DOXERCALCIFEROL

Product NDC
43598-850
11-digit product format
435980850
Labeler code
43598
Product ID
43598-850_7eef9f4d-4266-ea15-9f02-978034760eb7
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
DOXERCALCIFEROL
Dosage form
INJECTION
Route
INTRAVENOUS
Labeler
Dr.Reddy's Laboratories Inc
Application
ANDA210452
Marketing category
ANDA
Marketing start
2019-11-13
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

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
43598-850-11DOXERCALCIFEROL2 mL in 1 VIAL, MULTI-DOSEINJECTION24
43598-850-50DOXERCALCIFEROL50 in 1 CARTONINJECTION504

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
43598-850-11ML - Milliliter43598-8502c047f94-52cc-4a19-874a-44044b4ecff112019-12-10
43598-850-50ML - Milliliter43598-850abcde815-a93a-49b6-959e-c3f17ff912e012019-12-10

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
43598-850DOXERCALCIFEROL INJECTION [DR.REDDY'S LABORATORIES INC]4Current NDC, Legacy NDC, 2 package rows20241222_f472b60a-e6f5-1a87-3eff-539d6287d285.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
282609doxercalciferol 2 MCG/ML Injectable SolutionPSNf472b60a-e6f5-1a87-3eff-539d6287d2854
282609doxercalciferol 0.002 MG/ML Injectable SolutionSCDf472b60a-e6f5-1a87-3eff-539d6287d2854
282609doxercalciferol 2 MCG/ML Injectable SolutionSYf472b60a-e6f5-1a87-3eff-539d6287d2854

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
43598-850-11435980850112 mL in 1 VIAL, MULTI-DOSE2 mlHistorical
43598-850-504359808505050 VIAL, MULTI-DOSE in 1 CARTON (43598-850-50) / 2 mL in 1 VIAL, MULTI-DOSE (43598-850-11) 2019-11-130000-00-00NoNoCurrent