FDA.reportPublic FDA data

BACTERIOSTATIC SODIUM CHLORIDE

Product NDC
0409-1966
11-digit product format
004091966
Labeler code
0409
Product ID
0409-1966_6a0c5d7b-ef07-4f56-95ea-df0790203fac
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
SODIUM CHLORIDE
Dosage form
INJECTION, SOLUTION
Route
INTRAMUSCULAR; INTRAVENOUS; SUBCUTANEOUS
Labeler
Hospira, Inc.
Application
NDA018800
Marketing category
NDA
Marketing start
2005-04-30
Substance
SODIUM CHLORIDE
Active strength
9 mg/mL
NDC exclude flag
No
Listing certified through
2027-12-31
Current FDA listing
Yes

Additional Listing Data#

Finished product
Yes
Brand name base
BACTERIOSTATIC SODIUM CHLORIDE
Listing expiration
2027-12-31

Active Ingredients#

Ingredient, Strength table
IngredientStrength
SODIUM CHLORIDE9 mg/mL

Harmonized Identifiers#

Field, Values table
FieldValues
Unii451W47IQ8X
Rxcui313002

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
9869efd7-d6dd-0665-5b67-53adbe6ef15eProduct 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
0409-1966-01BACTERIOSTATIC SODIUM CHLORIDE20 mL in 1 VIAL, MULTI-DOSEINJECTION, SOLUTION2023
0409-1966-02BACTERIOSTATIC SODIUM CHLORIDE30 mL in 1 VIAL, MULTI-DOSEINJECTION, SOLUTION3023
0409-1966-05BACTERIOSTATIC SODIUM CHLORIDE25 in 1 TRAYINJECTION, SOLUTION2523
0409-1966-06BACTERIOSTATIC SODIUM CHLORIDE10 mL in 1 VIAL, MULTI-DOSEINJECTION, SOLUTION1023
0409-1966-07BACTERIOSTATIC SODIUM CHLORIDE25 in 1 TRAYINJECTION, SOLUTION2523
0409-1966-12BACTERIOSTATIC SODIUM CHLORIDE25 in 1 TRAYINJECTION, SOLUTION2523
0409-1966-07General Surgery Kit30 mL in 1 VIAL, MULTI-DOSEINJECTION30 mL9 mg in 1mL2
0409-1966-14General Surgery Kit30 mL in 1 VIAL, MULTI-DOSEINJECTION30 mL9 mg in 1mL2
0409-1966-07Cardiovascular Kit30 mL in 1 VIAL, MULTI-DOSEINJECTION30 mL9 mg in 1mL1
0409-1966-14Cardiovascular Kit30 mL in 1 VIAL, MULTI-DOSEINJECTION30 mL9 mg in 1mL1

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
0409-1966-01ML - Milliliter0409-196694994715-e628-498e-be89-f23f238afb1b12017-07-07
0409-1966-02ML - Milliliter0409-196638223985-3bf4-4967-85b9-dffa68c691fe12016-11-08
0409-1966-04ML - Milliliter0409-1966274526d9-bf97-4e1f-961e-94480a02750612012-07-24
0409-1966-05ML - Milliliter0409-1966c21e0eae-0594-4f3e-9f20-ddd06b150b8912012-07-24
0409-1966-06ML - Milliliter0409-19662a7e70e4-0511-4cad-be4f-97f197878aa812016-03-04
0409-1966-07ML - Milliliter0409-19666487a963-a4d7-48a3-b30b-d1dae86284ce12012-07-24
0409-1966-12ML - Milliliter0409-1966767ab65c-0f35-4a17-ad37-42618bee1f1f12012-07-24
0409-1966-14ML - Milliliter0409-196662a922e1-955e-4c72-9e0d-c787dad6c6c712012-07-24

DailyMed Socrata Ingredients#

Ingredient, Type, UNII table
IngredientTypeUNIIDailyMed labelSPL versionUploaded
SODIUM CHLORIDEACTIVE INGREDIENT451W47IQ8XGENERAL SURGERY KIT () KIT [CENTURION MEDICAL PRODUCTS]2
SODIUM CHLORIDEACTIVE INGREDIENT451W47IQ8XGENERAL SURGERY KIT () KIT [CENTURION MEDICAL PRODUCTS]2
CHLORIDE IONACTIVE MOIETYQ32ZN48698GENERAL SURGERY KIT () KIT [CENTURION MEDICAL PRODUCTS]2
CHLORIDE IONACTIVE MOIETYQ32ZN48698GENERAL SURGERY KIT () KIT [CENTURION MEDICAL PRODUCTS]2
BENZYL ALCOHOLINACTIVE INGREDIENTLKG8494WBHGENERAL SURGERY KIT () KIT [CENTURION MEDICAL PRODUCTS]2
BENZYL ALCOHOLINACTIVE INGREDIENTLKG8494WBHGENERAL SURGERY KIT () KIT [CENTURION MEDICAL PRODUCTS]2
WATERINACTIVE INGREDIENT059QF0KO0RGENERAL SURGERY KIT () KIT [CENTURION MEDICAL PRODUCTS]2
WATERINACTIVE INGREDIENT059QF0KO0RGENERAL SURGERY KIT () KIT [CENTURION MEDICAL PRODUCTS]2
SODIUM CHLORIDEACTIVE INGREDIENT451W47IQ8XCARDIOVASCULAR KIT () KIT [CENTURION MEDICAL PRODUCTS]1
SODIUM CHLORIDEACTIVE INGREDIENT451W47IQ8XSODIUM CHLORIDE INJECTION [US MEDSOURCE, LLC]1
SODIUM CHLORIDEACTIVE INGREDIENT451W47IQ8XSODIUM CHLORIDE INJECTION [PHYSICIANS TOTAL CARE, INC.]1
SODIUM CHLORIDEACTIVE INGREDIENT451W47IQ8XCARDIOVASCULAR KIT () KIT [CENTURION MEDICAL PRODUCTS]1
CHLORIDE IONACTIVE MOIETYQ32ZN48698SODIUM CHLORIDE INJECTION [PHYSICIANS TOTAL CARE, INC.]1
CHLORIDE IONACTIVE MOIETYQ32ZN48698SODIUM CHLORIDE INJECTION [US MEDSOURCE, LLC]1
CHLORIDE IONACTIVE MOIETYQ32ZN48698CARDIOVASCULAR KIT () KIT [CENTURION MEDICAL PRODUCTS]1
CHLORIDE IONACTIVE MOIETYQ32ZN48698CARDIOVASCULAR KIT () KIT [CENTURION MEDICAL PRODUCTS]1
BENZYL ALCOHOLINACTIVE INGREDIENTLKG8494WBHSODIUM CHLORIDE INJECTION [PHYSICIANS TOTAL CARE, INC.]1
BENZYL ALCOHOLINACTIVE INGREDIENTLKG8494WBHCARDIOVASCULAR KIT () KIT [CENTURION MEDICAL PRODUCTS]1
BENZYL ALCOHOLINACTIVE INGREDIENTLKG8494WBHSODIUM CHLORIDE INJECTION [US MEDSOURCE, LLC]1
BENZYL ALCOHOLINACTIVE INGREDIENTLKG8494WBHCARDIOVASCULAR KIT () KIT [CENTURION MEDICAL PRODUCTS]1
HYDROCHLORIC ACIDINACTIVE INGREDIENTQTT17582CBSODIUM CHLORIDE INJECTION [US MEDSOURCE, LLC]1
WATERINACTIVE INGREDIENT059QF0KO0RSODIUM CHLORIDE INJECTION [PHYSICIANS TOTAL CARE, INC.]1
WATERINACTIVE INGREDIENT059QF0KO0RSODIUM CHLORIDE INJECTION [US MEDSOURCE, LLC]1
WATERINACTIVE INGREDIENT059QF0KO0RCARDIOVASCULAR KIT () KIT [CENTURION MEDICAL PRODUCTS]1
WATERINACTIVE INGREDIENT059QF0KO0RCARDIOVASCULAR KIT () KIT [CENTURION MEDICAL PRODUCTS]1

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
0409-1966BACTERIOSTATIC SODIUM CHLORIDE (SODIUM CHLORIDE) INJECTION, SOLUTION [HOSPIRA, INC.]22Current NDC, Legacy NDC, 6 package rows20241108_376093e7-e09e-4a57-3199-195e45251866.zip
0409-1966GENERAL SURGERY KIT () KIT [CENTURION MEDICAL PRODUCTS]2Current NDC, Legacy NDC20120522_4a4b3ade-8dbd-465e-9ff2-ee067a483e27.zip
0409-1966GENERAL SURGERY KIT () KIT [CENTURION MEDICAL PRODUCTS]2Current NDC, Legacy NDC20120522_acc0470d-b876-4ba1-a37a-99922e1dec72.zip
0409-1966CARDIOVASCULAR KIT () KIT [CENTURION MEDICAL PRODUCTS]1Current NDC, Legacy NDC20120523_370ed894-7dfe-4ae0-8f9f-b13ac5c6b6b6.zip
0409-1966CARDIOVASCULAR KIT () KIT [CENTURION MEDICAL PRODUCTS]1Current NDC, Legacy NDC20120523_5465a3d1-131d-40e6-994c-162354e7a7a6.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
313002sodium chloride 0.9 % Injectable SolutionPSN376093e7-e09e-4a57-3199-195e4525186623
313002sodium chloride 9 MG/ML Injectable SolutionSCD376093e7-e09e-4a57-3199-195e4525186623
313002NaCl 9 MG/ML Injectable SolutionSY376093e7-e09e-4a57-3199-195e4525186623
313002sodium chloride 0.9 % Injectable SolutionSY376093e7-e09e-4a57-3199-195e4525186623
313002sodium chloride 9 MG/ML Injectable SolutionSY376093e7-e09e-4a57-3199-195e4525186623
313002sodium chloride 0.9 % Injectable SolutionPSN31188cdf-7bc8-4d78-bfaf-c1dc9f851fd49
313002sodium chloride 9 MG/ML Injectable SolutionSCD31188cdf-7bc8-4d78-bfaf-c1dc9f851fd49
313002NaCl 9 MG/ML Injectable SolutionSY31188cdf-7bc8-4d78-bfaf-c1dc9f851fd49
313002sodium chloride 0.9 % Injectable SolutionSY31188cdf-7bc8-4d78-bfaf-c1dc9f851fd49
313002sodium chloride 9 MG/ML Injectable SolutionSY31188cdf-7bc8-4d78-bfaf-c1dc9f851fd49
313002sodium chloride 0.9 % Injectable SolutionPSN763ff805-af1a-e8e9-e053-2a91aa0a82534
313002sodium chloride 0.9 % Injectable SolutionPSN7611e508-6da2-3a2f-e053-2a91aa0a9f404
313002sodium chloride 9 MG/ML Injectable SolutionSCD763ff805-af1a-e8e9-e053-2a91aa0a82534
313002sodium chloride 9 MG/ML Injectable SolutionSCD7611e508-6da2-3a2f-e053-2a91aa0a9f404
313002NaCl 9 MG/ML Injectable SolutionSY763ff805-af1a-e8e9-e053-2a91aa0a82534
313002NaCl 9 MG/ML Injectable SolutionSY7611e508-6da2-3a2f-e053-2a91aa0a9f404
313002sodium chloride 0.9 % Injectable SolutionSY763ff805-af1a-e8e9-e053-2a91aa0a82534
313002sodium chloride 0.9 % Injectable SolutionSY7611e508-6da2-3a2f-e053-2a91aa0a9f404
313002sodium chloride 9 MG/ML Injectable SolutionSY763ff805-af1a-e8e9-e053-2a91aa0a82534
313002sodium chloride 9 MG/ML Injectable SolutionSY7611e508-6da2-3a2f-e053-2a91aa0a9f404
313002sodium chloride 0.9 % Injectable SolutionPSN3868864f-4f46-d2a1-e063-6394a90a65d53
313002sodium chloride 9 MG/ML Injectable SolutionSCD3868864f-4f46-d2a1-e063-6394a90a65d53
313002NaCl 9 MG/ML Injectable SolutionSY3868864f-4f46-d2a1-e063-6394a90a65d53
313002sodium chloride 0.9 % Injectable SolutionSY3868864f-4f46-d2a1-e063-6394a90a65d53
313002sodium chloride 9 MG/ML Injectable SolutionSY3868864f-4f46-d2a1-e063-6394a90a65d53
313002sodium chloride 0.9 % Injectable SolutionPSN4a4b3ade-8dbd-465e-9ff2-ee067a483e272
313002sodium chloride 0.9 % Injectable SolutionPSNacc0470d-b876-4ba1-a37a-99922e1dec722
313002sodium chloride 0.9 % Injectable SolutionPSN8a0d24a9-d02a-0379-e053-2a95a90af7122
313002sodium chloride 9 MG/ML Injectable SolutionSCD4a4b3ade-8dbd-465e-9ff2-ee067a483e272
313002sodium chloride 9 MG/ML Injectable SolutionSCDacc0470d-b876-4ba1-a37a-99922e1dec722
313002sodium chloride 9 MG/ML Injectable SolutionSCD8a0d24a9-d02a-0379-e053-2a95a90af7122
313002NaCl 9 MG/ML Injectable SolutionSY4a4b3ade-8dbd-465e-9ff2-ee067a483e272
313002NaCl 9 MG/ML Injectable SolutionSYacc0470d-b876-4ba1-a37a-99922e1dec722
313002NaCl 9 MG/ML Injectable SolutionSY8a0d24a9-d02a-0379-e053-2a95a90af7122
313002sodium chloride 0.9 % Injectable SolutionSYacc0470d-b876-4ba1-a37a-99922e1dec722
313002sodium chloride 0.9 % Injectable SolutionSY8a0d24a9-d02a-0379-e053-2a95a90af7122
313002sodium chloride 0.9 % Injectable SolutionSY4a4b3ade-8dbd-465e-9ff2-ee067a483e272
313002sodium chloride 9 MG/ML Injectable SolutionSYacc0470d-b876-4ba1-a37a-99922e1dec722
313002sodium chloride 9 MG/ML Injectable SolutionSY8a0d24a9-d02a-0379-e053-2a95a90af7122
313002sodium chloride 9 MG/ML Injectable SolutionSY4a4b3ade-8dbd-465e-9ff2-ee067a483e272
313002sodium chloride 0.9 % Injectable SolutionPSNa5da52df-85d0-4776-90ed-f7eff9eace1e1
313002sodium chloride 0.9 % Injectable SolutionPSN979f320d-f91a-47b4-a4d1-958446a3b5ad1
313002sodium chloride 0.9 % Injectable SolutionPSN5465a3d1-131d-40e6-994c-162354e7a7a61
313002sodium chloride 0.9 % Injectable SolutionPSN370ed894-7dfe-4ae0-8f9f-b13ac5c6b6b61
313002sodium chloride 9 MG/ML Injectable SolutionSCD5465a3d1-131d-40e6-994c-162354e7a7a61
313002sodium chloride 9 MG/ML Injectable SolutionSCD979f320d-f91a-47b4-a4d1-958446a3b5ad1
313002sodium chloride 9 MG/ML Injectable SolutionSCD370ed894-7dfe-4ae0-8f9f-b13ac5c6b6b61
313002sodium chloride 9 MG/ML Injectable SolutionSCDa5da52df-85d0-4776-90ed-f7eff9eace1e1
313002NaCl 9 MG/ML Injectable SolutionSY370ed894-7dfe-4ae0-8f9f-b13ac5c6b6b61
313002NaCl 9 MG/ML Injectable SolutionSY979f320d-f91a-47b4-a4d1-958446a3b5ad1
313002NaCl 9 MG/ML Injectable SolutionSY5465a3d1-131d-40e6-994c-162354e7a7a61
313002NaCl 9 MG/ML Injectable SolutionSYa5da52df-85d0-4776-90ed-f7eff9eace1e1
313002sodium chloride 0.9 % Injectable SolutionSY979f320d-f91a-47b4-a4d1-958446a3b5ad1
313002sodium chloride 0.9 % Injectable SolutionSYa5da52df-85d0-4776-90ed-f7eff9eace1e1
313002sodium chloride 0.9 % Injectable SolutionSY5465a3d1-131d-40e6-994c-162354e7a7a61
313002sodium chloride 0.9 % Injectable SolutionSY370ed894-7dfe-4ae0-8f9f-b13ac5c6b6b61
313002sodium chloride 9 MG/ML Injectable SolutionSYa5da52df-85d0-4776-90ed-f7eff9eace1e1
313002sodium chloride 9 MG/ML Injectable SolutionSY979f320d-f91a-47b4-a4d1-958446a3b5ad1
313002sodium chloride 9 MG/ML Injectable SolutionSY5465a3d1-131d-40e6-994c-162354e7a7a61
313002sodium chloride 9 MG/ML Injectable SolutionSY370ed894-7dfe-4ae0-8f9f-b13ac5c6b6b61

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
0409-1966-010040919660120 mL in 1 VIAL, MULTI-DOSE20 mlHistorical
0409-1966-020040919660230 mL in 1 VIAL, MULTI-DOSE30 mlHistorical
0409-1966-050040919660525 VIAL, MULTI-DOSE in 1 TRAY (0409-1966-05) / 20 mL in 1 VIAL, MULTI-DOSE (0409-1966-01) 2005-05-020000-00-00NoNoCurrent
0409-1966-060040919660610 mL in 1 VIAL, MULTI-DOSE10 mlHistorical
0409-1966-070040919660725 VIAL, MULTI-DOSE in 1 TRAY (0409-1966-07) / 30 mL in 1 VIAL, MULTI-DOSE (0409-1966-02) 2005-04-300000-00-00NoNoCurrent
0409-1966-120040919661225 VIAL, MULTI-DOSE in 1 TRAY (0409-1966-12) / 10 mL in 1 VIAL, MULTI-DOSE (0409-1966-06) 2005-10-070000-00-00NoNoCurrent
0409-1966-140040919661430 mL in 1 VIAL, MULTI-DOSE30 mlHistorical