Home NDC 53041-420 Potassium Chloride
Product NDC 53041-420
11-digit product format 530410420
Labeler code 53041
Product ID 53041-420_5f75aa97-8df9-4594-a730-e4fd731498cd
Type HUMAN PRESCRIPTION DRUG
Nonproprietary name Potassium Chloride
Dosage form POWDER, FOR SOLUTION
Route ORAL
Labeler Guardian Drug Company
Application ANDA219009
Marketing category ANDA
Marketing start 2025-07-22
Substance POTASSIUM CHLORIDE
Active strength 1.5 g/1.57g
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 1 .
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 A219009-001 POTASSIUM CHLORIDE POTASSIUM CHLORIDE 20MEQ FOR SOLUTION / ORAL AA 2025-07-11
Therapeutic equivalence codes# Current TE-code rows page 1 of 1 · 1 matching rows.
Application-product, TE code table Application-product TE code A219009-001 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.
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 A219009-001 POTASSIUM CHLORIDE 20MEQ FOR SOLUTION / ORAL AA 2025-07-11 011fe1cb6892…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 A219009-001 POTASSIUM CHLORIDE 20MEQ FOR SOLUTION / ORAL AA 2025-07-11 31067a03dcf5…2025-08-23 18:47 UTC 2025-08 A219009-001 POTASSIUM CHLORIDE 20MEQ FOR SOLUTION / ORAL AA 2025-07-11 6a471c1ec25d…2026-07-26 02:55 UTC · 3 captures of this ZIP 2026-06 A219009-001 POTASSIUM CHLORIDE 20MEQ FOR SOLUTION / ORAL AA 2025-07-11 a50c72e98297…
Observed Orange Book normalized TE history# Captured, Edition, Application-product table Captured Edition Application-product TE code Order Source SHA-256 2026-02-19 14:30 UTC 2026-02 A219009-001 AA 1 011fe1cb6892…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 A219009-001 AA 1 31067a03dcf5…2025-08-23 18:47 UTC 2025-08 A219009-001 AA 1 6a471c1ec25d…2026-07-26 02:55 UTC · 3 captures of this ZIP 2026-06 A219009-001 AA 1 a50c72e98297…
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 1.5 g/1.57g
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 53041-420-01 Potassium Chloride 1.57 g in 1 POUCH POWDER, FOR SOLUTION 1.57 3 53041-420-49 Potassium Chloride 30 in 1 CARTON POWDER, FOR SOLUTION 30 3 53041-420-50 Potassium Chloride 100 in 1 CARTON POWDER, FOR SOLUTION 100 3
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 Sample Exclude flag Status 53041-420-01 53041042001 1.57 g in 1 POUCH 1.57 g Historical 53041-420-49 53041042049 30 POUCH in 1 CARTON (53041-420-49) / 1.57 g in 1 POUCH (53041-420-01) 30 pouch 2025-07-22 No No Current 53041-420-50 53041042050 100 POUCH in 1 CARTON (53041-420-50) / 1.57 g in 1 POUCH (53041-420-01) 100 pouch 2025-07-22 No No Current