doxercalciferol

Generic: doxercalciferol

Labeler: gland pharma limited
NDC Directory HUMAN PRESCRIPTION DRUG ANDA Inactive Finished

Drug Facts

Product Profile

Brand Name doxercalciferol
Generic Name doxercalciferol
Labeler gland pharma limited
Dosage Form INJECTION, SOLUTION
Routes
INTRAVENOUS
Active Ingredients

doxercalciferol 4 ug/2mL

Manufacturer
Gland Pharma Limited

Identifiers & Regulatory

Product NDC 68083-300
Product ID 68083-300_db27a30b-8264-4248-b83e-b6ba0feafbf0
Product Type HUMAN PRESCRIPTION DRUG
Marketing Category ANDA
Application Number ANDA210452
Listing Expiration 2026-12-31
Marketing Start 2019-09-26

Pharmacologic Class

Established (EPC)
vitamin d2 analog [epc]
Chemical Structure
ergocalciferols [cs]

Normalized Code Variants

Searchable formats for this product NDC code

Digits Only 68083300
Hyphenated Format 68083-300

Supplemental Identifiers

RxCUI
282609 1790219
UNII
3DIZ9LF5Y9
NUI
M0007651 N0000175907

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 doxercalciferol (source: ndc)
Generic Name doxercalciferol (source: ndc)
Application Number ANDA210452 (source: ndc)
Routes
INTRAVENOUS
source: ndc

Resolved Composition

Strengths
  • 4 ug/2mL
source: ndc
Packaging
  • 50 VIAL, SINGLE-DOSE in 1 CARTON (68083-300-50) / 2 mL in 1 VIAL, SINGLE-DOSE (68083-300-01)
source: ndc

Packages (1)

68083-300-50 50 VIAL, SINGLE-DOSE in 1 CARTON (68083-300-50) / 2 mL in 1 VIAL, SINGLE-DOSE (68083-300-01)

Ingredients (1)

doxercalciferol (4 ug/2mL)

Linked Drug Pages (1)

Doxercalciferol ndc-match (0.9)

Raw FDA Data

View complete raw FDA NDC JSON payload 
{"route": ["INTRAVENOUS"], "spl_id": "db27a30b-8264-4248-b83e-b6ba0feafbf0", "openfda": {"nui": ["M0007651", "N0000175907"], "unii": ["3DIZ9LF5Y9"], "rxcui": ["282609", "1790219"], "spl_set_id": ["f0d79a1b-c7fb-4521-941a-5d6c2fd50170"], "pharm_class_cs": ["Ergocalciferols [CS]"], "pharm_class_epc": ["Vitamin D2 Analog [EPC]"], "manufacturer_name": ["Gland Pharma Limited"], "is_original_packager": [true]}, "finished": true, "packaging": [{"sample": false, "description": "50 VIAL, SINGLE-DOSE in 1 CARTON (68083-300-50)  / 2 mL in 1 VIAL, SINGLE-DOSE (68083-300-01)", "package_ndc": "68083-300-50", "marketing_start_date": "20190926"}], "brand_name": "Doxercalciferol", "product_id": "68083-300_db27a30b-8264-4248-b83e-b6ba0feafbf0", "dosage_form": "INJECTION, SOLUTION", "pharm_class": ["Ergocalciferols [CS]", "Vitamin D2 Analog [EPC]"], "product_ndc": "68083-300", "generic_name": "Doxercalciferol", "labeler_name": "Gland Pharma Limited", "product_type": "HUMAN PRESCRIPTION DRUG", "brand_name_base": "Doxercalciferol", "active_ingredients": [{"name": "DOXERCALCIFEROL", "strength": "4 ug/2mL"}], "application_number": "ANDA210452", "marketing_category": "ANDA", "marketing_start_date": "20190926", "listing_expiration_date": "20261231"}