FDA.reportPublic FDA data

Dextrose

Product NDC
0409-4902
11-digit product format
004094902
Labeler code
0409
Product ID
0409-4902_2e27332e-01ed-4c16-8527-994199796ec0
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
DEXTROSE MONOHYDRATE
Dosage form
INJECTION, SOLUTION
Route
INTRAVENOUS
Labeler
Hospira, Inc.
Marketing category
UNAPPROVED DRUG OTHER
Marketing start
2005-12-07
Marketing end
0000-00-00
Substance
DEXTROSE MONOHYDRATE
Active strength
25 g/50mL
NDC exclude flag
No
Listing certified through
2022-12-31
Current FDA listing
Historical FDA.report record

NDC auxiliary status#

These records are reproduced from FDA’s unfinished, excluded, and compounder listings. They describe what appeared in the source files; a missing record does not establish a regulatory status. View all current auxiliary records, including entries without an NDC. · View the auxiliary file history.

Current NDC status page 1 of 1 · 2 matching rows.

Dataset, Scope, Product NDC table
DatasetScopeProduct NDCPackage NDCCodeStatusReporting periodSource date
excluded productproduct0409-4902DDiscontinued by firm2026-10-05
excluded packagepackage0409-49020409-4902-34DDiscontinued by firm2026-10-05

Observed NDC auxiliary status history#

This history shows the information present in each captured FDA auxiliary file. It is not a continuous regulatory timeline, and a missing record does not establish a status.

Historic NDC status page 1 of 1 · 2 matching rows.

View current auxiliary records. · View the auxiliary file history.

Captured / source date, Dataset, Scope table
Captured / source dateDatasetScopeProduct NDCPackage NDCCodeStatusReporting periodArchiveSnapshotSource SHA-256
2025-12-14 17:58 UTC · source 2025-12-05excluded productproduct0409-4902DDiscontinued by firmexcluded / ndc_excluded.zipd630ba8d3edf…732f749b63fb…
2025-12-14 17:58 UTC · source 2025-12-05excluded packagepackage0409-49020409-4902-34DDiscontinued by firmexcluded / ndc_excluded.zipd630ba8d3edf…732f749b63fb…

Reported adverse events (FAERS/openFDA)#

Adverse event summaries are temporarily unavailable. Other product information remains available.

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#

Effective, Related label table
EffectiveRelated label
2021-09-27These 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
2021-09-27These 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
2021-09-27These 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
2021-09-27These 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
2021-07-23These 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
2021-07-23These 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
2021-07-23These 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
2021-07-23These 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 Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
0409-4902-34ML - Milliliter0409-4902b511e3b8-5d0e-47c4-9ea1-e72f55c2e44112012-07-24

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
Dextrose MonohydrateACTIVE INGREDIENTLX22YL083GDEXTROSE INJECTION, SOLUTION [GENERAL INJECTABLES & VACCINES, INC.]2
DextroseACTIVE MOIETYIY9XDZ35W2DEXTROSE INJECTION, SOLUTION [GENERAL INJECTABLES & VACCINES, INC.]2

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
0409-4902DEXTROSE (DEXTROSE MONOHYDRATE) INJECTION, SOLUTION [HOSPIRA, INC.]28Legacy NDC20250417_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 SyringePSN677bb6d6-704b-5be5-e053-2991aa0a5f6f3
727517dextrose 50 % in 50 ML Prefilled SyringePSN9bd8168d-ab8f-4d70-e053-2995a90ac23c3
72751750 ML glucose 500 MG/ML Prefilled SyringeSCD677bb6d6-704b-5be5-e053-2991aa0a5f6f3
72751750 ML glucose 500 MG/ML Prefilled SyringeSCD9bd8168d-ab8f-4d70-e053-2995a90ac23c3
72751750 ML dextrose 50 % Prefilled SyringeSY677bb6d6-704b-5be5-e053-2991aa0a5f6f3
72751750 ML dextrose 50 % Prefilled SyringeSY9bd8168d-ab8f-4d70-e053-2995a90ac23c3
727517dextrose 25 GM per 50 ML Prefilled SyringeSY677bb6d6-704b-5be5-e053-2991aa0a5f6f3
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
0409-4902-340040949023410 CARTON in 1 CONTAINER (0409-4902-34) > 1 SYRINGE in 1 CARTON > 50 mL in 1 SYRINGE (0409-4902-64) 10 carton2005-12-070000-00-00NoNoCurrent