doxercalciferol

Generic: doxercalciferol

Labeler: meitheal pharmaceuticals inc.
NDC Directory HUMAN PRESCRIPTION DRUG ANDA Inactive Finished

Drug Facts

Product Profile

Brand Name doxercalciferol
Generic Name doxercalciferol
Labeler meitheal pharmaceuticals inc.
Dosage Form INJECTION, SOLUTION
Routes
INTRAVENOUS
Active Ingredients

doxercalciferol 4 ug/2mL

Manufacturer
Meitheal Pharmaceuticals Inc.

Identifiers & Regulatory

Product NDC 71288-802
Product ID 71288-802_76c7152a-bbff-478d-9a21-a67e1411c61b
Product Type HUMAN PRESCRIPTION DRUG
Marketing Category ANDA
Application Number ANDA211670
Listing Expiration 2026-12-31
Marketing Start 2020-02-11

Pharmacologic Class

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

Normalized Code Variants

Searchable formats for this product NDC code

Digits Only 71288802
Hyphenated Format 71288-802

Supplemental Identifiers

RxCUI
282609
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 ANDA211670 (source: ndc)
Routes
INTRAVENOUS
source: ndc

Resolved Composition

Strengths
  • 4 ug/2mL
source: ndc
Packaging
  • 25 VIAL, MULTI-DOSE in 1 CARTON (71288-802-04) / 2 mL in 1 VIAL, MULTI-DOSE (71288-802-02)
source: ndc

Packages (1)

Ingredients (1)

doxercalciferol (4 ug/2mL)

Linked Drug Pages (1)

Raw FDA Data

View complete raw FDA NDC JSON payload
{"route": ["INTRAVENOUS"], "spl_id": "76c7152a-bbff-478d-9a21-a67e1411c61b", "openfda": {"nui": ["M0007651", "N0000175907"], "unii": ["3DIZ9LF5Y9"], "rxcui": ["282609"], "spl_set_id": ["81a30e4b-be74-41d6-8277-b4f0ea5c15bc"], "pharm_class_cs": ["Ergocalciferols [CS]"], "pharm_class_epc": ["Vitamin D2 Analog [EPC]"], "manufacturer_name": ["Meitheal Pharmaceuticals Inc."], "is_original_packager": [true]}, "finished": true, "packaging": [{"sample": false, "description": "25 VIAL, MULTI-DOSE in 1 CARTON (71288-802-04)  / 2 mL in 1 VIAL, MULTI-DOSE (71288-802-02)", "package_ndc": "71288-802-04", "marketing_start_date": "20220209"}], "brand_name": "Doxercalciferol", "product_id": "71288-802_76c7152a-bbff-478d-9a21-a67e1411c61b", "dosage_form": "INJECTION, SOLUTION", "pharm_class": ["Ergocalciferols [CS]", "Vitamin D2 Analog [EPC]"], "product_ndc": "71288-802", "generic_name": "Doxercalciferol", "labeler_name": "Meitheal Pharmaceuticals Inc.", "product_type": "HUMAN PRESCRIPTION DRUG", "brand_name_base": "Doxercalciferol", "active_ingredients": [{"name": "DOXERCALCIFEROL", "strength": "4 ug/2mL"}], "application_number": "ANDA211670", "marketing_category": "ANDA", "marketing_start_date": "20200211", "listing_expiration_date": "20261231"}