FDA.reportPublic FDA data

Sodium Chloride

Product NDC
0264-2201
11-digit product format
002642201
Labeler code
0264
Product ID
0264-2201_7ba512da-d3fe-40c0-8ff4-99f9771f301e
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
Sodium Chloride
Dosage form
IRRIGANT
Route
IRRIGATION
Labeler
B. Braun Medical Inc.
Application
NDA016733
Marketing category
NDA
Marketing start
2009-09-14
Substance
SODIUM CHLORIDE
Active strength
.9 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
2027-12-31
Current FDA listing
Yes

Additional Listing Data#

Finished product
Yes
Brand name base
Sodium Chloride
Listing expiration
2027-12-31

Active Ingredients#

Ingredient, Strength table
IngredientStrength
SODIUM CHLORIDE.9 g/100mL

Harmonized Identifiers#

Field, Values table
FieldValues
Unii451W47IQ8X
Rxcui486515

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

FDA-Initiated Inactive NDC Indexing#

NDC, Effective, Action table
NDCEffectiveActionDocumentIndexing SPLRelated label
0264-2201-002022-02-28C16284748780-1d6a99b39-9e49-a426-e053-dadaa90af4c20.9% Sodium Chloride Irrigation USP
0264-2201-102022-02-28C16284748780-1d6a99b39-9e49-a426-e053-dadaa90af4c20.9% Sodium Chloride Irrigation USP
0264-2201-502022-02-28C16284748780-1d6a99b39-9e49-a426-e053-dadaa90af4c20.9% Sodium Chloride Irrigation USP
0264-2201-702022-02-28C16284748780-1d6a99b39-9e49-a426-e053-dadaa90af4c20.9% Sodium Chloride Irrigation USP
0264-2201-002022-01-28C16284748780-1d6a99b39-9e49-a426-e053-dadaa90af4c20.9% Sodium Chloride Irrigation USP
0264-2201-102022-01-28C16284748780-1d6a99b39-9e49-a426-e053-dadaa90af4c20.9% Sodium Chloride Irrigation USP
0264-2201-502022-01-28C16284748780-1d6a99b39-9e49-a426-e053-dadaa90af4c20.9% Sodium Chloride Irrigation USP
0264-2201-702022-01-28C16284748780-1d6a99b39-9e49-a426-e053-dadaa90af4c20.9% Sodium Chloride Irrigation USP

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
0264-2201-00Sodium Chloride16 in 1 CASEIRRIGANT1617
0264-2201-00Sodium Chloride1000 mL in 1 CONTAINERIRRIGANT100017
0264-2201-10Sodium Chloride16 in 1 CASEIRRIGANT1617
0264-2201-10Sodium Chloride500 mL in 1 CONTAINERIRRIGANT50017
0264-2201-50Sodium Chloride8 in 1 CASEIRRIGANT817
0264-2201-50Sodium Chloride2000 mL in 1 CONTAINERIRRIGANT200017
0264-2201-70Sodium Chloride4000 mL in 1 CONTAINERIRRIGANT400017
0264-2201-70Sodium Chloride4 in 1 CASEIRRIGANT417

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
0264-2201-00ML - Milliliter0264-2201a52a771a-8d79-4b9f-9478-94a22328518612012-07-24
0264-2201-10ML - Milliliter0264-22017f3af6d9-919b-4e82-a1f6-8121315049ac12012-07-24
0264-2201-50ML - Milliliter0264-22013381927e-1220-49c6-9364-6090cd774d4312012-07-24
0264-2201-70ML - Milliliter0264-2201f3dad2db-c85c-4906-9f28-99c55d52af9812012-07-24

DailyMed Socrata Ingredients#

Ingredient, Type, UNII table
IngredientTypeUNIIDailyMed labelSPL versionUploaded
SODIUM CHLORIDEACTIVE INGREDIENT451W47IQ8XSODIUM CHLORIDE IRRIGANT [B. BRAUN MEDICAL INC.]5
SODIUM CATIONACTIVE MOIETYLYR4M0NH37SODIUM CHLORIDE IRRIGANT [B. BRAUN MEDICAL INC.]5
HYDROCHLORIC ACIDINACTIVE INGREDIENTQTT17582CBSODIUM CHLORIDE IRRIGANT [B. BRAUN MEDICAL INC.]5
WATERINACTIVE INGREDIENT059QF0KO0RSODIUM CHLORIDE IRRIGANT [B. BRAUN MEDICAL INC.]5
SODIUM CHLORIDEACTIVE INGREDIENT451W47IQ8XSODIUM CHLORIDE IRRIGANT [REMEDYREPACK INC. ]1
CHLORIDE IONACTIVE MOIETYQ32ZN48698SODIUM CHLORIDE IRRIGANT [REMEDYREPACK INC. ]1
HYDROCHLORIC ACIDINACTIVE INGREDIENTQTT17582CBSODIUM CHLORIDE IRRIGANT [REMEDYREPACK INC. ]1
WATERINACTIVE INGREDIENT059QF0KO0RSODIUM CHLORIDE IRRIGANT [REMEDYREPACK INC. ]1

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
0264-2201SODIUM CHLORIDE IRRIGANT [B. BRAUN MEDICAL INC.]16Current NDC, Legacy NDC, 8 package rows20230910_0d59a04a-32e6-485b-b638-a1e6c09e9642.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
486515sodium chloride 0.9 % Irrigation SolutionPSN0d59a04a-32e6-485b-b638-a1e6c09e964217
486515sodium chloride 0.154 MEQ/ML Irrigation SolutionSCD0d59a04a-32e6-485b-b638-a1e6c09e964217
486515NaCl 0.154 MEQ/ML Irrigation SolutionSY0d59a04a-32e6-485b-b638-a1e6c09e964217
486515sodium chloride 0.9 % Irrigation SolutionSY0d59a04a-32e6-485b-b638-a1e6c09e964217
486515sodium chloride 0.9 % Irrigation SolutionPSN28d4f254-03d0-4362-a496-b7dd308c8d481
486515sodium chloride 0.154 MEQ/ML Irrigation SolutionSCD28d4f254-03d0-4362-a496-b7dd308c8d481
486515NaCl 0.154 MEQ/ML Irrigation SolutionSY28d4f254-03d0-4362-a496-b7dd308c8d481
486515sodium chloride 0.9 % Irrigation SolutionSY28d4f254-03d0-4362-a496-b7dd308c8d481

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
0264-2201-000026422010016 CONTAINER in 1 CASE (0264-2201-00) / 1000 mL in 1 CONTAINER16 container2009-09-140000-00-00NoNoCurrent
0264-2201-100026422011016 CONTAINER in 1 CASE (0264-2201-10) / 500 mL in 1 CONTAINER16 container2009-09-140000-00-00NoNoCurrent
0264-2201-50002642201508 CONTAINER in 1 CASE (0264-2201-50) > 2000 mL in 1 CONTAINER8 container2009-09-140000-00-00NoNoCurrent
0264-2201-70002642201704 CONTAINER in 1 CASE (0264-2201-70) > 4000 mL in 1 CONTAINER4 container2009-09-140000-00-00NoNoCurrent