Hectorol

Product NDC
58468-0127
11-digit product format
584680127
Labeler code
58468
Product ID
58468-0127_b646a8df-8c49-495a-be37-c842231a167c
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
DOXERCALCIFEROL
Dosage form
INJECTION, SOLUTION
Route
INTRAVENOUS
Labeler
Genzyme Corporation
Application
NDA021027
Marketing category
NDA
Marketing start
2008-12-08
Marketing end
0000-00-00
Substance
DOXERCALCIFEROL
Active strength
4 ug/2mL
Pharmacologic classes
Ergocalciferols [CS], Vitamin D2 Analog [EPC]
NDC exclude flag
No
Listing certified through
2024-12-31
Current FDA listing
Historical FDA.report record

FDA-Initiated Inactive NDC Indexing#

NDC, Effective, Action table
NDCEffectiveActionDocumentIndexing SPLRelated label
58468-0127-12023-01-06C16284748780-1e4f33bdf-a8cf-d8a0-e053-dadaa90a6e4e7efc3d9c-12f5-43f6-9a22-88d66cbe6f62
58468-0127-12022-07-29C16284748780-1e4f33bdf-a8cf-d8a0-e053-dadaa90a6e4e7efc3d9c-12f5-43f6-9a22-88d66cbe6f62

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
58468-0127-0ML - Milliliter58468-0127ff07c016-2f02-4e21-8562-065c52abf2e612021-05-05
58468-0127-1ML - Milliliter58468-01273c3534f8-ed29-44c9-954d-3d652f2ebfdd12014-07-02

DailyMed Socrata Ingredients#

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
58468-0127HECTOROL (DOXERCALCIFEROL) INJECTION, SOLUTION [GENZYME CORPORATION]15Legacy NDC20230429_7efc3d9c-12f5-43f6-9a22-88d66cbe6f62.zip

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionMarketing startMarketing endSampleExclude flagStatus
58468-0127-15846801270150 VIAL, MULTI-DOSE in 1 BOX (58468-0127-1) > 2 mL in 1 VIAL, MULTI-DOSE (58468-0127-0) 2008-12-080000-00-00NoNoCurrent