FDA.reportPublic FDA data

Sodium chloride

Product NDC
63323-626
11-digit product format
633230626
Labeler code
63323
Product ID
63323-626_713303dd-2658-4037-8583-a12a38eb367b
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
SODIUM CHLORIDE
Dosage form
INJECTION, SOLUTION
Route
INTRAVENOUS
Labeler
Fresenius Kabi USA, LLC
Application
ANDA208122
Marketing category
ANDA
Marketing start
2018-07-23
Substance
SODIUM CHLORIDE
Active strength
450 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
Sodium chloride
Listing expiration
2026-12-31

Active Ingredients#

Ingredient, Strength table
IngredientStrength
SODIUM CHLORIDE450 mg/100mL

Harmonized Identifiers#

Field, Values table
FieldValues
Unii451W47IQ8X
Rxcui1807548, 1807549, 1807550, 1807551, 1807552

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
63323-626-00Sodium chloride50 in 1 CASEINJECTION, SOLUTION507
63323-626-01Sodium chloride50 mL in 1 BAGINJECTION, SOLUTION507
63323-626-02Sodium chloride100 mL in 1 BAGINJECTION, SOLUTION1007
63323-626-03Sodium chloride250 mL in 1 BAGINJECTION, SOLUTION2507
63323-626-04Sodium chloride500 mL in 1 BAGINJECTION, SOLUTION5007
63323-626-05Sodium chloride1000 mL in 1 BAGINJECTION, SOLUTION10007
63323-626-10Sodium chloride10 in 1 CASEINJECTION, SOLUTION107
63323-626-25Sodium chloride30 in 1 CASEINJECTION, SOLUTION307
63323-626-50Sodium chloride60 in 1 CASEINJECTION, SOLUTION607
63323-626-55Sodium chloride20 in 1 CASEINJECTION, SOLUTION207

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
63323-626-00ML - Milliliter63323-6264b822173-1733-4366-9637-1168ee1668ce12019-11-12
63323-626-01ML - Milliliter63323-626353aa619-11bf-4238-86e1-d8be2d0538ce12019-11-12
63323-626-02ML - Milliliter63323-6263d1cdb2b-e6bb-475d-b6e8-8447d10028a012019-11-12
63323-626-03ML - Milliliter63323-6261fa1cb66-fb2c-4cb1-b763-5866e855000a12019-11-12
63323-626-04ML - Milliliter63323-626e2fd9849-bc3e-4a2e-8bb8-0f05a2e8fe5312019-11-12
63323-626-05ML - Milliliter63323-6260d925879-72d5-4762-8510-db4216908fd812019-11-12
63323-626-10ML - Milliliter63323-626d2c796f0-fa42-4bfd-9b4d-04a50fc2018812019-11-12
63323-626-25ML - Milliliter63323-62625f29fd1-0a13-41ac-9904-d9beda6407ab12019-11-12
63323-626-50ML - Milliliter63323-626decaba55-fc38-4182-ae87-9fd724e56c2412019-11-12
63323-626-55ML - Milliliter63323-626e405b344-c085-46f0-ac08-35150a6f483112019-11-12

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
63323-626SODIUM CHLORIDE INJECTION, SOLUTION [FRESENIUS KABI USA, LLC]7Current NDC, Legacy NDC, 10 package rows20240806_83994d0c-8484-4505-abb5-8a384ed12288.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
1807549sodium chloride 0.45 % in 100 ML InjectionPSN83994d0c-8484-4505-abb5-8a384ed122887
1807552sodium chloride 0.45 % in 1000 ML InjectionPSN83994d0c-8484-4505-abb5-8a384ed122887
1807550sodium chloride 0.45 % in 250 ML InjectionPSN83994d0c-8484-4505-abb5-8a384ed122887
1807548sodium chloride 0.45 % in 50 ML InjectionPSN83994d0c-8484-4505-abb5-8a384ed122887
1807551sodium chloride 0.45 % in 500 ML InjectionPSN83994d0c-8484-4505-abb5-8a384ed122887
1807549100 ML sodium chloride 4.5 MG/ML InjectionSCD83994d0c-8484-4505-abb5-8a384ed122887
18075521000 ML sodium chloride 4.5 MG/ML InjectionSCD83994d0c-8484-4505-abb5-8a384ed122887
1807550250 ML sodium chloride 4.5 MG/ML InjectionSCD83994d0c-8484-4505-abb5-8a384ed122887
180754850 ML sodium chloride 4.5 MG/ML InjectionSCD83994d0c-8484-4505-abb5-8a384ed122887
1807551500 ML sodium chloride 4.5 MG/ML InjectionSCD83994d0c-8484-4505-abb5-8a384ed122887
1807549100 ML NaCl 4.5 MG/ML InjectionSY83994d0c-8484-4505-abb5-8a384ed122887
18075521000 ML NaCl 4.5 MG/ML InjectionSY83994d0c-8484-4505-abb5-8a384ed122887
1807550250 ML NaCl 4.5 MG/ML InjectionSY83994d0c-8484-4505-abb5-8a384ed122887
180754850 ML NaCl 4.5 MG/ML InjectionSY83994d0c-8484-4505-abb5-8a384ed122887
1807551500 ML NaCl 4.5 MG/ML InjectionSY83994d0c-8484-4505-abb5-8a384ed122887
1807549sodium chloride 0.45 % per 100 ML InjectionSY83994d0c-8484-4505-abb5-8a384ed122887
1807552sodium chloride 0.45 % per 1000 ML InjectionSY83994d0c-8484-4505-abb5-8a384ed122887
1807550sodium chloride 0.45 % per 250 ML InjectionSY83994d0c-8484-4505-abb5-8a384ed122887
1807548sodium chloride 0.45 % per 50 ML InjectionSY83994d0c-8484-4505-abb5-8a384ed122887
1807551sodium chloride 0.45 % per 500 ML InjectionSY83994d0c-8484-4505-abb5-8a384ed122887

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
63323-626-006332306260050 BAG in 1 CASE (63323-626-00) / 100 mL in 1 BAG (63323-626-02) 50 bag2018-07-230000-00-00NoNoCurrent
63323-626-016332306260150 mL in 1 BAG50 mlHistorical
63323-626-0263323062602100 mL in 1 BAG100 mlHistorical
63323-626-0363323062603250 mL in 1 BAG250 mlHistorical
63323-626-0463323062604500 mL in 1 BAG500 mlHistorical
63323-626-05633230626051000 mL in 1 BAG1000 mlHistorical
63323-626-106332306261010 BAG in 1 CASE (63323-626-10) / 1000 mL in 1 BAG (63323-626-05) 10 bag2018-07-230000-00-00NoNoCurrent
63323-626-256332306262530 BAG in 1 CASE (63323-626-25) / 250 mL in 1 BAG (63323-626-03) 30 bag2018-07-230000-00-00NoNoCurrent
63323-626-506332306265060 BAG in 1 CASE (63323-626-50) / 50 mL in 1 BAG (63323-626-01) 60 bag2018-07-230000-00-00NoNoCurrent
63323-626-556332306265520 BAG in 1 CASE (63323-626-55) / 500 mL in 1 BAG (63323-626-04) 20 bag2018-07-230000-00-00NoNoCurrent