FDA.reportPublic FDA data

DEXTROSE MONOHYDRATE

Product NDC
51662-1453
11-digit product format
516621453
Labeler code
51662
Product ID
51662-1453_ef7c1a32-f72c-3c5a-e053-2995a90abd43
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
DEXTROSE MONOHYDRATE
Dosage form
INJECTION, SOLUTION
Route
INTRAVENOUS
Labeler
HF Acquisition Co LLC, DBA HealthFirst
Marketing category
UNAPPROVED DRUG OTHER
Marketing start
2020-01-11
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 UNII identifiers#

UNII identifiers page 1 of 1 · 1 matching rows.

Identifier, FDA.report destination table
IdentifierFDA.report destination
LX22YL083GInternal UNII lookup

Harmonized RxCUI identifiers#

RxCUI identifiers page 1 of 1 · 1 matching rows.

Identifier, FDA.report destination table
IdentifierFDA.report destination
727517Internal RxNorm lookup

Harmonized SPL set identifiers#

SPL set identifiers page 1 of 1 · 1 matching rows.

Identifier, FDA.report destination table
IdentifierFDA.report destination
9bd8168d-ab8f-4d70-e053-2995a90ac23cAvailable on FDA.report

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
51662-1453-1DEXTROSE MONOHYDRATE50 mL in 1 SYRINGEINJECTION, SOLUTION503
51662-1453-1DEXTROSE MONOHYDRATE1 in 1 CARTONINJECTION, SOLUTION13

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
51662-1453DEXTROSE MONOHYDRATE INJECTION, SOLUTION [HF ACQUISITION CO LLC, DBA HEALTHFIRST]3Current NDC, Legacy NDC, 2 package rows20221211_9bd8168d-ab8f-4d70-e053-2995a90ac23c.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 1 of 1 · 1 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
DEXTROSE MONOHYDRATEDEXTROSE MONOHYDRATEHF Acquisition Co LLC, DBA HealthFirst9bd8168d-ab8f-4d70-e053-2995a90ac23c2022-12-10Warnings, Adverse reactionsExact identifier
ndc (product): 51662-1453

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
727517dextrose 50 % in 50 ML Prefilled SyringePSN9bd8168d-ab8f-4d70-e053-2995a90ac23c3
72751750 ML glucose 500 MG/ML Prefilled SyringeSCD9bd8168d-ab8f-4d70-e053-2995a90ac23c3
72751750 ML dextrose 50 % Prefilled SyringeSY9bd8168d-ab8f-4d70-e053-2995a90ac23c3
727517dextrose 25 GM per 50 ML Prefilled SyringeSY9bd8168d-ab8f-4d70-e053-2995a90ac23c3

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
51662-1453-1516621453011 SYRINGE in 1 CARTON (51662-1453-1) / 50 mL in 1 SYRINGE1 syringe2020-01-110000-00-00NoNoCurrent