FDA.reportPublic FDA data

NDC 68083-359-01 - Doxercalciferol

This NDC is not currently matched to an FDA NDC product listing in FDA.report, but it is a valid NDC-form code. FDA.report is showing the available DailyMed label context for the product root.

Product NDC
68083-359
Requested NDC
68083-359-01
Package NDCs from labels
68083-359-01, 68083-359-50
Manufacturer
Gland Pharma Limited
Effective date
2024-11-06
Current FDA listing
Not matched in FDA.report NDC product tables

DailyMed Labels#

Label, Manufacturer, Effective date table
LabelManufacturerEffective dateType
Doxercalciferol - Gland Pharma LimitedGland Pharma Limited2024-11-06Human Prescription Drug Label

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
68083-359-01Doxercalciferol2 mL in 1 VIAL, MULTI-DOSEINJECTION, SOLUTION26
68083-359-50Doxercalciferol50 in 1 CARTONINJECTION, SOLUTION506

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
68083-359DOXERCALCIFEROL INJECTION, SOLUTION [GLAND PHARMA LIMITED]6Current NDC, 2 package rows20241107_f0d79a1b-c7fb-4521-941a-5d6c2fd50170.zip

openFDA label cross-check#

OpenFDA label data provides additional search and identifier links. DailyMed’s Structured Product Label is the canonical label on FDA.report. Matching records are deduplicated before they are shown below.

Matched openFDA labels page 137 of 186 · 3,705 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
DoveMOISTURIZING HAND SANITIZER WIPES SHEA BUTTER AND WARM VANILLA SCENTConopco Inc. d/b/a/ Unileverdebc5983-e8bc-c6d5-e053-2995a90af7742024-11-07WarningsExact identifier
unii: 3K9958V90M
Baby Dove8H MOISTURIZATION HAND SANITIZER FRAGRANCE FREEConopco Inc. d/b/a/ Unileverdf734b51-33ae-d6b7-e053-2995a90a08cc2024-11-07WarningsExact identifier
unii: 3K9958V90M
DoveHAND SANITIZER WIPES SHEA BUTTER AND WARM VANILLA SCENTConopco Inc. d/b/a/ Unileverdf73e518-caec-a73b-e053-2995a90a69f52024-11-07WarningsExact identifier
unii: 3K9958V90M
DoveHAND SANITIZER DEEP MOISTUREConopco Inc. d/b/a/ Unileverddca7c55-0a7e-cea6-e053-2995a90ace5a2024-11-07WarningsExact identifier
unii: 3K9958V90M
DoveHAND SANITIZER SHEA BUTTERConopco Inc. d/b/a/ Unileverddcad36b-1909-3bbb-e053-2995a90a295a2024-11-07WarningsExact identifier
unii: 3K9958V90M
DoveNOURISHING HAND SANITIZER SENSITIVE SKIN 8HR MOISTURIZATIONConopco Inc. d/b/a/ Unileverddcbab1c-7af9-2656-e053-2995a90ad07a2024-11-07WarningsExact identifier
unii: 3K9958V90M
DoveHAND SANITIZER WIPES ALOE AND EUCALYPTUS SCENTConopco Inc. d/b/a/ Unileverdf74d901-c86c-ed71-e053-2995a90a39c22024-11-07WarningsExact identifier
unii: 3K9958V90M
Dextrose and Sodium ChlorideDEXTROSE MONOHYDRATE AND SODIUM CHLORIDEBECTON DICKINSON AND COMPANYd3f90d2f-4536-4d32-800b-7a798f8a35db2024-11-07Warnings, Adverse reactionsExact identifier
unii: 451W47IQ8X
B-Pure Moisturizing Hand Sanitizer Ocean Breeze Scented with Hyaluronic AcidALCOHOLFOURSTAR GROUP USA, INC.ca9e9713-eae0-44aa-90df-09160f3812b52024-11-06WarningsExact identifier
unii: 3K9958V90M
Hand SanitizerALCOHOLZhejiang Ayan Biotech Co.,Ltd.aec30cdb-6e95-4790-9c47-93202cc17dab2024-11-06WarningsExact identifier
unii: 3K9958V90M
EUCALYPTUS EASE HAND SANITIZERALCOHOLORGANIC & SUSTAINABLE BEAUTY09d77591-9472-4771-9090-3390bddf788a2024-11-06WarningsExact identifier
unii: 3K9958V90M
Sodium ChlorideSODIUM CHLORIDEHospira, Inc.8eb172da-dcd4-4660-4a8f-ad44a14b4af72024-11-06Adverse reactionsExact identifier
unii: 451W47IQ8X
LEMON MYRTLE HAND SANITIZERALCOHOLORGANIC & SUSTAINABLE BEAUTYf341b24c-9466-42f4-98fe-d1a1225919152024-11-06WarningsExact identifier
unii: 3K9958V90M
DoxercalciferolDOXERCALCIFEROLGland Pharma Limitedf0d79a1b-c7fb-4521-941a-5d6c2fd501702024-11-06Warnings, Adverse reactionsExact identifier
application number: ANDA210452
ndc (package): 68083-359-50
ndc (package): 68083-359-01
ndc (package): 68083-300-50
ndc (package): 68083-300-01
ndc (product): 68083-359
ndc (product): 68083-300
ndc11 (package): 68083035901
rxcui: 1790219
rxcui: 282609
spl id: db27a30b-8264-4248-b83e-b6ba0feafbf0
spl set id: f0d79a1b-c7fb-4521-941a-5d6c2fd50170
unii: 3DIZ9LF5Y9
B-Pure Moisturizing Hand Sanitizer Passion Fruit Scented with CollagenALCOHOLFOURSTAR GROUP USA, INC.3523d797-8b5a-4c4c-838c-f743391c8a0d2024-11-05WarningsExact identifier
unii: 3K9958V90M
Licefreee EverydaySODIUM CHLORIDETec Laboratories,Inc.407b5fd6-2331-2ba7-e054-00144ff88e882024-11-05WarningsExact identifier
unii: 451W47IQ8X
LicefreeeHEAD LICE TREATMENTTec Laboratories, Inc.08c9d3dd-7177-0148-e054-00144ff8d46c2024-11-05WarningsExact identifier
unii: 451W47IQ8X
CALMING HAND SANITIZERALCOHOLORGANIC & SUSTAINABLE BEAUTYffcbe34d-3c53-47f9-9e4a-b5448afbbd5d2024-11-05WarningsExact identifier
unii: 3K9958V90M
Bladder ReliefCAUSTICUM, NATRUM MURIATICUM, NUX VOMICA, PULSATILLA (VULGARIS), SEPIA, STAPHYSAGRIA, THUJA OCCIDENTALISMagni Company5d0db70c-6360-493b-bcf2-8dbc953141402024-11-05WarningsExact identifier
unii: 451W47IQ8X
HealthWise Advanced Hand SanitizerETHYL ALCOHOL 70%Veridian Healthcare261bd056-c2f9-2a69-e063-6394a90af8df2024-11-04WarningsExact identifier
unii: 3K9958V90M

Reported adverse events (FAERS/openFDA)#

Adverse event summaries are temporarily unavailable. Other product information remains available.