FDA.reportPublic FDA data

Dextrose Monohydrate

Product NDC
76329-3302
11-digit product format
763293302
Labeler code
76329
Product ID
76329-3302_45b366a9-6c0c-4643-9951-4ff880b29c83
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
Dextrose Monohydrate
Dosage form
INJECTION, SOLUTION
Route
INTRAVENOUS
Labeler
International Medication Systems, Limited
Application
ANDA203451
Marketing category
ANDA
Marketing start
2021-11-11
Substance
DEXTROSE MONOHYDRATE
Active strength
25 g/50mL
NDC exclude flag
No
Listing certified through
2026-12-31
Current FDA listing
Yes

Additional Listing Data#

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

Active Ingredients#

Ingredient, Strength table
IngredientStrength
DEXTROSE MONOHYDRATE25 g/50mL

Harmonized Identifiers#

Field, Values table
FieldValues
UniiLX22YL083G
Rxcui727517

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

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
76329-3302-1Dextrose Monohydrate1 in 1 CARTONINJECTION, SOLUTION15
76329-3302-1Dextrose Monohydrate50 mL in 1 SYRINGEINJECTION, SOLUTION505

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
76329-3302DEXTROSE MONOHYDRATE (DEXTROSE MONOHYDRATE) INJECTION, SOLUTION [INTERNATIONAL MEDICATION SYSTEMS, LIMITED ]5Current NDC, Legacy NDC, 2 package rows20221221_fcc7ac79-cd70-4f03-a4de-f051f9ca1f7d.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
727517dextrose 50 % in 50 ML Prefilled SyringePSNfcc7ac79-cd70-4f03-a4de-f051f9ca1f7d5
72751750 ML glucose 500 MG/ML Prefilled SyringeSCDfcc7ac79-cd70-4f03-a4de-f051f9ca1f7d5
72751750 ML dextrose 50 % Prefilled SyringeSYfcc7ac79-cd70-4f03-a4de-f051f9ca1f7d5
727517dextrose 25 GM per 50 ML Prefilled SyringeSYfcc7ac79-cd70-4f03-a4de-f051f9ca1f7d5
727517dextrose 50 % in 50 ML Prefilled SyringePSNd7c4f9eb-9b89-c5a3-e053-2a95a90a28a24
72751750 ML glucose 500 MG/ML Prefilled SyringeSCDd7c4f9eb-9b89-c5a3-e053-2a95a90a28a24
72751750 ML dextrose 50 % Prefilled SyringeSYd7c4f9eb-9b89-c5a3-e053-2a95a90a28a24
727517dextrose 25 GM per 50 ML Prefilled SyringeSYd7c4f9eb-9b89-c5a3-e053-2a95a90a28a24
727517dextrose 50 % in 50 ML Prefilled SyringePSNdc6664a6-1be1-676c-e053-2995a90a34902
72751750 ML glucose 500 MG/ML Prefilled SyringeSCDdc6664a6-1be1-676c-e053-2995a90a34902
72751750 ML dextrose 50 % Prefilled SyringeSYdc6664a6-1be1-676c-e053-2995a90a34902
727517dextrose 25 GM per 50 ML Prefilled SyringeSYdc6664a6-1be1-676c-e053-2995a90a34902

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
76329-3302-1763293302011 SYRINGE in 1 CARTON (76329-3302-1) / 50 mL in 1 SYRINGE1 syringe2021-11-110000-00-00NoNoCurrent