Doxercalciferol

Product NDC
68083-300
11-digit product format
680830300
Labeler code
68083
Product ID
68083-300_db27a30b-8264-4248-b83e-b6ba0feafbf0
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
Doxercalciferol
Dosage form
INJECTION, SOLUTION
Route
INTRAVENOUS
Labeler
Gland Pharma Limited
Application
ANDA210452
Marketing category
ANDA
Marketing start
2019-09-26
Substance
DOXERCALCIFEROL
Active strength
4 ug/2mL
Pharmacologic classes
Ergocalciferols [CS], Vitamin D2 Analog [EPC]
NDC exclude flag
No
Listing certified through
2026-12-31
Current FDA listing
Yes

Related Records

Related UNII Ingredients

UNIIPreferred termRegistry numberMatched term
3DIZ9LF5Y9DOXERCALCIFEROL54573-75-0DOXERCALCIFEROL

Packages

Package NDC11-digit formatDescriptionMarketing startSampleExclude flagStatus
68083-300-506808303005050 VIAL, SINGLE-DOSE in 1 CARTON (68083-300-50) / 2 mL in 1 VIAL, SINGLE-DOSE (68083-300-01) 2019-09-26NoNoHistorical

Related DailyMed Labels

TitleManufacturerEffective dateTypeVersion
DoxercalciferolGland Pharma Limited2024-11-06Human Prescription Drug Label6