE, PLASTIC (71610-468-30)
source: ndc

Packages (2)

71610-468-09 9000 CAPSULE, LIQUID FILLED in 1 BOTTLE, PLASTIC (71610-468-09) 71610-468-30 30 CAPSULE, LIQUID FILLED in 1 BOTTLE, PLASTIC (71610-468-30)

Ingredients (1)

calcitriol (.25 ug/1)

Linked Drug Pages (1)

Calcitriol ndc-match (0.9)

Raw FDA Data

View complete raw FDA NDC JSON payload 
{"route": ["ORAL"], "spl_id": "e4a50edb-a1aa-436f-9379-63010ae70dae", "openfda": {"nui": ["M0004229", "N0000175908"], "unii": ["FXC9231JVH"], "rxcui": ["308867"], "spl_set_id": ["3c40c40c-1627-4bcd-ba35-bee9b952d985"], "pharm_class_cs": ["Cholecalciferol [CS]"], "pharm_class_epc": ["Vitamin D3 Analog [EPC]"], "manufacturer_name": ["Aphena Pharma Solutions - Tennessee, LLC"]}, "finished": true, "packaging": [{"sample": false, "description": "9000 CAPSULE, LIQUID FILLED in 1 BOTTLE, PLASTIC (71610-468-09)", "package_ndc": "71610-468-09", "marketing_start_date": "20200921"}, {"sample": false, "description": "30 CAPSULE, LIQUID FILLED in 1 BOTTLE, PLASTIC (71610-468-30)", "package_ndc": "71610-468-30", "marketing_start_date": "20230612"}], "brand_name": "Calcitriol", "product_id": "71610-468_e4a50edb-a1aa-436f-9379-63010ae70dae", "dosage_form": "CAPSULE, LIQUID FILLED", "pharm_class": ["Cholecalciferol [CS]", "Vitamin D3 Analog [EPC]"], "product_ndc": "71610-468", "generic_name": "Calcitriol", "labeler_name": "Aphena Pharma Solutions - Tennessee, LLC", "product_type": "HUMAN PRESCRIPTION DRUG", "brand_name_base": "Calcitriol", "active_ingredients": [{"name": "CALCITRIOL", "strength": ".25 ug/1"}], "application_number": "ANDA091174", "marketing_category": "ANDA", "marketing_start_date": "20130524", "listing_expiration_date": "20261231"}