FDA.reportPublic FDA data

Sodium Chloride

Product NDC
63323-088
11-digit product format
633230088
Labeler code
63323
Product ID
63323-088_5863f578-6c6e-4360-abf5-25b6abf62c1c
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
Sodium Chloride
Dosage form
INJECTION, SOLUTION
Route
INTRAVENOUS
Labeler
Fresenius Kabi USA, LLC
Marketing category
UNAPPROVED DRUG OTHER
Marketing start
2001-01-12
Substance
SODIUM CHLORIDE
Active strength
234 mg/mL
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
Sodium Chloride
Listing expiration
2026-12-31

Active Ingredients#

Ingredient, Strength table
IngredientStrength
SODIUM CHLORIDE234 mg/mL

Harmonized UNII identifiers#

UNII identifiers page 1 of 1 · 1 matching rows.

Identifier, FDA.report destination table
IdentifierFDA.report destination
451W47IQ8XInternal UNII lookup

Harmonized RxCUI identifiers#

RxCUI identifiers page 1 of 1 · 1 matching rows.

Identifier, FDA.report destination table
IdentifierFDA.report destination
313016Internal RxNorm lookup

Harmonized SPL set identifiers#

SPL set identifiers page 1 of 1 · 1 matching rows.

Identifier, FDA.report destination table
IdentifierFDA.report destination
c44b0fdb-33df-4747-b443-5fb4deb456cbAvailable on FDA.report

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
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
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
63323-088-61Sodium Chloride100 mL in 1 VIAL, PHARMACY BULK PACKAGEINJECTION, SOLUTION1003
63323-088-61Sodium Chloride10 in 1 TRAYINJECTION, SOLUTION103
63323-088-63Sodium Chloride10 in 1 TRAYINJECTION, SOLUTION103
63323-088-63Sodium Chloride200 mL in 1 VIAL, PHARMACY BULK PACKAGEINJECTION, SOLUTION2003

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
63323-088-61ML - Milliliter63323-088793b1d9f-52c8-4068-af14-ce1ffa330d1212013-02-13
63323-088-63ML - Milliliter63323-08898291201-6a0a-4491-981b-31a80df401c912013-02-13

DailyMed Socrata Ingredients#

Ingredient, Type, UNII table
IngredientTypeUNIIDailyMed labelSPL versionUploaded
SODIUM CHLORIDEACTIVE INGREDIENT451W47IQ8XSODIUM CHLORIDE INJECTION, SOLUTION [APP PHARMACEUTICALS, LLC]1
CHLORIDE IONACTIVE MOIETYQ32ZN48698SODIUM CHLORIDE INJECTION, SOLUTION [APP PHARMACEUTICALS, LLC]1

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
63323-088SODIUM CHLORIDE INJECTION, SOLUTION [FRESENIUS KABI USA, LLC]3Current NDC, Legacy NDC, 4 package rows20241018_c44b0fdb-33df-4747-b443-5fb4deb456cb.zip

openFDA label cross-check#

OpenFDA label data provides additional search and identifier links. DailyMed’s Structured Product Label is the canonical label on FDA.report. Matching records are deduplicated before they are shown below.

Matched openFDA labels page 1 of 1 · 1 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
Sodium ChlorideSODIUM CHLORIDEFresenius Kabi USA, LLCc44b0fdb-33df-4747-b443-5fb4deb456cb2024-10-11Warnings, Adverse reactionsExact identifier
ndc (product): 63323-088

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
313016sodium chloride 23.4 % Injectable SolutionPSNc44b0fdb-33df-4747-b443-5fb4deb456cb3
313016sodium chloride 234 MG/ML Injectable SolutionSCDc44b0fdb-33df-4747-b443-5fb4deb456cb3
313016NaCl 234 MG/ML Injectable SolutionSYc44b0fdb-33df-4747-b443-5fb4deb456cb3
313016sodium chloride 23.4 % (4 MEQ/ML) Injectable SolutionSYc44b0fdb-33df-4747-b443-5fb4deb456cb3
313016sodium chloride 23.4 % Injectable SolutionSYc44b0fdb-33df-4747-b443-5fb4deb456cb3

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionMarketing startMarketing endSampleExclude flagStatus
63323-088-616332300886110 VIAL, PHARMACY BULK PACKAGE in 1 TRAY (63323-088-61) / 100 mL in 1 VIAL, PHARMACY BULK PACKAGE2001-01-120000-00-00NoNoCurrent
63323-088-636332300886310 VIAL, PHARMACY BULK PACKAGE in 1 TRAY (63323-088-63) / 200 mL in 1 VIAL, PHARMACY BULK PACKAGE2001-01-120000-00-00NoNoCurrent