Application 019904

Type
NDA
Sponsor
BAXTER HLTHCARE

Application Products#

Product, Drug, Ingredient table
ProductDrugIngredientFormStrengthReference drugReference standard
001POTASSIUM CHLORIDE 10MEQ IN PLASTIC CONTAINERPOTASSIUM CHLORIDEINJECTABLE;INJECTION14.9MG/MLYesYes
002POTASSIUM CHLORIDE 20MEQ IN PLASTIC CONTAINERPOTASSIUM CHLORIDEINJECTABLE;INJECTION29.8MG/MLYesYes
003POTASSIUM CHLORIDE 30MEQ IN PLASTIC CONTAINERPOTASSIUM CHLORIDEINJECTABLE;INJECTION2.24GM/100MLYesYes
004POTASSIUM CHLORIDE 40MEQ IN PLASTIC CONTAINERPOTASSIUM CHLORIDEINJECTABLE;INJECTION2.98GM/100MLYesYes
005POTASSIUM CHLORIDE 10MEQ IN PLASTIC CONTAINERPOTASSIUM CHLORIDEINJECTABLE;INJECTION746MG/100MLYesYes
006POTASSIUM CHLORIDE 20MEQ IN PLASTIC CONTAINERPOTASSIUM CHLORIDEINJECTABLE;INJECTION1.49GM/100MLYesYes

Source provenance: Browse the complete Orange Book source catalog · source snapshot 1.

Orange Book products#

Current product rows page 1 of 1 · 6 matching rows.

Application-product, Trade name, Ingredient table
Application-productTrade nameIngredientStrengthDosage form / routeTE codesRLD / RSApproval date
N019904-001POTASSIUM CHLORIDE 10MEQ IN PLASTIC CONTAINERPOTASSIUM CHLORIDE14.9MG/MLINJECTABLE / INJECTIONAPRLD, RS1989-12-26
N019904-002POTASSIUM CHLORIDE 20MEQ IN PLASTIC CONTAINERPOTASSIUM CHLORIDE29.8MG/MLINJECTABLE / INJECTIONAPRLD, RS1989-12-26
N019904-003POTASSIUM CHLORIDE 30MEQ IN PLASTIC CONTAINERPOTASSIUM CHLORIDE2.24GM/100MLINJECTABLE / INJECTIONRLD1989-12-26
N019904-004POTASSIUM CHLORIDE 40MEQ IN PLASTIC CONTAINERPOTASSIUM CHLORIDE2.98GM/100MLINJECTABLE / INJECTIONAPRLD, RS1989-12-26
N019904-005POTASSIUM CHLORIDE 10MEQ IN PLASTIC CONTAINERPOTASSIUM CHLORIDE746MG/100MLINJECTABLE / INJECTIONAPRLD, RS1990-12-17
N019904-006POTASSIUM CHLORIDE 20MEQ IN PLASTIC CONTAINERPOTASSIUM CHLORIDE1.49GM/100MLINJECTABLE / INJECTIONAPRLD, RS1990-12-17

Therapeutic equivalence codes#

Current TE-code rows page 1 of 1 · 5 matching rows.

Application-product, TE code table
Application-productTE code
N019904-001AP
N019904-002AP
N019904-004AP
N019904-005AP
N019904-006AP

Observed Orange Book product history#

Observed FDA ZIP history: Each table is queried independently by exact application/product key from successfully parsed Orange Book snapshots. Capture times identify archived source observations; absence or a change between snapshots is not inferred. FDA publication files that were not recoverable as structured ZIP data are not represented as states.

Product history page 1 of 7 · 246 observed states.

Captured, Edition, Application-product table
CapturedEditionApplication-productTrade nameStrengthDosage form / routeProduct TE source textRLD / RSApproval dateSource SHA-256
2026-02-19 14:30 UTC2026-02N019904-001POTASSIUM CHLORIDE 10MEQ IN PLASTIC CONTAINER14.9MG/MLINJECTABLE / INJECTIONAPRLD, RS1989-12-26011fe1cb6892…
2026-02-19 14:30 UTC2026-02N019904-002POTASSIUM CHLORIDE 20MEQ IN PLASTIC CONTAINER29.8MG/MLINJECTABLE / INJECTIONAPRLD, RS1989-12-26011fe1cb6892…
2026-02-19 14:30 UTC2026-02N019904-003POTASSIUM CHLORIDE 30MEQ IN PLASTIC CONTAINER2.24GM/100MLINJECTABLE / INJECTIONRLD, RS1989-12-26011fe1cb6892…
2026-02-19 14:30 UTC2026-02N019904-004POTASSIUM CHLORIDE 40MEQ IN PLASTIC CONTAINER2.98GM/100MLINJECTABLE / INJECTIONAPRLD, RS1989-12-26011fe1cb6892…
2026-02-19 14:30 UTC2026-02N019904-005POTASSIUM CHLORIDE 10MEQ IN PLASTIC CONTAINER746MG/100MLINJECTABLE / INJECTIONAPRLD, RS1990-12-17011fe1cb6892…
2026-02-19 14:30 UTC2026-02N019904-006POTASSIUM CHLORIDE 20MEQ IN PLASTIC CONTAINER1.49GM/100MLINJECTABLE / INJECTIONAPRLD, RS1990-12-17011fe1cb6892…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12N019904-001POTASSIUM CHLORIDE 10MEQ IN PLASTIC CONTAINER14.9MG/MLINJECTABLE / INJECTIONAPRLD, RS1989-12-2631067a03dcf5…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12N019904-002POTASSIUM CHLORIDE 20MEQ IN PLASTIC CONTAINER29.8MG/MLINJECTABLE / INJECTIONAPRLD, RS1989-12-2631067a03dcf5…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12N019904-003POTASSIUM CHLORIDE 30MEQ IN PLASTIC CONTAINER2.24GM/100MLINJECTABLE / INJECTIONRLD, RS1989-12-2631067a03dcf5…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12N019904-004POTASSIUM CHLORIDE 40MEQ IN PLASTIC CONTAINER2.98GM/100MLINJECTABLE / INJECTIONAPRLD, RS1989-12-2631067a03dcf5…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12N019904-005POTASSIUM CHLORIDE 10MEQ IN PLASTIC CONTAINER746MG/100MLINJECTABLE / INJECTIONAPRLD, RS1990-12-1731067a03dcf5…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12N019904-006POTASSIUM CHLORIDE 20MEQ IN PLASTIC CONTAINER1.49GM/100MLINJECTABLE / INJECTIONAPRLD, RS1990-12-1731067a03dcf5…
2025-08-23 18:47 UTC2025-08N019904-001POTASSIUM CHLORIDE 10MEQ IN PLASTIC CONTAINER14.9MG/MLINJECTABLE / INJECTIONAPRLD, RS1989-12-266a471c1ec25d…
2025-08-23 18:47 UTC2025-08N019904-002POTASSIUM CHLORIDE 20MEQ IN PLASTIC CONTAINER29.8MG/MLINJECTABLE / INJECTIONAPRLD, RS1989-12-266a471c1ec25d…
2025-08-23 18:47 UTC2025-08N019904-003POTASSIUM CHLORIDE 30MEQ IN PLASTIC CONTAINER2.24GM/100MLINJECTABLE / INJECTIONRLD, RS1989-12-266a471c1ec25d…
2025-08-23 18:47 UTC2025-08N019904-004POTASSIUM CHLORIDE 40MEQ IN PLASTIC CONTAINER2.98GM/100MLINJECTABLE / INJECTIONAPRLD, RS1989-12-266a471c1ec25d…
2025-08-23 18:47 UTC2025-08N019904-005POTASSIUM CHLORIDE 10MEQ IN PLASTIC CONTAINER746MG/100MLINJECTABLE / INJECTIONAPRLD, RS1990-12-176a471c1ec25d…
2025-08-23 18:47 UTC2025-08N019904-006POTASSIUM CHLORIDE 20MEQ IN PLASTIC CONTAINER1.49GM/100MLINJECTABLE / INJECTIONAPRLD, RS1990-12-176a471c1ec25d…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03N019904-001POTASSIUM CHLORIDE 10MEQ IN PLASTIC CONTAINER14.9MG/MLINJECTABLE / INJECTIONAPRLD, RS1989-12-26fd3edfee7708…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03N019904-002POTASSIUM CHLORIDE 20MEQ IN PLASTIC CONTAINER29.8MG/MLINJECTABLE / INJECTIONAPRLD, RS1989-12-26fd3edfee7708…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03N019904-003POTASSIUM CHLORIDE 30MEQ IN PLASTIC CONTAINER2.24GM/100MLINJECTABLE / INJECTIONRLD, RS1989-12-26fd3edfee7708…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03N019904-004POTASSIUM CHLORIDE 40MEQ IN PLASTIC CONTAINER2.98GM/100MLINJECTABLE / INJECTIONAPRLD, RS1989-12-26fd3edfee7708…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03N019904-005POTASSIUM CHLORIDE 10MEQ IN PLASTIC CONTAINER746MG/100MLINJECTABLE / INJECTIONAPRLD, RS1990-12-17fd3edfee7708…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03N019904-006POTASSIUM CHLORIDE 20MEQ IN PLASTIC CONTAINER1.49GM/100MLINJECTABLE / INJECTIONAPRLD, RS1990-12-17fd3edfee7708…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02N019904-001POTASSIUM CHLORIDE 10MEQ IN PLASTIC CONTAINER14.9MG/MLINJECTABLE / INJECTIONAPRLD, RS1989-12-26b8a1b40f171c…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02N019904-002POTASSIUM CHLORIDE 20MEQ IN PLASTIC CONTAINER29.8MG/MLINJECTABLE / INJECTIONAPRLD, RS1989-12-26b8a1b40f171c…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02N019904-003POTASSIUM CHLORIDE 30MEQ IN PLASTIC CONTAINER2.24GM/100MLINJECTABLE / INJECTIONRLD, RS1989-12-26b8a1b40f171c…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02N019904-004POTASSIUM CHLORIDE 40MEQ IN PLASTIC CONTAINER2.98GM/100MLINJECTABLE / INJECTIONAPRLD, RS1989-12-26b8a1b40f171c…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02N019904-005POTASSIUM CHLORIDE 10MEQ IN PLASTIC CONTAINER746MG/100MLINJECTABLE / INJECTIONAPRLD, RS1990-12-17b8a1b40f171c…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02N019904-006POTASSIUM CHLORIDE 20MEQ IN PLASTIC CONTAINER1.49GM/100MLINJECTABLE / INJECTIONAPRLD, RS1990-12-17b8a1b40f171c…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01N019904-001POTASSIUM CHLORIDE 10MEQ IN PLASTIC CONTAINER14.9MG/MLINJECTABLE / INJECTIONAPRLD, RS1989-12-2603ed91905a0d…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01N019904-002POTASSIUM CHLORIDE 20MEQ IN PLASTIC CONTAINER29.8MG/MLINJECTABLE / INJECTIONAPRLD, RS1989-12-2603ed91905a0d…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01N019904-003POTASSIUM CHLORIDE 30MEQ IN PLASTIC CONTAINER2.24GM/100MLINJECTABLE / INJECTIONRLD, RS1989-12-2603ed91905a0d…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01N019904-004POTASSIUM CHLORIDE 40MEQ IN PLASTIC CONTAINER2.98GM/100MLINJECTABLE / INJECTIONAPRLD, RS1989-12-2603ed91905a0d…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01N019904-005POTASSIUM CHLORIDE 10MEQ IN PLASTIC CONTAINER746MG/100MLINJECTABLE / INJECTIONAPRLD, RS1990-12-1703ed91905a0d…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01N019904-006POTASSIUM CHLORIDE 20MEQ IN PLASTIC CONTAINER1.49GM/100MLINJECTABLE / INJECTIONAPRLD, RS1990-12-1703ed91905a0d…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12N019904-001POTASSIUM CHLORIDE 10MEQ IN PLASTIC CONTAINER14.9MG/MLINJECTABLE / INJECTIONAPRLD, RS1989-12-262680178bc6a6…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12N019904-002POTASSIUM CHLORIDE 20MEQ IN PLASTIC CONTAINER29.8MG/MLINJECTABLE / INJECTIONAPRLD, RS1989-12-262680178bc6a6…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12N019904-003POTASSIUM CHLORIDE 30MEQ IN PLASTIC CONTAINER2.24GM/100MLINJECTABLE / INJECTIONRLD, RS1989-12-262680178bc6a6…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12N019904-004POTASSIUM CHLORIDE 40MEQ IN PLASTIC CONTAINER2.98GM/100MLINJECTABLE / INJECTIONAPRLD, RS1989-12-262680178bc6a6…

Observed Orange Book normalized TE history#

Normalized TE history page 1 of 6 · 205 observed states.

Captured, Edition, Application-product table
CapturedEditionApplication-productTE codeOrderSource SHA-256
2026-02-19 14:30 UTC2026-02N019904-001AP1011fe1cb6892…
2026-02-19 14:30 UTC2026-02N019904-002AP1011fe1cb6892…
2026-02-19 14:30 UTC2026-02N019904-004AP1011fe1cb6892…
2026-02-19 14:30 UTC2026-02N019904-005AP1011fe1cb6892…
2026-02-19 14:30 UTC2026-02N019904-006AP1011fe1cb6892…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12N019904-001AP131067a03dcf5…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12N019904-002AP131067a03dcf5…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12N019904-004AP131067a03dcf5…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12N019904-005AP131067a03dcf5…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12N019904-006AP131067a03dcf5…
2025-08-23 18:47 UTC2025-08N019904-001AP16a471c1ec25d…
2025-08-23 18:47 UTC2025-08N019904-002AP16a471c1ec25d…
2025-08-23 18:47 UTC2025-08N019904-004AP16a471c1ec25d…
2025-08-23 18:47 UTC2025-08N019904-005AP16a471c1ec25d…
2025-08-23 18:47 UTC2025-08N019904-006AP16a471c1ec25d…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03N019904-001AP1fd3edfee7708…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03N019904-002AP1fd3edfee7708…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03N019904-004AP1fd3edfee7708…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03N019904-005AP1fd3edfee7708…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03N019904-006AP1fd3edfee7708…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02N019904-001AP1b8a1b40f171c…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02N019904-002AP1b8a1b40f171c…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02N019904-004AP1b8a1b40f171c…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02N019904-005AP1b8a1b40f171c…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02N019904-006AP1b8a1b40f171c…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01N019904-001AP103ed91905a0d…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01N019904-002AP103ed91905a0d…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01N019904-004AP103ed91905a0d…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01N019904-005AP103ed91905a0d…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01N019904-006AP103ed91905a0d…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12N019904-001AP12680178bc6a6…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12N019904-002AP12680178bc6a6…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12N019904-004AP12680178bc6a6…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12N019904-005AP12680178bc6a6…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12N019904-006AP12680178bc6a6…
2024-09-14 05:58 UTC · 2 captures of this ZIP2024-09N019904-001AP15bbf6a4d5a75…
2024-09-14 05:58 UTC · 2 captures of this ZIP2024-09N019904-002AP15bbf6a4d5a75…
2024-09-14 05:58 UTC · 2 captures of this ZIP2024-09N019904-004AP15bbf6a4d5a75…
2024-09-14 05:58 UTC · 2 captures of this ZIP2024-09N019904-005AP15bbf6a4d5a75…
2024-09-14 05:58 UTC · 2 captures of this ZIP2024-09N019904-006AP15bbf6a4d5a75…

openFDA label cross-check#

OpenFDA label data provides additional search and identifier links. DailyMed’s Structured Product Label is the canonical label on FDA.report. Matching records are deduplicated before they are shown below.

Matched openFDA labels page 1 of 1 · 1 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
Potassium ChloridePOTASSIUM CHLORIDEBaxter Healthcare Corporation092ddee4-572d-4771-8d95-880cea01097e2026-01-09Warnings, Adverse reactionsExact identifier
application applno (NDA): 019904
application number: NDA019904
ndc (product): 0338-0709
ndc (product): 0338-0703
ndc (product): 0338-0705

NDC Listings For This Application#

NDC listings for this application page 1 of 1 · 22 matching rows.

NDC, Name, Nonproprietary name table
NDCNameNonproprietary nameLabelerMarketing categoryStatus
0338-0703Potassium ChloridePOTASSIUM CHLORIDEBaxter Healthcare CorporationNDACurrent
0338-0703Potassium ChloridePOTASSIUM CHLORIDEBaxter Healthcare CorporationNDACurrent
0338-0703Potassium ChloridePOTASSIUM CHLORIDEBaxter Healthcare CorporationNDACurrent
0338-0703Potassium ChloridePOTASSIUM CHLORIDEBaxter Healthcare CorporationNDACurrent
0338-0703Potassium ChloridePOTASSIUM CHLORIDEBaxter Healthcare CorporationNDACurrent
0338-0703Potassium ChloridePOTASSIUM CHLORIDEBaxter Healthcare CorporationNDACurrent
0338-0703Potassium ChloridePOTASSIUM CHLORIDEBaxter Healthcare CorporaNDACurrent
0338-0705Potassium ChloridePOTASSIUM CHLORIDEBaxter Healthcare CorporationNDACurrent
0338-0705Potassium ChloridePOTASSIUM CHLORIDEBaxter Healthcare CorporationNDACurrent
0338-0705Potassium ChloridePOTASSIUM CHLORIDEBaxter Healthcare CorporationNDACurrent
0338-0705Potassium ChloridePOTASSIUM CHLORIDEBaxter Healthcare CorporationNDACurrent
0338-0705Potassium ChloridePOTASSIUM CHLORIDEBaxter Healthcare CorporationNDACurrent
0338-0705Potassium ChloridePOTASSIUM CHLORIDEBaxter Healthcare CorporationNDACurrent
0338-0705Potassium ChloridePOTASSIUM CHLORIDEBaxter Healthcare CorporaNDACurrent
0338-0707Potassium ChloridePOTASSIUM CHLORIDEBaxter Healthcare CorporaNDACurrent
0338-0709Potassium ChloridePOTASSIUM CHLORIDEBaxter Healthcare CorporationNDACurrent
0338-0709Potassium ChloridePOTASSIUM CHLORIDEBaxter Healthcare CorporationNDACurrent
0338-0709Potassium ChloridePOTASSIUM CHLORIDEBaxter Healthcare CorporationNDACurrent
0338-0709Potassium ChloridePOTASSIUM CHLORIDEBaxter Healthcare CorporationNDACurrent
0338-0709Potassium ChloridePOTASSIUM CHLORIDEBaxter Healthcare CorporationNDACurrent
0338-0709Potassium ChloridePOTASSIUM CHLORIDEBaxter Healthcare CorporationNDACurrent
0338-0709Potassium ChloridePOTASSIUM CHLORIDEBaxter Healthcare CorporaNDACurrent

Documents#

Document, Submission type, Date table
DocumentSubmission typeDate
78800SUPPL 2024-06-14
78798SUPPL 2024-06-14
71333SUPPL2022-06-15
71298SUPPL2022-06-14
59153SUPPL2019-06-21
59145SUPPL2019-06-21
46840SUPPL2017-01-13
46762SUPPL2017-01-06
1797SUPPL2012-03-16