Dextrose monohydrate

Product NDC
51662-1584
11-digit product format
516621584
Labeler code
51662
Product ID
51662-1584_11ff2610-3e97-79d1-e063-6294a90a6412
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
Dextrose monohydrate
Dosage form
INJECTION, SOLUTION
Route
INTRAVENOUS
Labeler
HF Acquisition Co LLC, DBA HealthFirst
Application
ANDA203451
Marketing category
ANDA
Marketing start
2022-02-11
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
51662-1584-1Dextrose monohydrate50 mL in 1 SYRINGEINJECTION, SOLUTION504
51662-1584-1Dextrose monohydrate1 in 1 CARTONINJECTION, SOLUTION14
51662-1584-2Dextrose monohydrate50 mL in 1 SYRINGEINJECTION, SOLUTION504
51662-1584-2Dextrose monohydrate1 in 1 POUCHINJECTION, SOLUTION14
51662-1584-3Dextrose monohydrate10 in 1 CASEINJECTION, SOLUTION104

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
51662-1584DEXTROSE MONOHYDRATE INJECTION, SOLUTION [HF ACQUISITION CO LLC, DBA HEALTHFIRST]4Current NDC, Legacy NDC, 5 package rows20240224_d7c4f9eb-9b89-c5a3-e053-2a95a90a28a2.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
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

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
51662-1584-1516621584011 SYRINGE in 1 CARTON (51662-1584-1) / 50 mL in 1 SYRINGE1 syringe2022-02-110000-00-00NoNoCurrent
51662-1584-25166215840250 mL in 1 SYRINGE50 mlHistorical
51662-1584-35166215840310 POUCH in 1 CASE (51662-1584-3) / 1 SYRINGE in 1 POUCH (51662-1584-2) / 50 mL in 1 SYRINGE10 pouch2022-02-11NoNoCurrent