calcitriol

Generic: calcitriol

Labeler: chartwell rx, llc
NDC Directory HUMAN PRESCRIPTION DRUG ANDA Inactive Finished

Drug Facts

Product Profile

Brand Name calcitriol
Generic Name calcitriol
Labeler chartwell rx, llc
Dosage Form CAPSULE
Routes
ORAL
Active Ingredients

calcitriol .25 ug/1

Manufacturer
Chartwell RX, LLC

Identifiers & Regulatory

Product NDC 62135-610
Product ID 62135-610_458c15a3-d256-681b-e063-6294a90a282a
Product Type HUMAN PRESCRIPTION DRUG
Marketing Category ANDA
Application Number ANDA091356
Listing Expiration 2026-12-31
Marketing Start 2018-05-29

Pharmacologic Class

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

Normalized Code Variants

Searchable formats for this product NDC code

Digits Only 62135610
Hyphenated Format 62135-610

Supplemental Identifiers

RxCUI
308867 308868
UPC
0362135611903 0362135610906
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 ANDA091356 (source: ndc)
Routes
ORAL
source: ndc

Resolved Composition

Strengths
  • .25 ug/1
source: ndc
Packaging
  • 90 CAPSULE in 1 BOTTLE (62135-610-90)
source: ndc

Packages (1)

62135-610-90 90 CAPSULE in 1 BOTTLE (62135-610-90)

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": "458c15a3-d256-681b-e063-6294a90a282a", "openfda": {"nui": ["M0004229", "N0000175908"], "upc": ["0362135611903", "0362135610906"], "unii": ["FXC9231JVH"], "rxcui": ["308867", "308868"], "spl_set_id": ["36820cd0-7b30-4454-9005-09d71e1d5796"], "pharm_class_cs": ["Cholecalciferol [CS]"], "pharm_class_epc": ["Vitamin D3 Analog [EPC]"], "manufacturer_name": ["Chartwell RX, LLC"], "is_original_packager": [true]}, "finished": true, "packaging": [{"sample": false, "description": "90 CAPSULE in 1 BOTTLE (62135-610-90)", "package_ndc": "62135-610-90", "marketing_start_date": "20230605"}], "brand_name": "Calcitriol", "product_id": "62135-610_458c15a3-d256-681b-e063-6294a90a282a", "dosage_form": "CAPSULE", "pharm_class": ["Cholecalciferol [CS]", "Vitamin D3 Analog [EPC]"], "product_ndc": "62135-610", "generic_name": "Calcitriol", "labeler_name": "Chartwell RX, LLC", "product_type": "HUMAN PRESCRIPTION DRUG", "brand_name_base": "Calcitriol", "active_ingredients": [{"name": "CALCITRIOL", "strength": ".25 ug/1"}], "application_number": "ANDA091356", "marketing_category": "ANDA", "marketing_start_date": "20180529", "listing_expiration_date": "20261231"}