calcitriol

Generic: calcitriol

Labeler: bionpharma inc.
NDC Directory HUMAN PRESCRIPTION DRUG ANDA Inactive Finished

Drug Facts

Product Profile

Brand Name calcitriol
Generic Name calcitriol
Labeler bionpharma inc.
Dosage Form CAPSULE, LIQUID FILLED
Routes
ORAL
Active Ingredients

calcitriol .5 ug/1

Manufacturer
BIONPHARMA INC.

Identifiers & Regulatory

Product NDC 69452-208
Product ID 69452-208_2dcfc64f-5782-372f-e063-6294a90afa46
Product Type HUMAN PRESCRIPTION DRUG
Marketing Category ANDA
Application Number ANDA091174
Listing Expiration 2026-12-31
Marketing Start 2018-06-12

Pharmacologic Class

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

Normalized Code Variants

Searchable formats for this product NDC code

Digits Only 69452208
Hyphenated Format 69452-208

Supplemental Identifiers

RxCUI
308867 308868
UPC
0369452208205 0369452207208
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 ANDA091174 (source: ndc)
Routes
ORAL
source: ndc

Resolved Composition

Strengths
  • .5 ug/1
source: ndc
Packaging
  • 30 CAPSULE, LIQUID FILLED in 1 BOTTLE, PLASTIC (69452-208-13)
  • 100 CAPSULE, LIQUID FILLED in 1 BOTTLE, PLASTIC (69452-208-20)
source: ndc

Packages (2)

69452-208-13 30 CAPSULE, LIQUID FILLED in 1 BOTTLE, PLASTIC (69452-208-13) 69452-208-20 100 CAPSULE, LIQUID FILLED in 1 BOTTLE, PLASTIC (69452-208-20)

Ingredients (1)

calcitriol (.5 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": "2dcfc64f-5782-372f-e063-6294a90afa46", "openfda": {"nui": ["M0004229", "N0000175908"], "upc": ["0369452208205", "0369452207208"], "unii": ["FXC9231JVH"], "rxcui": ["308867", "308868"], "spl_set_id": ["626f23d5-31e6-41ca-a696-191a4f2bc7ef"], "pharm_class_cs": ["Cholecalciferol [CS]"], "pharm_class_epc": ["Vitamin D3 Analog [EPC]"], "manufacturer_name": ["BIONPHARMA INC."], "is_original_packager": [true]}, "finished": true, "packaging": [{"sample": false, "description": "30 CAPSULE, LIQUID FILLED in 1 BOTTLE, PLASTIC (69452-208-13)", "package_ndc": "69452-208-13", "marketing_start_date": "20180612"}, {"sample": false, "description": "100 CAPSULE, LIQUID FILLED in 1 BOTTLE, PLASTIC (69452-208-20)", "package_ndc": "69452-208-20", "marketing_start_date": "20180612"}], "brand_name": "Calcitriol", "product_id": "69452-208_2dcfc64f-5782-372f-e063-6294a90afa46", "dosage_form": "CAPSULE, LIQUID FILLED", "pharm_class": ["Cholecalciferol [CS]", "Vitamin D3 Analog [EPC]"], "product_ndc": "69452-208", "generic_name": "Calcitriol", "labeler_name": "BIONPHARMA INC.", "product_type": "HUMAN PRESCRIPTION DRUG", "brand_name_base": "Calcitriol", "active_ingredients": [{"name": "CALCITRIOL", "strength": ".5 ug/1"}], "application_number": "ANDA091174", "marketing_category": "ANDA", "marketing_start_date": "20180612", "listing_expiration_date": "20261231"}