FDA.reportPublic FDA data

Dextrose and Sodium Chloride

Product NDC
63323-869
11-digit product format
633230869
Labeler code
63323
Product ID
63323-869_07c0fcbe-d4e6-4c20-b72c-5c217abafd7d
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
DEXTROSE MONOHYDRATE and SODIUM CHLORIDE
Dosage form
INJECTION, SOLUTION
Route
INTRAVENOUS
Labeler
Fresenius Kabi USA, LLC
Application
ANDA211276
Marketing category
ANDA
Marketing start
2020-10-26
Substance
DEXTROSE MONOHYDRATE; SODIUM CHLORIDE
Active strength
5; .45 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.45 g/100mL

Harmonized Identifiers#

Field, Values table
FieldValues
UniiLX22YL083G, 451W47IQ8X
Rxcui1795250, 1795252, 1795254

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
63323-869-01Dextrose and Sodium Chloride1000 mL in 1 BAGINJECTION, SOLUTION10003
63323-869-04Dextrose and Sodium Chloride500 mL in 1 BAGINJECTION, SOLUTION5003
63323-869-05Dextrose and Sodium Chloride250 mL in 1 BAGINJECTION, SOLUTION2503
63323-869-10Dextrose and Sodium Chloride10 in 1 CASEINJECTION, SOLUTION103
63323-869-74Dextrose and Sodium Chloride20 in 1 CASEINJECTION, SOLUTION203
63323-869-75Dextrose and Sodium Chloride30 in 1 CASEINJECTION, SOLUTION303

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
63323-869-01ML - Milliliter63323-869eb654ef4-bbe3-42a8-94a5-2077d3fa89e412025-06-13
63323-869-04ML - Milliliter63323-869eea56f3b-0208-4455-b48d-ed9bfd59c96d12025-11-13
63323-869-10ML - Milliliter63323-8696f2f203c-547d-46d1-a1e2-fc5323f4e3a012021-05-05
63323-869-74ML - Milliliter63323-8694cb5030b-9fd4-4baf-94d1-6d02faede6b812021-05-05
63323-869-75ML - Milliliter63323-869f7762f32-300c-4206-a80c-c9a13588bbe212021-05-05

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
63323-869DEXTROSE AND SODIUM CHLORIDE (DEXTROSE MONOHYDRATE AND SODIUM CHLORIDE) INJECTION, SOLUTION [FRESENIUS KABI USA, LLC]3Current NDC, Legacy NDC, 6 package rows20241010_3c5f0f65-8a54-4a55-ad4e-0f0be97631d7.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
1795250dextrose 5 % / sodium chloride 0.45 % in 1000 ML InjectionPSN3c5f0f65-8a54-4a55-ad4e-0f0be97631d73
1795254dextrose 5 % / sodium chloride 0.45 % in 250 ML InjectionPSN3c5f0f65-8a54-4a55-ad4e-0f0be97631d73
1795252dextrose 5 % / sodium chloride 0.45 % in 500 ML InjectionPSN3c5f0f65-8a54-4a55-ad4e-0f0be97631d73
17952501000 ML glucose 50 MG/ML / sodium chloride 4.5 MG/ML InjectionSCD3c5f0f65-8a54-4a55-ad4e-0f0be97631d73
1795254250 ML glucose 50 MG/ML / sodium chloride 4.5 MG/ML InjectionSCD3c5f0f65-8a54-4a55-ad4e-0f0be97631d73
1795252500 ML glucose 50 MG/ML / sodium chloride 4.5 MG/ML InjectionSCD3c5f0f65-8a54-4a55-ad4e-0f0be97631d73
17952501000 ML Glucose 50 MG/ML / NaCl 4.5 MG/ML InjectionSY3c5f0f65-8a54-4a55-ad4e-0f0be97631d73
1795254250 ML Glucose 50 MG/ML / NaCl 4.5 MG/ML InjectionSY3c5f0f65-8a54-4a55-ad4e-0f0be97631d73
1795252500 ML Glucose 50 MG/ML / NaCl 4.5 MG/ML InjectionSY3c5f0f65-8a54-4a55-ad4e-0f0be97631d73
1795250dextrose 5 % / sodium chloride 0.45 % per 1000 ML InjectionSY3c5f0f65-8a54-4a55-ad4e-0f0be97631d73
1795254dextrose 5 % / sodium chloride 0.45 % per 250 ML InjectionSY3c5f0f65-8a54-4a55-ad4e-0f0be97631d73
1795252dextrose 5 % / sodium chloride 0.45 % per 500 ML InjectionSY3c5f0f65-8a54-4a55-ad4e-0f0be97631d73

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
63323-869-01633230869011000 mL in 1 BAG1000 mlHistorical
63323-869-0463323086904500 mL in 1 BAG500 mlHistorical
63323-869-0563323086905250 mL in 1 BAG250 mlHistorical
63323-869-106332308691010 BAG in 1 CASE (63323-869-10) / 1000 mL in 1 BAG (63323-869-01) 10 bag2020-10-260000-00-00NoNoCurrent
63323-869-746332308697420 BAG in 1 CASE (63323-869-74) / 500 mL in 1 BAG (63323-869-04) 20 bag2020-10-260000-00-00NoNoCurrent
63323-869-756332308697530 BAG in 1 CASE (63323-869-75) / 250 mL in 1 BAG (63323-869-05) 30 bag2020-10-260000-00-00NoNoCurrent