Home NDC 63323-965 Potassium Chloride
Product NDC 63323-965
11-digit product format 633230965
Labeler code 63323
Product ID 63323-965_a1b31b46-2bb4-457e-a30b-e7dab47a2c54
Type HUMAN PRESCRIPTION DRUG
Nonproprietary name POTASSIUM CHLORIDE
Dosage form INJECTION, SOLUTION, CONCENTRATE
Route INTRAVENOUS
Labeler Fresenius Kabi USA, LLC
Application ANDA088901
Marketing category ANDA
Marketing start 1999-09-27
Substance POTASSIUM CHLORIDE
Active strength 2 meq/mL
Pharmacologic classes Increased Large Intestinal Motility [PE], Inhibition Large Intestine Fluid/Electrolyte Absorption [PE], Osmotic Activity [MoA], Osmotic Laxative [EPC], Potassium Compounds [CS], Potassium Salt [EPC]
NDC exclude flag No
Listing certified through 2026-12-31
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 A088901-001 POTASSIUM CHLORIDE IN PLASTIC CONTAINER POTASSIUM CHLORIDE 2MEQ/ML INJECTABLE / INJECTION AP 1985-01-25
Therapeutic equivalence codes# Current TE-code rows page 1 of 1 · 1 matching rows.
Application-product, TE code table Application-product TE code A088901-001 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 A088901-001 POTASSIUM CHLORIDE IN PLASTIC CONTAINER 2MEQ/ML INJECTABLE / INJECTION AP 1985-01-25 84e616aacf4f…2026-08-18 06:07:40 2026-07 A088901-001 POTASSIUM CHLORIDE IN PLASTIC CONTAINER 2MEQ/ML INJECTABLE / INJECTION AP 1985-01-25 caaa826d4ba7…2026-02-19 14:30 UTC 2026-02 A088901-001 POTASSIUM CHLORIDE IN PLASTIC CONTAINER 2MEQ/ML INJECTABLE / INJECTION AP 1985-01-25 011fe1cb6892…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 A088901-001 POTASSIUM CHLORIDE IN PLASTIC CONTAINER 2MEQ/ML INJECTABLE / INJECTION AP 1985-01-25 31067a03dcf5…2025-08-23 18:47 UTC 2025-08 A088901-001 POTASSIUM CHLORIDE IN PLASTIC CONTAINER 2MEQ/ML INJECTABLE / INJECTION AP 1985-01-25 6a471c1ec25d…2025-03-22 03:13 UTC · 3 captures of this ZIP 2025-03 A088901-001 POTASSIUM CHLORIDE IN PLASTIC CONTAINER 2MEQ/ML INJECTABLE / INJECTION AP 1985-01-25 fd3edfee7708…2025-02-26 10:13 UTC · 3 captures of this ZIP 2025-02 A088901-001 POTASSIUM CHLORIDE IN PLASTIC CONTAINER 2MEQ/ML INJECTABLE / INJECTION AP 1985-01-25 b8a1b40f171c…2025-01-19 17:59 UTC · 7 captures of this ZIP 2025-01 A088901-001 POTASSIUM CHLORIDE IN PLASTIC CONTAINER 2MEQ/ML INJECTABLE / INJECTION AP 1985-01-25 03ed91905a0d…2024-12-13 21:23 UTC · 2 captures of this ZIP 2024-12 A088901-001 POTASSIUM CHLORIDE IN PLASTIC CONTAINER 2MEQ/ML INJECTABLE / INJECTION AP 1985-01-25 2680178bc6a6…2024-09-14 05:58 UTC · 2 captures of this ZIP 2024-09 A088901-001 POTASSIUM CHLORIDE IN PLASTIC CONTAINER 2MEQ/ML INJECTABLE / INJECTION AP 1985-01-25 5bbf6a4d5a75…2024-11-08 22:44 UTC · 3 captures of this ZIP 2024-11 A088901-001 POTASSIUM CHLORIDE IN PLASTIC CONTAINER 2MEQ/ML INJECTABLE / INJECTION AP 1985-01-25 d8e5a09893c0…2024-10-29 15:01 UTC 2024-10 A088901-001 POTASSIUM CHLORIDE IN PLASTIC CONTAINER 2MEQ/ML INJECTABLE / INJECTION AP 1985-01-25 d06236e962d9…2024-08-13 05:28 UTC · 3 captures of this ZIP 2024-08 A088901-001 POTASSIUM CHLORIDE IN PLASTIC CONTAINER 2MEQ/ML INJECTABLE / INJECTION AP 1985-01-25 79d66fd596c7…2024-07-13 05:37 UTC · 2 captures of this ZIP 2024-07 A088901-001 POTASSIUM CHLORIDE IN PLASTIC CONTAINER 2MEQ/ML INJECTABLE / INJECTION AP 1985-01-25 301d65b070ca…2024-06-18 03:08 UTC · 5 captures of this ZIP 2024-06 A088901-001 POTASSIUM CHLORIDE IN PLASTIC CONTAINER 2MEQ/ML INJECTABLE / INJECTION AP 1985-01-25 1e350fbaab3a…2024-05-31 18:47 UTC 2024-05 A088901-001 POTASSIUM CHLORIDE IN PLASTIC CONTAINER 2MEQ/ML INJECTABLE / INJECTION AP 1985-01-25 8072bd15b7f6…2022-06-29 02:47 UTC · 2 captures of this ZIP 2022-06 A088901-001 POTASSIUM CHLORIDE IN PLASTIC CONTAINER 2MEQ/ML INJECTABLE / INJECTION AP 1985-01-25 5c6f7cd8ea54…2022-04-08 23:34 UTC 2022-04 A088901-001 POTASSIUM CHLORIDE IN PLASTIC CONTAINER 2MEQ/ML INJECTABLE / INJECTION AP 1985-01-25 5d02ea3f76ae…2022-04-04 05:41 UTC 2022-04 A088901-001 POTASSIUM CHLORIDE IN PLASTIC CONTAINER 2MEQ/ML INJECTABLE / INJECTION AP 1985-01-25 4b0b4de00fa7…2019-12-13 00:20 UTC 2019-12 A088901-001 POTASSIUM CHLORIDE IN PLASTIC CONTAINER 2MEQ/ML INJECTABLE / INJECTION AP 1985-01-25 74a2ff9319b5…2022-03-09 01:35 UTC 2022-03 A088901-001 POTASSIUM CHLORIDE IN PLASTIC CONTAINER 2MEQ/ML INJECTABLE / INJECTION AP 1985-01-25 bb7c543d1eb4…2021-12-28 21:50 UTC 2021-12 A088901-001 POTASSIUM CHLORIDE IN PLASTIC CONTAINER 2MEQ/ML INJECTABLE / INJECTION AP 1985-01-25 782e0a99824c…2021-05-05 16:15 UTC · 3 captures of this ZIP 2021-05 A088901-001 POTASSIUM CHLORIDE IN PLASTIC CONTAINER 2MEQ/ML INJECTABLE / INJECTION AP 1985-01-25 87673890dc5c…2021-03-12 10:30 UTC 2021-03 A088901-001 POTASSIUM CHLORIDE IN PLASTIC CONTAINER 2MEQ/ML INJECTABLE / INJECTION AP 1985-01-25 5aa47cf7b7d7…2020-12-22 03:56 UTC 2020-12 A088901-001 POTASSIUM CHLORIDE IN PLASTIC CONTAINER 2MEQ/ML INJECTABLE / INJECTION AP 1985-01-25 8869cabd3fbd…2020-11-12 02:37 UTC 2020-11 A088901-001 POTASSIUM CHLORIDE IN PLASTIC CONTAINER 2MEQ/ML INJECTABLE / INJECTION AP 1985-01-25 c0c555d07b60…2019-12-14 00:12 UTC 2019-12 A088901-001 POTASSIUM CHLORIDE IN PLASTIC CONTAINER 2MEQ/ML INJECTABLE / INJECTION AP 1985-01-25 3f01610625f2…2019-09-15 20:21 UTC 2019-09 A088901-001 POTASSIUM CHLORIDE IN PLASTIC CONTAINER 2MEQ/ML INJECTABLE / INJECTION AP 1985-01-25 b00525d2431f…2019-07-19 19:46 UTC 2019-07 A088901-001 POTASSIUM CHLORIDE IN PLASTIC CONTAINER 2MEQ/ML INJECTABLE / INJECTION AP 1985-01-25 ea99ee380514…2024-03-16 18:09 UTC · 4 captures of this ZIP 2024-03 A088901-001 POTASSIUM CHLORIDE IN PLASTIC CONTAINER 2MEQ/ML INJECTABLE / INJECTION AP 1985-01-25 6a51e52b5d6a…2024-02-18 07:12 UTC 2024-02 A088901-001 POTASSIUM CHLORIDE IN PLASTIC CONTAINER 2MEQ/ML INJECTABLE / INJECTION AP 1985-01-25 1c564ffb4f44…2023-12-20 04:57 UTC 2023-12 A088901-001 POTASSIUM CHLORIDE IN PLASTIC CONTAINER 2MEQ/ML INJECTABLE / INJECTION AP 1985-01-25 ea1830bbd6c7…2023-11-28 05:40 UTC · 2 captures of this ZIP 2023-11 A088901-001 POTASSIUM CHLORIDE IN PLASTIC CONTAINER 2MEQ/ML INJECTABLE / INJECTION AP 1985-01-25 a72a2bbeb626…2023-10-25 00:34 UTC · 2 captures of this ZIP 2023-10 A088901-001 POTASSIUM CHLORIDE IN PLASTIC CONTAINER 2MEQ/ML INJECTABLE / INJECTION AP 1985-01-25 9b2671bbb829…2023-07-15 15:27 UTC · 2 captures of this ZIP 2023-07 A088901-001 POTASSIUM CHLORIDE IN PLASTIC CONTAINER 2MEQ/ML INJECTABLE / INJECTION AP 1985-01-25 a67488948f0b…2023-06-13 01:57 UTC · 3 captures of this ZIP 2023-06 A088901-001 POTASSIUM CHLORIDE IN PLASTIC CONTAINER 2MEQ/ML INJECTABLE / INJECTION AP 1985-01-25 3f0d92c62455…2023-05-13 08:27 UTC 2023-05 A088901-001 POTASSIUM CHLORIDE IN PLASTIC CONTAINER 2MEQ/ML INJECTABLE / INJECTION AP 1985-01-25 053a50430f4f…2023-01-26 05:58 UTC 2023-01 A088901-001 POTASSIUM CHLORIDE IN PLASTIC CONTAINER 2MEQ/ML INJECTABLE / INJECTION AP 1985-01-25 3bdfa0b2c4d7…2022-11-12 20:34 UTC · 5 captures of this ZIP 2022-11 A088901-001 POTASSIUM CHLORIDE IN PLASTIC CONTAINER 2MEQ/ML INJECTABLE / INJECTION AP 1985-01-25 3a93d1ddd44b…2022-10-28 04:53 UTC 2022-10 A088901-001 POTASSIUM CHLORIDE IN PLASTIC CONTAINER 2MEQ/ML INJECTABLE / INJECTION AP 1985-01-25 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
Listing expiration 2026-12-31 Active Ingredients# Ingredient, Strength table Ingredient Strength POTASSIUM CHLORIDE 2 meq/mL
Harmonized UNII identifiers# UNII identifiers page 1 of 1 · 1 matching rows.
Identifier, FDA.report destination table Identifier FDA.report destination 660YQ98I10 Internal UNII lookup
Harmonized RxCUI identifiers# RxCUI identifiers page 1 of 1 · 4 matching rows.
Identifier, FDA.report destination table Identifier FDA.report destination 204520 Internal RxNorm lookup 1860132 Internal RxNorm lookup 1860136 Internal RxNorm lookup 1860139 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 63323-965-01 Potassium Chloride 5 mL in 1 VIAL, SINGLE-DOSE INJECTION, SOLUTION, CONCENTRATE 5 5 63323-965-02 Potassium Chloride 20 mL in 1 VIAL, SINGLE-DOSE INJECTION, SOLUTION, CONCENTRATE 20 5 63323-965-03 Potassium Chloride 10 mL in 1 VIAL, SINGLE-DOSE INJECTION, SOLUTION, CONCENTRATE 10 5 63323-965-05 Potassium Chloride 25 in 1 TRAY INJECTION, SOLUTION, CONCENTRATE 25 5 63323-965-10 Potassium Chloride 25 in 1 TRAY INJECTION, SOLUTION, CONCENTRATE 25 5 63323-965-20 Potassium Chloride 25 in 1 TRAY INJECTION, SOLUTION, CONCENTRATE 25 5
DailyMed Socrata Ingredients# Ingredient, Type, UNII table Ingredient Type UNII DailyMed label SPL version Uploaded Potassium Chloride ACTIVE INGREDIENT 660YQ98I10 POTASSIUM CHLORIDE INJECTION, SOLUTION [GENERAL INJECTABLES & VACCINES, INC] 4 Potassium Cation ACTIVE MOIETY 295O53K152 POTASSIUM CHLORIDE INJECTION, SOLUTION [GENERAL INJECTABLES & VACCINES, INC] 4 POTASSIUM CHLORIDE ACTIVE INGREDIENT 660YQ98I10 POTASSIUM CHLORIDE INJECTION, SOLUTION, CONCENTRATE [APP PHARMACEUTICALS, LLC] 1 POTASSIUM CATION ACTIVE MOIETY 295O53K152 POTASSIUM CHLORIDE INJECTION, SOLUTION, CONCENTRATE [APP PHARMACEUTICALS, LLC] 1 HYDROCHLORIC ACID INACTIVE INGREDIENT QTT17582CB POTASSIUM CHLORIDE INJECTION, SOLUTION, CONCENTRATE [APP PHARMACEUTICALS, LLC] 1 METHYLPARABEN INACTIVE INGREDIENT A2I8C7HI9T POTASSIUM CHLORIDE INJECTION, SOLUTION, CONCENTRATE [APP PHARMACEUTICALS, LLC] 1 POTASSIUM HYDROXIDE INACTIVE INGREDIENT WZH3C48M4T POTASSIUM CHLORIDE INJECTION, SOLUTION, CONCENTRATE [APP PHARMACEUTICALS, LLC] 1 PROPYLPARABEN INACTIVE INGREDIENT Z8IX2SC1OH POTASSIUM CHLORIDE INJECTION, SOLUTION, CONCENTRATE [APP PHARMACEUTICALS, LLC] 1
DailyMed Dashboard NDC Coverage# NDC, Dashboard title, SPL version table NDC Dashboard title SPL version Validation Dashboard ZIP 63323-965 POTASSIUM CHLORIDE INJECTION, SOLUTION, CONCENTRATE [FRESENIUS KABI USA, LLC] 5 Current NDC, Legacy NDC, 6 package rows 20230316_fcd4f458-ce27-417e-9bb6-de1cc49d44b9.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 · 2 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 63323-965-01 63323096501 5 mL in 1 VIAL, SINGLE-DOSE 5 ml Historical 63323-965-02 63323096502 20 mL in 1 VIAL, SINGLE-DOSE 20 ml Historical 63323-965-03 63323096503 10 mL in 1 VIAL, SINGLE-DOSE 10 ml Historical 63323-965-05 63323096505 25 VIAL, SINGLE-DOSE in 1 TRAY (63323-965-05) / 5 mL in 1 VIAL, SINGLE-DOSE (63323-965-01) 1999-09-27 0000-00-00 No No Current 63323-965-10 63323096510 25 VIAL, SINGLE-DOSE in 1 TRAY (63323-965-10) / 10 mL in 1 VIAL, SINGLE-DOSE (63323-965-03) 1999-09-27 0000-00-00 No No Current 63323-965-20 63323096520 25 VIAL, SINGLE-DOSE in 1 TRAY (63323-965-20) / 20 mL in 1 VIAL, SINGLE-DOSE (63323-965-02) 1999-09-27 0000-00-00 No No Current