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
Routes
ORAL
Active Ingredients

calcitriol .25 ug/1

Manufacturer
Aphena Pharma Solutions - Tennessee, LLC

Identifiers & Regulatory

Product NDC 71610-521
Product ID 71610-521_73591ad3-4894-41a5-968a-1955b2a52105
Product Type HUMAN PRESCRIPTION DRUG
Marketing Category ANDA
Application Number ANDA076917
Listing Expiration 2026-12-31
Marketing Start 2006-03-27

Pharmacologic Class

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

Normalized Code Variants

Searchable formats for this product NDC code

Digits Only 71610521
Hyphenated Format 71610-521

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 ANDA076917 (source: ndc)
Routes
ORAL
source: ndc

Resolved Composition

Strengths
  • .25 ug/1
source: ndc
Packaging
  • 9000 CAPSULE in 1 BOTTLE, PLASTIC (71610-521-09)
source: ndc

Packages (1)

71610-521-09 9000 CAPSULE in 1 BOTTLE, PLASTIC (71610-521-09)

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": "73591ad3-4894-41a5-968a-1955b2a52105", "openfda": {"nui": ["M0004229", "N0000175908"], "unii": ["FXC9231JVH"], "rxcui": ["308867"], "spl_set_id": ["adb1b2d5-33a7-4442-9074-cc1a89966528"], "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 in 1 BOTTLE, PLASTIC (71610-521-09)", "package_ndc": "71610-521-09", "marketing_start_date": "20210204"}], "brand_name": "Calcitriol", "product_id": "71610-521_73591ad3-4894-41a5-968a-1955b2a52105", "dosage_form": "CAPSULE", "pharm_class": ["Cholecalciferol [CS]", "Vitamin D3 Analog [EPC]"], "product_ndc": "71610-521", "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": "ANDA076917", "marketing_category": "ANDA", "marketing_start_date": "20060327", "listing_expiration_date": "20261231"}