FDA.reportPublic FDA data

Dextrose

Product NDC
0409-7100
11-digit product format
004097100
Labeler code
0409
Product ID
0409-7100_033b46e6-d83b-4c4f-8329-4bba3e0617b5
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
dextrose monohydrate
Dosage form
INJECTION, SOLUTION
Route
INTRAVENOUS
Labeler
Hospira, Inc.
Application
NDA019466
Marketing category
NDA
Marketing start
2005-06-27
Marketing end
2026-11-30
Substance
DEXTROSE MONOHYDRATE
Active strength
50 mg/mL
NDC exclude flag
No
Listing certified through
2027-12-31
Current FDA listing
Yes

Additional Listing Data#

Finished product
Yes
Brand name base
Dextrose

Active Ingredients#

Ingredient, Strength table
IngredientStrength
DEXTROSE MONOHYDRATE50 mg/mL

Harmonized Identifiers#

Field, Values table
FieldValues
UniiLX22YL083G
Rxcui1795609, 1795610, 1795616

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

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
0409-7100-02Dextrose2 in 1 POUCHINJECTION, SOLUTION226
0409-7100-02Dextrose12 in 1 CASEINJECTION, SOLUTION1226
0409-7100-04Dextrose250 mL in 1 BAGINJECTION, SOLUTION25026
0409-7100-66Dextrose5 in 1 POUCHINJECTION, SOLUTION526
0409-7100-66Dextrose10 in 1 CASEINJECTION, SOLUTION1026
0409-7100-67Dextrose5 in 1 POUCHINJECTION, SOLUTION526
0409-7100-67Dextrose10 in 1 CASEINJECTION, SOLUTION1026
0409-7100-68Dextrose50 mL in 1 BAGINJECTION, SOLUTION5026
0409-7100-69Dextrose100 mL in 1 BAGINJECTION, SOLUTION10026

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
0409-7100-02ML - Milliliter0409-710075a363cb-1f3c-45e0-99a1-ba4fd73b9c8112012-07-24
0409-7100-04ML - Milliliter0409-7100a26fc434-eae5-4706-844d-ca047691aa4112015-04-03
0409-7100-66ML - Milliliter0409-7100bfcddfd8-3b59-467a-b1c3-703f1e9c51ee12012-07-24
0409-7100-67ML - Milliliter0409-710031e2a1f9-6723-44f7-883c-c30330a8eef512012-07-24
0409-7100-68ML - Milliliter0409-7100ca474d6c-dd70-4e9f-9538-7c2eaf0e944012015-04-03
0409-7100-69ML - Milliliter0409-710072330bea-a82c-4237-8838-f5a79a3bdfa412015-04-03

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
WATERINACTIVE INGREDIENT059QF0KO0RDEXTROSE (DEXTROSE MONOHYDRATE) INJECTION, SOLUTION [HOSPIRA, INC.]13

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
0409-7100DEXTROSE (DEXTROSE MONOHYDRATE) INJECTION, SOLUTION [HOSPIRA, INC.]24Current NDC, Legacy NDC, 9 package rows20211020_10e98cb0-31a5-4ad1-3eaa-aa4af387a42d.zip

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
0409-7100-020040971000212 POUCH in 1 CASE (0409-7100-02) / 2 BAG in 1 POUCH / 250 mL in 1 BAG (0409-7100-04) 12 pouch2005-06-270000-00-00NoNoCurrent
0409-7100-0400409710004250 mL in 1 BAG250 mlHistorical
0409-7100-660040971006610 POUCH in 1 CASE (0409-7100-66) / 5 BAG in 1 POUCH / 50 mL in 1 BAG (0409-7100-68) 10 pouch2005-08-040000-00-00NoNoCurrent
0409-7100-670040971006710 POUCH in 1 CASE (0409-7100-67) / 5 BAG in 1 POUCH / 100 mL in 1 BAG (0409-7100-69) 10 pouch2005-09-140000-00-00NoNoCurrent
0409-7100-680040971006850 mL in 1 BAG50 mlHistorical
0409-7100-6900409710069100 mL in 1 BAG100 mlHistorical