NDC 58468-0127

Hectorol

Doxercalciferol

Hectorol is a Intravenous Injection, Solution in the Human Prescription Drug category. It is labeled and distributed by Genzyme Corporation. The primary component is Doxercalciferol.

• Product ID: 58468-0127_6eb95fe3-4632-40f2-9567-5c7790c0a537
• NDC: 58468-0127
• Product Type: Human Prescription Drug
• Proprietary Name: Hectorol
• Generic Name: Doxercalciferol
• Dosage Form: Injection, Solution
• Route of Administration: INTRAVENOUS
• Marketing Start Date: 2008-12-08
• Marketing Category: NDA / NDA
• Application Number: NDA021027
• Labeler Name: Genzyme Corporation
• Substance Name: DOXERCALCIFEROL
• Active Ingredient Strength: 4 ug/2mL
• Pharm Classes: Ergocalciferols [CS],Vitamin D2 Analog [EPC]
• NDC Exclude Flag: N
• Listing Certified Through: 2022-12-31

Packaging

NDC 58468-0127-1

50 VIAL, MULTI-DOSE in 1 BOX (58468-0127-1) > 2 mL in 1 VIAL, MULTI-DOSE (58468-0127-0)

• Marketing Start Date: 2008-12-08
• NDC Exclude Flag: N
• Sample Package?: N

NDC SPL Data Element Entries

NDC 58468-0127-1 [58468012701]

Hectorol INJECTION, SOLUTION

• Marketing Category: NDA
• Application Number: NDA021027
• Product Type: HUMAN PRESCRIPTION DRUG
• Billing Unit: ML
• Marketing Start Date: 2008-12-08

Drug Details

Active Ingredients

Ingredient	Strength
DOXERCALCIFEROL	4 ug/2mL

OpenFDA Data

• SPL SET ID: 7efc3d9c-12f5-43f6-9a22-88d66cbe6f62
• Manufacturer:
  • Genzyme Corporation
• UNII:
  • 3DIZ9LF5Y9
• RxNorm Concept Unique ID - RxCUI:
  • 282609
  • 284411
  • 1790210
  • 1790208
  • 1790219
  • 1790220

Pharmacological Class

• Ergocalciferols [CS]
• Vitamin D2 Analog [EPC]
• Ergocalciferols [CS]
• Vitamin D2 Analog [EPC]

NDC Crossover Matching brand name "Hectorol" or generic name "Doxercalciferol"

NDC	Brand Name	Generic Name
58468-0123	Hectorol	Hectorol
58468-0126	Hectorol	Hectorol
58468-0127	Hectorol	Hectorol
0054-0338	Doxercalciferol	Doxercalciferol
0054-0339	Doxercalciferol	Doxercalciferol
0054-0388	Doxercalciferol	Doxercalciferol
0409-1330	DOXERCALCIFEROL	DOXERCALCIFEROL
0641-6154	Doxercalciferol	Doxercalciferol
0781-3305	Doxercalciferol	Doxercalciferol
0955-1720	Doxercalciferol	Doxercalciferol
0955-1721	Doxercalciferol	Doxercalciferol
0955-1722	Doxercalciferol	Doxercalciferol
17478-987	Doxercalciferol	Doxercalciferol
17478-988	Doxercalciferol	Doxercalciferol
23155-538	Doxercalciferol	Doxercalciferol
23155-539	Doxercalciferol	Doxercalciferol