calcitriol

Generic: calcitriol

Labeler: amneal pharmaceuticals llc
NDC Directory HUMAN PRESCRIPTION DRUG ANDA Inactive Finished

Drug Facts

Product Profile

Brand Name calcitriol
Generic Name calcitriol
Labeler amneal pharmaceuticals llc
Dosage Form CAPSULE
Routes
ORAL
Active Ingredients

calcitriol .5 ug/1

Manufacturer
Amneal Pharmaceuticals LLC

Identifiers & Regulatory

Product NDC 65162-576
Product ID 65162-576_ef9469b2-7a07-48f6-b7be-8a8ae57f08e4
Product Type HUMAN PRESCRIPTION DRUG
Marketing Category ANDA
Application Number ANDA203289
Listing Expiration 2026-12-31
Marketing Start 2017-06-18

Pharmacologic Class

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

Normalized Code Variants

Searchable formats for this product NDC code

Digits Only 65162576
Hyphenated Format 65162-576

Supplemental Identifiers

RxCUI
308867 308868
UPC
0365162519037 0365162576030
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 ANDA203289 (source: ndc)
Routes
ORAL
source: ndc

Resolved Composition

Strengths
  • .5 ug/1
source: ndc
Packaging
  • 30 CAPSULE in 1 BOTTLE (65162-576-03)
  • 100 CAPSULE in 1 BOTTLE (65162-576-10)
  • 250 CAPSULE in 1 BOTTLE (65162-576-25)
source: ndc

Packages (3)

65162-576-03 30 CAPSULE in 1 BOTTLE (65162-576-03) 65162-576-10 100 CAPSULE in 1 BOTTLE (65162-576-10) 65162-576-25 250 CAPSULE in 1 BOTTLE (65162-576-25)

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": "ef9469b2-7a07-48f6-b7be-8a8ae57f08e4", "openfda": {"nui": ["M0004229", "N0000175908"], "upc": ["0365162519037", "0365162576030"], "unii": ["FXC9231JVH"], "rxcui": ["308867", "308868"], "spl_set_id": ["b1fef137-63c5-4662-8cd9-b9e8b12bacb6"], "pharm_class_cs": ["Cholecalciferol [CS]"], "pharm_class_epc": ["Vitamin D3 Analog [EPC]"], "manufacturer_name": ["Amneal Pharmaceuticals LLC"], "is_original_packager": [true]}, "finished": true, "packaging": [{"sample": false, "description": "30 CAPSULE in 1 BOTTLE (65162-576-03)", "package_ndc": "65162-576-03", "marketing_start_date": "20170618"}, {"sample": false, "description": "100 CAPSULE in 1 BOTTLE (65162-576-10)", "package_ndc": "65162-576-10", "marketing_start_date": "20170618"}, {"sample": false, "description": "250 CAPSULE in 1 BOTTLE (65162-576-25)", "package_ndc": "65162-576-25", "marketing_start_date": "20170618"}], "brand_name": "Calcitriol", "product_id": "65162-576_ef9469b2-7a07-48f6-b7be-8a8ae57f08e4", "dosage_form": "CAPSULE", "pharm_class": ["Cholecalciferol [CS]", "Vitamin D3 Analog [EPC]"], "product_ndc": "65162-576", "generic_name": "Calcitriol", "labeler_name": "Amneal Pharmaceuticals LLC", "product_type": "HUMAN PRESCRIPTION DRUG", "brand_name_base": "Calcitriol", "active_ingredients": [{"name": "CALCITRIOL", "strength": ".5 ug/1"}], "application_number": "ANDA203289", "marketing_category": "ANDA", "marketing_start_date": "20170618", "listing_expiration_date": "20261231"}