Home NDC 50268-674 Potassium Chloride
Product NDC 50268-674
11-digit product format 502680674
Labeler code 50268
Product ID 50268-674_47fb4ce6-78ac-6467-e063-6294a90ace55
Type HUMAN PRESCRIPTION DRUG
Nonproprietary name Potassium Chloride
Dosage form SOLUTION
Route ORAL
Labeler AvPAK
Application ANDA210041
Marketing category ANDA
Marketing start 2023-01-26
Substance POTASSIUM CHLORIDE
Active strength 1.5 g/15mL
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 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 · 2 matching rows.
Application-product, Trade name, Ingredient table Application-product Trade name Ingredient Strength Dosage form / route TE codes RLD / RS Approval date A210041-001 POTASSIUM CHLORIDE POTASSIUM CHLORIDE 20MEQ/15ML SOLUTION / ORAL AA 2018-07-19 A210041-002 POTASSIUM CHLORIDE POTASSIUM CHLORIDE 40MEQ/15ML SOLUTION / ORAL AA 2018-07-19
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 3 · 86 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 A210041-001 POTASSIUM CHLORIDE 20MEQ/15ML SOLUTION / ORAL AA 2018-07-19 84e616aacf4f…2026-09-14 22:38:34 2026-08 A210041-002 POTASSIUM CHLORIDE 40MEQ/15ML SOLUTION / ORAL AA 2018-07-19 84e616aacf4f…2026-08-18 06:07:40 2026-07 A210041-001 POTASSIUM CHLORIDE 20MEQ/15ML SOLUTION / ORAL AA 2018-07-19 caaa826d4ba7…2026-08-18 06:07:40 2026-07 A210041-002 POTASSIUM CHLORIDE 40MEQ/15ML SOLUTION / ORAL AA 2018-07-19 caaa826d4ba7…2026-02-19 14:30 UTC 2026-02 A210041-001 POTASSIUM CHLORIDE 20MEQ/15ML SOLUTION / ORAL AA 2018-07-19 011fe1cb6892…2026-02-19 14:30 UTC 2026-02 A210041-002 POTASSIUM CHLORIDE 40MEQ/15ML SOLUTION / ORAL AA 2018-07-19 011fe1cb6892…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 A210041-001 POTASSIUM CHLORIDE 20MEQ/15ML SOLUTION / ORAL AA 2018-07-19 31067a03dcf5…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 A210041-002 POTASSIUM CHLORIDE 40MEQ/15ML SOLUTION / ORAL AA 2018-07-19 31067a03dcf5…2025-08-23 18:47 UTC 2025-08 A210041-001 POTASSIUM CHLORIDE 20MEQ/15ML SOLUTION / ORAL AA 2018-07-19 6a471c1ec25d…2025-08-23 18:47 UTC 2025-08 A210041-002 POTASSIUM CHLORIDE 40MEQ/15ML SOLUTION / ORAL AA 2018-07-19 6a471c1ec25d…2025-03-22 03:13 UTC · 3 captures of this ZIP 2025-03 A210041-001 POTASSIUM CHLORIDE 20MEQ/15ML SOLUTION / ORAL AA 2018-07-19 fd3edfee7708…2025-03-22 03:13 UTC · 3 captures of this ZIP 2025-03 A210041-002 POTASSIUM CHLORIDE 40MEQ/15ML SOLUTION / ORAL AA 2018-07-19 fd3edfee7708…2025-02-26 10:13 UTC · 3 captures of this ZIP 2025-02 A210041-001 POTASSIUM CHLORIDE 20MEQ/15ML SOLUTION / ORAL AA 2018-07-19 b8a1b40f171c…2025-02-26 10:13 UTC · 3 captures of this ZIP 2025-02 A210041-002 POTASSIUM CHLORIDE 40MEQ/15ML SOLUTION / ORAL AA 2018-07-19 b8a1b40f171c…2025-01-19 17:59 UTC · 7 captures of this ZIP 2025-01 A210041-001 POTASSIUM CHLORIDE 20MEQ/15ML SOLUTION / ORAL AA 2018-07-19 03ed91905a0d…2025-01-19 17:59 UTC · 7 captures of this ZIP 2025-01 A210041-002 POTASSIUM CHLORIDE 40MEQ/15ML SOLUTION / ORAL AA 2018-07-19 03ed91905a0d…2024-12-13 21:23 UTC · 2 captures of this ZIP 2024-12 A210041-001 POTASSIUM CHLORIDE 20MEQ/15ML SOLUTION / ORAL AA 2018-07-19 2680178bc6a6…2024-12-13 21:23 UTC · 2 captures of this ZIP 2024-12 A210041-002 POTASSIUM CHLORIDE 40MEQ/15ML SOLUTION / ORAL AA 2018-07-19 2680178bc6a6…2024-09-14 05:58 UTC · 2 captures of this ZIP 2024-09 A210041-001 POTASSIUM CHLORIDE 20MEQ/15ML SOLUTION / ORAL AA 2018-07-19 5bbf6a4d5a75…2024-09-14 05:58 UTC · 2 captures of this ZIP 2024-09 A210041-002 POTASSIUM CHLORIDE 40MEQ/15ML SOLUTION / ORAL AA 2018-07-19 5bbf6a4d5a75…2024-11-08 22:44 UTC · 3 captures of this ZIP 2024-11 A210041-001 POTASSIUM CHLORIDE 20MEQ/15ML SOLUTION / ORAL AA 2018-07-19 d8e5a09893c0…2024-11-08 22:44 UTC · 3 captures of this ZIP 2024-11 A210041-002 POTASSIUM CHLORIDE 40MEQ/15ML SOLUTION / ORAL AA 2018-07-19 d8e5a09893c0…2024-10-29 15:01 UTC 2024-10 A210041-001 POTASSIUM CHLORIDE 20MEQ/15ML SOLUTION / ORAL AA 2018-07-19 d06236e962d9…2024-10-29 15:01 UTC 2024-10 A210041-002 POTASSIUM CHLORIDE 40MEQ/15ML SOLUTION / ORAL AA 2018-07-19 d06236e962d9…2024-08-13 05:28 UTC · 3 captures of this ZIP 2024-08 A210041-001 POTASSIUM CHLORIDE 20MEQ/15ML SOLUTION / ORAL AA 2018-07-19 79d66fd596c7…2024-08-13 05:28 UTC · 3 captures of this ZIP 2024-08 A210041-002 POTASSIUM CHLORIDE 40MEQ/15ML SOLUTION / ORAL AA 2018-07-19 79d66fd596c7…2024-07-13 05:37 UTC · 2 captures of this ZIP 2024-07 A210041-001 POTASSIUM CHLORIDE 20MEQ/15ML SOLUTION / ORAL AA 2018-07-19 301d65b070ca…2024-07-13 05:37 UTC · 2 captures of this ZIP 2024-07 A210041-002 POTASSIUM CHLORIDE 40MEQ/15ML SOLUTION / ORAL AA 2018-07-19 301d65b070ca…2024-06-18 03:08 UTC · 5 captures of this ZIP 2024-06 A210041-001 POTASSIUM CHLORIDE 20MEQ/15ML SOLUTION / ORAL AA 2018-07-19 1e350fbaab3a…2024-06-18 03:08 UTC · 5 captures of this ZIP 2024-06 A210041-002 POTASSIUM CHLORIDE 40MEQ/15ML SOLUTION / ORAL AA 2018-07-19 1e350fbaab3a…2024-05-31 18:47 UTC 2024-05 A210041-001 POTASSIUM CHLORIDE 20MEQ/15ML SOLUTION / ORAL AA 2018-07-19 8072bd15b7f6…2024-05-31 18:47 UTC 2024-05 A210041-002 POTASSIUM CHLORIDE 40MEQ/15ML SOLUTION / ORAL AA 2018-07-19 8072bd15b7f6…2022-06-29 02:47 UTC · 2 captures of this ZIP 2022-06 A210041-001 POTASSIUM CHLORIDE 20MEQ/15ML SOLUTION / ORAL AA 2018-07-19 5c6f7cd8ea54…2022-06-29 02:47 UTC · 2 captures of this ZIP 2022-06 A210041-002 POTASSIUM CHLORIDE 40MEQ/15ML SOLUTION / ORAL AA 2018-07-19 5c6f7cd8ea54…2022-04-08 23:34 UTC 2022-04 A210041-001 POTASSIUM CHLORIDE 20MEQ/15ML SOLUTION / ORAL AA 2018-07-19 5d02ea3f76ae…2022-04-08 23:34 UTC 2022-04 A210041-002 POTASSIUM CHLORIDE 40MEQ/15ML SOLUTION / ORAL AA 2018-07-19 5d02ea3f76ae…2022-04-04 05:41 UTC 2022-04 A210041-001 POTASSIUM CHLORIDE 20MEQ/15ML SOLUTION / ORAL AA 2018-07-19 4b0b4de00fa7…2022-04-04 05:41 UTC 2022-04 A210041-002 POTASSIUM CHLORIDE 40MEQ/15ML SOLUTION / ORAL AA 2018-07-19 4b0b4de00fa7…2019-12-13 00:20 UTC 2019-12 A210041-001 POTASSIUM CHLORIDE 20MEQ/15ML SOLUTION / ORAL AA 2018-07-19 74a2ff9319b5…2019-12-13 00:20 UTC 2019-12 A210041-002 POTASSIUM CHLORIDE 40MEQ/15ML SOLUTION / ORAL AA 2018-07-19 74a2ff9319b5…
Observed Orange Book normalized TE history# Normalized TE history page 1 of 3 · 86 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 2027-12-31 Active Ingredients# Ingredient, Strength table Ingredient Strength POTASSIUM CHLORIDE 1.5 g/15mL
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 · 2 matching rows.
Identifier, FDA.report destination table Identifier FDA.report destination 312515 Internal RxNorm lookup 314182 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 50268-674-11 Potassium Chloride 15 mL in 1 CUP SOLUTION 15 2 50268-674-15 Potassium Chloride 50 in 1 BOX SOLUTION 50 2
DailyMed Dashboard NDC Coverage# NDC, Dashboard title, SPL version table NDC Dashboard title SPL version Validation Dashboard ZIP 50268-674 POTASSIUM CHLORIDE SOLUTION [AVPAK] 1 Current NDC, 2 package rows 20230127_f32df7c0-33eb-e6d6-e053-2a95a90a2e8d.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 · 3 matching rows.
DailyMed RxNorm Mappings# Packages# Package NDC, 11-digit format, Description table Package NDC 11-digit format Description Units Marketing start Sample Exclude flag Status 50268-674-11 50268067411 15 mL in 1 CUP 15 ml Historical 50268-674-15 50268067415 50 CUP in 1 BOX (50268-674-15) / 15 mL in 1 CUP (50268-674-11) 50 cup 2023-01-26 No No Current