FDA.reportPublic FDA data

Potassium Acetate

Product NDC
0409-3294
11-digit product format
004093294
Labeler code
0409
Product ID
0409-3294_0e632089-d515-4a4f-87a9-40d585864eff
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
POTASSIUM ACETATE
Dosage form
INJECTION, SOLUTION, CONCENTRATE
Route
INTRAVENOUS
Labeler
Hospira, Inc.
Application
NDA018896
Marketing category
NDA
Marketing start
2013-12-23
Substance
POTASSIUM ACETATE
Active strength
196.3 mg/mL
Pharmacologic classes
Increased Large Intestinal Motility [PE], Inhibition Large Intestine Fluid/Electrolyte Absorption [PE], Osmotic Activity [MoA], Osmotic Laxative [EPC], Potassium Compounds [CS], Potassium Salt [EPC]
NDC exclude flag
No
Listing certified through
2027-12-31
Current FDA listing
Yes

Additional Listing Data#

Finished product
Yes
Brand name base
Potassium Acetate
Listing expiration
2027-12-31

Active Ingredients#

Ingredient, Strength table
IngredientStrength
POTASSIUM ACETATE196.3 mg/mL

Harmonized Identifiers#

Field, Values table
FieldValues
UniiM911911U02
Rxcui237381

DailyMed Product Concepts#

Product concept, Relation, Version table
Product conceptRelationVersionEffective
9e37788c-b1bf-42ae-aac9-b60601606144Product name820260122
95250459-30e4-45c1-b08a-993044f49109Product name220250805
d9771140-739b-484b-ae64-b79528ff1211Product name320250801
efd58dcf-540a-4531-8766-e713129ca6f2Product name120250307
1527ac37-808d-43be-a63e-74e1258dbe46Product name920250219
bed0530e-f939-4541-956b-6928a2f6404fProduct name120241008
cefa60e2-a5b5-493e-9c54-24735b7dc509Product name620240814
362d7abb-94e6-4c60-9a58-266894157713Product name120231023
9fcb7a91-de07-4f00-aabf-e4d6fda403d5Product name820230322
6bd95106-a412-1dad-b9cc-4cb74bfb27ceProduct name220230315
9badc7be-250a-44ab-aa36-926af3f02679Product name120210527
0ec3537a-6c9b-432a-896c-b9ea8723049aProduct name920200701
444b3e50-f226-46ef-bfca-2e7035d140cdProduct name120190611
816b97af-edc5-4060-aff1-b814bdbcad50Product name120190415
7cda52fc-125f-421c-8fea-bc1974370c49Product name220180703
7916de40-e296-41f0-b811-6d0df1a33e2cProduct name920180627
48747306-602a-42cc-957b-5b0c69158eeeProduct name120180604
cefa60e2-a5b5-493e-9c54-24735b7dc509Product name220171212
419aab54-5d5a-4146-9453-026d4a9991beProduct name220170525
26acd337-b838-40ac-bcbc-05c3b81c8712Product name120170323
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
5668b646-cd56-c3c7-bdea-3f6b1a8840dbProduct name120140508
810ab97e-f109-f41c-7c83-6a652a9cbf43Product name120140508
87711080-88eb-65c5-b2dd-bf99e700a372Product name120140508
8dbefedf-0a0d-a224-5a3c-66dc9e11c2ddProduct 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
0409-3294-15Potassium Acetate50 mL in 1 VIAL, PHARMACY BULK PACKAGEINJECTION, SOLUTION, CONCENTRATE5010
0409-3294-25Potassium Acetate25 in 1 TRAYINJECTION, SOLUTION, CONCENTRATE2510
0409-3294-51Potassium Acetate25 in 1 TRAYINJECTION, SOLUTION, CONCENTRATE258
0409-3294-61Potassium Acetate50 mL in 1 VIAL, PHARMACY BULK PACKAGEINJECTION, SOLUTION, CONCENTRATE508

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
0409-3294-15ML - Milliliter0409-329486e190fd-42a6-43f0-b633-3dc1ef6774ec12018-02-20
0409-3294-25ML - Milliliter0409-329453854f64-8b1e-4d81-bf61-2844946fe34112014-07-02
0409-3294-51ML - Milliliter0409-329464cf7e99-ccdf-4383-b105-9f69445d464512012-07-24
0409-3294-61ML - Milliliter0409-32941a74aa9d-2921-44c2-b4dd-ea38bced3fd512018-02-20

DailyMed Socrata Ingredients#

Ingredient, Type, UNII table
IngredientTypeUNIIDailyMed labelSPL versionUploaded
POTASSIUM ACETATEACTIVE INGREDIENTM911911U02POTASSIUM ACETATE INJECTION, SOLUTION, CONCENTRATE [HOSPIRA, INC.]1
POTASSIUM ACETATEACTIVE INGREDIENTM911911U02POTASSIUM ACETATE INJECTION, SOLUTION, CONCENTRATE [HOSPIRA, INC.]1
POTASSIUM CATIONACTIVE MOIETY295O53K152POTASSIUM ACETATE INJECTION, SOLUTION, CONCENTRATE [HOSPIRA, INC.]1
POTASSIUM CATIONACTIVE MOIETY295O53K152POTASSIUM ACETATE INJECTION, SOLUTION, CONCENTRATE [HOSPIRA, INC.]1
ACETIC ACIDINACTIVE INGREDIENTQ40Q9N063PPOTASSIUM ACETATE INJECTION, SOLUTION, CONCENTRATE [HOSPIRA, INC.]1
ACETIC ACIDINACTIVE INGREDIENTQ40Q9N063PPOTASSIUM ACETATE INJECTION, SOLUTION, CONCENTRATE [HOSPIRA, INC.]1
WATERINACTIVE INGREDIENT059QF0KO0RPOTASSIUM ACETATE INJECTION, SOLUTION, CONCENTRATE [HOSPIRA, INC.]1
WATERINACTIVE INGREDIENT059QF0KO0RPOTASSIUM ACETATE INJECTION, SOLUTION, CONCENTRATE [HOSPIRA, INC.]1

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
0409-3294POTASSIUM ACETATE INJECTION, SOLUTION, CONCENTRATE [HOSPIRA, INC.]9Current NDC, Legacy NDC, 2 package rows20241113_c58f8112-d587-493a-91b7-2b48c80bb7bf.zip
0409-3294POTASSIUM ACETATE INJECTION, SOLUTION, CONCENTRATE [HOSPIRA, INC.]7Current NDC, Legacy NDC, 2 package rows20241116_e9772b82-1e2b-4c4b-aa47-677491dbf73c.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
237381potassium acetate 2 MEQ/ML Injectable SolutionPSNc58f8112-d587-493a-91b7-2b48c80bb7bf10
237381potassium acetate 2 MEQ/ML Injectable SolutionSCDc58f8112-d587-493a-91b7-2b48c80bb7bf10
237381K+ Acetate 2 MEQ/ML Injectable SolutionSYc58f8112-d587-493a-91b7-2b48c80bb7bf10
237381Pot Acetate 2 MEQ/ML Injectable SolutionSYc58f8112-d587-493a-91b7-2b48c80bb7bf10
237381potassium acetate 196 MG per 1 ML Injectable SolutionSYc58f8112-d587-493a-91b7-2b48c80bb7bf10
237381potassium acetate 2 MEQ/ML Injectable SolutionPSNe9772b82-1e2b-4c4b-aa47-677491dbf73c8
237381potassium acetate 2 MEQ/ML Injectable SolutionSCDe9772b82-1e2b-4c4b-aa47-677491dbf73c8
237381K+ Acetate 2 MEQ/ML Injectable SolutionSYe9772b82-1e2b-4c4b-aa47-677491dbf73c8
237381Pot Acetate 2 MEQ/ML Injectable SolutionSYe9772b82-1e2b-4c4b-aa47-677491dbf73c8
237381potassium acetate 196 MG per 1 ML Injectable SolutionSYe9772b82-1e2b-4c4b-aa47-677491dbf73c8

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
0409-3294-150040932941550 mL in 1 VIAL, PHARMACY BULK PACKAGE50 mlHistorical
0409-3294-250040932942525 VIAL, PHARMACY BULK PACKAGE in 1 TRAY (0409-3294-25) / 50 mL in 1 VIAL, PHARMACY BULK PACKAGE (0409-3294-15) 2013-12-230000-00-00NoNoCurrent
0409-3294-510040932945125 VIAL, PHARMACY BULK PACKAGE in 1 TRAY (0409-3294-51) / 50 mL in 1 VIAL, PHARMACY BULK PACKAGE (0409-3294-61) 2005-07-050000-00-00NoNoCurrent
0409-3294-610040932946150 mL in 1 VIAL, PHARMACY BULK PACKAGE50 mlHistorical