Home NDC 63323-686 Potassium Chloride in Sodium Chloride
Product NDC 63323-686
11-digit product format 633230686
Labeler code 63323
Product ID 63323-686_23c084c3-6c81-4691-9e86-0c2a17df7076
Type HUMAN PRESCRIPTION DRUG
Nonproprietary name Sodium Chloride and Potassium Chloride
Dosage form INJECTION, SOLUTION
Route INTRAVENOUS
Labeler Fresenius Kabi USA, LLC
Application ANDA212347
Marketing category ANDA
Marketing start 2021-06-02
Substance SODIUM CHLORIDE; POTASSIUM CHLORIDE
Active strength 900; 150 mg/100mL; mg/100mL
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 44 .
Orange Book products# Current product rows page 1 of 1 · 3 matching rows.
Application-product, Trade name, Ingredient table Application-product Trade name Ingredient Strength Dosage form / route TE codes RLD / RS Approval date A212347-001 POTASSIUM CHLORIDE 0.15% IN SODIUM CHLORIDE 0.45% POTASSIUM CHLORIDE; SODIUM CHLORIDE 150MG/100ML;450MG/100ML INJECTABLE / INJECTION AP 2020-09-17 A212347-002 POTASSIUM CHLORIDE 0.3% AND SODIUM CHLORIDE 0.9% POTASSIUM CHLORIDE; SODIUM CHLORIDE 300MG/100ML;900MG/100ML INJECTABLE / INJECTION AP 2020-09-17 A212347-003 POTASSIUM CHLORIDE 0.15% IN SODIUM CHLORIDE 0.9% POTASSIUM CHLORIDE; SODIUM CHLORIDE 150MG/100ML;900MG/100ML INJECTABLE / INJECTION AP 2021-06-02
Therapeutic equivalence codes# Current TE-code rows page 1 of 1 · 3 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 3 · 116 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 2026-10-15 13:18:30 2026-09 A212347-001 POTASSIUM CHLORIDE 0.15% IN SODIUM CHLORIDE 0.45% 150MG/100ML;450MG/100ML INJECTABLE / INJECTION AP 2020-09-17 c2088c7a36db…2026-10-15 13:18:30 2026-09 A212347-002 POTASSIUM CHLORIDE 0.3% AND SODIUM CHLORIDE 0.9% 300MG/100ML;900MG/100ML INJECTABLE / INJECTION AP 2020-09-17 c2088c7a36db…2026-10-15 13:18:30 2026-09 A212347-003 POTASSIUM CHLORIDE 0.15% IN SODIUM CHLORIDE 0.9% 150MG/100ML;900MG/100ML INJECTABLE / INJECTION AP 2021-06-02 c2088c7a36db…2026-09-14 22:38:34 2026-08 A212347-001 POTASSIUM CHLORIDE 0.15% IN SODIUM CHLORIDE 0.45% 150MG/100ML;450MG/100ML INJECTABLE / INJECTION AP 2020-09-17 84e616aacf4f…2026-09-14 22:38:34 2026-08 A212347-002 POTASSIUM CHLORIDE 0.3% AND SODIUM CHLORIDE 0.9% 300MG/100ML;900MG/100ML INJECTABLE / INJECTION AP 2020-09-17 84e616aacf4f…2026-09-14 22:38:34 2026-08 A212347-003 POTASSIUM CHLORIDE 0.15% IN SODIUM CHLORIDE 0.9% 150MG/100ML;900MG/100ML INJECTABLE / INJECTION AP 2021-06-02 84e616aacf4f…2026-08-18 06:07:40 2026-07 A212347-001 POTASSIUM CHLORIDE 0.15% IN SODIUM CHLORIDE 0.45% 150MG/100ML;450MG/100ML INJECTABLE / INJECTION AP 2020-09-17 caaa826d4ba7…2026-08-18 06:07:40 2026-07 A212347-002 POTASSIUM CHLORIDE 0.3% AND SODIUM CHLORIDE 0.9% 300MG/100ML;900MG/100ML INJECTABLE / INJECTION AP 2020-09-17 caaa826d4ba7…2026-08-18 06:07:40 2026-07 A212347-003 POTASSIUM CHLORIDE 0.15% IN SODIUM CHLORIDE 0.9% 150MG/100ML;900MG/100ML INJECTABLE / INJECTION AP 2021-06-02 caaa826d4ba7…2026-02-19 14:30 UTC 2026-02 A212347-001 POTASSIUM CHLORIDE 0.15% IN SODIUM CHLORIDE 0.45% 150MG/100ML;450MG/100ML INJECTABLE / INJECTION AP 2020-09-17 011fe1cb6892…2026-02-19 14:30 UTC 2026-02 A212347-002 POTASSIUM CHLORIDE 0.3% AND SODIUM CHLORIDE 0.9% 300MG/100ML;900MG/100ML INJECTABLE / INJECTION AP 2020-09-17 011fe1cb6892…2026-02-19 14:30 UTC 2026-02 A212347-003 POTASSIUM CHLORIDE 0.15% IN SODIUM CHLORIDE 0.9% 150MG/100ML;900MG/100ML INJECTABLE / INJECTION AP 2021-06-02 011fe1cb6892…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 A212347-001 POTASSIUM CHLORIDE 0.15% IN SODIUM CHLORIDE 0.45% 150MG/100ML;450MG/100ML INJECTABLE / INJECTION AP 2020-09-17 31067a03dcf5…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 A212347-002 POTASSIUM CHLORIDE 0.3% AND SODIUM CHLORIDE 0.9% 300MG/100ML;900MG/100ML INJECTABLE / INJECTION AP 2020-09-17 31067a03dcf5…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 A212347-003 POTASSIUM CHLORIDE 0.15% IN SODIUM CHLORIDE 0.9% 150MG/100ML;900MG/100ML INJECTABLE / INJECTION AP 2021-06-02 31067a03dcf5…2025-08-23 18:47 UTC 2025-08 A212347-001 POTASSIUM CHLORIDE 0.15% IN SODIUM CHLORIDE 0.45% 150MG/100ML;450MG/100ML INJECTABLE / INJECTION AP 2020-09-17 6a471c1ec25d…2025-08-23 18:47 UTC 2025-08 A212347-002 POTASSIUM CHLORIDE 0.3% AND SODIUM CHLORIDE 0.9% 300MG/100ML;900MG/100ML INJECTABLE / INJECTION AP 2020-09-17 6a471c1ec25d…2025-08-23 18:47 UTC 2025-08 A212347-003 POTASSIUM CHLORIDE 0.15% IN SODIUM CHLORIDE 0.9% 150MG/100ML;900MG/100ML INJECTABLE / INJECTION AP 2021-06-02 6a471c1ec25d…2025-03-22 03:13 UTC · 3 captures of this ZIP 2025-03 A212347-001 POTASSIUM CHLORIDE 0.15% IN SODIUM CHLORIDE 0.45% 150MG/100ML;450MG/100ML INJECTABLE / INJECTION AP 2020-09-17 fd3edfee7708…2025-03-22 03:13 UTC · 3 captures of this ZIP 2025-03 A212347-002 POTASSIUM CHLORIDE 0.3% AND SODIUM CHLORIDE 0.9% 300MG/100ML;900MG/100ML INJECTABLE / INJECTION AP 2020-09-17 fd3edfee7708…2025-03-22 03:13 UTC · 3 captures of this ZIP 2025-03 A212347-003 POTASSIUM CHLORIDE 0.15% IN SODIUM CHLORIDE 0.9% 150MG/100ML;900MG/100ML INJECTABLE / INJECTION AP 2021-06-02 fd3edfee7708…2025-02-26 10:13 UTC · 3 captures of this ZIP 2025-02 A212347-001 POTASSIUM CHLORIDE 0.15% IN SODIUM CHLORIDE 0.45% 150MG/100ML;450MG/100ML INJECTABLE / INJECTION AP 2020-09-17 b8a1b40f171c…2025-02-26 10:13 UTC · 3 captures of this ZIP 2025-02 A212347-002 POTASSIUM CHLORIDE 0.3% AND SODIUM CHLORIDE 0.9% 300MG/100ML;900MG/100ML INJECTABLE / INJECTION AP 2020-09-17 b8a1b40f171c…2025-02-26 10:13 UTC · 3 captures of this ZIP 2025-02 A212347-003 POTASSIUM CHLORIDE 0.15% IN SODIUM CHLORIDE 0.9% 150MG/100ML;900MG/100ML INJECTABLE / INJECTION AP 2021-06-02 b8a1b40f171c…2025-01-19 17:59 UTC · 7 captures of this ZIP 2025-01 A212347-001 POTASSIUM CHLORIDE 0.15% IN SODIUM CHLORIDE 0.45% 150MG/100ML;450MG/100ML INJECTABLE / INJECTION AP 2020-09-17 03ed91905a0d…2025-01-19 17:59 UTC · 7 captures of this ZIP 2025-01 A212347-002 POTASSIUM CHLORIDE 0.3% AND SODIUM CHLORIDE 0.9% 300MG/100ML;900MG/100ML INJECTABLE / INJECTION AP 2020-09-17 03ed91905a0d…2025-01-19 17:59 UTC · 7 captures of this ZIP 2025-01 A212347-003 POTASSIUM CHLORIDE 0.15% IN SODIUM CHLORIDE 0.9% 150MG/100ML;900MG/100ML INJECTABLE / INJECTION AP 2021-06-02 03ed91905a0d…2024-12-13 21:23 UTC · 2 captures of this ZIP 2024-12 A212347-001 POTASSIUM CHLORIDE 0.15% IN SODIUM CHLORIDE 0.45% 150MG/100ML;450MG/100ML INJECTABLE / INJECTION AP 2020-09-17 2680178bc6a6…2024-12-13 21:23 UTC · 2 captures of this ZIP 2024-12 A212347-002 POTASSIUM CHLORIDE 0.3% AND SODIUM CHLORIDE 0.9% 300MG/100ML;900MG/100ML INJECTABLE / INJECTION AP 2020-09-17 2680178bc6a6…2024-12-13 21:23 UTC · 2 captures of this ZIP 2024-12 A212347-003 POTASSIUM CHLORIDE 0.15% IN SODIUM CHLORIDE 0.9% 150MG/100ML;900MG/100ML INJECTABLE / INJECTION AP 2021-06-02 2680178bc6a6…2024-09-14 05:58 UTC · 2 captures of this ZIP 2024-09 A212347-001 POTASSIUM CHLORIDE 0.15% IN SODIUM CHLORIDE 0.45% 150MG/100ML;450MG/100ML INJECTABLE / INJECTION AP 2020-09-17 5bbf6a4d5a75…2024-09-14 05:58 UTC · 2 captures of this ZIP 2024-09 A212347-002 POTASSIUM CHLORIDE 0.3% AND SODIUM CHLORIDE 0.9% 300MG/100ML;900MG/100ML INJECTABLE / INJECTION AP 2020-09-17 5bbf6a4d5a75…2024-09-14 05:58 UTC · 2 captures of this ZIP 2024-09 A212347-003 POTASSIUM CHLORIDE 0.15% IN SODIUM CHLORIDE 0.9% 150MG/100ML;900MG/100ML INJECTABLE / INJECTION AP 2021-06-02 5bbf6a4d5a75…2024-11-08 22:44 UTC · 3 captures of this ZIP 2024-11 A212347-001 POTASSIUM CHLORIDE 0.15% IN SODIUM CHLORIDE 0.45% 150MG/100ML;450MG/100ML INJECTABLE / INJECTION AP 2020-09-17 d8e5a09893c0…2024-11-08 22:44 UTC · 3 captures of this ZIP 2024-11 A212347-002 POTASSIUM CHLORIDE 0.3% AND SODIUM CHLORIDE 0.9% 300MG/100ML;900MG/100ML INJECTABLE / INJECTION AP 2020-09-17 d8e5a09893c0…2024-11-08 22:44 UTC · 3 captures of this ZIP 2024-11 A212347-003 POTASSIUM CHLORIDE 0.15% IN SODIUM CHLORIDE 0.9% 150MG/100ML;900MG/100ML INJECTABLE / INJECTION AP 2021-06-02 d8e5a09893c0…2024-10-29 15:01 UTC 2024-10 A212347-001 POTASSIUM CHLORIDE 0.15% IN SODIUM CHLORIDE 0.45% 150MG/100ML;450MG/100ML INJECTABLE / INJECTION AP 2020-09-17 d06236e962d9…2024-10-29 15:01 UTC 2024-10 A212347-002 POTASSIUM CHLORIDE 0.3% AND SODIUM CHLORIDE 0.9% 300MG/100ML;900MG/100ML INJECTABLE / INJECTION AP 2020-09-17 d06236e962d9…2024-10-29 15:01 UTC 2024-10 A212347-003 POTASSIUM CHLORIDE 0.15% IN SODIUM CHLORIDE 0.9% 150MG/100ML;900MG/100ML INJECTABLE / INJECTION AP 2021-06-02 d06236e962d9…2024-08-13 05:28 UTC · 3 captures of this ZIP 2024-08 A212347-001 POTASSIUM CHLORIDE 0.15% IN SODIUM CHLORIDE 0.45% 150MG/100ML;450MG/100ML INJECTABLE / INJECTION AP 2020-09-17 79d66fd596c7…
Observed Orange Book normalized TE history# Normalized TE history page 2 of 3 · 96 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 900 mg/100mL POTASSIUM CHLORIDE 150 mg/100mL
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 · 3 matching rows.
Identifier, FDA.report destination table Identifier FDA.report destination 237367 Internal RxNorm lookup 403890 Internal RxNorm lookup 637551 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 63323-686-01 Potassium Chloride in Sodium Chloride 1000 mL in 1 BAG INJECTION, SOLUTION 1000 5 63323-686-10 Potassium Chloride in Sodium Chloride 10 in 1 CARTON INJECTION, SOLUTION 10 5
DailyMed Dashboard NDC Coverage# NDC, Dashboard title, SPL version table NDC Dashboard title SPL version Validation Dashboard ZIP 63323-686 POTASSIUM CHLORIDE IN SODIUM CHLORIDE (SODIUM CHLORIDE AND POTASSIUM CHLORIDE) INJECTION, SOLUTION [FRESENIUS KABI USA, LLC] 5 Current NDC, Legacy NDC, 2 package rows 20240502_c2467d57-cd2d-4409-bcc0-50128bd01bba.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 63323-686-01 63323068601 1000 mL in 1 BAG 1000 ml Historical 63323-686-10 63323068610 10 BAG in 1 CARTON (63323-686-10) / 1000 mL in 1 BAG (63323-686-01) 10 bag 2021-06-02 0000-00-00 No No Current