FDA.reportPublic FDA data

Dextrose

Product NDC
65219-238
11-digit product format
652190238
Labeler code
65219
Product ID
65219-238_39549d47-5040-4b1f-8b46-f0dd95832e1e
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
12500 mg/250mL
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 MONOHYDRATE12500 mg/250mL

Harmonized Identifiers#

Field, Values table
FieldValues
UniiLX22YL083G
Rxcui1795607, 1795609, 1795610, 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
65219-238-01Dextrose250 mL in 1 BAGINJECTION, SOLUTION2506
65219-238-25Dextrose30 in 1 CASEINJECTION, SOLUTION306

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
65219-238-01ML - Milliliter65219-238ef44aef1-82f4-4a66-9fa7-51437193bc7a12022-08-04
65219-238-25ML - Milliliter65219-238cfda71bb-daea-47e8-a8d6-910d789157be12022-08-04

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
65219-238DEXTROSE (DEXTROSE MONOHYDRATE) INJECTION, SOLUTION [FRESENIUS KABI USA, LLC]5Current NDC, Legacy NDC, 2 package rows20240524_bd250a46-d229-4e80-b5a1-b34169ccecc4.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
1795609dextrose 5 % in 100 ML InjectionPSNbd250a46-d229-4e80-b5a1-b34169ccecc46
1795610dextrose 5 % in 250 ML InjectionPSNbd250a46-d229-4e80-b5a1-b34169ccecc46
1795616dextrose 5 % in 50 ML InjectionPSNbd250a46-d229-4e80-b5a1-b34169ccecc46
1795607dextrose 5 % in 500 ML InjectionPSNbd250a46-d229-4e80-b5a1-b34169ccecc46
1795609100 ML glucose 50 MG/ML InjectionSCDbd250a46-d229-4e80-b5a1-b34169ccecc46
1795610250 ML glucose 50 MG/ML InjectionSCDbd250a46-d229-4e80-b5a1-b34169ccecc46
179561650 ML glucose 50 MG/ML InjectionSCDbd250a46-d229-4e80-b5a1-b34169ccecc46
1795607500 ML glucose 50 MG/ML InjectionSCDbd250a46-d229-4e80-b5a1-b34169ccecc46
1795609dextrose 5 % per 100 ML InjectionSYbd250a46-d229-4e80-b5a1-b34169ccecc46
1795610dextrose 5 % per 250 ML InjectionSYbd250a46-d229-4e80-b5a1-b34169ccecc46
1795616dextrose 5 % per 50 ML InjectionSYbd250a46-d229-4e80-b5a1-b34169ccecc46
1795607dextrose 5 % per 500 ML InjectionSYbd250a46-d229-4e80-b5a1-b34169ccecc46

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
65219-238-0165219023801250 mL in 1 BAG250 mlHistorical
65219-238-256521902382530 BAG in 1 CASE (65219-238-25) / 250 mL in 1 BAG (65219-238-01) 30 bag2021-11-100000-00-00NoNoCurrent