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 SOLUTION
Routes
ORAL
Active Ingredients

calcitriol 1 ug/mL

Manufacturer
Hikma Pharmaceuticals USA Inc.

Identifiers & Regulatory

Product NDC 0054-3120
Product ID 0054-3120_2b8745f3-5289-474e-bd44-48b59a40dd78
Product Type HUMAN PRESCRIPTION DRUG
Marketing Category ANDA
Application Number ANDA076242
Listing Expiration 2026-12-31
Marketing Start 2003-07-18

Pharmacologic Class

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

Normalized Code Variants

Searchable formats for this product NDC code

Digits Only 00543120
Hyphenated Format 0054-3120

Supplemental Identifiers

RxCUI
313932
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 ANDA076242 (source: ndc)
Routes
ORAL
source: ndc

Resolved Composition

Strengths
  • 1 ug/mL
source: ndc
Packaging
  • 1 BOTTLE, GLASS in 1 CARTON (0054-3120-41) / 15 mL in 1 BOTTLE, GLASS
source: ndc

Packages (1)

0054-3120-41 1 BOTTLE, GLASS in 1 CARTON (0054-3120-41) / 15 mL in 1 BOTTLE, GLASS

Ingredients (1)

calcitriol (1 ug/mL)

Linked Drug Pages (1)

Calcitriol ndc-match (0.9)

Raw FDA Data

View complete raw FDA NDC JSON payload 
{"route": ["ORAL"], "spl_id": "2b8745f3-5289-474e-bd44-48b59a40dd78", "openfda": {"nui": ["M0004229", "N0000175908"], "unii": ["FXC9231JVH"], "rxcui": ["313932"], "spl_set_id": ["3289b482-8733-484d-b1db-d7f4cdcd1ac2"], "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": "1 BOTTLE, GLASS in 1 CARTON (0054-3120-41)  / 15 mL in 1 BOTTLE, GLASS", "package_ndc": "0054-3120-41", "marketing_start_date": "20030718"}], "brand_name": "Calcitriol", "product_id": "0054-3120_2b8745f3-5289-474e-bd44-48b59a40dd78", "dosage_form": "SOLUTION", "pharm_class": ["Cholecalciferol [CS]", "Vitamin D3 Analog [EPC]"], "product_ndc": "0054-3120", "generic_name": "Calcitriol", "labeler_name": "Hikma Pharmaceuticals USA Inc.", "product_type": "HUMAN PRESCRIPTION DRUG", "brand_name_base": "Calcitriol", "active_ingredients": [{"name": "CALCITRIOL", "strength": "1 ug/mL"}], "application_number": "ANDA076242", "marketing_category": "ANDA", "marketing_start_date": "20030718", "listing_expiration_date": "20261231"}