FDA.reportPublic FDA data

Dextrose

Product NDC
0990-7922
11-digit product format
009907922
Labeler code
0990
Product ID
0990-7922_ea5b9574-2321-442f-b550-3ac4f10dcaf8
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
dextrose monohydrate
Dosage form
INJECTION, SOLUTION
Route
INTRAVENOUS
Labeler
ICU Medical, Inc.
Application
NDA016367
Marketing category
NDA
Marketing start
2019-07-15
Substance
DEXTROSE MONOHYDRATE
Active strength
5 g/100mL
NDC exclude flag
No
Listing certified through
2026-12-31
Current FDA listing
Yes

Additional Listing Data#

Finished product
Yes
Brand name base
Dextrose
Listing expiration
2026-12-31

Active Ingredients#

Ingredient, Strength table
IngredientStrength
DEXTROSE MONOHYDRATE5 g/100mL

Harmonized Identifiers#

Field, Values table
FieldValues
UniiLX22YL083G
Rxcui1795477, 1795480, 1795481, 1795607, 1795609, 1795610, 1795612, 1795616, 1795618, 1795621

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
0990-7922-02Dextrose1 in 1 POUCHINJECTION, SOLUTION117
0990-7922-02Dextrose24 in 1 CASEINJECTION, SOLUTION2417
0990-7922-03Dextrose24 in 1 CASEINJECTION, SOLUTION2417
0990-7922-03Dextrose1 in 1 POUCHINJECTION, SOLUTION117
0990-7922-09Dextrose12 in 1 CASEINJECTION, SOLUTION1217
0990-7922-09Dextrose1 in 1 POUCHINJECTION, SOLUTION117
0990-7922-53Dextrose1 in 1 POUCHINJECTION, SOLUTION117
0990-7922-53Dextrose24 in 1 CASEINJECTION, SOLUTION2417
0990-7922-55Dextrose18 in 1 CASEINJECTION, SOLUTION1817
0990-7922-55Dextrose1 in 1 POUCHINJECTION, SOLUTION117
0990-7922-61Dextrose32 in 1 CASEINJECTION, SOLUTION3217
0990-7922-61Dextrose1 in 1 POUCHINJECTION, SOLUTION117

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
0990-7922-02ML - Milliliter0990-792277ab64fe-2857-430f-9f21-a61fea2f90cc12020-01-03
0990-7922-03ML - Milliliter0990-79221228635a-10a0-4052-8249-164a239a14ac12020-07-13
0990-7922-09ML - Milliliter0990-7922c757dd40-5cd4-49b3-b357-2c7ff03aa54112020-03-10
0990-7922-25ML - Milliliter0990-79229cc83c48-9eb9-4584-88ee-f2136c89945912020-07-13
0990-7922-53ML - Milliliter0990-7922fea18487-30de-49c9-8e0e-6ffc079ca47b12025-08-11
0990-7922-55ML - Milliliter0990-79222fb83bf2-ea3a-461f-8631-e6ce50d5b38612020-01-03
0990-7922-61ML - Milliliter0990-792256f44477-3708-40e6-a9ed-d9403008d65712020-02-13

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
0990-7922DEXTROSE (DEXTROSE MONOHYDRATE) INJECTION, SOLUTION [ICU MEDICAL INC.]12Current NDC, Legacy NDC, 12 package rows20240711_8b25b7e0-703e-4b43-a4eb-52863511602d.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
1795481dextrose 10 % in 1000 ML InjectionPSN8b25b7e0-703e-4b43-a4eb-52863511602d17
1795480dextrose 10 % in 250 ML InjectionPSN8b25b7e0-703e-4b43-a4eb-52863511602d17
1795477dextrose 10 % in 500 ML InjectionPSN8b25b7e0-703e-4b43-a4eb-52863511602d17
1795609dextrose 5 % in 100 ML InjectionPSN8b25b7e0-703e-4b43-a4eb-52863511602d17
1795612dextrose 5 % in 1000 ML InjectionPSN8b25b7e0-703e-4b43-a4eb-52863511602d17
1795621dextrose 5 % in 150 ML InjectionPSN8b25b7e0-703e-4b43-a4eb-52863511602d17
1795618dextrose 5 % in 25 ML InjectionPSN8b25b7e0-703e-4b43-a4eb-52863511602d17
1795610dextrose 5 % in 250 ML InjectionPSN8b25b7e0-703e-4b43-a4eb-52863511602d17
1795616dextrose 5 % in 50 ML InjectionPSN8b25b7e0-703e-4b43-a4eb-52863511602d17
1795607dextrose 5 % in 500 ML InjectionPSN8b25b7e0-703e-4b43-a4eb-52863511602d17
1795609100 ML glucose 50 MG/ML InjectionSCD8b25b7e0-703e-4b43-a4eb-52863511602d17
17954811000 ML glucose 100 MG/ML InjectionSCD8b25b7e0-703e-4b43-a4eb-52863511602d17
17956121000 ML glucose 50 MG/ML InjectionSCD8b25b7e0-703e-4b43-a4eb-52863511602d17
1795621150 ML glucose 50 MG/ML InjectionSCD8b25b7e0-703e-4b43-a4eb-52863511602d17
179561825 ML glucose 50 MG/ML InjectionSCD8b25b7e0-703e-4b43-a4eb-52863511602d17
1795480250 ML glucose 100 MG/ML InjectionSCD8b25b7e0-703e-4b43-a4eb-52863511602d17
1795610250 ML glucose 50 MG/ML InjectionSCD8b25b7e0-703e-4b43-a4eb-52863511602d17
179561650 ML glucose 50 MG/ML InjectionSCD8b25b7e0-703e-4b43-a4eb-52863511602d17
1795477500 ML glucose 100 MG/ML InjectionSCD8b25b7e0-703e-4b43-a4eb-52863511602d17
1795607500 ML glucose 50 MG/ML InjectionSCD8b25b7e0-703e-4b43-a4eb-52863511602d17
1795481dextrose 10 % per 1000 ML InjectionSY8b25b7e0-703e-4b43-a4eb-52863511602d17
1795480dextrose 10 % per 250 ML InjectionSY8b25b7e0-703e-4b43-a4eb-52863511602d17
1795477dextrose 10 % per 500 ML InjectionSY8b25b7e0-703e-4b43-a4eb-52863511602d17
1795609dextrose 5 % per 100 ML InjectionSY8b25b7e0-703e-4b43-a4eb-52863511602d17
1795612dextrose 5 % per 1000 ML InjectionSY8b25b7e0-703e-4b43-a4eb-52863511602d17
1795621dextrose 5 % per 150 ML InjectionSY8b25b7e0-703e-4b43-a4eb-52863511602d17
1795618dextrose 5 % per 25 ML InjectionSY8b25b7e0-703e-4b43-a4eb-52863511602d17
1795610dextrose 5 % per 250 ML InjectionSY8b25b7e0-703e-4b43-a4eb-52863511602d17
1795616dextrose 5 % per 50 ML InjectionSY8b25b7e0-703e-4b43-a4eb-52863511602d17
1795607dextrose 5 % per 500 ML InjectionSY8b25b7e0-703e-4b43-a4eb-52863511602d17
1795610dextrose 5 % in 250 ML InjectionPSN9be55a08-e93b-4b86-e053-2a95a90a94b92
1795610250 ML glucose 50 MG/ML InjectionSCD9be55a08-e93b-4b86-e053-2a95a90a94b92
1795610dextrose 5 % per 250 ML InjectionSY9be55a08-e93b-4b86-e053-2a95a90a94b92

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
0990-7922-020099079220224 POUCH in 1 CASE (0990-7922-02) / 1 BAG in 1 POUCH / 250 mL in 1 BAG24 pouch2019-08-010000-00-00NoNoCurrent
0990-7922-030099079220324 POUCH in 1 CASE (0990-7922-03) / 1 BAG in 1 POUCH / 500 mL in 1 BAG24 pouch2019-08-010000-00-00NoNoCurrent
0990-7922-090099079220912 POUCH in 1 CASE (0990-7922-09) / 1 BAG in 1 POUCH / 1000 mL in 1 BAG12 pouch2019-09-010000-00-00NoNoCurrent
0990-7922-250099079222524 BAG in 1 CASE (0990-7922-25) > 250 mL in 1 BAG24 bag2019-10-010000-00-00NoNoCurrent
0990-7922-530099079225324 POUCH in 1 CASE (0990-7922-53) / 1 BAG in 1 POUCH / 250 mL in 1 BAG24 pouch2019-10-010000-00-00NoNoCurrent
0990-7922-550099079225518 POUCH in 1 CASE (0990-7922-55) / 1 BAG in 1 POUCH / 500 mL in 1 BAG18 pouch2019-08-010000-00-00NoNoCurrent
0990-7922-610099079226132 POUCH in 1 CASE (0990-7922-61) / 1 BAG in 1 POUCH / 150 mL in 1 BAG32 pouch2019-08-010000-00-00NoNoCurrent