calcitriol

Generic: calcitriol

Labeler: hikma pharmaceuticals usa inc.
NDC Directory HUMAN PRESCRIPTION DRUG ANDA Inactive Finished

Drug Facts

Product Profile

Brand Name calcitriol
Generic Name calcitriol
Labeler hikma pharmaceuticals usa inc.
Dosage Form CAPSULE
Routes
ORAL
Active Ingredients

calcitriol .25 ug/1

Manufacturer
Hikma Pharmaceuticals USA Inc.

Identifiers & Regulatory

Product NDC 0054-0007
Product ID 0054-0007_b5e53ff9-faab-4e0b-ae45-b3b2a4522557
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 00540007
Hyphenated Format 0054-0007

Supplemental Identifiers

RxCUI
308867
UPC
0300540007133
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 ANDA076917 (source: ndc)
Routes
ORAL
source: ndc

Resolved Composition

Strengths
  • .25 ug/1
source: ndc
Packaging
  • 30 CAPSULE in 1 BOTTLE, PLASTIC (0054-0007-13)
  • 100 CAPSULE in 1 BOTTLE, PLASTIC (0054-0007-25)
source: ndc

Packages (2)

0054-0007-13 30 CAPSULE in 1 BOTTLE, PLASTIC (0054-0007-13) 0054-0007-25 100 CAPSULE in 1 BOTTLE, PLASTIC (0054-0007-25)

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": "b5e53ff9-faab-4e0b-ae45-b3b2a4522557", "openfda": {"nui": ["M0004229", "N0000175908"], "upc": ["0300540007133"], "unii": ["FXC9231JVH"], "rxcui": ["308867"], "spl_set_id": ["cdcaffc6-e14e-4607-b77b-fc78a8382f60"], "pharm_class_cs": ["Cholecalciferol [CS]"], "pharm_class_epc": ["Vitamin D3 Analog [EPC]"], "manufacturer_name": ["Hikma Pharmaceuticals USA Inc."], "is_original_packager": [true]}, "finished": true, "packaging": [{"sample": false, "description": "30 CAPSULE in 1 BOTTLE, PLASTIC (0054-0007-13)", "package_ndc": "0054-0007-13", "marketing_start_date": "20060327"}, {"sample": false, "description": "100 CAPSULE in 1 BOTTLE, PLASTIC (0054-0007-25)", "package_ndc": "0054-0007-25", "marketing_start_date": "20060327"}], "brand_name": "Calcitriol", "product_id": "0054-0007_b5e53ff9-faab-4e0b-ae45-b3b2a4522557", "dosage_form": "CAPSULE", "pharm_class": ["Cholecalciferol [CS]", "Vitamin D3 Analog [EPC]"], "product_ndc": "0054-0007", "generic_name": "Calcitriol", "labeler_name": "Hikma Pharmaceuticals USA 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"}