calcitriol

Generic: calcitriol

Labeler: sun pharmaceutical industries, inc.
NDC Directory HUMAN PRESCRIPTION DRUG ANDA Inactive Finished

Drug Facts

Product Profile

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

calcitriol .5 ug/1

Manufacturer
Sun Pharmaceutical Industries, Inc.

Identifiers & Regulatory

Product NDC 62756-968
Product ID 62756-968_fb99b865-fb41-4c92-8db9-7953feed2394
Product Type HUMAN PRESCRIPTION DRUG
Marketing Category ANDA
Application Number ANDA204556
Listing Expiration 2026-12-31
Marketing Start 2020-05-01

Pharmacologic Class

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

Normalized Code Variants

Searchable formats for this product NDC code

Digits Only 62756968
Hyphenated Format 62756-968

Supplemental Identifiers

RxCUI
308867 308868
UPC
0362756968882 0362756967885
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 ANDA204556 (source: ndc)
Routes
ORAL
source: ndc

Resolved Composition

Strengths
  • .5 ug/1
source: ndc
Packaging
  • 1000 CAPSULE, LIQUID FILLED in 1 BOTTLE (62756-968-18)
  • 30 CAPSULE, LIQUID FILLED in 1 BOTTLE (62756-968-83)
  • 100 CAPSULE, LIQUID FILLED in 1 BOTTLE (62756-968-88)
source: ndc

Packages (3)

62756-968-18 1000 CAPSULE, LIQUID FILLED in 1 BOTTLE (62756-968-18) 62756-968-83 30 CAPSULE, LIQUID FILLED in 1 BOTTLE (62756-968-83) 62756-968-88 100 CAPSULE, LIQUID FILLED in 1 BOTTLE (62756-968-88)

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": "fb99b865-fb41-4c92-8db9-7953feed2394", "openfda": {"nui": ["M0004229", "N0000175908"], "upc": ["0362756968882", "0362756967885"], "unii": ["FXC9231JVH"], "rxcui": ["308867", "308868"], "spl_set_id": ["97cf7807-3b48-403b-bae2-2fe585946e0c"], "pharm_class_cs": ["Cholecalciferol [CS]"], "pharm_class_epc": ["Vitamin D3 Analog [EPC]"], "manufacturer_name": ["Sun Pharmaceutical Industries, Inc."], "is_original_packager": [true]}, "finished": true, "packaging": [{"sample": false, "description": "1000 CAPSULE, LIQUID FILLED in 1 BOTTLE (62756-968-18)", "package_ndc": "62756-968-18", "marketing_start_date": "20200501"}, {"sample": false, "description": "30 CAPSULE, LIQUID FILLED in 1 BOTTLE (62756-968-83)", "package_ndc": "62756-968-83", "marketing_start_date": "20200501"}, {"sample": false, "description": "100 CAPSULE, LIQUID FILLED in 1 BOTTLE (62756-968-88)", "package_ndc": "62756-968-88", "marketing_start_date": "20200501"}], "brand_name": "Calcitriol", "product_id": "62756-968_fb99b865-fb41-4c92-8db9-7953feed2394", "dosage_form": "CAPSULE, LIQUID FILLED", "pharm_class": ["Cholecalciferol [CS]", "Vitamin D3 Analog [EPC]"], "product_ndc": "62756-968", "generic_name": "Calcitriol", "labeler_name": "Sun Pharmaceutical Industries, Inc.", "product_type": "HUMAN PRESCRIPTION DRUG", "brand_name_base": "Calcitriol", "active_ingredients": [{"name": "CALCITRIOL", "strength": ".5 ug/1"}], "application_number": "ANDA204556", "marketing_category": "ANDA", "marketing_start_date": "20200501", "listing_expiration_date": "20261231"}