Home NDC 0603-1554 Potassium Chloride
Product NDC 0603-1554
11-digit product format 006031554
Labeler code 0603
Product ID 0603-1554_05260a26-2484-4fd1-9ca1-8445f239923e
Type HUMAN PRESCRIPTION DRUG
Nonproprietary name Potassium Chloride
Dosage form POWDER, FOR SOLUTION
Route ORAL
Labeler Endo USA, Inc.
Application NDA208019
Marketing category NDA
Marketing start 2015-09-18
Substance POTASSIUM CHLORIDE
Active strength 1.5 g/1.58g
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 42 .
Orange Book products# Current product rows page 1 of 1 · 4 matching rows.
Application-product, Trade name, Ingredient table Application-product Trade name Ingredient Strength Dosage form / route TE codes RLD / RS Approval date N208019-001 POTASSIUM CHLORIDE POTASSIUM CHLORIDE 20MEQ FOR SOLUTION / ORAL AA RLD 2015-08-19 N208019-002 POKONZA POTASSIUM CHLORIDE 10MEQ FOR SOLUTION / ORAL RLD 2023-08-25 N208019-003 POTASSIUM CHLORIDE POTASSIUM CHLORIDE 40MEQ FOR SOLUTION / ORAL RLD 2023-08-25 N208019-004 POKONZA POTASSIUM CHLORIDE 15MEQ FOR SOLUTION / ORAL RLD 2025-11-12
Therapeutic equivalence codes# Current TE-code rows page 1 of 1 · 1 matching rows.
Application-product, TE code table Application-product TE code N208019-001 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 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 2026-08-18 06:07:40 2026-07 N208019-001 POTASSIUM CHLORIDE 20MEQ FOR SOLUTION / ORAL AA RLD 2015-08-19 caaa826d4ba7…2026-08-18 06:07:40 2026-07 N208019-002 POKONZA 10MEQ FOR SOLUTION / ORAL RLD 2023-08-25 caaa826d4ba7…2026-08-18 06:07:40 2026-07 N208019-003 POTASSIUM CHLORIDE 40MEQ FOR SOLUTION / ORAL RLD 2023-08-25 caaa826d4ba7…2026-08-18 06:07:40 2026-07 N208019-004 POKONZA 15MEQ FOR SOLUTION / ORAL RLD 2025-11-12 caaa826d4ba7…2026-02-19 14:30 UTC 2026-02 N208019-001 POTASSIUM CHLORIDE 20MEQ FOR SOLUTION / ORAL AA RLD 2015-08-19 011fe1cb6892…2026-02-19 14:30 UTC 2026-02 N208019-002 POKONZA 10MEQ FOR SOLUTION / ORAL RLD 2023-08-25 011fe1cb6892…2026-02-19 14:30 UTC 2026-02 N208019-003 POTASSIUM CHLORIDE 40MEQ FOR SOLUTION / ORAL RLD, RS 2023-08-25 011fe1cb6892…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 N208019-001 POTASSIUM CHLORIDE 20MEQ FOR SOLUTION / ORAL AA RLD 2015-08-19 31067a03dcf5…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 N208019-002 POKONZA 10MEQ FOR SOLUTION / ORAL RLD 2023-08-25 31067a03dcf5…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 N208019-003 POTASSIUM CHLORIDE 40MEQ FOR SOLUTION / ORAL RLD, RS 2023-08-25 31067a03dcf5…2025-08-23 18:47 UTC 2025-08 N208019-001 POTASSIUM CHLORIDE 20MEQ FOR SOLUTION / ORAL AA RLD, RS 2015-08-19 6a471c1ec25d…2025-08-23 18:47 UTC 2025-08 N208019-002 POKONZA 10MEQ FOR SOLUTION / ORAL RLD 2023-08-25 6a471c1ec25d…2025-08-23 18:47 UTC 2025-08 N208019-003 POTASSIUM CHLORIDE 40MEQ FOR SOLUTION / ORAL RLD 2023-08-25 6a471c1ec25d…2025-03-22 03:13 UTC · 3 captures of this ZIP 2025-03 N208019-001 POTASSIUM CHLORIDE 20MEQ FOR SOLUTION / ORAL AA RLD, RS 2015-08-19 fd3edfee7708…2025-03-22 03:13 UTC · 3 captures of this ZIP 2025-03 N208019-002 POKONZA 10MEQ FOR SOLUTION / ORAL RLD 2023-08-25 fd3edfee7708…2025-03-22 03:13 UTC · 3 captures of this ZIP 2025-03 N208019-003 POTASSIUM CHLORIDE 40MEQ FOR SOLUTION / ORAL RLD 2023-08-25 fd3edfee7708…2025-02-26 10:13 UTC · 3 captures of this ZIP 2025-02 N208019-001 POTASSIUM CHLORIDE 20MEQ FOR SOLUTION / ORAL AA RLD, RS 2015-08-19 b8a1b40f171c…2025-02-26 10:13 UTC · 3 captures of this ZIP 2025-02 N208019-002 POKONZA 10MEQ FOR SOLUTION / ORAL RLD 2023-08-25 b8a1b40f171c…2025-02-26 10:13 UTC · 3 captures of this ZIP 2025-02 N208019-003 POTASSIUM CHLORIDE 40MEQ FOR SOLUTION / ORAL RLD 2023-08-25 b8a1b40f171c…2025-01-19 17:59 UTC · 7 captures of this ZIP 2025-01 N208019-001 POTASSIUM CHLORIDE 20MEQ FOR SOLUTION / ORAL AA RLD 2015-08-19 03ed91905a0d…2025-01-19 17:59 UTC · 7 captures of this ZIP 2025-01 N208019-002 POKONZA 10MEQ FOR SOLUTION / ORAL RLD 2023-08-25 03ed91905a0d…2025-01-19 17:59 UTC · 7 captures of this ZIP 2025-01 N208019-003 POTASSIUM CHLORIDE 40MEQ FOR SOLUTION / ORAL RLD, RS 2023-08-25 03ed91905a0d…2024-12-13 21:23 UTC · 2 captures of this ZIP 2024-12 N208019-001 POTASSIUM CHLORIDE 20MEQ FOR SOLUTION / ORAL AA RLD 2015-08-19 2680178bc6a6…2024-12-13 21:23 UTC · 2 captures of this ZIP 2024-12 N208019-002 POKONZA 10MEQ FOR SOLUTION / ORAL RLD 2023-08-25 2680178bc6a6…2024-12-13 21:23 UTC · 2 captures of this ZIP 2024-12 N208019-003 POTASSIUM CHLORIDE 40MEQ FOR SOLUTION / ORAL RLD, RS 2023-08-25 2680178bc6a6…2024-09-14 05:58 UTC · 2 captures of this ZIP 2024-09 N208019-001 POTASSIUM CHLORIDE 20MEQ FOR SOLUTION / ORAL AA RLD 2015-08-19 5bbf6a4d5a75…2024-09-14 05:58 UTC · 2 captures of this ZIP 2024-09 N208019-002 POKONZA 10MEQ FOR SOLUTION / ORAL RLD 2023-08-25 5bbf6a4d5a75…2024-09-14 05:58 UTC · 2 captures of this ZIP 2024-09 N208019-003 POTASSIUM CHLORIDE 40MEQ FOR SOLUTION / ORAL RLD, RS 2023-08-25 5bbf6a4d5a75…2024-11-08 22:44 UTC · 3 captures of this ZIP 2024-11 N208019-001 POTASSIUM CHLORIDE 20MEQ FOR SOLUTION / ORAL AA RLD 2015-08-19 d8e5a09893c0…2024-11-08 22:44 UTC · 3 captures of this ZIP 2024-11 N208019-002 POKONZA 10MEQ FOR SOLUTION / ORAL RLD 2023-08-25 d8e5a09893c0…2024-11-08 22:44 UTC · 3 captures of this ZIP 2024-11 N208019-003 POTASSIUM CHLORIDE 40MEQ FOR SOLUTION / ORAL RLD, RS 2023-08-25 d8e5a09893c0…2024-10-29 15:01 UTC 2024-10 N208019-001 POTASSIUM CHLORIDE 20MEQ FOR SOLUTION / ORAL AA RLD 2015-08-19 d06236e962d9…2024-10-29 15:01 UTC 2024-10 N208019-002 POKONZA 10MEQ FOR SOLUTION / ORAL RLD 2023-08-25 d06236e962d9…2024-10-29 15:01 UTC 2024-10 N208019-003 POTASSIUM CHLORIDE 40MEQ FOR SOLUTION / ORAL RLD, RS 2023-08-25 d06236e962d9…2024-08-13 05:28 UTC · 3 captures of this ZIP 2024-08 N208019-001 POTASSIUM CHLORIDE 20MEQ FOR SOLUTION / ORAL AA RLD 2015-08-19 79d66fd596c7…2024-08-13 05:28 UTC · 3 captures of this ZIP 2024-08 N208019-002 POKONZA 10MEQ FOR SOLUTION / ORAL RLD 2023-08-25 79d66fd596c7…2024-08-13 05:28 UTC · 3 captures of this ZIP 2024-08 N208019-003 POTASSIUM CHLORIDE 40MEQ FOR SOLUTION / ORAL RLD, RS 2023-08-25 79d66fd596c7…2024-07-13 05:37 UTC · 2 captures of this ZIP 2024-07 N208019-001 POTASSIUM CHLORIDE 20MEQ FOR SOLUTION / ORAL AA RLD 2015-08-19 301d65b070ca…2024-07-13 05:37 UTC · 2 captures of this ZIP 2024-07 N208019-002 POKONZA 10MEQ FOR SOLUTION / ORAL RLD 2023-08-25 301d65b070ca…2024-07-13 05:37 UTC · 2 captures of this ZIP 2024-07 N208019-003 POTASSIUM CHLORIDE 40MEQ FOR SOLUTION / ORAL RLD, RS 2023-08-25 301d65b070ca…
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
Listing expiration 2026-12-31 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# FDA-Initiated Inactive NDC Indexing# DailyMed Package Descriptions# Package NDC, Product, Description table Package NDC Product Description Form Quantity Strength SPL version 0603-1554-04 Potassium Chloride 100 in 1 CARTON POWDER, FOR SOLUTION 100 6 0603-1554-10 Potassium Chloride 1.58 g in 1 POUCH POWDER, FOR SOLUTION 1.58 6 0603-1554-16 Potassium Chloride 30 in 1 CARTON POWDER, FOR SOLUTION 30 6
DailyMed Socrata Ingredients# DailyMed Dashboard NDC Coverage# NDC, Dashboard title, SPL version table NDC Dashboard title SPL version Validation Dashboard ZIP 0603-1554 POTASSIUM CHLORIDE POWDER, FOR SOLUTION [ENDO USA, INC.] 6 Current NDC, Legacy NDC, 3 package rows 20250330_a64d7151-09a6-474c-83fc-36c7cf582d32.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 · 5 matching rows.
Brand, Generic, Manufacturer table Brand Generic Manufacturer SPL set ID Effective date Available safety fields Join POKONZA POTASSIUM CHLORIDE Carwin Pharmaceutical Associates, LLC 0700c19e-abca-4527-8944-e4440a32e3af 2025-12-18 Warnings, Adverse reactions Exact identifier application applno (NDA): 208019 application number: NDA208019 Potassium Chloride POTASSIUM CHLORIDE IPG Pharmaceuticals, Inc. 5dad0879-0f97-4c7d-98fa-baaed51cd2d8 2025-12-09 Warnings, Adverse reactions Exact identifier application applno (NDA): 208019 application number: NDA208019 Potassium Chloride POTASSIUM CHLORIDE Endo USA, Inc. a64d7151-09a6-474c-83fc-36c7cf582d32 2025-03-26 Warnings, Adverse reactions Exact identifier application applno (NDA): 208019 application number: NDA208019 ndc (product): 0603-1554 POKONZA POTASSIUM CHLORIDE Carwin Pharmaceutical Associates, LLC 7c5cc705-e5da-4487-86c9-9d545a95afb4 2024-03-22 Warnings, Adverse reactions Exact identifier application applno (NDA): 208019 application number: NDA208019 Potassium Chloride POTASSIUM CHLORIDE Genus Lifesciences Inc. 23d818e7-c076-40de-8dc1-0b51ba4be96a 2020-04-28 Warnings, Adverse reactions Exact identifier application applno (NDA): 208019 application number: NDA208019
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 0603-1554-04 00603155404 100 POUCH in 1 CARTON (0603-1554-04) / 1.58 g in 1 POUCH (0603-1554-10) 100 pouch 2015-09-18 0000-00-00 No No Current 0603-1554-10 00603155410 1.58 g in 1 POUCH 1.58 g Historical 0603-1554-16 00603155416 30 POUCH in 1 CARTON (0603-1554-16) / 1.58 g in 1 POUCH (0603-1554-10) 30 pouch 2015-09-18 0000-00-00 No No Current