Home NDC 54288-125 Potassium Chloride for Oral Solution
Product NDC 54288-125
11-digit product format 542880125
Labeler code 54288
Product ID 54288-125_3f059da8-fc8c-4f34-9aa6-f86234957975
Type HUMAN PRESCRIPTION DRUG
Nonproprietary name Potassium Chloride for Oral Solution
Dosage form POWDER, FOR SOLUTION
Route ORAL
Labeler BPI Labs LLC
Application ANDA212183
Marketing category ANDA
Marketing start 2019-10-21
Substance POTASSIUM CHLORIDE
Active strength 1.5 g/1.58g
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 42 .
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 A212183-001 POTASSIUM CHLORIDE POTASSIUM CHLORIDE 20MEQ FOR SOLUTION / ORAL AA 2019-05-06
Therapeutic equivalence codes# Current TE-code rows page 1 of 1 · 1 matching rows.
Application-product, TE code table Application-product TE code A212183-001 AA
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 · 42 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 2026-08-18 06:07:40 2026-07 A212183-001 POTASSIUM CHLORIDE 20MEQ FOR SOLUTION / ORAL AA 2019-05-06 caaa826d4ba7…2026-02-19 14:30 UTC 2026-02 A212183-001 POTASSIUM CHLORIDE 20MEQ FOR SOLUTION / ORAL AA 2019-05-06 011fe1cb6892…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 A212183-001 POTASSIUM CHLORIDE 20MEQ FOR SOLUTION / ORAL AA 2019-05-06 31067a03dcf5…2025-08-23 18:47 UTC 2025-08 A212183-001 POTASSIUM CHLORIDE 20MEQ FOR SOLUTION / ORAL AA 2019-05-06 6a471c1ec25d…2025-03-22 03:13 UTC · 3 captures of this ZIP 2025-03 A212183-001 POTASSIUM CHLORIDE 20MEQ FOR SOLUTION / ORAL AA 2019-05-06 fd3edfee7708…2025-02-26 10:13 UTC · 3 captures of this ZIP 2025-02 A212183-001 POTASSIUM CHLORIDE 20MEQ FOR SOLUTION / ORAL AA 2019-05-06 b8a1b40f171c…2025-01-19 17:59 UTC · 7 captures of this ZIP 2025-01 A212183-001 POTASSIUM CHLORIDE 20MEQ FOR SOLUTION / ORAL AA 2019-05-06 03ed91905a0d…2024-12-13 21:23 UTC · 2 captures of this ZIP 2024-12 A212183-001 POTASSIUM CHLORIDE 20MEQ FOR SOLUTION / ORAL AA 2019-05-06 2680178bc6a6…2024-09-14 05:58 UTC · 2 captures of this ZIP 2024-09 A212183-001 POTASSIUM CHLORIDE 20MEQ FOR SOLUTION / ORAL AA 2019-05-06 5bbf6a4d5a75…2024-11-08 22:44 UTC · 3 captures of this ZIP 2024-11 A212183-001 POTASSIUM CHLORIDE 20MEQ FOR SOLUTION / ORAL AA 2019-05-06 d8e5a09893c0…2024-10-29 15:01 UTC 2024-10 A212183-001 POTASSIUM CHLORIDE 20MEQ FOR SOLUTION / ORAL AA 2019-05-06 d06236e962d9…2024-08-13 05:28 UTC · 3 captures of this ZIP 2024-08 A212183-001 POTASSIUM CHLORIDE 20MEQ FOR SOLUTION / ORAL AA 2019-05-06 79d66fd596c7…2024-07-13 05:37 UTC · 2 captures of this ZIP 2024-07 A212183-001 POTASSIUM CHLORIDE 20MEQ FOR SOLUTION / ORAL AA 2019-05-06 301d65b070ca…2024-06-18 03:08 UTC · 5 captures of this ZIP 2024-06 A212183-001 POTASSIUM CHLORIDE 20MEQ FOR SOLUTION / ORAL AA 2019-05-06 1e350fbaab3a…2024-05-31 18:47 UTC 2024-05 A212183-001 POTASSIUM CHLORIDE 20MEQ FOR SOLUTION / ORAL AA 2019-05-06 8072bd15b7f6…2022-06-29 02:47 UTC · 2 captures of this ZIP 2022-06 A212183-001 POTASSIUM CHLORIDE 20MEQ FOR SOLUTION / ORAL AA 2019-05-06 5c6f7cd8ea54…2022-04-08 23:34 UTC 2022-04 A212183-001 POTASSIUM CHLORIDE 20MEQ FOR SOLUTION / ORAL AA 2019-05-06 5d02ea3f76ae…2022-04-04 05:41 UTC 2022-04 A212183-001 POTASSIUM CHLORIDE 20MEQ FOR SOLUTION / ORAL AA 2019-05-06 4b0b4de00fa7…2019-12-13 00:20 UTC 2019-12 A212183-001 POTASSIUM CHLORIDE 20MEQ FOR SOLUTION / ORAL AA 2019-05-06 74a2ff9319b5…2022-03-09 01:35 UTC 2022-03 A212183-001 POTASSIUM CHLORIDE 20MEQ FOR SOLUTION / ORAL AA 2019-05-06 bb7c543d1eb4…2021-12-28 21:50 UTC 2021-12 A212183-001 POTASSIUM CHLORIDE 20MEQ FOR SOLUTION / ORAL AA 2019-05-06 782e0a99824c…2021-05-05 16:15 UTC · 3 captures of this ZIP 2021-05 A212183-001 POTASSIUM CHLORIDE 20MEQ FOR SOLUTION / ORAL AA 2019-05-06 87673890dc5c…2021-03-12 10:30 UTC 2021-03 A212183-001 POTASSIUM CHLORIDE 20MEQ FOR SOLUTION / ORAL AA 2019-05-06 5aa47cf7b7d7…2020-12-22 03:56 UTC 2020-12 A212183-001 POTASSIUM CHLORIDE 20MEQ FOR SOLUTION / ORAL AA 2019-05-06 8869cabd3fbd…2020-11-12 02:37 UTC 2020-11 A212183-001 POTASSIUM CHLORIDE 20MEQ FOR SOLUTION / ORAL AA 2019-05-06 c0c555d07b60…2019-12-14 00:12 UTC 2019-12 A212183-001 POTASSIUM CHLORIDE 20MEQ FOR SOLUTION / ORAL AA 2019-05-06 3f01610625f2…2019-09-15 20:21 UTC 2019-09 A212183-001 POTASSIUM CHLORIDE 20MEQ FOR SOLUTION / ORAL AA 2019-05-06 b00525d2431f…2019-07-19 19:46 UTC 2019-07 A212183-001 POTASSIUM CHLORIDE 20MEQ FOR SOLUTION / ORAL AA 2019-05-06 ea99ee380514…2024-03-16 18:09 UTC · 4 captures of this ZIP 2024-03 A212183-001 POTASSIUM CHLORIDE 20MEQ FOR SOLUTION / ORAL AA 2019-05-06 6a51e52b5d6a…2024-02-18 07:12 UTC 2024-02 A212183-001 POTASSIUM CHLORIDE 20MEQ FOR SOLUTION / ORAL AA 2019-05-06 1c564ffb4f44…2023-12-20 04:57 UTC 2023-12 A212183-001 POTASSIUM CHLORIDE 20MEQ FOR SOLUTION / ORAL AA 2019-05-06 ea1830bbd6c7…2023-11-28 05:40 UTC · 2 captures of this ZIP 2023-11 A212183-001 POTASSIUM CHLORIDE 20MEQ FOR SOLUTION / ORAL AA 2019-05-06 a72a2bbeb626…2023-10-25 00:34 UTC · 2 captures of this ZIP 2023-10 A212183-001 POTASSIUM CHLORIDE 20MEQ FOR SOLUTION / ORAL AA 2019-05-06 9b2671bbb829…2023-07-15 15:27 UTC · 2 captures of this ZIP 2023-07 A212183-001 POTASSIUM CHLORIDE 20MEQ FOR SOLUTION / ORAL AA 2019-05-06 a67488948f0b…2023-06-13 01:57 UTC · 3 captures of this ZIP 2023-06 A212183-001 POTASSIUM CHLORIDE 20MEQ FOR SOLUTION / ORAL AA 2019-05-06 3f0d92c62455…2023-05-13 08:27 UTC 2023-05 A212183-001 POTASSIUM CHLORIDE 20MEQ FOR SOLUTION / ORAL AA 2019-05-06 053a50430f4f…2023-01-26 05:58 UTC 2023-01 A212183-001 POTASSIUM CHLORIDE 20MEQ FOR SOLUTION / ORAL AA 2019-05-06 3bdfa0b2c4d7…2022-11-12 20:34 UTC · 5 captures of this ZIP 2022-11 A212183-001 POTASSIUM CHLORIDE 20MEQ FOR SOLUTION / ORAL AA 2019-05-06 3a93d1ddd44b…2022-10-28 04:53 UTC 2022-10 A212183-001 POTASSIUM CHLORIDE 20MEQ FOR SOLUTION / ORAL AA 2019-05-06 f41ea6bd6efb…2022-09-29 23:25 UTC 2022-09 A212183-001 POTASSIUM CHLORIDE 20MEQ FOR SOLUTION / ORAL AA 2019-05-06 e64feba35796…
Observed Orange Book normalized TE history# Normalized TE history page 1 of 2 · 42 observed states.
Additional Listing Data#
Finished product Yes
Brand name base Potassium Chloride for Oral Solution
Listing expiration 2027-12-31 Active Ingredients# Ingredient, Strength table Ingredient Strength POTASSIUM CHLORIDE 1.5 g/1.58g
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 · 1 matching rows.
Identifier, FDA.report destination table Identifier FDA.report destination 1867544 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 54288-125-01 Potassium Chloride for Oral Solution 1.58 g in 1 POUCH POWDER, FOR SOLUTION 1.58 10 54288-125-10 Potassium Chloride for Oral Solution 100 in 1 CARTON POWDER, FOR SOLUTION 100 10 54288-125-30 Potassium Chloride for Oral Solution 30 in 1 CARTON POWDER, FOR SOLUTION 30 10
DailyMed Dashboard NDC Coverage# NDC, Dashboard title, SPL version table NDC Dashboard title SPL version Validation Dashboard ZIP 54288-125 POTASSIUM CHLORIDE FOR ORAL SOLUTION POWDER, FOR SOLUTION [BPI LABS LLC] 7 Current NDC, Legacy NDC, 3 package rows 20250213_1ea4345e-f8bb-4d41-9003-c87b21169d7c.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 · 4 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 54288-125-01 54288012501 1.58 g in 1 POUCH 1.58 g Historical 54288-125-10 54288012510 100 POUCH in 1 CARTON (54288-125-10) / 1.58 g in 1 POUCH (54288-125-01) 100 pouch 2019-10-21 0000-00-00 No No Current 54288-125-30 54288012530 30 POUCH in 1 CARTON (54288-125-30) / 1.58 g in 1 POUCH (54288-125-01) 30 pouch 2019-10-21 0000-00-00 No No Current