Home NDC 0990-9257 Potassium Chloride in Sodium Chloride
Product NDC 0990-9257
11-digit product format 009909257
Labeler code 0990
Product ID 0990-9257_e1156695-d301-429c-946e-6a1862af172e
Type HUMAN PRESCRIPTION DRUG
Nonproprietary name SODIUM CHLORIDE and POTASSIUM CHLORIDE
Dosage form INJECTION, SOLUTION
Route INTRAVENOUS
Labeler ICU Medical Inc.
Application ANDA078446
Marketing category ANDA
Marketing start 2020-01-01
Substance SODIUM CHLORIDE; POTASSIUM CHLORIDE
Active strength 4.5; 1.49 g/1000mL; g/1000mL
Pharmacologic classes Increased Large Intestinal Motility [PE], Increased Large Intestinal Motility [PE], Inhibition Large Intestine Fluid/Electrolyte Absorption [PE], Inhibition Large Intestine Fluid/Electrolyte Absorption [PE], Osmotic Activity [MoA], Osmotic Activity [MoA], Osmotic Laxative [EPC], Osmotic Laxative [EPC], Potassium Compounds [CS], Potassium Salt [EPC]
NDC exclude flag No
Listing certified through 2027-12-31
Current FDA listing Yes Source provenance: Browse the complete Orange Book source catalog · source snapshot 43 .
Orange Book products# Current product rows page 1 of 1 · 1 matching rows.
Application-product, Trade name, Ingredient table Application-product Trade name Ingredient Strength Dosage form / route TE codes RLD / RS Approval date A078446-001 POTASSIUM CHLORIDE 0.149% IN SODIUM CHLORIDE 0.45% IN PLASTIC CONTAINER POTASSIUM CHLORIDE; SODIUM CHLORIDE 149MG/100ML;450MG/100ML INJECTABLE / INJECTION AP 2008-09-10
Therapeutic equivalence codes# Current TE-code rows page 1 of 1 · 1 matching rows.
Application-product, TE code table Application-product TE code A078446-001 AP
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 · 43 observed states.
Captured, Edition, Application-product table Captured Edition Application-product Trade name Strength Dosage form / route Product TE source text RLD / RS Approval date Source SHA-256 2026-09-14 22:38:34 2026-08 A078446-001 POTASSIUM CHLORIDE 0.149% IN SODIUM CHLORIDE 0.45% IN PLASTIC CONTAINER 149MG/100ML;450MG/100ML INJECTABLE / INJECTION AP 2008-09-10 84e616aacf4f…2026-08-18 06:07:40 2026-07 A078446-001 POTASSIUM CHLORIDE 0.149% IN SODIUM CHLORIDE 0.45% IN PLASTIC CONTAINER 149MG/100ML;450MG/100ML INJECTABLE / INJECTION AP 2008-09-10 caaa826d4ba7…2026-02-19 14:30 UTC 2026-02 A078446-001 POTASSIUM CHLORIDE 0.149% IN SODIUM CHLORIDE 0.45% IN PLASTIC CONTAINER 149MG/100ML;450MG/100ML INJECTABLE / INJECTION AP 2008-09-10 011fe1cb6892…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 A078446-001 POTASSIUM CHLORIDE 0.149% IN SODIUM CHLORIDE 0.45% IN PLASTIC CONTAINER 149MG/100ML;450MG/100ML INJECTABLE / INJECTION AP 2008-09-10 31067a03dcf5…2025-08-23 18:47 UTC 2025-08 A078446-001 POTASSIUM CHLORIDE 0.149% IN SODIUM CHLORIDE 0.45% IN PLASTIC CONTAINER 149MG/100ML;450MG/100ML INJECTABLE / INJECTION AP 2008-09-10 6a471c1ec25d…2025-03-22 03:13 UTC · 3 captures of this ZIP 2025-03 A078446-001 POTASSIUM CHLORIDE 0.149% IN SODIUM CHLORIDE 0.45% IN PLASTIC CONTAINER 149MG/100ML;450MG/100ML INJECTABLE / INJECTION AP 2008-09-10 fd3edfee7708…2025-02-26 10:13 UTC · 3 captures of this ZIP 2025-02 A078446-001 POTASSIUM CHLORIDE 0.149% IN SODIUM CHLORIDE 0.45% IN PLASTIC CONTAINER 149MG/100ML;450MG/100ML INJECTABLE / INJECTION AP 2008-09-10 b8a1b40f171c…2025-01-19 17:59 UTC · 7 captures of this ZIP 2025-01 A078446-001 POTASSIUM CHLORIDE 0.149% IN SODIUM CHLORIDE 0.45% IN PLASTIC CONTAINER 149MG/100ML;450MG/100ML INJECTABLE / INJECTION AP 2008-09-10 03ed91905a0d…2024-12-13 21:23 UTC · 2 captures of this ZIP 2024-12 A078446-001 POTASSIUM CHLORIDE 0.149% IN SODIUM CHLORIDE 0.45% IN PLASTIC CONTAINER 149MG/100ML;450MG/100ML INJECTABLE / INJECTION AP 2008-09-10 2680178bc6a6…2024-09-14 05:58 UTC · 2 captures of this ZIP 2024-09 A078446-001 POTASSIUM CHLORIDE 0.149% IN SODIUM CHLORIDE 0.45% IN PLASTIC CONTAINER 149MG/100ML;450MG/100ML INJECTABLE / INJECTION AP 2008-09-10 5bbf6a4d5a75…2024-11-08 22:44 UTC · 3 captures of this ZIP 2024-11 A078446-001 POTASSIUM CHLORIDE 0.149% IN SODIUM CHLORIDE 0.45% IN PLASTIC CONTAINER 149MG/100ML;450MG/100ML INJECTABLE / INJECTION AP 2008-09-10 d8e5a09893c0…2024-10-29 15:01 UTC 2024-10 A078446-001 POTASSIUM CHLORIDE 0.149% IN SODIUM CHLORIDE 0.45% IN PLASTIC CONTAINER 149MG/100ML;450MG/100ML INJECTABLE / INJECTION AP 2008-09-10 d06236e962d9…2024-08-13 05:28 UTC · 3 captures of this ZIP 2024-08 A078446-001 POTASSIUM CHLORIDE 0.149% IN SODIUM CHLORIDE 0.45% IN PLASTIC CONTAINER 149MG/100ML;450MG/100ML INJECTABLE / INJECTION AP 2008-09-10 79d66fd596c7…2024-07-13 05:37 UTC · 2 captures of this ZIP 2024-07 A078446-001 POTASSIUM CHLORIDE 0.149% IN SODIUM CHLORIDE 0.45% IN PLASTIC CONTAINER 149MG/100ML;450MG/100ML INJECTABLE / INJECTION AP 2008-09-10 301d65b070ca…2024-06-18 03:08 UTC · 5 captures of this ZIP 2024-06 A078446-001 POTASSIUM CHLORIDE 0.149% IN SODIUM CHLORIDE 0.45% IN PLASTIC CONTAINER 149MG/100ML;450MG/100ML INJECTABLE / INJECTION AP 2008-09-10 1e350fbaab3a…2024-05-31 18:47 UTC 2024-05 A078446-001 POTASSIUM CHLORIDE 0.149% IN SODIUM CHLORIDE 0.45% IN PLASTIC CONTAINER 149MG/100ML;450MG/100ML INJECTABLE / INJECTION AP 2008-09-10 8072bd15b7f6…2022-06-29 02:47 UTC · 2 captures of this ZIP 2022-06 A078446-001 POTASSIUM CHLORIDE 0.149% IN SODIUM CHLORIDE 0.45% IN PLASTIC CONTAINER 149MG/100ML;450MG/100ML INJECTABLE / INJECTION AP 2008-09-10 5c6f7cd8ea54…2022-04-08 23:34 UTC 2022-04 A078446-001 POTASSIUM CHLORIDE 0.149% IN SODIUM CHLORIDE 0.45% IN PLASTIC CONTAINER 149MG/100ML;450MG/100ML INJECTABLE / INJECTION AP 2008-09-10 5d02ea3f76ae…2022-04-04 05:41 UTC 2022-04 A078446-001 POTASSIUM CHLORIDE 0.149% IN SODIUM CHLORIDE 0.45% IN PLASTIC CONTAINER 149MG/100ML;450MG/100ML INJECTABLE / INJECTION AP 2008-09-10 4b0b4de00fa7…2019-12-13 00:20 UTC 2019-12 A078446-001 POTASSIUM CHLORIDE 0.149% IN SODIUM CHLORIDE 0.45% IN PLASTIC CONTAINER 149MG/100ML;450MG/100ML INJECTABLE / INJECTION AP 2008-09-10 74a2ff9319b5…2022-03-09 01:35 UTC 2022-03 A078446-001 POTASSIUM CHLORIDE 0.149% IN SODIUM CHLORIDE 0.45% IN PLASTIC CONTAINER 149MG/100ML;450MG/100ML INJECTABLE / INJECTION AP 2008-09-10 bb7c543d1eb4…2021-12-28 21:50 UTC 2021-12 A078446-001 POTASSIUM CHLORIDE 0.149% IN SODIUM CHLORIDE 0.45% IN PLASTIC CONTAINER 149MG/100ML;450MG/100ML INJECTABLE / INJECTION AP 2008-09-10 782e0a99824c…2021-05-05 16:15 UTC · 3 captures of this ZIP 2021-05 A078446-001 POTASSIUM CHLORIDE 0.149% IN SODIUM CHLORIDE 0.45% IN PLASTIC CONTAINER 149MG/100ML;450MG/100ML INJECTABLE / INJECTION AP 2008-09-10 87673890dc5c…2021-03-12 10:30 UTC 2021-03 A078446-001 POTASSIUM CHLORIDE 0.149% IN SODIUM CHLORIDE 0.45% IN PLASTIC CONTAINER 149MG/100ML;450MG/100ML INJECTABLE / INJECTION AP 2008-09-10 5aa47cf7b7d7…2020-12-22 03:56 UTC 2020-12 A078446-001 POTASSIUM CHLORIDE 0.149% IN SODIUM CHLORIDE 0.45% IN PLASTIC CONTAINER 149MG/100ML;450MG/100ML INJECTABLE / INJECTION AP 2008-09-10 8869cabd3fbd…2020-11-12 02:37 UTC 2020-11 A078446-001 POTASSIUM CHLORIDE 0.149% IN SODIUM CHLORIDE 0.45% IN PLASTIC CONTAINER 149MG/100ML;450MG/100ML INJECTABLE / INJECTION AP 2008-09-10 c0c555d07b60…2019-12-14 00:12 UTC 2019-12 A078446-001 POTASSIUM CHLORIDE 0.149% IN SODIUM CHLORIDE 0.45% IN PLASTIC CONTAINER 149MG/100ML;450MG/100ML INJECTABLE / INJECTION AP 2008-09-10 3f01610625f2…2019-09-15 20:21 UTC 2019-09 A078446-001 POTASSIUM CHLORIDE 0.149% IN SODIUM CHLORIDE 0.45% IN PLASTIC CONTAINER 149MG/100ML;450MG/100ML INJECTABLE / INJECTION AP 2008-09-10 b00525d2431f…2019-07-19 19:46 UTC 2019-07 A078446-001 POTASSIUM CHLORIDE 0.149% IN SODIUM CHLORIDE 0.45% IN PLASTIC CONTAINER 149MG/100ML;450MG/100ML INJECTABLE / INJECTION AP 2008-09-10 ea99ee380514…2024-03-16 18:09 UTC · 4 captures of this ZIP 2024-03 A078446-001 POTASSIUM CHLORIDE 0.149% IN SODIUM CHLORIDE 0.45% IN PLASTIC CONTAINER 149MG/100ML;450MG/100ML INJECTABLE / INJECTION AP 2008-09-10 6a51e52b5d6a…2024-02-18 07:12 UTC 2024-02 A078446-001 POTASSIUM CHLORIDE 0.149% IN SODIUM CHLORIDE 0.45% IN PLASTIC CONTAINER 149MG/100ML;450MG/100ML INJECTABLE / INJECTION AP 2008-09-10 1c564ffb4f44…2023-12-20 04:57 UTC 2023-12 A078446-001 POTASSIUM CHLORIDE 0.149% IN SODIUM CHLORIDE 0.45% IN PLASTIC CONTAINER 149MG/100ML;450MG/100ML INJECTABLE / INJECTION AP 2008-09-10 ea1830bbd6c7…2023-11-28 05:40 UTC · 2 captures of this ZIP 2023-11 A078446-001 POTASSIUM CHLORIDE 0.149% IN SODIUM CHLORIDE 0.45% IN PLASTIC CONTAINER 149MG/100ML;450MG/100ML INJECTABLE / INJECTION AP 2008-09-10 a72a2bbeb626…2023-10-25 00:34 UTC · 2 captures of this ZIP 2023-10 A078446-001 POTASSIUM CHLORIDE 0.149% IN SODIUM CHLORIDE 0.45% IN PLASTIC CONTAINER 149MG/100ML;450MG/100ML INJECTABLE / INJECTION AP 2008-09-10 9b2671bbb829…2023-07-15 15:27 UTC · 2 captures of this ZIP 2023-07 A078446-001 POTASSIUM CHLORIDE 0.149% IN SODIUM CHLORIDE 0.45% IN PLASTIC CONTAINER 149MG/100ML;450MG/100ML INJECTABLE / INJECTION AP 2008-09-10 a67488948f0b…2023-06-13 01:57 UTC · 3 captures of this ZIP 2023-06 A078446-001 POTASSIUM CHLORIDE 0.149% IN SODIUM CHLORIDE 0.45% IN PLASTIC CONTAINER 149MG/100ML;450MG/100ML INJECTABLE / INJECTION AP 2008-09-10 3f0d92c62455…2023-05-13 08:27 UTC 2023-05 A078446-001 POTASSIUM CHLORIDE 0.149% IN SODIUM CHLORIDE 0.45% IN PLASTIC CONTAINER 149MG/100ML;450MG/100ML INJECTABLE / INJECTION AP 2008-09-10 053a50430f4f…2023-01-26 05:58 UTC 2023-01 A078446-001 POTASSIUM CHLORIDE 0.149% IN SODIUM CHLORIDE 0.45% IN PLASTIC CONTAINER 149MG/100ML;450MG/100ML INJECTABLE / INJECTION AP 2008-09-10 3bdfa0b2c4d7…2022-11-12 20:34 UTC · 5 captures of this ZIP 2022-11 A078446-001 POTASSIUM CHLORIDE 0.149% IN SODIUM CHLORIDE 0.45% IN PLASTIC CONTAINER 149MG/100ML;450MG/100ML INJECTABLE / INJECTION AP 2008-09-10 3a93d1ddd44b…2022-10-28 04:53 UTC 2022-10 A078446-001 POTASSIUM CHLORIDE 0.149% IN SODIUM CHLORIDE 0.45% IN PLASTIC CONTAINER 149MG/100ML;450MG/100ML INJECTABLE / INJECTION AP 2008-09-10 f41ea6bd6efb…
Observed Orange Book normalized TE history# Normalized TE history page 1 of 2 · 43 observed states.
Reported adverse events (FAERS/openFDA)# Adverse event summaries are temporarily unavailable. Other product information remains available.
Additional Listing Data#
Finished product Yes
Brand name base Potassium Chloride in Sodium Chloride
Listing expiration 2027-12-31 Active Ingredients# Ingredient, Strength table Ingredient Strength SODIUM CHLORIDE 4.5 g/1000mL POTASSIUM CHLORIDE 1.49 g/1000mL
Harmonized UNII identifiers# UNII identifiers page 1 of 1 · 2 matching rows.
Identifier, FDA.report destination table Identifier FDA.report destination 451W47IQ8X Internal UNII lookup 660YQ98I10 Internal UNII lookup
Harmonized RxCUI identifiers# RxCUI identifiers page 1 of 1 · 1 matching rows.
Identifier, FDA.report destination table Identifier FDA.report destination 403890 Internal RxNorm lookup
Harmonized SPL set identifiers# SPL set identifiers page 1 of 1 · 1 matching rows.
DailyMed Product Concepts# DailyMed Package Descriptions# Package NDC, Product, Description table Package NDC Product Description Form Quantity Strength SPL version 0990-9257-39 Potassium Chloride in Sodium Chloride 12 in 1 CASE INJECTION, SOLUTION 12 12 0990-9257-39 Potassium Chloride in Sodium Chloride 1 in 1 POUCH INJECTION, SOLUTION 1 12
DailyMed Dashboard NDC Coverage# NDC, Dashboard title, SPL version table NDC Dashboard title SPL version Validation Dashboard ZIP 0990-9257 POTASSIUM CHLORIDE IN SODIUM CHLORIDE (SODIUM CHLORIDE AND POTASSIUM CHLORIDE) INJECTION, SOLUTION [ICU MEDICAL INC.] 10 Current NDC, Legacy NDC, 2 package rows 20241109_243fe8fc-996a-4855-8daf-069628e547c4.zip
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.
DailyMed RxNorm Mappings# Packages# Package NDC, 11-digit format, Description table Package NDC 11-digit format Description Units Marketing start Marketing end Sample Exclude flag Status 0990-9257-39 00990925739 12 POUCH in 1 CASE (0990-9257-39) / 1 BAG in 1 POUCH / 1000 mL in 1 BAG 12 pouch 2020-03-01 0000-00-00 No No Current