FDA.reportPublic FDA data

Dextrose

Product NDC
0409-7517
11-digit product format
004097517
Labeler code
0409
Product ID
0409-7517_2f05a8f1-4651-405c-a66b-8e96a46c1db8
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
DEXTROSE MONOHYDRATE
Dosage form
INJECTION, SOLUTION
Route
INTRAVENOUS
Labeler
Hospira, Inc.
Application
NDA019445
Marketing category
NDA
Marketing start
2005-12-02
Substance
DEXTROSE MONOHYDRATE
Active strength
25 g/50mL
NDC exclude flag
No
Listing certified through
2027-12-31
Current FDA listing
Yes

Additional Listing Data#

Finished product
Yes
Brand name base
Dextrose
Listing expiration
2027-12-31

Active Ingredients#

Ingredient, Strength table
IngredientStrength
DEXTROSE MONOHYDRATE25 g/50mL

Harmonized Identifiers#

Field, Values table
FieldValues
UniiLX22YL083G
Rxcui727517, 1795514

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

FDA-Initiated Inactive NDC Indexing#

NDC, Effective, Action table
NDCEffectiveActionDocumentIndexing SPLRelated label
0409-7517-162021-09-27C16284748780-1c7ccaba7-1b69-fd44-e053-dadaa90aa01bThese highlights do not include all the information needed to use DEXTROSE INJECTION (50%) safely and effectively. See full prescribing information for DEXTROSE INJECTION (50%). DEXTROSE injection, for intravenous use Initial U.S. Approval: 1940
0409-7517-162021-09-27C16284748780-1c7ccaba7-1b69-fd44-e053-dadaa90aa01bThese highlights do not include all the information needed to use DEXTROSE INJECTION (50%) safely and effectively. See full prescribing information for DEXTROSE INJECTION (50%). DEXTROSE injection, for intravenous use Initial U.S. Approval: 1940
0409-7517-162021-07-23C16284748780-1c7ccaba7-1b69-fd44-e053-dadaa90aa01bThese highlights do not include all the information needed to use DEXTROSE INJECTION (50%) safely and effectively. See full prescribing information for DEXTROSE INJECTION (50%). DEXTROSE injection, for intravenous use Initial U.S. Approval: 1940
0409-7517-162021-07-23C16284748780-1c7ccaba7-1b69-fd44-e053-dadaa90aa01bThese highlights do not include all the information needed to use DEXTROSE INJECTION (50%) safely and effectively. See full prescribing information for DEXTROSE INJECTION (50%). DEXTROSE injection, for intravenous use Initial U.S. Approval: 1940

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
0409-7517-16Dextrose10 in 1 CONTAINERINJECTION, SOLUTION1032
0409-7517-16Dextrose1 in 1 CARTONINJECTION, SOLUTION132
0409-7517-66Dextrose50 mL in 1 SYRINGE, PLASTICINJECTION, SOLUTION5032

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
0409-7517-16ML - Milliliter0409-7517d2eecd39-de62-480a-a667-c285d8449bff12012-07-24

DailyMed Socrata Ingredients#

Ingredient, Type, UNII table
IngredientTypeUNIIDailyMed labelSPL versionUploaded
DEXTROSE MONOHYDRATEACTIVE INGREDIENTLX22YL083GDEXTROSE (DEXTROSE MONOHYDRATE) INJECTION, SOLUTION [HOSPIRA, INC.]13
ANHYDROUS DEXTROSEACTIVE MOIETY5SL0G7R0OKDEXTROSE (DEXTROSE MONOHYDRATE) INJECTION, SOLUTION [HOSPIRA, INC.]13
HYDROCHLORIC ACIDINACTIVE INGREDIENTQTT17582CBDEXTROSE (DEXTROSE MONOHYDRATE) INJECTION, SOLUTION [HOSPIRA, INC.]13
SODIUM HYDROXIDEINACTIVE INGREDIENT55X04QC32IDEXTROSE (DEXTROSE MONOHYDRATE) INJECTION, SOLUTION [HOSPIRA, INC.]13
WATERINACTIVE INGREDIENT059QF0KO0RDEXTROSE (DEXTROSE MONOHYDRATE) INJECTION, SOLUTION [HOSPIRA, INC.]13

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
0409-7517DEXTROSE (DEXTROSE MONOHYDRATE) INJECTION, SOLUTION [HOSPIRA, INC.]28Current NDC, Legacy NDC, 3 package rows20250417_4ed365da-4e62-4329-c1b9-c197ab4fb6e1.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
1795514dextrose 50 % in 50 ML InjectionPSN4ed365da-4e62-4329-c1b9-c197ab4fb6e132
727517dextrose 50 % in 50 ML Prefilled SyringePSN4ed365da-4e62-4329-c1b9-c197ab4fb6e132
179551450 ML glucose 500 MG/ML InjectionSCD4ed365da-4e62-4329-c1b9-c197ab4fb6e132
72751750 ML glucose 500 MG/ML Prefilled SyringeSCD4ed365da-4e62-4329-c1b9-c197ab4fb6e132
72751750 ML dextrose 50 % Prefilled SyringeSY4ed365da-4e62-4329-c1b9-c197ab4fb6e132
727517dextrose 25 GM per 50 ML Prefilled SyringeSY4ed365da-4e62-4329-c1b9-c197ab4fb6e132
1795514dextrose 50 % per 50 ML InjectionSY4ed365da-4e62-4329-c1b9-c197ab4fb6e132
727517dextrose 50 % in 50 ML Prefilled SyringePSN8027a2bf-3019-428a-8a23-621898b5a7a315
72751750 ML glucose 500 MG/ML Prefilled SyringeSCD8027a2bf-3019-428a-8a23-621898b5a7a315
72751750 ML dextrose 50 % Prefilled SyringeSY8027a2bf-3019-428a-8a23-621898b5a7a315
727517dextrose 25 GM per 50 ML Prefilled SyringeSY8027a2bf-3019-428a-8a23-621898b5a7a315
727517dextrose 50 % in 50 ML Prefilled SyringePSN8cf6943f-16e8-4521-863c-09bb0b55e2a96
72751750 ML glucose 500 MG/ML Prefilled SyringeSCD8cf6943f-16e8-4521-863c-09bb0b55e2a96
72751750 ML dextrose 50 % Prefilled SyringeSY8cf6943f-16e8-4521-863c-09bb0b55e2a96
727517dextrose 25 GM per 50 ML Prefilled SyringeSY8cf6943f-16e8-4521-863c-09bb0b55e2a96
727517dextrose 50 % in 50 ML Prefilled SyringePSN763b1cb8-1151-5f59-e053-2991aa0a4e015
72751750 ML glucose 500 MG/ML Prefilled SyringeSCD763b1cb8-1151-5f59-e053-2991aa0a4e015
72751750 ML dextrose 50 % Prefilled SyringeSY763b1cb8-1151-5f59-e053-2991aa0a4e015
727517dextrose 25 GM per 50 ML Prefilled SyringeSY763b1cb8-1151-5f59-e053-2991aa0a4e015
727517dextrose 50 % in 50 ML Prefilled SyringePSNb8b77421-d687-45aa-82f6-d49bce644c104
72751750 ML glucose 500 MG/ML Prefilled SyringeSCDb8b77421-d687-45aa-82f6-d49bce644c104
72751750 ML dextrose 50 % Prefilled SyringeSYb8b77421-d687-45aa-82f6-d49bce644c104
727517dextrose 25 GM per 50 ML Prefilled SyringeSYb8b77421-d687-45aa-82f6-d49bce644c104
727517dextrose 50 % in 50 ML Prefilled SyringePSN66713d9c-f404-4ec8-e053-2a91aa0a620a3
72751750 ML glucose 500 MG/ML Prefilled SyringeSCD66713d9c-f404-4ec8-e053-2a91aa0a620a3
72751750 ML dextrose 50 % Prefilled SyringeSY66713d9c-f404-4ec8-e053-2a91aa0a620a3
727517dextrose 25 GM per 50 ML Prefilled SyringeSY66713d9c-f404-4ec8-e053-2a91aa0a620a3
727517dextrose 50 % in 50 ML Prefilled SyringePSN3842a9c0-8b15-1c94-e063-6394a90ae1202
72751750 ML glucose 500 MG/ML Prefilled SyringeSCD3842a9c0-8b15-1c94-e063-6394a90ae1202
72751750 ML dextrose 50 % Prefilled SyringeSY3842a9c0-8b15-1c94-e063-6394a90ae1202
727517dextrose 25 GM per 50 ML Prefilled SyringeSY3842a9c0-8b15-1c94-e063-6394a90ae1202

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
0409-7517-160040975171610 CARTON in 1 CONTAINER (0409-7517-16) / 1 SYRINGE, PLASTIC in 1 CARTON / 50 mL in 1 SYRINGE, PLASTIC (0409-7517-66) 10 carton2005-12-020000-00-00NoNoCurrent
0409-7517-660040975176650 mL in 1 SYRINGE, PLASTIC50 mlHistorical