Home NDC 63323-669 Potassium Chloride
Product NDC 63323-669
11-digit product format 633230669
Labeler code 63323
Product ID 63323-669_fa0a4b99-d041-42d8-843d-e7dbead01d89
Type HUMAN PRESCRIPTION DRUG
Nonproprietary name Potassium Chloride, Dextrose Monohydrate
Dosage form INJECTION, SOLUTION
Route INTRAVENOUS
Labeler Fresenius Kabi USA, LLC
Application ANDA212346
Marketing category ANDA
Marketing start 2021-04-23
Substance POTASSIUM CHLORIDE; DEXTROSE MONOHYDRATE
Active strength 150; 5 mg/100mL; g/100mL
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 · 2 matching rows.
Application-product, Trade name, Ingredient table Application-product Trade name Ingredient Strength Dosage form / route TE codes RLD / RS Approval date A212346-001 DEXTROSE 5% AND POTASSIUM CHLORIDE 0.075% DEXTROSE; POTASSIUM CHLORIDE 5GM/100ML;75MG/100ML INJECTABLE / INJECTION AP 2020-09-10 A212346-002 DEXTROSE 5% AND POTASSIUM CHLORIDE 0.15% DEXTROSE; POTASSIUM CHLORIDE 5GM/100ML;150MG/100ML INJECTABLE / INJECTION AP 2020-09-10
Therapeutic equivalence codes# Current TE-code rows page 1 of 1 · 2 matching rows.
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 · 78 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 A212346-001 DEXTROSE 5% AND POTASSIUM CHLORIDE 0.075% 5GM/100ML;75MG/100ML INJECTABLE / INJECTION AP 2020-09-10 84e616aacf4f…2026-09-14 22:38:34 2026-08 A212346-002 DEXTROSE 5% AND POTASSIUM CHLORIDE 0.15% 5GM/100ML;150MG/100ML INJECTABLE / INJECTION AP 2020-09-10 84e616aacf4f…2026-08-18 06:07:40 2026-07 A212346-001 DEXTROSE 5% AND POTASSIUM CHLORIDE 0.075% 5GM/100ML;75MG/100ML INJECTABLE / INJECTION AP 2020-09-10 caaa826d4ba7…2026-08-18 06:07:40 2026-07 A212346-002 DEXTROSE 5% AND POTASSIUM CHLORIDE 0.15% 5GM/100ML;150MG/100ML INJECTABLE / INJECTION AP 2020-09-10 caaa826d4ba7…2026-02-19 14:30 UTC 2026-02 A212346-001 DEXTROSE 5% AND POTASSIUM CHLORIDE 0.075% 5GM/100ML;75MG/100ML INJECTABLE / INJECTION AP 2020-09-10 011fe1cb6892…2026-02-19 14:30 UTC 2026-02 A212346-002 DEXTROSE 5% AND POTASSIUM CHLORIDE 0.15% 5GM/100ML;150MG/100ML INJECTABLE / INJECTION AP 2020-09-10 011fe1cb6892…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 A212346-001 DEXTROSE 5% AND POTASSIUM CHLORIDE 0.075% 5GM/100ML;75MG/100ML INJECTABLE / INJECTION AP 2020-09-10 31067a03dcf5…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 A212346-002 DEXTROSE 5% AND POTASSIUM CHLORIDE 0.15% 5GM/100ML;150MG/100ML INJECTABLE / INJECTION AP 2020-09-10 31067a03dcf5…2025-08-23 18:47 UTC 2025-08 A212346-001 DEXTROSE 5% AND POTASSIUM CHLORIDE 0.075% 5GM/100ML;75MG/100ML INJECTABLE / INJECTION AP 2020-09-10 6a471c1ec25d…2025-08-23 18:47 UTC 2025-08 A212346-002 DEXTROSE 5% AND POTASSIUM CHLORIDE 0.15% 5GM/100ML;150MG/100ML INJECTABLE / INJECTION AP 2020-09-10 6a471c1ec25d…2025-03-22 03:13 UTC · 3 captures of this ZIP 2025-03 A212346-001 DEXTROSE 5% AND POTASSIUM CHLORIDE 0.075% 5GM/100ML;75MG/100ML INJECTABLE / INJECTION AP 2020-09-10 fd3edfee7708…2025-03-22 03:13 UTC · 3 captures of this ZIP 2025-03 A212346-002 DEXTROSE 5% AND POTASSIUM CHLORIDE 0.15% 5GM/100ML;150MG/100ML INJECTABLE / INJECTION AP 2020-09-10 fd3edfee7708…2025-02-26 10:13 UTC · 3 captures of this ZIP 2025-02 A212346-001 DEXTROSE 5% AND POTASSIUM CHLORIDE 0.075% 5GM/100ML;75MG/100ML INJECTABLE / INJECTION AP 2020-09-10 b8a1b40f171c…2025-02-26 10:13 UTC · 3 captures of this ZIP 2025-02 A212346-002 DEXTROSE 5% AND POTASSIUM CHLORIDE 0.15% 5GM/100ML;150MG/100ML INJECTABLE / INJECTION AP 2020-09-10 b8a1b40f171c…2025-01-19 17:59 UTC · 7 captures of this ZIP 2025-01 A212346-001 DEXTROSE 5% AND POTASSIUM CHLORIDE 0.075% 5GM/100ML;75MG/100ML INJECTABLE / INJECTION AP 2020-09-10 03ed91905a0d…2025-01-19 17:59 UTC · 7 captures of this ZIP 2025-01 A212346-002 DEXTROSE 5% AND POTASSIUM CHLORIDE 0.15% 5GM/100ML;150MG/100ML INJECTABLE / INJECTION AP 2020-09-10 03ed91905a0d…2024-12-13 21:23 UTC · 2 captures of this ZIP 2024-12 A212346-001 DEXTROSE 5% AND POTASSIUM CHLORIDE 0.075% 5GM/100ML;75MG/100ML INJECTABLE / INJECTION AP 2020-09-10 2680178bc6a6…2024-12-13 21:23 UTC · 2 captures of this ZIP 2024-12 A212346-002 DEXTROSE 5% AND POTASSIUM CHLORIDE 0.15% 5GM/100ML;150MG/100ML INJECTABLE / INJECTION AP 2020-09-10 2680178bc6a6…2024-09-14 05:58 UTC · 2 captures of this ZIP 2024-09 A212346-001 DEXTROSE 5% AND POTASSIUM CHLORIDE 0.075% 5GM/100ML;75MG/100ML INJECTABLE / INJECTION AP 2020-09-10 5bbf6a4d5a75…2024-09-14 05:58 UTC · 2 captures of this ZIP 2024-09 A212346-002 DEXTROSE 5% AND POTASSIUM CHLORIDE 0.15% 5GM/100ML;150MG/100ML INJECTABLE / INJECTION AP 2020-09-10 5bbf6a4d5a75…2024-11-08 22:44 UTC · 3 captures of this ZIP 2024-11 A212346-001 DEXTROSE 5% AND POTASSIUM CHLORIDE 0.075% 5GM/100ML;75MG/100ML INJECTABLE / INJECTION AP 2020-09-10 d8e5a09893c0…2024-11-08 22:44 UTC · 3 captures of this ZIP 2024-11 A212346-002 DEXTROSE 5% AND POTASSIUM CHLORIDE 0.15% 5GM/100ML;150MG/100ML INJECTABLE / INJECTION AP 2020-09-10 d8e5a09893c0…2024-10-29 15:01 UTC 2024-10 A212346-001 DEXTROSE 5% AND POTASSIUM CHLORIDE 0.075% 5GM/100ML;75MG/100ML INJECTABLE / INJECTION AP 2020-09-10 d06236e962d9…2024-10-29 15:01 UTC 2024-10 A212346-002 DEXTROSE 5% AND POTASSIUM CHLORIDE 0.15% 5GM/100ML;150MG/100ML INJECTABLE / INJECTION AP 2020-09-10 d06236e962d9…2024-08-13 05:28 UTC · 3 captures of this ZIP 2024-08 A212346-001 DEXTROSE 5% AND POTASSIUM CHLORIDE 0.075% 5GM/100ML;75MG/100ML INJECTABLE / INJECTION AP 2020-09-10 79d66fd596c7…2024-08-13 05:28 UTC · 3 captures of this ZIP 2024-08 A212346-002 DEXTROSE 5% AND POTASSIUM CHLORIDE 0.15% 5GM/100ML;150MG/100ML INJECTABLE / INJECTION AP 2020-09-10 79d66fd596c7…2024-07-13 05:37 UTC · 2 captures of this ZIP 2024-07 A212346-001 DEXTROSE 5% AND POTASSIUM CHLORIDE 0.075% 5GM/100ML;75MG/100ML INJECTABLE / INJECTION AP 2020-09-10 301d65b070ca…2024-07-13 05:37 UTC · 2 captures of this ZIP 2024-07 A212346-002 DEXTROSE 5% AND POTASSIUM CHLORIDE 0.15% 5GM/100ML;150MG/100ML INJECTABLE / INJECTION AP 2020-09-10 301d65b070ca…2024-06-18 03:08 UTC · 5 captures of this ZIP 2024-06 A212346-001 DEXTROSE 5% AND POTASSIUM CHLORIDE 0.075% 5GM/100ML;75MG/100ML INJECTABLE / INJECTION AP 2020-09-10 1e350fbaab3a…2024-06-18 03:08 UTC · 5 captures of this ZIP 2024-06 A212346-002 DEXTROSE 5% AND POTASSIUM CHLORIDE 0.15% 5GM/100ML;150MG/100ML INJECTABLE / INJECTION AP 2020-09-10 1e350fbaab3a…2024-05-31 18:47 UTC 2024-05 A212346-001 DEXTROSE 5% AND POTASSIUM CHLORIDE 0.075% 5GM/100ML;75MG/100ML INJECTABLE / INJECTION AP 2020-09-10 8072bd15b7f6…2024-05-31 18:47 UTC 2024-05 A212346-002 DEXTROSE 5% AND POTASSIUM CHLORIDE 0.15% 5GM/100ML;150MG/100ML INJECTABLE / INJECTION AP 2020-09-10 8072bd15b7f6…2022-06-29 02:47 UTC · 2 captures of this ZIP 2022-06 A212346-001 DEXTROSE 5% AND POTASSIUM CHLORIDE 0.075% 5GM/100ML;75MG/100ML INJECTABLE / INJECTION 2020-09-10 5c6f7cd8ea54…2022-06-29 02:47 UTC · 2 captures of this ZIP 2022-06 A212346-002 DEXTROSE 5% AND POTASSIUM CHLORIDE 0.15% 5GM/100ML;150MG/100ML INJECTABLE / INJECTION 2020-09-10 5c6f7cd8ea54…2022-04-08 23:34 UTC 2022-04 A212346-001 DEXTROSE 5% AND POTASSIUM CHLORIDE 0.075% 5GM/100ML;75MG/100ML INJECTABLE / INJECTION 2020-09-10 5d02ea3f76ae…2022-04-08 23:34 UTC 2022-04 A212346-002 DEXTROSE 5% AND POTASSIUM CHLORIDE 0.15% 5GM/100ML;150MG/100ML INJECTABLE / INJECTION 2020-09-10 5d02ea3f76ae…2022-04-04 05:41 UTC 2022-04 A212346-001 DEXTROSE 5% AND POTASSIUM CHLORIDE 0.075% 5GM/100ML;75MG/100ML INJECTABLE / INJECTION 2020-09-10 4b0b4de00fa7…2022-04-04 05:41 UTC 2022-04 A212346-002 DEXTROSE 5% AND POTASSIUM CHLORIDE 0.15% 5GM/100ML;150MG/100ML INJECTABLE / INJECTION 2020-09-10 4b0b4de00fa7…2022-03-09 01:35 UTC 2022-03 A212346-001 DEXTROSE 5% AND POTASSIUM CHLORIDE 0.075% 5GM/100ML;75MG/100ML INJECTABLE / INJECTION 2020-09-10 bb7c543d1eb4…2022-03-09 01:35 UTC 2022-03 A212346-002 DEXTROSE 5% AND POTASSIUM CHLORIDE 0.15% 5GM/100ML;150MG/100ML INJECTABLE / INJECTION 2020-09-10 bb7c543d1eb4…
Observed Orange Book normalized TE history# Normalized TE history page 1 of 2 · 62 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 150 mg/100mL DEXTROSE MONOHYDRATE 5 g/100mL
Harmonized UNII identifiers# UNII identifiers page 1 of 1 · 2 matching rows.
Identifier, FDA.report destination table Identifier FDA.report destination LX22YL083G Internal UNII lookup 660YQ98I10 Internal UNII lookup
Harmonized RxCUI identifiers# RxCUI identifiers page 1 of 1 · 2 matching rows.
Identifier, FDA.report destination table Identifier FDA.report destination 309783 Internal RxNorm lookup 2566844 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 63323-669-01 Potassium Chloride 1000 mL in 1 BAG INJECTION, SOLUTION 1000 4 63323-669-10 Potassium Chloride 10 in 1 CASE INJECTION, SOLUTION 10 4
DailyMed Dashboard NDC Coverage# NDC, Dashboard title, SPL version table NDC Dashboard title SPL version Validation Dashboard ZIP 63323-669 POTASSIUM CHLORIDE (POTASSIUM CHLORIDE, DEXTROSE MONOHYDRATE) INJECTION, SOLUTION [FRESENIUS KABI USA, LLC] 4 Current NDC, Legacy NDC, 2 package rows 20240511_55d9ae37-4553-47e7-a2e3-86b48b5227cd.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 63323-669-01 63323066901 1000 mL in 1 BAG 1000 ml Historical 63323-669-10 63323066910 10 BAG in 1 CASE (63323-669-10) / 1000 mL in 1 BAG (63323-669-01) 10 bag 2021-04-23 0000-00-00 No No Current