Application 212348

Type
ANDA
Sponsor
FRESENIUS KABI USA

Application Products#

Product, Drug, Ingredient table
ProductDrugIngredientFormStrengthReference drugReference standard
001POTASSIUM CHLORIDE 10MEQ IN DEXTROSE 5% AND SODIUM CHLORIDE 0.225% IN PLASTIC CONTAINERDEXTROSE; POTASSIUM CHLORIDE; SODIUM CHLORIDEINJECTABLE;INJECTION5GM/100ML;149MG/100ML;225MG/100MLNoNo
002POTASSIUM CHLORIDE 20MEQ IN DEXTROSE 5% AND SODIUM CHLORIDE 0.225% IN PLASTIC CONTAINERDEXTROSE; POTASSIUM CHLORIDE; SODIUM CHLORIDEINJECTABLE;INJECTION5GM/100ML;149MG/100ML;225MG/100MLNoNo

Source provenance: Browse the complete Orange Book source catalog · source snapshot 43.

Orange Book products#

Current product rows page 1 of 1 · 2 matching rows.

Application-product, Trade name, Ingredient table
Application-productTrade nameIngredientStrengthDosage form / routeTE codesRLD / RSApproval date
A212348-001POTASSIUM CHLORIDE 10MEQ IN DEXTROSE 5% AND SODIUM CHLORIDE 0.225% IN PLASTIC CONTAINERDEXTROSE; POTASSIUM CHLORIDE; SODIUM CHLORIDE5GM/100ML;149MG/100ML;225MG/100MLINJECTABLE / INJECTIONAP2021-07-30
A212348-002POTASSIUM CHLORIDE 20MEQ IN DEXTROSE 5% AND SODIUM CHLORIDE 0.225% IN PLASTIC CONTAINERDEXTROSE; POTASSIUM CHLORIDE; SODIUM CHLORIDE5GM/100ML;149MG/100ML;225MG/100MLINJECTABLE / INJECTIONAP2021-07-30

Therapeutic equivalence codes#

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

Application-product, TE code table
Application-productTE code
A212348-001AP
A212348-002AP

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 2 · 70 observed states.

Captured, Edition, Application-product table
CapturedEditionApplication-productTrade nameStrengthDosage form / routeProduct TE source textRLD / RSApproval dateSource SHA-256
2026-09-14 22:38:342026-08A212348-001POTASSIUM CHLORIDE 10MEQ IN DEXTROSE 5% AND SODIUM CHLORIDE 0.225% IN PLASTIC CONTAINER5GM/100ML;149MG/100ML;225MG/100MLINJECTABLE / INJECTIONAP2021-07-3084e616aacf4f…
2026-09-14 22:38:342026-08A212348-002POTASSIUM CHLORIDE 20MEQ IN DEXTROSE 5% AND SODIUM CHLORIDE 0.225% IN PLASTIC CONTAINER5GM/100ML;149MG/100ML;225MG/100MLINJECTABLE / INJECTIONAP2021-07-3084e616aacf4f…
2026-08-18 06:07:402026-07A212348-001POTASSIUM CHLORIDE 10MEQ IN DEXTROSE 5% AND SODIUM CHLORIDE 0.225% IN PLASTIC CONTAINER5GM/100ML;149MG/100ML;225MG/100MLINJECTABLE / INJECTIONAP2021-07-30caaa826d4ba7…
2026-08-18 06:07:402026-07A212348-002POTASSIUM CHLORIDE 20MEQ IN DEXTROSE 5% AND SODIUM CHLORIDE 0.225% IN PLASTIC CONTAINER5GM/100ML;149MG/100ML;225MG/100MLINJECTABLE / INJECTIONAP2021-07-30caaa826d4ba7…
2026-02-19 14:30 UTC2026-02A212348-001POTASSIUM CHLORIDE 10MEQ IN DEXTROSE 5% AND SODIUM CHLORIDE 0.225% IN PLASTIC CONTAINER5GM/100ML;149MG/100ML;225MG/100MLINJECTABLE / INJECTIONAP2021-07-30011fe1cb6892…
2026-02-19 14:30 UTC2026-02A212348-002POTASSIUM CHLORIDE 20MEQ IN DEXTROSE 5% AND SODIUM CHLORIDE 0.225% IN PLASTIC CONTAINER5GM/100ML;149MG/100ML;225MG/100MLINJECTABLE / INJECTIONAP2021-07-30011fe1cb6892…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A212348-001POTASSIUM CHLORIDE 10MEQ IN DEXTROSE 5% AND SODIUM CHLORIDE 0.225% IN PLASTIC CONTAINER5GM/100ML;149MG/100ML;225MG/100MLINJECTABLE / INJECTIONAP2021-07-3031067a03dcf5…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A212348-002POTASSIUM CHLORIDE 20MEQ IN DEXTROSE 5% AND SODIUM CHLORIDE 0.225% IN PLASTIC CONTAINER5GM/100ML;149MG/100ML;225MG/100MLINJECTABLE / INJECTIONAP2021-07-3031067a03dcf5…
2025-08-23 18:47 UTC2025-08A212348-001POTASSIUM CHLORIDE 10MEQ IN DEXTROSE 5% AND SODIUM CHLORIDE 0.225% IN PLASTIC CONTAINER5GM/100ML;149MG/100ML;225MG/100MLINJECTABLE / INJECTIONAP2021-07-306a471c1ec25d…
2025-08-23 18:47 UTC2025-08A212348-002POTASSIUM CHLORIDE 20MEQ IN DEXTROSE 5% AND SODIUM CHLORIDE 0.225% IN PLASTIC CONTAINER5GM/100ML;149MG/100ML;225MG/100MLINJECTABLE / INJECTIONAP2021-07-306a471c1ec25d…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03A212348-001POTASSIUM CHLORIDE 10MEQ IN DEXTROSE 5% AND SODIUM CHLORIDE 0.225% IN PLASTIC CONTAINER5GM/100ML;149MG/100ML;225MG/100MLINJECTABLE / INJECTIONAP2021-07-30fd3edfee7708…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03A212348-002POTASSIUM CHLORIDE 20MEQ IN DEXTROSE 5% AND SODIUM CHLORIDE 0.225% IN PLASTIC CONTAINER5GM/100ML;149MG/100ML;225MG/100MLINJECTABLE / INJECTIONAP2021-07-30fd3edfee7708…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02A212348-001POTASSIUM CHLORIDE 10MEQ IN DEXTROSE 5% AND SODIUM CHLORIDE 0.225% IN PLASTIC CONTAINER5GM/100ML;149MG/100ML;225MG/100MLINJECTABLE / INJECTIONAP2021-07-30b8a1b40f171c…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02A212348-002POTASSIUM CHLORIDE 20MEQ IN DEXTROSE 5% AND SODIUM CHLORIDE 0.225% IN PLASTIC CONTAINER5GM/100ML;149MG/100ML;225MG/100MLINJECTABLE / INJECTIONAP2021-07-30b8a1b40f171c…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01A212348-001POTASSIUM CHLORIDE 10MEQ IN DEXTROSE 5% AND SODIUM CHLORIDE 0.225% IN PLASTIC CONTAINER5GM/100ML;149MG/100ML;225MG/100MLINJECTABLE / INJECTIONAP2021-07-3003ed91905a0d…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01A212348-002POTASSIUM CHLORIDE 20MEQ IN DEXTROSE 5% AND SODIUM CHLORIDE 0.225% IN PLASTIC CONTAINER5GM/100ML;149MG/100ML;225MG/100MLINJECTABLE / INJECTIONAP2021-07-3003ed91905a0d…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12A212348-001POTASSIUM CHLORIDE 10MEQ IN DEXTROSE 5% AND SODIUM CHLORIDE 0.225% IN PLASTIC CONTAINER5GM/100ML;149MG/100ML;225MG/100MLINJECTABLE / INJECTIONAP2021-07-302680178bc6a6…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12A212348-002POTASSIUM CHLORIDE 20MEQ IN DEXTROSE 5% AND SODIUM CHLORIDE 0.225% IN PLASTIC CONTAINER5GM/100ML;149MG/100ML;225MG/100MLINJECTABLE / INJECTIONAP2021-07-302680178bc6a6…
2024-09-14 05:58 UTC · 2 captures of this ZIP2024-09A212348-001POTASSIUM CHLORIDE 10MEQ IN DEXTROSE 5% AND SODIUM CHLORIDE 0.225% IN PLASTIC CONTAINER5GM/100ML;149MG/100ML;225MG/100MLINJECTABLE / INJECTIONAP2021-07-305bbf6a4d5a75…
2024-09-14 05:58 UTC · 2 captures of this ZIP2024-09A212348-002POTASSIUM CHLORIDE 20MEQ IN DEXTROSE 5% AND SODIUM CHLORIDE 0.225% IN PLASTIC CONTAINER5GM/100ML;149MG/100ML;225MG/100MLINJECTABLE / INJECTIONAP2021-07-305bbf6a4d5a75…
2024-11-08 22:44 UTC · 3 captures of this ZIP2024-11A212348-001POTASSIUM CHLORIDE 10MEQ IN DEXTROSE 5% AND SODIUM CHLORIDE 0.225% IN PLASTIC CONTAINER5GM/100ML;149MG/100ML;225MG/100MLINJECTABLE / INJECTIONAP2021-07-30d8e5a09893c0…
2024-11-08 22:44 UTC · 3 captures of this ZIP2024-11A212348-002POTASSIUM CHLORIDE 20MEQ IN DEXTROSE 5% AND SODIUM CHLORIDE 0.225% IN PLASTIC CONTAINER5GM/100ML;149MG/100ML;225MG/100MLINJECTABLE / INJECTIONAP2021-07-30d8e5a09893c0…
2024-10-29 15:01 UTC2024-10A212348-001POTASSIUM CHLORIDE 10MEQ IN DEXTROSE 5% AND SODIUM CHLORIDE 0.225% IN PLASTIC CONTAINER5GM/100ML;149MG/100ML;225MG/100MLINJECTABLE / INJECTIONAP2021-07-30d06236e962d9…
2024-10-29 15:01 UTC2024-10A212348-002POTASSIUM CHLORIDE 20MEQ IN DEXTROSE 5% AND SODIUM CHLORIDE 0.225% IN PLASTIC CONTAINER5GM/100ML;149MG/100ML;225MG/100MLINJECTABLE / INJECTIONAP2021-07-30d06236e962d9…
2024-08-13 05:28 UTC · 3 captures of this ZIP2024-08A212348-001POTASSIUM CHLORIDE 10MEQ IN DEXTROSE 5% AND SODIUM CHLORIDE 0.225% IN PLASTIC CONTAINER5GM/100ML;149MG/100ML;225MG/100MLINJECTABLE / INJECTIONAP2021-07-3079d66fd596c7…
2024-08-13 05:28 UTC · 3 captures of this ZIP2024-08A212348-002POTASSIUM CHLORIDE 20MEQ IN DEXTROSE 5% AND SODIUM CHLORIDE 0.225% IN PLASTIC CONTAINER5GM/100ML;149MG/100ML;225MG/100MLINJECTABLE / INJECTIONAP2021-07-3079d66fd596c7…
2024-07-13 05:37 UTC · 2 captures of this ZIP2024-07A212348-001POTASSIUM CHLORIDE 10MEQ IN DEXTROSE 5% AND SODIUM CHLORIDE 0.225% IN PLASTIC CONTAINER5GM/100ML;149MG/100ML;225MG/100MLINJECTABLE / INJECTIONAP2021-07-30301d65b070ca…
2024-07-13 05:37 UTC · 2 captures of this ZIP2024-07A212348-002POTASSIUM CHLORIDE 20MEQ IN DEXTROSE 5% AND SODIUM CHLORIDE 0.225% IN PLASTIC CONTAINER5GM/100ML;149MG/100ML;225MG/100MLINJECTABLE / INJECTIONAP2021-07-30301d65b070ca…
2024-06-18 03:08 UTC · 5 captures of this ZIP2024-06A212348-001POTASSIUM CHLORIDE 10MEQ IN DEXTROSE 5% AND SODIUM CHLORIDE 0.225% IN PLASTIC CONTAINER5GM/100ML;149MG/100ML;225MG/100MLINJECTABLE / INJECTIONAP2021-07-301e350fbaab3a…
2024-06-18 03:08 UTC · 5 captures of this ZIP2024-06A212348-002POTASSIUM CHLORIDE 20MEQ IN DEXTROSE 5% AND SODIUM CHLORIDE 0.225% IN PLASTIC CONTAINER5GM/100ML;149MG/100ML;225MG/100MLINJECTABLE / INJECTIONAP2021-07-301e350fbaab3a…
2024-05-31 18:47 UTC2024-05A212348-001POTASSIUM CHLORIDE 10MEQ IN DEXTROSE 5% AND SODIUM CHLORIDE 0.225% IN PLASTIC CONTAINER5GM/100ML;149MG/100ML;225MG/100MLINJECTABLE / INJECTIONAP2021-07-308072bd15b7f6…
2024-05-31 18:47 UTC2024-05A212348-002POTASSIUM CHLORIDE 20MEQ IN DEXTROSE 5% AND SODIUM CHLORIDE 0.225% IN PLASTIC CONTAINER5GM/100ML;149MG/100ML;225MG/100MLINJECTABLE / INJECTIONAP2021-07-308072bd15b7f6…
2022-06-29 02:47 UTC · 2 captures of this ZIP2022-06A212348-001POTASSIUM CHLORIDE 10MEQ IN DEXTROSE 5% AND SODIUM CHLORIDE 0.225% IN PLASTIC CONTAINER5GM/100ML;149MG/100ML;225MG/100MLINJECTABLE / INJECTION2021-07-305c6f7cd8ea54…
2022-06-29 02:47 UTC · 2 captures of this ZIP2022-06A212348-002POTASSIUM CHLORIDE 20MEQ IN DEXTROSE 5% AND SODIUM CHLORIDE 0.225% IN PLASTIC CONTAINER5GM/100ML;149MG/100ML;225MG/100MLINJECTABLE / INJECTION2021-07-305c6f7cd8ea54…
2022-04-08 23:34 UTC2022-04A212348-001POTASSIUM CHLORIDE 10MEQ IN DEXTROSE 5% AND SODIUM CHLORIDE 0.225% IN PLASTIC CONTAINER5GM/100ML;149MG/100ML;225MG/100MLINJECTABLE / INJECTION2021-07-305d02ea3f76ae…
2022-04-08 23:34 UTC2022-04A212348-002POTASSIUM CHLORIDE 20MEQ IN DEXTROSE 5% AND SODIUM CHLORIDE 0.225% IN PLASTIC CONTAINER5GM/100ML;149MG/100ML;225MG/100MLINJECTABLE / INJECTION2021-07-305d02ea3f76ae…
2022-04-04 05:41 UTC2022-04A212348-001POTASSIUM CHLORIDE 10MEQ IN DEXTROSE 5% AND SODIUM CHLORIDE 0.225% IN PLASTIC CONTAINER5GM/100ML;149MG/100ML;225MG/100MLINJECTABLE / INJECTION2021-07-304b0b4de00fa7…
2022-04-04 05:41 UTC2022-04A212348-002POTASSIUM CHLORIDE 20MEQ IN DEXTROSE 5% AND SODIUM CHLORIDE 0.225% IN PLASTIC CONTAINER5GM/100ML;149MG/100ML;225MG/100MLINJECTABLE / INJECTION2021-07-304b0b4de00fa7…
2022-03-09 01:35 UTC2022-03A212348-001POTASSIUM CHLORIDE 10MEQ IN DEXTROSE 5% AND SODIUM CHLORIDE 0.225% IN PLASTIC CONTAINER5GM/100ML;149MG/100ML;225MG/100MLINJECTABLE / INJECTION2021-07-30bb7c543d1eb4…
2022-03-09 01:35 UTC2022-03A212348-002POTASSIUM CHLORIDE 20MEQ IN DEXTROSE 5% AND SODIUM CHLORIDE 0.225% IN PLASTIC CONTAINER5GM/100ML;149MG/100ML;225MG/100MLINJECTABLE / INJECTION2021-07-30bb7c543d1eb4…

Observed Orange Book normalized TE history#

Normalized TE history page 1 of 2 · 50 observed states.

Captured, Edition, Application-product table
CapturedEditionApplication-productTE codeOrderSource SHA-256
2026-09-14 22:38:342026-08A212348-001AP184e616aacf4f…
2026-09-14 22:38:342026-08A212348-002AP184e616aacf4f…
2026-08-18 06:07:402026-07A212348-001AP1caaa826d4ba7…
2026-08-18 06:07:402026-07A212348-002AP1caaa826d4ba7…
2026-02-19 14:30 UTC2026-02A212348-001AP1011fe1cb6892…
2026-02-19 14:30 UTC2026-02A212348-002AP1011fe1cb6892…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A212348-001AP131067a03dcf5…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A212348-002AP131067a03dcf5…
2025-08-23 18:47 UTC2025-08A212348-001AP16a471c1ec25d…
2025-08-23 18:47 UTC2025-08A212348-002AP16a471c1ec25d…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03A212348-001AP1fd3edfee7708…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03A212348-002AP1fd3edfee7708…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02A212348-001AP1b8a1b40f171c…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02A212348-002AP1b8a1b40f171c…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01A212348-001AP103ed91905a0d…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01A212348-002AP103ed91905a0d…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12A212348-001AP12680178bc6a6…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12A212348-002AP12680178bc6a6…
2024-09-14 05:58 UTC · 2 captures of this ZIP2024-09A212348-001AP15bbf6a4d5a75…
2024-09-14 05:58 UTC · 2 captures of this ZIP2024-09A212348-002AP15bbf6a4d5a75…
2024-11-08 22:44 UTC · 3 captures of this ZIP2024-11A212348-001AP1d8e5a09893c0…
2024-11-08 22:44 UTC · 3 captures of this ZIP2024-11A212348-002AP1d8e5a09893c0…
2024-10-29 15:01 UTC2024-10A212348-001AP1d06236e962d9…
2024-10-29 15:01 UTC2024-10A212348-002AP1d06236e962d9…
2024-08-13 05:28 UTC · 3 captures of this ZIP2024-08A212348-001AP179d66fd596c7…
2024-08-13 05:28 UTC · 3 captures of this ZIP2024-08A212348-002AP179d66fd596c7…
2024-07-13 05:37 UTC · 2 captures of this ZIP2024-07A212348-001AP1301d65b070ca…
2024-07-13 05:37 UTC · 2 captures of this ZIP2024-07A212348-002AP1301d65b070ca…
2024-06-18 03:08 UTC · 5 captures of this ZIP2024-06A212348-001AP11e350fbaab3a…
2024-06-18 03:08 UTC · 5 captures of this ZIP2024-06A212348-002AP11e350fbaab3a…
2024-05-31 18:47 UTC2024-05A212348-001AP18072bd15b7f6…
2024-05-31 18:47 UTC2024-05A212348-002AP18072bd15b7f6…
2024-03-16 18:09 UTC · 4 captures of this ZIP2024-03A212348-001AP16a51e52b5d6a…
2024-03-16 18:09 UTC · 4 captures of this ZIP2024-03A212348-002AP16a51e52b5d6a…
2024-02-18 07:12 UTC2024-02A212348-001AP11c564ffb4f44…
2024-02-18 07:12 UTC2024-02A212348-002AP11c564ffb4f44…
2023-12-20 04:57 UTC2023-12A212348-001AP1ea1830bbd6c7…
2023-12-20 04:57 UTC2023-12A212348-002AP1ea1830bbd6c7…
2023-11-28 05:40 UTC · 2 captures of this ZIP2023-11A212348-001AP1a72a2bbeb626…
2023-11-28 05:40 UTC · 2 captures of this ZIP2023-11A212348-002AP1a72a2bbeb626…

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 Dextrose and Sodium ChlorideDEXTROSE MONOHYDRATE, SODIUM CHLORIDE, AND POTASSIUM CHLORIDEFresenius Kabi USA, LLCf0cc6713-4d47-49be-8116-901c99002b6b2024-05-07Warnings, Adverse reactionsExact identifier
application applno (ANDA): 212348
application number: ANDA212348
ndc (product): 65219-153
ndc (product): 65219-151

Reported adverse events (FAERS/openFDA)#

Adverse event summaries are temporarily unavailable. Other product information remains available.

NDC Listings For This Application#

NDC listings for this application page 1 of 1 · 2 matching rows.

NDC, Name, Nonproprietary name table
NDCNameNonproprietary nameLabelerMarketing categoryStatus
65219-151Potassium Chloride in Dextrose and Sodium ChlorideDEXTROSE MONOHYDRATE, SODIUM CHLORIDE, and POTASSIUM CHLORIDEFresenius Kabi USA, LLCANDACurrent
65219-153Potassium Chloride in Dextrose and Sodium ChlorideDEXTROSE MONOHYDRATE, SODIUM CHLORIDE, and POTASSIUM CHLORIDEFresenius Kabi USA, LLCANDACurrent

Documents#

Document, Submission type, Date table
DocumentSubmission typeDate
68377ORIG2021-08-16