FDA.reportPublic FDA data

Dextrose and Sodium Chloride

Product NDC
0990-7925
11-digit product format
009907925
Labeler code
0990
Product ID
0990-7925_391a9854-64db-4da4-b8a5-a230001aa81c
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
DEXTROSE MONOHYDRATE and SODIUM CHLORIDE
Dosage form
INJECTION, SOLUTION
Route
INTRAVENOUS
Labeler
ICU Medical Inc.
Application
NDA017799
Marketing category
NDA
Marketing start
2019-09-01
Substance
DEXTROSE MONOHYDRATE; SODIUM CHLORIDE
Active strength
5; .3 g/100mL; g/100mL
Pharmacologic classes
Increased Large Intestinal Motility [PE], Inhibition Large Intestine Fluid/Electrolyte Absorption [PE], Osmotic Activity [MoA], Osmotic Laxative [EPC]
NDC exclude flag
No
Listing certified through
2026-12-31
Current FDA listing
Yes

Additional Listing Data#

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

Active Ingredients#

Ingredient, Strength table
IngredientStrength
DEXTROSE MONOHYDRATE5 g/100mL
SODIUM CHLORIDE.3 g/100mL

Harmonized Identifiers#

Field, Values table
FieldValues
UniiLX22YL083G, 451W47IQ8X
Rxcui1794902, 1794904, 1794905, 1795149, 1795150, 1795250, 1795252, 1795254, 1795344, 1795346

DailyMed Product Concepts#

Product concept, Relation, Version table
Product conceptRelationVersionEffective
95250459-30e4-45c1-b08a-993044f49109Product name220250805
30b0ac6e-02aa-0e5c-0d8b-cffdf3a282b2Product name520250304
726062af-1135-4707-a1d7-57256991bbf9Product name220250226
a21a21e5-f36d-4c1f-8918-def921b8f7e3Product name320250124
bed0530e-f939-4541-956b-6928a2f6404fProduct name120241008
cefa60e2-a5b5-493e-9c54-24735b7dc509Product name620240814
fb7ab793-2c12-4079-b100-a64f73bef25aProduct name420240712
362d7abb-94e6-4c60-9a58-266894157713Product name120231023
b0cbf770-6cc3-4aa4-9158-755110c2b9f7Product name220230717
cb89b86a-369e-4204-8910-ae797c503af3Product name120230706
dc7c5daa-021f-40dd-b00d-63982cb2067aProduct name120230426
6bd95106-a412-1dad-b9cc-4cb74bfb27ceProduct name220230315
f1e0dc7e-7d61-4625-b6d9-4894927679d7Product name220211025
9badc7be-250a-44ab-aa36-926af3f02679Product name120210527
08ffbcbf-26df-b99c-1dab-64fc4cfae89fProduct name520200925
e4870509-7e28-6f92-f0be-dd3dd889a9cfProduct name520200810
6e9d4a47-c464-b93e-aebc-ad7bffc9c4cdProduct name220190619
444b3e50-f226-46ef-bfca-2e7035d140cdProduct name120190611
816b97af-edc5-4060-aff1-b814bdbcad50Product name120190415
d4880ace-a516-8c47-8dfd-73a4ba5887d7Product name220180830
7cda52fc-125f-421c-8fea-bc1974370c49Product name220180703
cefa60e2-a5b5-493e-9c54-24735b7dc509Product name220171212
419aab54-5d5a-4146-9453-026d4a9991beProduct name220170525
26acd337-b838-40ac-bcbc-05c3b81c8712Product name120170323
08ffbcbf-26df-b99c-1dab-64fc4cfae89fProduct name220160823
d5e51f11-ad28-caa4-4b49-4143974782adProduct name120150831
290f523a-f9db-9774-b5a9-e1f908ac1782Product name120150828
0ca1d589-929b-4b33-bc5b-1d84abdafa6aProduct name120150324
fc363c46-397b-4476-ac0f-70e43e8e4592Product name120150324
89dac932-b90a-4410-9ab1-84c53e57de25Product name120150316
19c71a3d-ed9c-166b-a7e5-38c250c35631Product name120140508
5668b646-cd56-c3c7-bdea-3f6b1a8840dbProduct name120140508
597b1cfd-7b31-5048-62be-ca5cd740da2fProduct name120140508
684ea482-2e8b-14af-5664-b98f1e402036Product name120140508
810ab97e-f109-f41c-7c83-6a652a9cbf43Product name120140508
87711080-88eb-65c5-b2dd-bf99e700a372Product name120140508
8dbefedf-0a0d-a224-5a3c-66dc9e11c2ddProduct name120140508
b060cc1a-fe47-856b-0b77-4448b5963de8Product name120140508
c6b65c52-69c7-df49-550a-a50c137f6218Product name120140508
ec2149b3-5c6d-5344-f757-c86411073075Product name120140508
ed912195-5da0-0f2f-6f4b-3ef17710cbe3Product name120140508

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
0990-7925-03Dextrose and Sodium Chloride24 in 1 CASEINJECTION, SOLUTION2424
0990-7925-03Dextrose and Sodium Chloride1 in 1 POUCHINJECTION, SOLUTION124
0990-7925-09Dextrose and Sodium Chloride1 in 1 POUCHINJECTION, SOLUTION124
0990-7925-09Dextrose and Sodium Chloride12 in 1 CASEINJECTION, SOLUTION1224

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
0990-7925-03ML - Milliliter0990-7925369e59b9-5dc2-46cd-99a0-5e0c9ca2f86112020-02-13
0990-7925-09ML - Milliliter0990-7925427081c0-d69f-485c-b44e-875170b3f35d12021-06-02

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
0990-7925DEXTROSE AND SODIUM CHLORIDE (DEXTROSE MONOHYDRATE AND SODIUM CHLORIDE) INJECTION, SOLUTION [ICU MEDICAL INC.]21Current NDC, Legacy NDC, 4 package rows20231202_4555b1bf-6d97-4798-a63d-6d34291c85ce.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
1794905dextrose 5 % / sodium chloride 0.225 % in 1000 ML InjectionPSN4555b1bf-6d97-4798-a63d-6d34291c85ce24
1794902dextrose 5 % / sodium chloride 0.225 % in 250 ML InjectionPSN4555b1bf-6d97-4798-a63d-6d34291c85ce24
1794904dextrose 5 % / sodium chloride 0.225 % in 500 ML InjectionPSN4555b1bf-6d97-4798-a63d-6d34291c85ce24
1795150dextrose 5 % / sodium chloride 0.3 % in 1000 ML InjectionPSN4555b1bf-6d97-4798-a63d-6d34291c85ce24
1795149dextrose 5 % / sodium chloride 0.3 % in 500 ML InjectionPSN4555b1bf-6d97-4798-a63d-6d34291c85ce24
1795250dextrose 5 % / sodium chloride 0.45 % in 1000 ML InjectionPSN4555b1bf-6d97-4798-a63d-6d34291c85ce24
1795254dextrose 5 % / sodium chloride 0.45 % in 250 ML InjectionPSN4555b1bf-6d97-4798-a63d-6d34291c85ce24
1795252dextrose 5 % / sodium chloride 0.45 % in 500 ML InjectionPSN4555b1bf-6d97-4798-a63d-6d34291c85ce24
1795346dextrose 5 % / sodium chloride 0.9 % in 1000 ML InjectionPSN4555b1bf-6d97-4798-a63d-6d34291c85ce24
1795344dextrose 5 % / sodium chloride 0.9 % in 500 ML InjectionPSN4555b1bf-6d97-4798-a63d-6d34291c85ce24
17949051000 ML glucose 50 MG/ML / sodium chloride 2.25 MG/ML InjectionSCD4555b1bf-6d97-4798-a63d-6d34291c85ce24
17951501000 ML glucose 50 MG/ML / sodium chloride 3 MG/ML InjectionSCD4555b1bf-6d97-4798-a63d-6d34291c85ce24
17952501000 ML glucose 50 MG/ML / sodium chloride 4.5 MG/ML InjectionSCD4555b1bf-6d97-4798-a63d-6d34291c85ce24
17953461000 ML glucose 50 MG/ML / sodium chloride 9 MG/ML InjectionSCD4555b1bf-6d97-4798-a63d-6d34291c85ce24
1794902250 ML glucose 50 MG/ML / sodium chloride 2.25 MG/ML InjectionSCD4555b1bf-6d97-4798-a63d-6d34291c85ce24
1795254250 ML glucose 50 MG/ML / sodium chloride 4.5 MG/ML InjectionSCD4555b1bf-6d97-4798-a63d-6d34291c85ce24
1794904500 ML glucose 50 MG/ML / sodium chloride 2.25 MG/ML InjectionSCD4555b1bf-6d97-4798-a63d-6d34291c85ce24
1795149500 ML glucose 50 MG/ML / sodium chloride 3 MG/ML InjectionSCD4555b1bf-6d97-4798-a63d-6d34291c85ce24
1795252500 ML glucose 50 MG/ML / sodium chloride 4.5 MG/ML InjectionSCD4555b1bf-6d97-4798-a63d-6d34291c85ce24
1795344500 ML glucose 50 MG/ML / sodium chloride 9 MG/ML InjectionSCD4555b1bf-6d97-4798-a63d-6d34291c85ce24
17949051000 ML Glucose 50 MG/ML / NaCl 2.25 MG/ML InjectionSY4555b1bf-6d97-4798-a63d-6d34291c85ce24
17951501000 ML Glucose 50 MG/ML / NaCl 3 MG/ML InjectionSY4555b1bf-6d97-4798-a63d-6d34291c85ce24
17952501000 ML Glucose 50 MG/ML / NaCl 4.5 MG/ML InjectionSY4555b1bf-6d97-4798-a63d-6d34291c85ce24
17953461000 ML Glucose 50 MG/ML / NaCl 9 MG/ML InjectionSY4555b1bf-6d97-4798-a63d-6d34291c85ce24
1794902250 ML Glucose 50 MG/ML / NaCl 2.25 MG/ML InjectionSY4555b1bf-6d97-4798-a63d-6d34291c85ce24
1795254250 ML Glucose 50 MG/ML / NaCl 4.5 MG/ML InjectionSY4555b1bf-6d97-4798-a63d-6d34291c85ce24
1794904500 ML Glucose 50 MG/ML / NaCl 2.25 MG/ML InjectionSY4555b1bf-6d97-4798-a63d-6d34291c85ce24
1795149500 ML Glucose 50 MG/ML / NaCl 3 MG/ML InjectionSY4555b1bf-6d97-4798-a63d-6d34291c85ce24
1795252500 ML Glucose 50 MG/ML / NaCl 4.5 MG/ML InjectionSY4555b1bf-6d97-4798-a63d-6d34291c85ce24
1795344500 ML Glucose 50 MG/ML / NaCl 9 MG/ML InjectionSY4555b1bf-6d97-4798-a63d-6d34291c85ce24
1794905dextrose 5 % / sodium chloride 0.225 % per 1000 ML InjectionSY4555b1bf-6d97-4798-a63d-6d34291c85ce24
1794902dextrose 5 % / sodium chloride 0.225 % per 250 ML InjectionSY4555b1bf-6d97-4798-a63d-6d34291c85ce24
1794904dextrose 5 % / sodium chloride 0.225 % per 500 ML InjectionSY4555b1bf-6d97-4798-a63d-6d34291c85ce24
1795150dextrose 5 % / sodium chloride 0.3 % per 1000 ML InjectionSY4555b1bf-6d97-4798-a63d-6d34291c85ce24
1795149dextrose 5 % / sodium chloride 0.3 % per 500 ML InjectionSY4555b1bf-6d97-4798-a63d-6d34291c85ce24
1795250dextrose 5 % / sodium chloride 0.45 % per 1000 ML InjectionSY4555b1bf-6d97-4798-a63d-6d34291c85ce24
1795254dextrose 5 % / sodium chloride 0.45 % per 250 ML InjectionSY4555b1bf-6d97-4798-a63d-6d34291c85ce24
1795252dextrose 5 % / sodium chloride 0.45 % per 500 ML InjectionSY4555b1bf-6d97-4798-a63d-6d34291c85ce24
1795346dextrose 5 % / sodium chloride 0.9 % per 1000 ML InjectionSY4555b1bf-6d97-4798-a63d-6d34291c85ce24
1795344dextrose 5 % / sodium chloride 0.9 % per 500 ML InjectionSY4555b1bf-6d97-4798-a63d-6d34291c85ce24

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
0990-7925-030099079250324 POUCH in 1 CASE (0990-7925-03) / 1 BAG in 1 POUCH / 500 mL in 1 BAG24 pouch2019-11-250000-00-00NoNoCurrent
0990-7925-090099079250912 POUCH in 1 CASE (0990-7925-09) / 1 BAG in 1 POUCH / 1000 mL in 1 BAG12 pouch2019-12-010000-00-00NoNoCurrent