Potassium Chloride in Dextrose

Product NDC
0409-7905
Requested package NDC
0409-7905-09
11-digit product format
004097905
Labeler code
0409
Product ID
0409-7905_553bb3f1-a136-4103-bd9c-8952f5be0f08
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
DEXTROSE MONOHYDRATE and POTASSIUM CHLORIDE
Dosage form
INJECTION, SOLUTION
Route
INTRAVENOUS
Labeler
Hospira, Inc.
Application
NDA018371
Marketing category
NDA
Marketing start
1980-05-29
Marketing end
2021-03-01
Substance
DEXTROSE MONOHYDRATE; POTASSIUM CHLORIDE
Active strength
5 g/100mL; g/100mL
Pharmacologic classes
Potassium Compounds [CS],Potassium Salt [EPC],Osmotic Laxative [EPC],Increased Large Intestinal Motility [PE],Inhibition Large Intestine Fluid/Electrolyte Absorption [PE],Osmotic Activity [MoA]
NDC exclude flag
No
Listing certified through
0000-00-00
Current FDA listing
Historical FDA.report record

NDC auxiliary status#

These records are reproduced from FDA’s unfinished, excluded, and compounder listings. They describe what appeared in the source files; a missing record does not establish a regulatory status. View all current auxiliary records, including entries without an NDC. · View the auxiliary file history.

Current NDC status page 1 of 1 · 1 matching rows.

Dataset, Scope, Product NDC table
DatasetScopeProduct NDCPackage NDCCodeStatusReporting periodSource date
excluded packagepackage0409-79050409-7905-09DDiscontinued by firm2026-10-05

Observed NDC auxiliary status history#

This history shows the information present in each captured FDA auxiliary file. It is not a continuous regulatory timeline, and a missing record does not establish a status.

Historic NDC status page 1 of 1 · 12 matching rows.

View current auxiliary records. · View the auxiliary file history.

Captured / source date, Snapshot, Source SHA-256 table
Captured / source dateSnapshotSource SHA-256
2025-12-14 17:58 UTC · source 2025-12-05d630ba8d3edf…732f749b63fb…
2025-08-27 00:01 UTC · source 2025-08-26f5e01cc5f278…a2eaf40c39c3…
2025-04-01 02:39 UTC · source 2025-03-312ef7874e63bc…57b86245f4fa…
2025-03-28 20:22 UTC · source 2025-03-28a1b67e2a42f9…c4cf2c586c0d…
2025-03-22 03:12 UTC · source 2025-03-21cfe11265f3b6…090c488252e2…
2025-03-10 12:48 UTC · source 2025-03-10cdf11ea48f46…ba0047e9e063…
2025-02-02 03:52 UTC · source 2025-01-31302b2466d912…e7b80fea0513…
2025-01-20 13:05 UTC · source 2025-01-20ed331223b511…672a5bd82f5f…
2025-01-11 03:41 UTC · source 2025-01-100efc9e666f02…f202fb6c5f17…
2024-11-09 02:27 UTC · source 2024-11-08ad56d346431e…cc804d4bbf1e…
2024-10-04 04:10 UTC · source 2024-10-03367a005e9d99…383a685ebd0f…
2024-07-10 04:00 UTC · source 2024-07-09557ba5c1ecfa…9c80585c8c6e…

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

Orange Book products#

Current product rows page 1 of 1 · 3 matching rows.

Application-product, Trade name, Ingredient table
Application-productTrade nameIngredientStrengthDosage form / routeTE codesRLD / RSApproval date
N018371-001POTASSIUM CHLORIDE 20MEQ IN DEXTROSE 5% IN PLASTIC CONTAINERDEXTROSE; POTASSIUM CHLORIDE5GM/100ML;149MG/100MLINJECTABLE / INJECTIONApproved before 1982
N018371-002POTASSIUM CHLORIDE 40MEQ IN DEXTROSE 5% IN PLASTIC CONTAINERDEXTROSE; POTASSIUM CHLORIDE5GM/100ML;298MG/100MLINJECTABLE / INJECTIONApproved before 1982
N018371-003POTASSIUM CHLORIDE 30MEQ IN DEXTROSE 5% IN PLASTIC CONTAINERDEXTROSE; POTASSIUM CHLORIDE5GM/100ML;224MG/100MLINJECTABLE / INJECTIONApproved before 1982

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 4 · 129 observed states.

Captured, Edition, Application-product table
CapturedEditionApplication-productTrade nameStrengthDosage form / routeProduct TE source textRLD / RSApproval dateSource SHA-256
2026-09-14 22:38:342026-08N018371-001POTASSIUM CHLORIDE 20MEQ IN DEXTROSE 5% IN PLASTIC CONTAINER5GM/100ML;149MG/100MLINJECTABLE / INJECTIONApproved before 198284e616aacf4f…
2026-09-14 22:38:342026-08N018371-002POTASSIUM CHLORIDE 40MEQ IN DEXTROSE 5% IN PLASTIC CONTAINER5GM/100ML;298MG/100MLINJECTABLE / INJECTIONApproved before 198284e616aacf4f…
2026-09-14 22:38:342026-08N018371-003POTASSIUM CHLORIDE 30MEQ IN DEXTROSE 5% IN PLASTIC CONTAINER5GM/100ML;224MG/100MLINJECTABLE / INJECTIONApproved before 198284e616aacf4f…
2026-08-18 06:07:402026-07N018371-001POTASSIUM CHLORIDE 20MEQ IN DEXTROSE 5% IN PLASTIC CONTAINER5GM/100ML;149MG/100MLINJECTABLE / INJECTIONApproved before 1982caaa826d4ba7…
2026-08-18 06:07:402026-07N018371-002POTASSIUM CHLORIDE 40MEQ IN DEXTROSE 5% IN PLASTIC CONTAINER5GM/100ML;298MG/100MLINJECTABLE / INJECTIONApproved before 1982caaa826d4ba7…
2026-08-18 06:07:402026-07N018371-003POTASSIUM CHLORIDE 30MEQ IN DEXTROSE 5% IN PLASTIC CONTAINER5GM/100ML;224MG/100MLINJECTABLE / INJECTIONApproved before 1982caaa826d4ba7…
2026-02-19 14:30 UTC2026-02N018371-001POTASSIUM CHLORIDE 20MEQ IN DEXTROSE 5% IN PLASTIC CONTAINER5GM/100ML;149MG/100MLINJECTABLE / INJECTIONApproved before 1982011fe1cb6892…
2026-02-19 14:30 UTC2026-02N018371-002POTASSIUM CHLORIDE 40MEQ IN DEXTROSE 5% IN PLASTIC CONTAINER5GM/100ML;298MG/100MLINJECTABLE / INJECTIONApproved before 1982011fe1cb6892…
2026-02-19 14:30 UTC2026-02N018371-003POTASSIUM CHLORIDE 30MEQ IN DEXTROSE 5% IN PLASTIC CONTAINER5GM/100ML;224MG/100MLINJECTABLE / INJECTIONApproved before 1982011fe1cb6892…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12N018371-001POTASSIUM CHLORIDE 20MEQ IN DEXTROSE 5% IN PLASTIC CONTAINER5GM/100ML;149MG/100MLINJECTABLE / INJECTIONApproved before 198231067a03dcf5…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12N018371-002POTASSIUM CHLORIDE 40MEQ IN DEXTROSE 5% IN PLASTIC CONTAINER5GM/100ML;298MG/100MLINJECTABLE / INJECTIONApproved before 198231067a03dcf5…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12N018371-003POTASSIUM CHLORIDE 30MEQ IN DEXTROSE 5% IN PLASTIC CONTAINER5GM/100ML;224MG/100MLINJECTABLE / INJECTIONApproved before 198231067a03dcf5…
2025-08-23 18:47 UTC2025-08N018371-001POTASSIUM CHLORIDE 20MEQ IN DEXTROSE 5% IN PLASTIC CONTAINER5GM/100ML;149MG/100MLINJECTABLE / INJECTIONApproved before 19826a471c1ec25d…
2025-08-23 18:47 UTC2025-08N018371-002POTASSIUM CHLORIDE 40MEQ IN DEXTROSE 5% IN PLASTIC CONTAINER5GM/100ML;298MG/100MLINJECTABLE / INJECTIONApproved before 19826a471c1ec25d…
2025-08-23 18:47 UTC2025-08N018371-003POTASSIUM CHLORIDE 30MEQ IN DEXTROSE 5% IN PLASTIC CONTAINER5GM/100ML;224MG/100MLINJECTABLE / INJECTIONApproved before 19826a471c1ec25d…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03N018371-001POTASSIUM CHLORIDE 20MEQ IN DEXTROSE 5% IN PLASTIC CONTAINER5GM/100ML;149MG/100MLINJECTABLE / INJECTIONApproved before 1982fd3edfee7708…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03N018371-002POTASSIUM CHLORIDE 40MEQ IN DEXTROSE 5% IN PLASTIC CONTAINER5GM/100ML;298MG/100MLINJECTABLE / INJECTIONApproved before 1982fd3edfee7708…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03N018371-003POTASSIUM CHLORIDE 30MEQ IN DEXTROSE 5% IN PLASTIC CONTAINER5GM/100ML;224MG/100MLINJECTABLE / INJECTIONApproved before 1982fd3edfee7708…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02N018371-001POTASSIUM CHLORIDE 20MEQ IN DEXTROSE 5% IN PLASTIC CONTAINER5GM/100ML;149MG/100MLINJECTABLE / INJECTIONApproved before 1982b8a1b40f171c…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02N018371-002POTASSIUM CHLORIDE 40MEQ IN DEXTROSE 5% IN PLASTIC CONTAINER5GM/100ML;298MG/100MLINJECTABLE / INJECTIONApproved before 1982b8a1b40f171c…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02N018371-003POTASSIUM CHLORIDE 30MEQ IN DEXTROSE 5% IN PLASTIC CONTAINER5GM/100ML;224MG/100MLINJECTABLE / INJECTIONApproved before 1982b8a1b40f171c…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01N018371-001POTASSIUM CHLORIDE 20MEQ IN DEXTROSE 5% IN PLASTIC CONTAINER5GM/100ML;149MG/100MLINJECTABLE / INJECTIONApproved before 198203ed91905a0d…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01N018371-002POTASSIUM CHLORIDE 40MEQ IN DEXTROSE 5% IN PLASTIC CONTAINER5GM/100ML;298MG/100MLINJECTABLE / INJECTIONApproved before 198203ed91905a0d…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01N018371-003POTASSIUM CHLORIDE 30MEQ IN DEXTROSE 5% IN PLASTIC CONTAINER5GM/100ML;224MG/100MLINJECTABLE / INJECTIONApproved before 198203ed91905a0d…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12N018371-001POTASSIUM CHLORIDE 20MEQ IN DEXTROSE 5% IN PLASTIC CONTAINER5GM/100ML;149MG/100MLINJECTABLE / INJECTIONApproved before 19822680178bc6a6…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12N018371-002POTASSIUM CHLORIDE 40MEQ IN DEXTROSE 5% IN PLASTIC CONTAINER5GM/100ML;298MG/100MLINJECTABLE / INJECTIONApproved before 19822680178bc6a6…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12N018371-003POTASSIUM CHLORIDE 30MEQ IN DEXTROSE 5% IN PLASTIC CONTAINER5GM/100ML;224MG/100MLINJECTABLE / INJECTIONApproved before 19822680178bc6a6…
2024-09-14 05:58 UTC · 2 captures of this ZIP2024-09N018371-001POTASSIUM CHLORIDE 20MEQ IN DEXTROSE 5% IN PLASTIC CONTAINER5GM/100ML;149MG/100MLINJECTABLE / INJECTIONApproved before 19825bbf6a4d5a75…
2024-09-14 05:58 UTC · 2 captures of this ZIP2024-09N018371-002POTASSIUM CHLORIDE 40MEQ IN DEXTROSE 5% IN PLASTIC CONTAINER5GM/100ML;298MG/100MLINJECTABLE / INJECTIONApproved before 19825bbf6a4d5a75…
2024-09-14 05:58 UTC · 2 captures of this ZIP2024-09N018371-003POTASSIUM CHLORIDE 30MEQ IN DEXTROSE 5% IN PLASTIC CONTAINER5GM/100ML;224MG/100MLINJECTABLE / INJECTIONApproved before 19825bbf6a4d5a75…
2024-11-08 22:44 UTC · 3 captures of this ZIP2024-11N018371-001POTASSIUM CHLORIDE 20MEQ IN DEXTROSE 5% IN PLASTIC CONTAINER5GM/100ML;149MG/100MLINJECTABLE / INJECTIONApproved before 1982d8e5a09893c0…
2024-11-08 22:44 UTC · 3 captures of this ZIP2024-11N018371-002POTASSIUM CHLORIDE 40MEQ IN DEXTROSE 5% IN PLASTIC CONTAINER5GM/100ML;298MG/100MLINJECTABLE / INJECTIONApproved before 1982d8e5a09893c0…
2024-11-08 22:44 UTC · 3 captures of this ZIP2024-11N018371-003POTASSIUM CHLORIDE 30MEQ IN DEXTROSE 5% IN PLASTIC CONTAINER5GM/100ML;224MG/100MLINJECTABLE / INJECTIONApproved before 1982d8e5a09893c0…
2024-10-29 15:01 UTC2024-10N018371-001POTASSIUM CHLORIDE 20MEQ IN DEXTROSE 5% IN PLASTIC CONTAINER5GM/100ML;149MG/100MLINJECTABLE / INJECTIONApproved before 1982d06236e962d9…
2024-10-29 15:01 UTC2024-10N018371-002POTASSIUM CHLORIDE 40MEQ IN DEXTROSE 5% IN PLASTIC CONTAINER5GM/100ML;298MG/100MLINJECTABLE / INJECTIONApproved before 1982d06236e962d9…
2024-10-29 15:01 UTC2024-10N018371-003POTASSIUM CHLORIDE 30MEQ IN DEXTROSE 5% IN PLASTIC CONTAINER5GM/100ML;224MG/100MLINJECTABLE / INJECTIONApproved before 1982d06236e962d9…
2024-08-13 05:28 UTC · 3 captures of this ZIP2024-08N018371-001POTASSIUM CHLORIDE 20MEQ IN DEXTROSE 5% IN PLASTIC CONTAINER5GM/100ML;149MG/100MLINJECTABLE / INJECTIONApproved before 198279d66fd596c7…
2024-08-13 05:28 UTC · 3 captures of this ZIP2024-08N018371-002POTASSIUM CHLORIDE 40MEQ IN DEXTROSE 5% IN PLASTIC CONTAINER5GM/100ML;298MG/100MLINJECTABLE / INJECTIONApproved before 198279d66fd596c7…
2024-08-13 05:28 UTC · 3 captures of this ZIP2024-08N018371-003POTASSIUM CHLORIDE 30MEQ IN DEXTROSE 5% IN PLASTIC CONTAINER5GM/100ML;224MG/100MLINJECTABLE / INJECTIONApproved before 198279d66fd596c7…
2024-07-13 05:37 UTC · 2 captures of this ZIP2024-07N018371-001POTASSIUM CHLORIDE 20MEQ IN DEXTROSE 5% IN PLASTIC CONTAINER5GM/100ML;149MG/100MLINJECTABLE / INJECTIONApproved before 1982301d65b070ca…

Observed Orange Book normalized TE history#

Captured, Edition, Application-product table
CapturedEditionApplication-productTE codeOrderSource SHA-256
2019-07-19 19:46 UTC2019-07N018371-003AP1ea99ee380514…

Reported adverse events (FAERS/openFDA)#

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

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
0409-7905-09ML - Milliliter0409-790574a6cc55-5eba-4cb5-93d6-86bc162570ba12012-07-24

DailyMed Socrata Ingredients#

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 MONOHYDRATE AND POTASSIUM CHLORIDE INJECTION, SOLUTIONICU Medical Inc.02d694b5-3600-4d55-bd5c-924abaec53152025-10-30Warnings, Adverse reactionsExact identifier
application applno (NDA): 018371
application number: NDA018371

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
0409-7905-090040979050912 POUCH in 1 CASE (0409-7905-09) > 1 BAG in 1 POUCH > 1000 mL in 1 BAG12 pouch1980-05-292021-03-01NoNoCurrent