FDA.reportPublic FDA data

Dextrose

Product NDC
63323-624
11-digit product format
633230624
Labeler code
63323
Product ID
63323-624_40c07bed-7ccc-4117-a595-78c2a053e8a9
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
Dextrose Monohydrate
Dosage form
INJECTION, SOLUTION
Route
INTRAVENOUS
Labeler
Fresenius Kabi USA, LLC
Application
ANDA207449
Marketing category
ANDA
Marketing start
2016-10-21
Substance
DEXTROSE MONOHYDRATE
Active strength
50 mg/mL
NDC exclude flag
No
Listing certified through
2026-12-31
Current FDA listing
Yes

Additional Listing Data#

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

Active Ingredients#

Ingredient, Strength table
IngredientStrength
DEXTROSE MONOHYDRATE50 mg/mL

Harmonized Identifiers#

Field, Values table
FieldValues
UniiLX22YL083G
Rxcui1795607, 1795609, 1795610, 1795612, 1795616

DailyMed Product Concepts#

Product concept, Relation, Version table
Product conceptRelationVersionEffective
cb89b86a-369e-4204-8910-ae797c503af3Product name120230706
d4880ace-a516-8c47-8dfd-73a4ba5887d7Product name220180830
7cda52fc-125f-421c-8fea-bc1974370c49Product name220180703
0ca1d589-929b-4b33-bc5b-1d84abdafa6aProduct name120150324
fc363c46-397b-4476-ac0f-70e43e8e4592Product name120150324
ed912195-5da0-0f2f-6f4b-3ef17710cbe3Product name120140508

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
63323-624-03Dextrose1000 mL in 1 BAGINJECTION, SOLUTION10007
63323-624-04Dextrose250 mL in 1 BAGINJECTION, SOLUTION2507
63323-624-05Dextrose50 mL in 1 BAGINJECTION, SOLUTION507
63323-624-06Dextrose100 mL in 1 BAGINJECTION, SOLUTION1007
63323-624-07Dextrose500 mL in 1 BAGINJECTION, SOLUTION5007
63323-624-10Dextrose10 in 1 CASEINJECTION, SOLUTION107
63323-624-50Dextrose60 in 1 CASEINJECTION, SOLUTION607
63323-624-61Dextrose50 in 1 CASEINJECTION, SOLUTION507
63323-624-74Dextrose30 in 1 CASEINJECTION, SOLUTION307
63323-624-75Dextrose20 in 1 CASEINJECTION, SOLUTION207

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
63323-624-03ML - Milliliter63323-6244fb0b62e-c170-41e3-8d55-d6686d07255312025-01-14
63323-624-04ML - Milliliter63323-624ba451c15-d000-40d8-9ec2-6db27b773b5112020-08-06
63323-624-05ML - Milliliter63323-62433091252-80e7-492f-ba23-0be7b1d8c39f12019-12-10
63323-624-06ML - Milliliter63323-6243ee3424e-6480-4d76-871b-ab4784f1fbfc12020-08-06
63323-624-07ML - Milliliter63323-624f7722f8f-0f2f-4987-9bfc-d332eb0817a812022-07-06
63323-624-10ML - Milliliter63323-62445426336-b95c-4b96-a8ab-332e39fe707612017-07-07
63323-624-50ML - Milliliter63323-624d4c7bafa-ccd8-4dc3-8a91-bc61ed75c61312019-12-10
63323-624-61ML - Milliliter63323-62473465176-b942-4554-9c19-8b18e365583712017-10-13
63323-624-74ML - Milliliter63323-62431e4494f-ab9f-42cf-aa90-b0c1859aef5112017-05-04
63323-624-75ML - Milliliter63323-624af12bccc-8f36-4e89-8020-20faa4cb4c3412017-05-04

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
63323-624DEXTROSE (DEXTROSE MONOHYDRATE) INJECTION, SOLUTION [FRESENIUS KABI USA, LLC]7Current NDC, Legacy NDC, 10 package rows20240427_f2379398-a07b-417e-a022-f7b41f962067.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
1795609dextrose 5 % in 100 ML InjectionPSNf2379398-a07b-417e-a022-f7b41f9620677
1795612dextrose 5 % in 1000 ML InjectionPSNf2379398-a07b-417e-a022-f7b41f9620677
1795610dextrose 5 % in 250 ML InjectionPSNf2379398-a07b-417e-a022-f7b41f9620677
1795616dextrose 5 % in 50 ML InjectionPSNf2379398-a07b-417e-a022-f7b41f9620677
1795607dextrose 5 % in 500 ML InjectionPSNf2379398-a07b-417e-a022-f7b41f9620677
1795609100 ML glucose 50 MG/ML InjectionSCDf2379398-a07b-417e-a022-f7b41f9620677
17956121000 ML glucose 50 MG/ML InjectionSCDf2379398-a07b-417e-a022-f7b41f9620677
1795610250 ML glucose 50 MG/ML InjectionSCDf2379398-a07b-417e-a022-f7b41f9620677
179561650 ML glucose 50 MG/ML InjectionSCDf2379398-a07b-417e-a022-f7b41f9620677
1795607500 ML glucose 50 MG/ML InjectionSCDf2379398-a07b-417e-a022-f7b41f9620677
1795609dextrose 5 % per 100 ML InjectionSYf2379398-a07b-417e-a022-f7b41f9620677
1795612dextrose 5 % per 1000 ML InjectionSYf2379398-a07b-417e-a022-f7b41f9620677
1795610dextrose 5 % per 250 ML InjectionSYf2379398-a07b-417e-a022-f7b41f9620677
1795616dextrose 5 % per 50 ML InjectionSYf2379398-a07b-417e-a022-f7b41f9620677
1795607dextrose 5 % per 500 ML InjectionSYf2379398-a07b-417e-a022-f7b41f9620677

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
63323-624-03633230624031000 mL in 1 BAG1000 mlHistorical
63323-624-0463323062404250 mL in 1 BAG250 mlHistorical
63323-624-056332306240550 mL in 1 BAG50 mlHistorical
63323-624-0663323062406100 mL in 1 BAG100 mlHistorical
63323-624-0763323062407500 mL in 1 BAG500 mlHistorical
63323-624-106332306241010 BAG in 1 CASE (63323-624-10) / 1000 mL in 1 BAG (63323-624-03) 10 bag2016-10-210000-00-00NoNoCurrent
63323-624-506332306245060 BAG in 1 CASE (63323-624-50) / 50 mL in 1 BAG (63323-624-05) 60 bag2018-07-310000-00-00NoNoCurrent
63323-624-616332306246150 BAG in 1 CASE (63323-624-61) / 100 mL in 1 BAG (63323-624-06) 50 bag2016-10-210000-00-00NoNoCurrent
63323-624-746332306247430 BAG in 1 CASE (63323-624-74) / 250 mL in 1 BAG (63323-624-04) 30 bag2016-10-210000-00-00NoNoCurrent
63323-624-756332306247520 BAG in 1 CASE (63323-624-75) / 500 mL in 1 BAG (63323-624-07) 20 bag2016-10-210000-00-00NoNoCurrent