FDA.reportPublic FDA data

Application 019699

Type
NDA
Sponsor
B BRAUN

Application Products#

Product, Drug, Ingredient table
ProductDrugIngredientFormStrengthReference drugReference standard
001POTASSIUM CHLORIDE 0.037% IN DEXTROSE 5% IN PLASTIC CONTAINERDEXTROSE; POTASSIUM CHLORIDEINJECTABLE;INJECTION5GM/100ML;37MG/100MLNoNo
002POTASSIUM CHLORIDE 0.075% IN DEXTROSE 5% IN PLASTIC CONTAINERDEXTROSE; POTASSIUM CHLORIDEINJECTABLE;INJECTION5GM/100ML;75MG/100MLNoNo
003POTASSIUM CHLORIDE 0.11% IN DEXTROSE 5% IN PLASTIC CONTAINERDEXTROSE; POTASSIUM CHLORIDEINJECTABLE;INJECTION5GM/100ML;110MG/100MLNoNo
004POTASSIUM CHLORIDE 0.15% IN DEXTROSE 5% IN PLASTIC CONTAINERDEXTROSE; POTASSIUM CHLORIDEINJECTABLE;INJECTION5GM/100ML;150MG/100MLNoNo
005POTASSIUM CHLORIDE 0.22% IN DEXTROSE 5% IN PLASTIC CONTAINERDEXTROSE; POTASSIUM CHLORIDEINJECTABLE;INJECTION5GM/100ML;220MG/100MLNoNo
006POTASSIUM CHLORIDE 0.3% IN DEXTROSE 5% IN PLASTIC CONTAINERDEXTROSE; POTASSIUM CHLORIDEINJECTABLE;INJECTION5GM/100ML;300MG/100MLNoNo

Source provenance: Browse the complete Orange Book source catalog · source snapshot 42.

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
N019699-001POTASSIUM CHLORIDE 0.037% IN DEXTROSE 5% IN PLASTIC CONTAINERDEXTROSE; POTASSIUM CHLORIDE5GM/100ML;37MG/100MLINJECTABLE / INJECTION1989-09-29
N019699-002POTASSIUM CHLORIDE 0.075% IN DEXTROSE 5% IN PLASTIC CONTAINERDEXTROSE; POTASSIUM CHLORIDE5GM/100ML;75MG/100MLINJECTABLE / INJECTION1989-09-29
N019699-003POTASSIUM CHLORIDE 0.11% IN DEXTROSE 5% IN PLASTIC CONTAINERDEXTROSE; POTASSIUM CHLORIDE5GM/100ML;110MG/100MLINJECTABLE / INJECTION1989-09-29
N019699-004POTASSIUM CHLORIDE 0.15% IN DEXTROSE 5% IN PLASTIC CONTAINERDEXTROSE; POTASSIUM CHLORIDE5GM/100ML;150MG/100MLINJECTABLE / INJECTIONAP1989-09-29
N019699-005POTASSIUM CHLORIDE 0.22% IN DEXTROSE 5% IN PLASTIC CONTAINERDEXTROSE; POTASSIUM CHLORIDE5GM/100ML;220MG/100MLINJECTABLE / INJECTION1989-09-29
N019699-006POTASSIUM CHLORIDE 0.3% IN DEXTROSE 5% IN PLASTIC CONTAINERDEXTROSE; POTASSIUM CHLORIDE5GM/100ML;300MG/100MLINJECTABLE / INJECTIONAP1989-09-29

Therapeutic equivalence codes#

Current TE-code rows page 1 of 1 · 2 matching rows.

Application-product, TE code table
Application-productTE code
N019699-004AP
N019699-006AP

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 · 252 observed states.

Captured, Edition, Application-product table
CapturedEditionApplication-productTrade nameStrengthDosage form / routeProduct TE source textRLD / RSApproval dateSource SHA-256
2026-08-18 06:07:402026-07N019699-001POTASSIUM CHLORIDE 0.037% IN DEXTROSE 5% IN PLASTIC CONTAINER5GM/100ML;37MG/100MLINJECTABLE / INJECTION1989-09-29caaa826d4ba7…
2026-08-18 06:07:402026-07N019699-002POTASSIUM CHLORIDE 0.075% IN DEXTROSE 5% IN PLASTIC CONTAINER5GM/100ML;75MG/100MLINJECTABLE / INJECTION1989-09-29caaa826d4ba7…
2026-08-18 06:07:402026-07N019699-003POTASSIUM CHLORIDE 0.11% IN DEXTROSE 5% IN PLASTIC CONTAINER5GM/100ML;110MG/100MLINJECTABLE / INJECTION1989-09-29caaa826d4ba7…
2026-08-18 06:07:402026-07N019699-004POTASSIUM CHLORIDE 0.15% IN DEXTROSE 5% IN PLASTIC CONTAINER5GM/100ML;150MG/100MLINJECTABLE / INJECTIONAP1989-09-29caaa826d4ba7…
2026-08-18 06:07:402026-07N019699-005POTASSIUM CHLORIDE 0.22% IN DEXTROSE 5% IN PLASTIC CONTAINER5GM/100ML;220MG/100MLINJECTABLE / INJECTION1989-09-29caaa826d4ba7…
2026-08-18 06:07:402026-07N019699-006POTASSIUM CHLORIDE 0.3% IN DEXTROSE 5% IN PLASTIC CONTAINER5GM/100ML;300MG/100MLINJECTABLE / INJECTIONAP1989-09-29caaa826d4ba7…
2026-02-19 14:30 UTC2026-02N019699-001POTASSIUM CHLORIDE 0.037% IN DEXTROSE 5% IN PLASTIC CONTAINER5GM/100ML;37MG/100MLINJECTABLE / INJECTION1989-09-29011fe1cb6892…
2026-02-19 14:30 UTC2026-02N019699-002POTASSIUM CHLORIDE 0.075% IN DEXTROSE 5% IN PLASTIC CONTAINER5GM/100ML;75MG/100MLINJECTABLE / INJECTION1989-09-29011fe1cb6892…
2026-02-19 14:30 UTC2026-02N019699-003POTASSIUM CHLORIDE 0.11% IN DEXTROSE 5% IN PLASTIC CONTAINER5GM/100ML;110MG/100MLINJECTABLE / INJECTION1989-09-29011fe1cb6892…
2026-02-19 14:30 UTC2026-02N019699-004POTASSIUM CHLORIDE 0.15% IN DEXTROSE 5% IN PLASTIC CONTAINER5GM/100ML;150MG/100MLINJECTABLE / INJECTIONAP1989-09-29011fe1cb6892…
2026-02-19 14:30 UTC2026-02N019699-005POTASSIUM CHLORIDE 0.22% IN DEXTROSE 5% IN PLASTIC CONTAINER5GM/100ML;220MG/100MLINJECTABLE / INJECTION1989-09-29011fe1cb6892…
2026-02-19 14:30 UTC2026-02N019699-006POTASSIUM CHLORIDE 0.3% IN DEXTROSE 5% IN PLASTIC CONTAINER5GM/100ML;300MG/100MLINJECTABLE / INJECTIONAP1989-09-29011fe1cb6892…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12N019699-001POTASSIUM CHLORIDE 0.037% IN DEXTROSE 5% IN PLASTIC CONTAINER5GM/100ML;37MG/100MLINJECTABLE / INJECTION1989-09-2931067a03dcf5…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12N019699-002POTASSIUM CHLORIDE 0.075% IN DEXTROSE 5% IN PLASTIC CONTAINER5GM/100ML;75MG/100MLINJECTABLE / INJECTION1989-09-2931067a03dcf5…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12N019699-003POTASSIUM CHLORIDE 0.11% IN DEXTROSE 5% IN PLASTIC CONTAINER5GM/100ML;110MG/100MLINJECTABLE / INJECTION1989-09-2931067a03dcf5…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12N019699-004POTASSIUM CHLORIDE 0.15% IN DEXTROSE 5% IN PLASTIC CONTAINER5GM/100ML;150MG/100MLINJECTABLE / INJECTIONAP1989-09-2931067a03dcf5…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12N019699-005POTASSIUM CHLORIDE 0.22% IN DEXTROSE 5% IN PLASTIC CONTAINER5GM/100ML;220MG/100MLINJECTABLE / INJECTION1989-09-2931067a03dcf5…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12N019699-006POTASSIUM CHLORIDE 0.3% IN DEXTROSE 5% IN PLASTIC CONTAINER5GM/100ML;300MG/100MLINJECTABLE / INJECTIONAP1989-09-2931067a03dcf5…
2025-08-23 18:47 UTC2025-08N019699-001POTASSIUM CHLORIDE 0.037% IN DEXTROSE 5% IN PLASTIC CONTAINER5GM/100ML;37MG/100MLINJECTABLE / INJECTION1989-09-296a471c1ec25d…
2025-08-23 18:47 UTC2025-08N019699-002POTASSIUM CHLORIDE 0.075% IN DEXTROSE 5% IN PLASTIC CONTAINER5GM/100ML;75MG/100MLINJECTABLE / INJECTION1989-09-296a471c1ec25d…
2025-08-23 18:47 UTC2025-08N019699-003POTASSIUM CHLORIDE 0.11% IN DEXTROSE 5% IN PLASTIC CONTAINER5GM/100ML;110MG/100MLINJECTABLE / INJECTION1989-09-296a471c1ec25d…
2025-08-23 18:47 UTC2025-08N019699-004POTASSIUM CHLORIDE 0.15% IN DEXTROSE 5% IN PLASTIC CONTAINER5GM/100ML;150MG/100MLINJECTABLE / INJECTIONAP1989-09-296a471c1ec25d…
2025-08-23 18:47 UTC2025-08N019699-005POTASSIUM CHLORIDE 0.22% IN DEXTROSE 5% IN PLASTIC CONTAINER5GM/100ML;220MG/100MLINJECTABLE / INJECTION1989-09-296a471c1ec25d…
2025-08-23 18:47 UTC2025-08N019699-006POTASSIUM CHLORIDE 0.3% IN DEXTROSE 5% IN PLASTIC CONTAINER5GM/100ML;300MG/100MLINJECTABLE / INJECTIONAP1989-09-296a471c1ec25d…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03N019699-001POTASSIUM CHLORIDE 0.037% IN DEXTROSE 5% IN PLASTIC CONTAINER5GM/100ML;37MG/100MLINJECTABLE / INJECTION1989-09-29fd3edfee7708…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03N019699-002POTASSIUM CHLORIDE 0.075% IN DEXTROSE 5% IN PLASTIC CONTAINER5GM/100ML;75MG/100MLINJECTABLE / INJECTION1989-09-29fd3edfee7708…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03N019699-003POTASSIUM CHLORIDE 0.11% IN DEXTROSE 5% IN PLASTIC CONTAINER5GM/100ML;110MG/100MLINJECTABLE / INJECTION1989-09-29fd3edfee7708…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03N019699-004POTASSIUM CHLORIDE 0.15% IN DEXTROSE 5% IN PLASTIC CONTAINER5GM/100ML;150MG/100MLINJECTABLE / INJECTIONAP1989-09-29fd3edfee7708…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03N019699-005POTASSIUM CHLORIDE 0.22% IN DEXTROSE 5% IN PLASTIC CONTAINER5GM/100ML;220MG/100MLINJECTABLE / INJECTION1989-09-29fd3edfee7708…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03N019699-006POTASSIUM CHLORIDE 0.3% IN DEXTROSE 5% IN PLASTIC CONTAINER5GM/100ML;300MG/100MLINJECTABLE / INJECTIONAP1989-09-29fd3edfee7708…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02N019699-001POTASSIUM CHLORIDE 0.037% IN DEXTROSE 5% IN PLASTIC CONTAINER5GM/100ML;37MG/100MLINJECTABLE / INJECTION1989-09-29b8a1b40f171c…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02N019699-002POTASSIUM CHLORIDE 0.075% IN DEXTROSE 5% IN PLASTIC CONTAINER5GM/100ML;75MG/100MLINJECTABLE / INJECTION1989-09-29b8a1b40f171c…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02N019699-003POTASSIUM CHLORIDE 0.11% IN DEXTROSE 5% IN PLASTIC CONTAINER5GM/100ML;110MG/100MLINJECTABLE / INJECTION1989-09-29b8a1b40f171c…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02N019699-004POTASSIUM CHLORIDE 0.15% IN DEXTROSE 5% IN PLASTIC CONTAINER5GM/100ML;150MG/100MLINJECTABLE / INJECTIONAP1989-09-29b8a1b40f171c…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02N019699-005POTASSIUM CHLORIDE 0.22% IN DEXTROSE 5% IN PLASTIC CONTAINER5GM/100ML;220MG/100MLINJECTABLE / INJECTION1989-09-29b8a1b40f171c…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02N019699-006POTASSIUM CHLORIDE 0.3% IN DEXTROSE 5% IN PLASTIC CONTAINER5GM/100ML;300MG/100MLINJECTABLE / INJECTIONAP1989-09-29b8a1b40f171c…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01N019699-001POTASSIUM CHLORIDE 0.037% IN DEXTROSE 5% IN PLASTIC CONTAINER5GM/100ML;37MG/100MLINJECTABLE / INJECTION1989-09-2903ed91905a0d…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01N019699-002POTASSIUM CHLORIDE 0.075% IN DEXTROSE 5% IN PLASTIC CONTAINER5GM/100ML;75MG/100MLINJECTABLE / INJECTION1989-09-2903ed91905a0d…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01N019699-003POTASSIUM CHLORIDE 0.11% IN DEXTROSE 5% IN PLASTIC CONTAINER5GM/100ML;110MG/100MLINJECTABLE / INJECTION1989-09-2903ed91905a0d…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01N019699-004POTASSIUM CHLORIDE 0.15% IN DEXTROSE 5% IN PLASTIC CONTAINER5GM/100ML;150MG/100MLINJECTABLE / INJECTIONAP1989-09-2903ed91905a0d…

Observed Orange Book normalized TE history#

Normalized TE history page 1 of 3 · 84 observed states.

Captured, Edition, Application-product table
CapturedEditionApplication-productTE codeOrderSource SHA-256
2026-08-18 06:07:402026-07N019699-004AP1caaa826d4ba7…
2026-08-18 06:07:402026-07N019699-006AP1caaa826d4ba7…
2026-02-19 14:30 UTC2026-02N019699-004AP1011fe1cb6892…
2026-02-19 14:30 UTC2026-02N019699-006AP1011fe1cb6892…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12N019699-004AP131067a03dcf5…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12N019699-006AP131067a03dcf5…
2025-08-23 18:47 UTC2025-08N019699-004AP16a471c1ec25d…
2025-08-23 18:47 UTC2025-08N019699-006AP16a471c1ec25d…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03N019699-004AP1fd3edfee7708…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03N019699-006AP1fd3edfee7708…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02N019699-004AP1b8a1b40f171c…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02N019699-006AP1b8a1b40f171c…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01N019699-004AP103ed91905a0d…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01N019699-006AP103ed91905a0d…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12N019699-004AP12680178bc6a6…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12N019699-006AP12680178bc6a6…
2024-09-14 05:58 UTC · 2 captures of this ZIP2024-09N019699-004AP15bbf6a4d5a75…
2024-09-14 05:58 UTC · 2 captures of this ZIP2024-09N019699-006AP15bbf6a4d5a75…
2024-11-08 22:44 UTC · 3 captures of this ZIP2024-11N019699-004AP1d8e5a09893c0…
2024-11-08 22:44 UTC · 3 captures of this ZIP2024-11N019699-006AP1d8e5a09893c0…
2024-10-29 15:01 UTC2024-10N019699-004AP1d06236e962d9…
2024-10-29 15:01 UTC2024-10N019699-006AP1d06236e962d9…
2024-08-13 05:28 UTC · 3 captures of this ZIP2024-08N019699-004AP179d66fd596c7…
2024-08-13 05:28 UTC · 3 captures of this ZIP2024-08N019699-006AP179d66fd596c7…
2024-07-13 05:37 UTC · 2 captures of this ZIP2024-07N019699-004AP1301d65b070ca…
2024-07-13 05:37 UTC · 2 captures of this ZIP2024-07N019699-006AP1301d65b070ca…
2024-06-18 03:08 UTC · 5 captures of this ZIP2024-06N019699-004AP11e350fbaab3a…
2024-06-18 03:08 UTC · 5 captures of this ZIP2024-06N019699-006AP11e350fbaab3a…
2024-05-31 18:47 UTC2024-05N019699-004AP18072bd15b7f6…
2024-05-31 18:47 UTC2024-05N019699-006AP18072bd15b7f6…
2022-06-29 02:47 UTC · 2 captures of this ZIP2022-06N019699-004AP15c6f7cd8ea54…
2022-06-29 02:47 UTC · 2 captures of this ZIP2022-06N019699-006AP15c6f7cd8ea54…
2022-04-08 23:34 UTC2022-04N019699-004AP15d02ea3f76ae…
2022-04-08 23:34 UTC2022-04N019699-006AP15d02ea3f76ae…
2022-04-04 05:41 UTC2022-04N019699-004AP14b0b4de00fa7…
2022-04-04 05:41 UTC2022-04N019699-006AP14b0b4de00fa7…
2019-12-13 00:20 UTC2019-12N019699-004AP174a2ff9319b5…
2019-12-13 00:20 UTC2019-12N019699-006AP174a2ff9319b5…
2022-03-09 01:35 UTC2022-03N019699-004AP1bb7c543d1eb4…
2022-03-09 01:35 UTC2022-03N019699-006AP1bb7c543d1eb4…

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 CHLORIDE IN DEXTROSEDEXTROSE AND POTASSIUM CHLORIDEB. Braun Medical Inc.e5bbb3e1-ab50-4ec7-a2b4-ce4091712e232020-07-31Warnings, Adverse reactionsExact identifier
application applno (NDA): 019699
application number: NDA019699
ndc (product): 0264-7625
ndc (product): 0264-7628

NDC Listings For This Application#

NDC listings for this application page 1 of 1 · 4 matching rows.

NDC, Name, Nonproprietary name table
NDCNameNonproprietary nameLabelerMarketing categoryStatus
0264-7625POTASSIUM CHLORIDE IN DEXTROSEDEXTROSE and POTASSIUM CHLORIDEB. Braun Medical Inc.NDACurrent
0264-7625POTASSIUM CHLORIDE IN DEXTROSEDEXTROSE and POTASSIUM CHLORIDEB. Braun Medical Inc.NDACurrent
0264-7628POTASSIUM CHLORIDE IN DEXTROSEDEXTROSE and POTASSIUM CHLORIDEB. Braun Medical Inc.NDACurrent
0264-7628POTASSIUM CHLORIDE IN DEXTROSEDEXTROSE and POTASSIUM CHLORIDEB. Braun Medical Inc.NDACurrent

Documents#

Document, Submission type, Date table
DocumentSubmission typeDate
63889SUPPL2020-07-14
63854SUPPL2020-07-13
33875SUPPL2004-09-29
19106SUPPL2004-09-29