FDA.reportPublic FDA data

SODIUM CHLORIDE

Product NDC
0338-9543
11-digit product format
003389543
Labeler code
0338
Product ID
0338-9543_ba9e58a5-60c5-4aab-9cef-36320d052091
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
sodium chloride
Dosage form
INJECTION, SOLUTION
Route
INTRAVENOUS
Labeler
Baxter Healthcare Corporation
Application
NDA016677
Marketing category
NDA
Marketing start
1970-12-09
Substance
SODIUM CHLORIDE
Active strength
9 g/1000mL
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
2027-12-31
Current FDA listing
Yes

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
0338-9543-01SODIUM CHLORIDE250 mL in 1 BAGINJECTION, SOLUTION25019
0338-9543-02SODIUM CHLORIDE250 mL in 1 BAGINJECTION, SOLUTION25019
0338-9543-03SODIUM CHLORIDE500 mL in 1 BAGINJECTION, SOLUTION50019
0338-9543-04SODIUM CHLORIDE500 mL in 1 BAGINJECTION, SOLUTION50019
0338-9543-05SODIUM CHLORIDE1000 mL in 1 BAGINJECTION, SOLUTION100019
0338-9543-06SODIUM CHLORIDE1000 mL in 1 BAGINJECTION, SOLUTION100019
0338-9543-12SODIUM CHLORIDE1000 mL in 1 BAGINJECTION, SOLUTION100019

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
0338-9543-01ML - Milliliter0338-9543a03c3624-1afa-4c4b-bdde-d81880b625f812022-02-07
0338-9543-02ML - Milliliter0338-95434f6bb774-26fc-4f54-856b-552993c8056112016-02-04
0338-9543-03ML - Milliliter0338-9543d6526019-3358-4519-9628-81ed2b8a47e412025-02-10
0338-9543-04ML - Milliliter0338-95437ef3f3cd-8a40-4518-a097-6f1732daab2312016-03-04
0338-9543-05ML - Milliliter0338-95439b14a029-cdff-4cc1-bb76-03dff827127712025-02-10
0338-9543-06ML - Milliliter0338-954389c5b044-657b-4f8e-9c7b-9b5497f5e03412016-03-04

DailyMed Socrata Ingredients#

Ingredient, Type, UNII table
IngredientTypeUNIIDailyMed labelSPL versionUploaded
SODIUM CHLORIDEACTIVE INGREDIENT451W47IQ8XSODIUM CHLORIDE INJECTION, SOLUTION [BAXTER HEALTHCARE CORPORATION]2
CHLORIDE IONACTIVE MOIETYQ32ZN48698SODIUM CHLORIDE INJECTION, SOLUTION [BAXTER HEALTHCARE CORPORATION]2
WATERINACTIVE INGREDIENT059QF0KO0RSODIUM CHLORIDE INJECTION, SOLUTION [BAXTER HEALTHCARE CORPORATION]2

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
0338-9543SODIUM CHLORIDE INJECTION, SOLUTION [BAXTER HEALTHCARE CORPORATION]16Current NDC, Legacy NDC, 7 package rows20250511_958d35f0-6834-43be-a700-fa58f38b4c19.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
1807632sodium chloride 0.9 % in 100 ML InjectionPSN958d35f0-6834-43be-a700-fa58f38b4c1919
1807639sodium chloride 0.9 % in 1000 ML InjectionPSN958d35f0-6834-43be-a700-fa58f38b4c1919
1807633sodium chloride 0.9 % in 250 ML InjectionPSN958d35f0-6834-43be-a700-fa58f38b4c1919
1807631sodium chloride 0.9 % in 50 ML InjectionPSN958d35f0-6834-43be-a700-fa58f38b4c1919
1807634sodium chloride 0.9 % in 500 ML InjectionPSN958d35f0-6834-43be-a700-fa58f38b4c1919
1807632100 ML sodium chloride 9 MG/ML InjectionSCD958d35f0-6834-43be-a700-fa58f38b4c1919
18076391000 ML sodium chloride 9 MG/ML InjectionSCD958d35f0-6834-43be-a700-fa58f38b4c1919
1807633250 ML sodium chloride 9 MG/ML InjectionSCD958d35f0-6834-43be-a700-fa58f38b4c1919
180763150 ML sodium chloride 9 MG/ML InjectionSCD958d35f0-6834-43be-a700-fa58f38b4c1919
1807634500 ML sodium chloride 9 MG/ML InjectionSCD958d35f0-6834-43be-a700-fa58f38b4c1919
1807632100 ML NaCl 9 MG/ML InjectionSY958d35f0-6834-43be-a700-fa58f38b4c1919
18076391000 ML NaCl 9 MG/ML InjectionSY958d35f0-6834-43be-a700-fa58f38b4c1919
1807633250 ML NaCl 9 MG/ML InjectionSY958d35f0-6834-43be-a700-fa58f38b4c1919
180763150 ML NaCl 9 MG/ML InjectionSY958d35f0-6834-43be-a700-fa58f38b4c1919
1807634500 ML NaCl 9 MG/ML InjectionSY958d35f0-6834-43be-a700-fa58f38b4c1919
1807632sodium chloride 0.9 % per 100 ML InjectionSY958d35f0-6834-43be-a700-fa58f38b4c1919
1807639sodium chloride 0.9 % per 1000 ML InjectionSY958d35f0-6834-43be-a700-fa58f38b4c1919
1807633sodium chloride 0.9 % per 250 ML InjectionSY958d35f0-6834-43be-a700-fa58f38b4c1919
1807631sodium chloride 0.9 % per 50 ML InjectionSY958d35f0-6834-43be-a700-fa58f38b4c1919
1807634sodium chloride 0.9 % per 500 ML InjectionSY958d35f0-6834-43be-a700-fa58f38b4c1919

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
0338-9543-0100338954301250 mL in 1 BAG (0338-9543-01) 250 ml1970-12-090000-00-00NoNoCurrent
0338-9543-0200338954302250 mL in 1 BAG (0338-9543-02) 250 ml1970-12-090000-00-00NoNoCurrent
0338-9543-0300338954303500 mL in 1 BAG (0338-9543-03) 500 ml1970-12-090000-00-00NoNoCurrent
0338-9543-0400338954304500 mL in 1 BAG (0338-9543-04) 500 ml1970-12-090000-00-00NoNoCurrent
0338-9543-05003389543051000 mL in 1 BAG (0338-9543-05) 1000 ml1970-12-090000-00-00NoNoCurrent
0338-9543-06003389543061000 mL in 1 BAG (0338-9543-06) 1000 ml1970-12-090000-00-00NoNoCurrent
0338-9543-12003389543121000 mL in 1 BAG (0338-9543-12) 1000 ml1970-12-09NoNoHistorical