Home NDC 54288-161-47 Potassium Chloride
Product NDC 54288-161
Requested package NDC 54288-161-47
11-digit product format 542880161
Labeler code 54288
Product ID 54288-161_d5ffd201-1ecb-4326-93fc-cc25b128a71c
Type HUMAN PRESCRIPTION DRUG
Nonproprietary name Potassium Chloride
Dosage form SOLUTION
Route ORAL
Labeler BPI Labs LLC
Application ANDA216156
Marketing category ANDA
Marketing start 2023-07-04
Substance POTASSIUM CHLORIDE
Active strength 40 meq/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 2026-12-31
Current FDA listing Yes Observed NDC auxiliary status history# This history shows the information present in each captured FDA auxiliary file. It is not a continuous regulatory timeline, and a missing record does not establish a status.
Historic NDC status page 1 of 1 · 3 matching rows.
View current auxiliary records. · View the auxiliary file history.
Captured / source date, Dataset, Scope table Captured / source date Dataset Scope Product NDC Package NDC Code Status Reporting period Archive Snapshot Source SHA-256 2025-02-02 03:52 UTC · source 2025-01-31 excluded package package 54288-161 54288-161-47 U Excluded because listing certification expired excluded / ndc_excluded.zip 302b2466d912…e7b80fea0513…2025-01-20 13:05 UTC · source 2025-01-20 excluded package package 54288-161 54288-161-47 U Excluded because listing certification expired excluded / ndc_excluded.zip ed331223b511…672a5bd82f5f…2025-01-11 03:41 UTC · source 2025-01-10 excluded package package 54288-161 54288-161-47 U Excluded because listing certification expired excluded / ndc_excluded.zip 0efc9e666f02…f202fb6c5f17…
Source provenance: Browse the complete Orange Book source catalog · source snapshot 1 .
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 A216156-001 POTASSIUM CHLORIDE POTASSIUM CHLORIDE 20MEQ/15ML SOLUTION / ORAL AA 2023-03-07 A216156-002 POTASSIUM CHLORIDE POTASSIUM CHLORIDE 40MEQ/15ML SOLUTION / ORAL AA 2023-03-07
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 · 46 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 2026-02-19 14:30 UTC 2026-02 A216156-001 POTASSIUM CHLORIDE 20MEQ/15ML SOLUTION / ORAL AA 2023-03-07 011fe1cb6892…2026-02-19 14:30 UTC 2026-02 A216156-002 POTASSIUM CHLORIDE 40MEQ/15ML SOLUTION / ORAL AA 2023-03-07 011fe1cb6892…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 A216156-001 POTASSIUM CHLORIDE 20MEQ/15ML SOLUTION / ORAL AA 2023-03-07 31067a03dcf5…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 A216156-002 POTASSIUM CHLORIDE 40MEQ/15ML SOLUTION / ORAL AA 2023-03-07 31067a03dcf5…2025-08-23 18:47 UTC 2025-08 A216156-001 POTASSIUM CHLORIDE 20MEQ/15ML SOLUTION / ORAL AA 2023-03-07 6a471c1ec25d…2025-08-23 18:47 UTC 2025-08 A216156-002 POTASSIUM CHLORIDE 40MEQ/15ML SOLUTION / ORAL AA 2023-03-07 6a471c1ec25d…2025-03-22 03:13 UTC · 3 captures of this ZIP 2025-03 A216156-001 POTASSIUM CHLORIDE 20MEQ/15ML SOLUTION / ORAL AA 2023-03-07 fd3edfee7708…2025-03-22 03:13 UTC · 3 captures of this ZIP 2025-03 A216156-002 POTASSIUM CHLORIDE 40MEQ/15ML SOLUTION / ORAL AA 2023-03-07 fd3edfee7708…2025-02-26 10:13 UTC · 3 captures of this ZIP 2025-02 A216156-001 POTASSIUM CHLORIDE 20MEQ/15ML SOLUTION / ORAL AA 2023-03-07 b8a1b40f171c…2025-02-26 10:13 UTC · 3 captures of this ZIP 2025-02 A216156-002 POTASSIUM CHLORIDE 40MEQ/15ML SOLUTION / ORAL AA 2023-03-07 b8a1b40f171c…2025-01-19 17:59 UTC · 7 captures of this ZIP 2025-01 A216156-001 POTASSIUM CHLORIDE 20MEQ/15ML SOLUTION / ORAL AA 2023-03-07 03ed91905a0d…2025-01-19 17:59 UTC · 7 captures of this ZIP 2025-01 A216156-002 POTASSIUM CHLORIDE 40MEQ/15ML SOLUTION / ORAL AA 2023-03-07 03ed91905a0d…2024-12-13 21:23 UTC · 2 captures of this ZIP 2024-12 A216156-001 POTASSIUM CHLORIDE 20MEQ/15ML SOLUTION / ORAL AA 2023-03-07 2680178bc6a6…2024-12-13 21:23 UTC · 2 captures of this ZIP 2024-12 A216156-002 POTASSIUM CHLORIDE 40MEQ/15ML SOLUTION / ORAL AA 2023-03-07 2680178bc6a6…2024-09-14 05:58 UTC · 2 captures of this ZIP 2024-09 A216156-001 POTASSIUM CHLORIDE 20MEQ/15ML SOLUTION / ORAL AA 2023-03-07 5bbf6a4d5a75…2024-09-14 05:58 UTC · 2 captures of this ZIP 2024-09 A216156-002 POTASSIUM CHLORIDE 40MEQ/15ML SOLUTION / ORAL AA 2023-03-07 5bbf6a4d5a75…2024-11-08 22:44 UTC · 3 captures of this ZIP 2024-11 A216156-001 POTASSIUM CHLORIDE 20MEQ/15ML SOLUTION / ORAL AA 2023-03-07 d8e5a09893c0…2024-11-08 22:44 UTC · 3 captures of this ZIP 2024-11 A216156-002 POTASSIUM CHLORIDE 40MEQ/15ML SOLUTION / ORAL AA 2023-03-07 d8e5a09893c0…2024-10-29 15:01 UTC 2024-10 A216156-001 POTASSIUM CHLORIDE 20MEQ/15ML SOLUTION / ORAL AA 2023-03-07 d06236e962d9…2024-10-29 15:01 UTC 2024-10 A216156-002 POTASSIUM CHLORIDE 40MEQ/15ML SOLUTION / ORAL AA 2023-03-07 d06236e962d9…2024-08-13 05:28 UTC · 3 captures of this ZIP 2024-08 A216156-001 POTASSIUM CHLORIDE 20MEQ/15ML SOLUTION / ORAL AA 2023-03-07 79d66fd596c7…2024-08-13 05:28 UTC · 3 captures of this ZIP 2024-08 A216156-002 POTASSIUM CHLORIDE 40MEQ/15ML SOLUTION / ORAL AA 2023-03-07 79d66fd596c7…2024-07-13 05:37 UTC · 2 captures of this ZIP 2024-07 A216156-001 POTASSIUM CHLORIDE 20MEQ/15ML SOLUTION / ORAL AA 2023-03-07 301d65b070ca…2024-07-13 05:37 UTC · 2 captures of this ZIP 2024-07 A216156-002 POTASSIUM CHLORIDE 40MEQ/15ML SOLUTION / ORAL AA 2023-03-07 301d65b070ca…2024-06-18 03:08 UTC · 5 captures of this ZIP 2024-06 A216156-001 POTASSIUM CHLORIDE 20MEQ/15ML SOLUTION / ORAL AA 2023-03-07 1e350fbaab3a…2024-06-18 03:08 UTC · 5 captures of this ZIP 2024-06 A216156-002 POTASSIUM CHLORIDE 40MEQ/15ML SOLUTION / ORAL AA 2023-03-07 1e350fbaab3a…2024-05-31 18:47 UTC 2024-05 A216156-001 POTASSIUM CHLORIDE 20MEQ/15ML SOLUTION / ORAL AA 2023-03-07 8072bd15b7f6…2024-05-31 18:47 UTC 2024-05 A216156-002 POTASSIUM CHLORIDE 40MEQ/15ML SOLUTION / ORAL AA 2023-03-07 8072bd15b7f6…2024-03-16 18:09 UTC · 4 captures of this ZIP 2024-03 A216156-001 POTASSIUM CHLORIDE 20MEQ/15ML SOLUTION / ORAL AA 2023-03-07 6a51e52b5d6a…2024-03-16 18:09 UTC · 4 captures of this ZIP 2024-03 A216156-002 POTASSIUM CHLORIDE 40MEQ/15ML SOLUTION / ORAL AA 2023-03-07 6a51e52b5d6a…2024-02-18 07:12 UTC 2024-02 A216156-001 POTASSIUM CHLORIDE 20MEQ/15ML SOLUTION / ORAL AA 2023-03-07 1c564ffb4f44…2024-02-18 07:12 UTC 2024-02 A216156-002 POTASSIUM CHLORIDE 40MEQ/15ML SOLUTION / ORAL AA 2023-03-07 1c564ffb4f44…2023-12-20 04:57 UTC 2023-12 A216156-001 POTASSIUM CHLORIDE 20MEQ/15ML SOLUTION / ORAL AA 2023-03-07 ea1830bbd6c7…2023-12-20 04:57 UTC 2023-12 A216156-002 POTASSIUM CHLORIDE 40MEQ/15ML SOLUTION / ORAL AA 2023-03-07 ea1830bbd6c7…2023-11-28 05:40 UTC · 2 captures of this ZIP 2023-11 A216156-001 POTASSIUM CHLORIDE 20MEQ/15ML SOLUTION / ORAL AA 2023-03-07 a72a2bbeb626…2023-11-28 05:40 UTC · 2 captures of this ZIP 2023-11 A216156-002 POTASSIUM CHLORIDE 40MEQ/15ML SOLUTION / ORAL AA 2023-03-07 a72a2bbeb626…2023-10-25 00:34 UTC · 2 captures of this ZIP 2023-10 A216156-001 POTASSIUM CHLORIDE 20MEQ/15ML SOLUTION / ORAL AA 2023-03-07 9b2671bbb829…2023-10-25 00:34 UTC · 2 captures of this ZIP 2023-10 A216156-002 POTASSIUM CHLORIDE 40MEQ/15ML SOLUTION / ORAL AA 2023-03-07 9b2671bbb829…2023-07-15 15:27 UTC · 2 captures of this ZIP 2023-07 A216156-001 POTASSIUM CHLORIDE 20MEQ/15ML SOLUTION / ORAL AA 2023-03-07 a67488948f0b…2023-07-15 15:27 UTC · 2 captures of this ZIP 2023-07 A216156-002 POTASSIUM CHLORIDE 40MEQ/15ML SOLUTION / ORAL AA 2023-03-07 a67488948f0b…
Observed Orange Book normalized TE history# Normalized TE history page 1 of 2 · 46 observed states.
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 40 meq/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# FDA-Initiated Inactive NDC Indexing# DailyMed Package Descriptions# Package NDC, Product, Description table Package NDC Product Description Form Quantity Strength SPL version 54288-161-47 Potassium Chloride 473 mL in 1 BOTTLE, PLASTIC SOLUTION 473 5
DailyMed Dashboard NDC Coverage# NDC, Dashboard title, SPL version table NDC Dashboard title SPL version Validation Dashboard ZIP 54288-161 POTASSIUM CHLORIDE SOLUTION [BPI LABS LLC] 4 Current NDC, 1 package rows 20250420_aeb2e14e-cd7c-49d0-a15f-fbbe89a03c6b.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 Sample Exclude flag Status 54288-161-47 54288016147 473 mL in 1 BOTTLE, PLASTIC (54288-161-47) 473 ml 2023-07-04 No No Current