FDA.reportPublic FDA data

Sodium Acetate

Product NDC
0409-3299
11-digit product format
004093299
Labeler code
0409
Product ID
0409-3299_4e6137c2-6b7c-4882-985c-03b591b6c046
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
sodium acetate
Dosage form
INJECTION, SOLUTION, CONCENTRATE
Route
INTRAVENOUS
Labeler
Hospira, Inc.
Application
NDA018893
Marketing category
NDA
Marketing start
2005-04-30
Substance
SODIUM ACETATE ANHYDROUS
Active strength
164 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
Sodium Acetate
Listing expiration
2027-12-31

Active Ingredients#

Ingredient, Strength table
IngredientStrength
SODIUM ACETATE ANHYDROUS164 mg/mL

Harmonized Identifiers#

Field, Values table
FieldValues
UniiNVG71ZZ7P0
Rxcui237371

DailyMed Product Concepts#

Product concept, Relation, Version table
Product conceptRelationVersionEffective
95250459-30e4-45c1-b08a-993044f49109Product name220250805
726062af-1135-4707-a1d7-57256991bbf9Product name220250226
a21a21e5-f36d-4c1f-8918-def921b8f7e3Product name320250124
fb7ab793-2c12-4079-b100-a64f73bef25aProduct name420240712
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
48747306-602a-42cc-957b-5b0c69158eeeProduct name120180604
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
db5ebcdb-b6ae-21cd-4dc5-76cd84b5578bProduct name120140508
ec2149b3-5c6d-5344-f757-c86411073075Product name120140508
ed912195-5da0-0f2f-6f4b-3ef17710cbe3Product name120140508

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
0409-3299-05Sodium Acetate25 in 1 TRAYINJECTION, SOLUTION, CONCENTRATE2515
0409-3299-06Sodium Acetate25 in 1 CASEINJECTION, SOLUTION, CONCENTRATE2515
0409-3299-15Sodium Acetate50 mL in 1 VIALINJECTION, SOLUTION, CONCENTRATE5015
0409-3299-16Sodium Acetate100 mL in 1 VIALINJECTION, SOLUTION, CONCENTRATE10015
0409-3299-25Sodium Acetate25 in 1 CASEINJECTION, SOLUTION, CONCENTRATE2512
0409-3299-26Sodium Acetate25 in 1 TRAYINJECTION, SOLUTION, CONCENTRATE2512
0409-3299-45Sodium Acetate100 mL in 1 VIALINJECTION, SOLUTION, CONCENTRATE10012
0409-3299-46Sodium Acetate50 mL in 1 VIALINJECTION, SOLUTION, CONCENTRATE5012

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
0409-3299-05ML - Milliliter0409-329912d3c4eb-100c-45b1-b2bb-cbf23fc1de6112013-05-02
0409-3299-06ML - Milliliter0409-32996319ede0-a2b5-4a8d-8146-2c259d7ccab112013-05-02
0409-3299-15ML - Milliliter0409-3299484d5cac-9c43-492d-bbb6-f34999221fa912018-02-20
0409-3299-16ML - Milliliter0409-3299725e6127-ae0e-47a5-a0c9-b8fc57bfc66112017-11-06
0409-3299-25ML - Milliliter0409-3299661926dd-4837-4a15-9b7e-d85bbb8c8ecc12014-04-03
0409-3299-26ML - Milliliter0409-32995fe5e51a-0df8-418f-a254-9dced9aa6abd12014-04-03
0409-3299-45ML - Milliliter0409-3299b17ed8e7-1a49-4b12-b5da-9ae19776bbe712018-03-08
0409-3299-46ML - Milliliter0409-3299fcad2d16-9c14-4e9d-b460-f85261168e1e12019-04-11

DailyMed Socrata Ingredients#

Ingredient, Type, UNII table
IngredientTypeUNIIDailyMed labelSPL versionUploaded
SODIUM ACETATE ANHYDROUSACTIVE INGREDIENTNVG71ZZ7P0SODIUM ACETATE INJECTION, SOLUTION, CONCENTRATE [HOSPIRA, INC.]5
SODIUM CATIONACTIVE MOIETYLYR4M0NH37SODIUM ACETATE INJECTION, SOLUTION, CONCENTRATE [HOSPIRA, INC.]5
ACETIC ACIDINACTIVE INGREDIENTQ40Q9N063PSODIUM ACETATE INJECTION, SOLUTION, CONCENTRATE [HOSPIRA, INC.]5
WATERINACTIVE INGREDIENT059QF0KO0RSODIUM ACETATE INJECTION, SOLUTION, CONCENTRATE [HOSPIRA, INC.]5
SODIUM ACETATE ANHYDROUSACTIVE INGREDIENTNVG71ZZ7P0SODIUM ACETATE INJECTION, SOLUTION, CONCENTRATE [HOSPIRA, INC.]2
SODIUM CATIONACTIVE MOIETYLYR4M0NH37SODIUM ACETATE INJECTION, SOLUTION, CONCENTRATE [HOSPIRA, INC.]2
ACETIC ACIDINACTIVE INGREDIENTQ40Q9N063PSODIUM ACETATE INJECTION, SOLUTION, CONCENTRATE [HOSPIRA, INC.]2
WATERINACTIVE INGREDIENT059QF0KO0RSODIUM ACETATE INJECTION, SOLUTION, CONCENTRATE [HOSPIRA, INC.]2

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
0409-3299SODIUM ACETATE INJECTION, SOLUTION, CONCENTRATE [HOSPIRA, INC.]14Current NDC, Legacy NDC, 4 package rows20241108_abc41ed1-9512-4bea-9295-1a9ca134b6c2.zip
0409-3299SODIUM ACETATE INJECTION, SOLUTION, CONCENTRATE [HOSPIRA, INC.]11Current NDC, Legacy NDC, 4 package rows20241109_c3be2468-45e8-4ecc-a30b-e966743a563f.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
237371sodium acetate 2 MEQ/ML Injectable SolutionPSNabc41ed1-9512-4bea-9295-1a9ca134b6c215
237371sodium acetate 2 MEQ/ML Injectable SolutionSCDabc41ed1-9512-4bea-9295-1a9ca134b6c215
237371sodium acetate 164 MG per 1 ML Injectable SolutionSYabc41ed1-9512-4bea-9295-1a9ca134b6c215
237371sodium acetate 2 MEQ/ML Injectable SolutionPSNc3be2468-45e8-4ecc-a30b-e966743a563f12
237371sodium acetate 2 MEQ/ML Injectable SolutionSCDc3be2468-45e8-4ecc-a30b-e966743a563f12
237371sodium acetate 164 MG per 1 ML Injectable SolutionSYc3be2468-45e8-4ecc-a30b-e966743a563f12

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
0409-3299-050040932990525 VIAL in 1 TRAY (0409-3299-05) / 50 mL in 1 VIAL (0409-3299-15) 25 vial2005-05-160000-00-00NoNoCurrent
0409-3299-060040932990625 VIAL in 1 CASE (0409-3299-06) / 100 mL in 1 VIAL (0409-3299-16) 25 vial2005-04-300000-00-00NoNoCurrent
0409-3299-150040932991550 mL in 1 VIAL50 mlHistorical
0409-3299-1600409329916100 mL in 1 VIAL100 mlHistorical
0409-3299-250040932992525 VIAL in 1 CASE (0409-3299-25) / 100 mL in 1 VIAL (0409-3299-45) 25 vial2013-11-190000-00-00NoNoCurrent
0409-3299-260040932992625 VIAL in 1 TRAY (0409-3299-26) / 50 mL in 1 VIAL (0409-3299-46) 25 vial2013-11-190000-00-00NoNoCurrent
0409-3299-4500409329945100 mL in 1 VIAL100 mlHistorical
0409-3299-460040932994650 mL in 1 VIAL50 mlHistorical