FDA.reportPublic FDA data

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

Additional Listing Data#

Finished product
Yes
Brand name base
Doxercalciferol
Listing expiration
2026-12-31

Active Ingredients#

Ingredient, Strength table
IngredientStrength
DOXERCALCIFEROL4 ug/2mL

Harmonized Identifiers#

Field, Values table
FieldValues
Unii3DIZ9LF5Y9
Rxcui282609, 1790219

DailyMed Product Concepts#

Product concept, Relation, Version table
Product conceptRelationVersionEffective
726062af-1135-4707-a1d7-57256991bbf9Product name220250226
6d09ee63-cbd8-4742-9f11-2e20c9f8cd54Product name720240722
de957a3a-b26a-1797-ad5b-e5b01f363505Product name320210511
19c71a3d-ed9c-166b-a7e5-38c250c35631Product name120140508

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
68083-300-01Doxercalciferol2 mL in 1 VIAL, SINGLE-DOSEINJECTION, SOLUTION26
68083-300-50Doxercalciferol50 in 1 CARTONINJECTION, SOLUTION506

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
68083-300DOXERCALCIFEROL INJECTION, SOLUTION [GLAND PHARMA LIMITED]6Current NDC, 2 package rows20241107_f0d79a1b-c7fb-4521-941a-5d6c2fd50170.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
282609doxercalciferol 2 MCG/ML Injectable SolutionPSNf0d79a1b-c7fb-4521-941a-5d6c2fd501706
1790219doxercalciferol 4 MCG in 2 ML InjectionPSNf0d79a1b-c7fb-4521-941a-5d6c2fd501706
17902192 ML doxercalciferol 0.002 MG/ML InjectionSCDf0d79a1b-c7fb-4521-941a-5d6c2fd501706
282609doxercalciferol 0.002 MG/ML Injectable SolutionSCDf0d79a1b-c7fb-4521-941a-5d6c2fd501706
282609doxercalciferol 2 MCG/ML Injectable SolutionSYf0d79a1b-c7fb-4521-941a-5d6c2fd501706
1790219doxercalciferol 4 MCG per 2 ML InjectionSYf0d79a1b-c7fb-4521-941a-5d6c2fd501706

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startSampleExclude flagStatus
68083-300-01680830300012 mL in 1 VIAL, SINGLE-DOSE2 mlHistorical
68083-300-506808303005050 VIAL, SINGLE-DOSE in 1 CARTON (68083-300-50) / 2 mL in 1 VIAL, SINGLE-DOSE (68083-300-01) 2019-09-26NoNoCurrent