calcitriol

Generic: calcitriol

Labeler: pd-rx pharmaceuticals, inc.
NDC Directory HUMAN PRESCRIPTION DRUG ANDA Inactive Finished

Drug Facts

Product Profile

Brand Name calcitriol
Generic Name calcitriol
Labeler pd-rx pharmaceuticals, inc.
Dosage Form CAPSULE
Routes
ORAL
Active Ingredients

calcitriol .25 ug/1

Manufacturer
PD-Rx Pharmaceuticals, Inc.

Identifiers & Regulatory

Product NDC 72789-058
Product ID 72789-058_2c25214d-d149-70d8-e063-6394a90a7b08
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 72789058
Hyphenated Format 72789-058

Supplemental Identifiers

RxCUI
308867
UPC
0372789058306
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
  • 100 CAPSULE in 1 BOTTLE, PLASTIC (72789-058-01)
  • 30 CAPSULE in 1 BOTTLE, PLASTIC (72789-058-30)
source: ndc

Packages (2)

72789-058-01 100 CAPSULE in 1 BOTTLE, PLASTIC (72789-058-01) 72789-058-30 30 CAPSULE in 1 BOTTLE, PLASTIC (72789-058-30)

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": "2c25214d-d149-70d8-e063-6394a90a7b08", "openfda": {"nui": ["M0004229", "N0000175908"], "upc": ["0372789058306"], "unii": ["FXC9231JVH"], "rxcui": ["308867"], "spl_set_id": ["e1fcb1c7-11a9-4a23-a64a-2c8ce9698321"], "pharm_class_cs": ["Cholecalciferol [CS]"], "pharm_class_epc": ["Vitamin D3 Analog [EPC]"], "manufacturer_name": ["PD-Rx Pharmaceuticals, Inc."]}, "finished": true, "packaging": [{"sample": false, "description": "100 CAPSULE in 1 BOTTLE, PLASTIC (72789-058-01)", "package_ndc": "72789-058-01", "marketing_start_date": "20200226"}, {"sample": false, "description": "30 CAPSULE in 1 BOTTLE, PLASTIC (72789-058-30)", "package_ndc": "72789-058-30", "marketing_start_date": "20230714"}], "brand_name": "Calcitriol", "product_id": "72789-058_2c25214d-d149-70d8-e063-6394a90a7b08", "dosage_form": "CAPSULE", "pharm_class": ["Cholecalciferol [CS]", "Vitamin D3 Analog [EPC]"], "product_ndc": "72789-058", "generic_name": "Calcitriol", "labeler_name": "PD-Rx Pharmaceuticals, Inc.", "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"}