FDA.reportPublic FDA data

Dextrose and Sodium Chloride

Product NDC
0338-0085
11-digit product format
003380085
Labeler code
0338
Product ID
0338-0085_b4404498-6ab7-4c25-a5a2-5377a6dfecca
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
Dextrose and Sodium Chloride
Dosage form
INJECTION, SOLUTION
Route
INTRAVENOUS
Labeler
Baxter Healthcare Company
Application
NDA016683
Marketing category
NDA
Marketing start
1971-03-22
Substance
DEXTROSE MONOHYDRATE; SODIUM CHLORIDE
Active strength
5; 450 g/100mL; mg/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 CHLORIDE450 mg/100mL

Harmonized Identifiers#

Field, Values table
FieldValues
UniiLX22YL083G, 451W47IQ8X
Rxcui1794881, 1794886, 1794887, 1795250, 1795252, 1795344, 1795346, 1795470

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
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5668b646-cd56-c3c7-bdea-3f6b1a8840dbProduct name120140508
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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
0338-0085-03Dextrose and Sodium Chloride24 in 1 CARTONINJECTION, SOLUTION2416
0338-0085-03Dextrose and Sodium Chloride500 mL in 1 BAGINJECTION, SOLUTION50016
0338-0085-04Dextrose and Sodium Chloride1000 mL in 1 BAGINJECTION, SOLUTION100016
0338-0085-04Dextrose and Sodium Chloride14 in 1 CARTONINJECTION, SOLUTION1416

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
0338-0085-02ML - Milliliter0338-00857cc74067-4f0a-44cd-a545-78725fa15cf512012-07-24
0338-0085-03ML - Milliliter0338-0085db67d4b3-c5b2-4060-997e-36c61977b5fa12012-07-24
0338-0085-04ML - Milliliter0338-0085f39ffc44-c3f7-42a0-a70b-d6b8c84992e612012-07-24

DailyMed Socrata Ingredients#

Ingredient, Type, UNII table
IngredientTypeUNIIDailyMed labelSPL versionUploaded
DEXTROSE MONOHYDRATEACTIVE INGREDIENTLX22YL083GDEXTROSE AND SODIUM CHLORIDE INJECTION, SOLUTION [BAXTER HEALTHCARE CORPORATION]6
SODIUM CHLORIDEACTIVE INGREDIENT451W47IQ8XDEXTROSE AND SODIUM CHLORIDE INJECTION, SOLUTION [BAXTER HEALTHCARE CORPORATION]6
ANHYDROUS DEXTROSEACTIVE MOIETY5SL0G7R0OKDEXTROSE AND SODIUM CHLORIDE INJECTION, SOLUTION [BAXTER HEALTHCARE CORPORATION]6
CHLORIDE IONACTIVE MOIETYQ32ZN48698DEXTROSE AND SODIUM CHLORIDE INJECTION, SOLUTION [BAXTER HEALTHCARE CORPORATION]6
WATERINACTIVE INGREDIENT059QF0KO0RDEXTROSE AND SODIUM CHLORIDE INJECTION, SOLUTION [BAXTER HEALTHCARE CORPORATION]6

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
0338-0085DEXTROSE AND SODIUM CHLORIDE INJECTION, SOLUTION [BAXTER HEALTHCARE COMPANY]14Current NDC, Legacy NDC, 4 package rows20250519_dcbf1907-1841-4afc-ab5d-a9893a2d7256.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
1795470dextrose 2.5 % / sodium chloride 0.45 % in 1000 ML InjectionPSNdcbf1907-1841-4afc-ab5d-a9893a2d725616
1794887dextrose 5 % / sodium chloride 0.2 % in 1000 ML InjectionPSNdcbf1907-1841-4afc-ab5d-a9893a2d725616
1794881dextrose 5 % / sodium chloride 0.2 % in 250 ML InjectionPSNdcbf1907-1841-4afc-ab5d-a9893a2d725616
1794886dextrose 5 % / sodium chloride 0.2 % in 500 ML InjectionPSNdcbf1907-1841-4afc-ab5d-a9893a2d725616
1795250dextrose 5 % / sodium chloride 0.45 % in 1000 ML InjectionPSNdcbf1907-1841-4afc-ab5d-a9893a2d725616
1795252dextrose 5 % / sodium chloride 0.45 % in 500 ML InjectionPSNdcbf1907-1841-4afc-ab5d-a9893a2d725616
1795346dextrose 5 % / sodium chloride 0.9 % in 1000 ML InjectionPSNdcbf1907-1841-4afc-ab5d-a9893a2d725616
1795344dextrose 5 % / sodium chloride 0.9 % in 500 ML InjectionPSNdcbf1907-1841-4afc-ab5d-a9893a2d725616
17954701000 ML glucose 25 MG/ML / sodium chloride 4.5 MG/ML InjectionSCDdcbf1907-1841-4afc-ab5d-a9893a2d725616
17948871000 ML glucose 50 MG/ML / sodium chloride 2 MG/ML InjectionSCDdcbf1907-1841-4afc-ab5d-a9893a2d725616
17952501000 ML glucose 50 MG/ML / sodium chloride 4.5 MG/ML InjectionSCDdcbf1907-1841-4afc-ab5d-a9893a2d725616
17953461000 ML glucose 50 MG/ML / sodium chloride 9 MG/ML InjectionSCDdcbf1907-1841-4afc-ab5d-a9893a2d725616
1794881250 ML glucose 50 MG/ML / sodium chloride 2 MG/ML InjectionSCDdcbf1907-1841-4afc-ab5d-a9893a2d725616
1794886500 ML glucose 50 MG/ML / sodium chloride 2 MG/ML InjectionSCDdcbf1907-1841-4afc-ab5d-a9893a2d725616
1795252500 ML glucose 50 MG/ML / sodium chloride 4.5 MG/ML InjectionSCDdcbf1907-1841-4afc-ab5d-a9893a2d725616
1795344500 ML glucose 50 MG/ML / sodium chloride 9 MG/ML InjectionSCDdcbf1907-1841-4afc-ab5d-a9893a2d725616
17954701000 ML Glucose 25 MG/ML / NaCl 4.5 MG/ML InjectionSYdcbf1907-1841-4afc-ab5d-a9893a2d725616
17948871000 ML Glucose 50 MG/ML / NaCl 2 MG/ML InjectionSYdcbf1907-1841-4afc-ab5d-a9893a2d725616
17952501000 ML Glucose 50 MG/ML / NaCl 4.5 MG/ML InjectionSYdcbf1907-1841-4afc-ab5d-a9893a2d725616
17953461000 ML Glucose 50 MG/ML / NaCl 9 MG/ML InjectionSYdcbf1907-1841-4afc-ab5d-a9893a2d725616
1794881250 ML Glucose 50 MG/ML / NaCl 2 MG/ML InjectionSYdcbf1907-1841-4afc-ab5d-a9893a2d725616
1794886500 ML Glucose 50 MG/ML / NaCl 2 MG/ML InjectionSYdcbf1907-1841-4afc-ab5d-a9893a2d725616
1795252500 ML Glucose 50 MG/ML / NaCl 4.5 MG/ML InjectionSYdcbf1907-1841-4afc-ab5d-a9893a2d725616
1795344500 ML Glucose 50 MG/ML / NaCl 9 MG/ML InjectionSYdcbf1907-1841-4afc-ab5d-a9893a2d725616
1795470dextrose 2.5 % / sodium chloride 0.45 % per 1000 ML InjectionSYdcbf1907-1841-4afc-ab5d-a9893a2d725616
1794887dextrose 5 % / sodium chloride 0.2 % per 1000 ML InjectionSYdcbf1907-1841-4afc-ab5d-a9893a2d725616
1794881dextrose 5 % / sodium chloride 0.2 % per 250 ML InjectionSYdcbf1907-1841-4afc-ab5d-a9893a2d725616
1794886dextrose 5 % / sodium chloride 0.2 % per 500 ML InjectionSYdcbf1907-1841-4afc-ab5d-a9893a2d725616
1795250dextrose 5 % / sodium chloride 0.45 % per 1000 ML InjectionSYdcbf1907-1841-4afc-ab5d-a9893a2d725616
1795252dextrose 5 % / sodium chloride 0.45 % per 500 ML InjectionSYdcbf1907-1841-4afc-ab5d-a9893a2d725616
1795346dextrose 5 % / sodium chloride 0.9 % per 1000 ML InjectionSYdcbf1907-1841-4afc-ab5d-a9893a2d725616
1795344dextrose 5 % / sodium chloride 0.9 % per 500 ML InjectionSYdcbf1907-1841-4afc-ab5d-a9893a2d725616

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
0338-0085-030033800850324 BAG in 1 CARTON (0338-0085-03) / 500 mL in 1 BAG24 bag1971-03-220000-00-00NoNoCurrent
0338-0085-040033800850414 BAG in 1 CARTON (0338-0085-04) / 1000 mL in 1 BAG14 bag1971-03-220000-00-00NoNoCurrent