Doxercalciferol

Product NDC
0641-6154
11-digit product format
006416154
Labeler code
0641
Product ID
0641-6154_1de15826-5859-4ea1-a0c0-c26ff3698861
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
Doxercalciferol
Dosage form
INJECTION
Route
INTRAVENOUS
Labeler
Hikma Pharmaceuticals USA Inc.
Application
ANDA091101
Marketing category
ANDA
Marketing start
2013-08-30
Marketing end
0000-00-00
Substance
DOXERCALCIFEROL
Active strength
2 ug/mL
Pharmacologic classes
Ergocalciferols [CS],Vitamin D2 Analog [EPC]
NDC exclude flag
No
Listing certified through
2020-12-31
Current FDA listing
Historical FDA.report record

FDA-Initiated Inactive NDC Indexing#

NDC, Effective, Action table
NDCEffectiveActionDocumentIndexing SPLRelated label
0641-6154-252025-01-30C16284748780-12cef2736-af7b-d83d-e063-dadaa90ab31fe99a1d29-3989-4437-999e-4e9cab8b9b1e

DailyMed Socrata Ingredients#

Ingredient, Type, UNII table
IngredientTypeUNIIDailyMed labelSPL versionUploaded
DOXERCALCIFEROLACTIVE INGREDIENT3DIZ9LF5Y9DOXERCALCIFEROL INJECTION [WEST-WARD PHARMACEUTICAL CORP.]3
DOXERCALCIFEROLACTIVE MOIETY3DIZ9LF5Y9DOXERCALCIFEROL INJECTION [WEST-WARD PHARMACEUTICAL CORP.]3
EDETATE DISODIUMINACTIVE INGREDIENT7FLD91C86KDOXERCALCIFEROL INJECTION [WEST-WARD PHARMACEUTICAL CORP.]3
POLYSORBATE 20INACTIVE INGREDIENT7T1F30V5YHDOXERCALCIFEROL INJECTION [WEST-WARD PHARMACEUTICAL CORP.]3
SODIUM ASCORBATEINACTIVE INGREDIENTS033EH8359DOXERCALCIFEROL INJECTION [WEST-WARD PHARMACEUTICAL CORP.]3
SODIUM CHLORIDEINACTIVE INGREDIENT451W47IQ8XDOXERCALCIFEROL INJECTION [WEST-WARD PHARMACEUTICAL CORP.]3
SODIUM PHOSPHATE, DIBASIC, ANHYDROUSINACTIVE INGREDIENT22ADO53M6FDOXERCALCIFEROL INJECTION [WEST-WARD PHARMACEUTICAL CORP.]3
SODIUM PHOSPHATE, MONOBASICINACTIVE INGREDIENT3980JIH2SWDOXERCALCIFEROL INJECTION [WEST-WARD PHARMACEUTICAL CORP.]3
WATERINACTIVE INGREDIENT059QF0KO0RDOXERCALCIFEROL INJECTION [WEST-WARD PHARMACEUTICAL CORP.]3

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
0641-6154DOXERCALCIFEROL INJECTION [HIKMA PHARMACEUTICALS USA INC.]6Legacy NDC20191231_e99a1d29-3989-4437-999e-4e9cab8b9b1e.zip

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
0641-6154-250064161542525 AMPULE in 1 BOX (0641-6154-25) > 2 mL in 1 AMPULE (0641-6154-01) 25 ampule2013-08-300000-00-00NoNoCurrent