Home NDC 0404-9937 Potassium Chloride
Product NDC 0404-9937
11-digit product format 004049937
Labeler code 0404
Product ID 0404-9937_b10f2db5-f661-422e-b335-a9c2914aa69d
Type HUMAN PRESCRIPTION DRUG
Nonproprietary name Potassium Chloride
Dosage form INJECTION, SOLUTION, CONCENTRATE
Route INTRAVENOUS
Labeler Henry Schein, Inc.
Application ANDA080205
Marketing category ANDA
Marketing start 2022-01-13
Substance POTASSIUM CHLORIDE
Active strength 149 mg/mL
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 · 4 matching rows.
Application-product, Trade name, Ingredient table Application-product Trade name Ingredient Strength Dosage form / route TE codes RLD / RS Approval date A080205-001 POTASSIUM CHLORIDE POTASSIUM CHLORIDE 2MEQ/ML INJECTABLE / INJECTION AP RLD, RS, Approved before 1982 A080205-003 POTASSIUM CHLORIDE POTASSIUM CHLORIDE 1MEQ/ML INJECTABLE / INJECTION Approved before 1982 A080205-004 POTASSIUM CHLORIDE POTASSIUM CHLORIDE 2.4MEQ/ML INJECTABLE / INJECTION Approved before 1982 A080205-005 POTASSIUM CHLORIDE POTASSIUM CHLORIDE 3.2MEQ/ML INJECTABLE / INJECTION Approved before 1982
Therapeutic equivalence codes# Current TE-code rows page 1 of 1 · 1 matching rows.
Application-product, TE code table Application-product TE code A080205-001 AP
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 5 · 164 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 A080205-001 POTASSIUM CHLORIDE 2MEQ/ML INJECTABLE / INJECTION AP RLD, RS, Approved before 1982 011fe1cb6892…2026-02-19 14:30 UTC 2026-02 A080205-003 POTASSIUM CHLORIDE 1MEQ/ML INJECTABLE / INJECTION Approved before 1982 011fe1cb6892…2026-02-19 14:30 UTC 2026-02 A080205-004 POTASSIUM CHLORIDE 2.4MEQ/ML INJECTABLE / INJECTION Approved before 1982 011fe1cb6892…2026-02-19 14:30 UTC 2026-02 A080205-005 POTASSIUM CHLORIDE 3.2MEQ/ML INJECTABLE / INJECTION Approved before 1982 011fe1cb6892…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 A080205-001 POTASSIUM CHLORIDE 2MEQ/ML INJECTABLE / INJECTION AP RLD, RS, Approved before 1982 31067a03dcf5…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 A080205-003 POTASSIUM CHLORIDE 1MEQ/ML INJECTABLE / INJECTION Approved before 1982 31067a03dcf5…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 A080205-004 POTASSIUM CHLORIDE 2.4MEQ/ML INJECTABLE / INJECTION Approved before 1982 31067a03dcf5…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 A080205-005 POTASSIUM CHLORIDE 3.2MEQ/ML INJECTABLE / INJECTION Approved before 1982 31067a03dcf5…2025-08-23 18:47 UTC 2025-08 A080205-001 POTASSIUM CHLORIDE 2MEQ/ML INJECTABLE / INJECTION AP RLD, RS, Approved before 1982 6a471c1ec25d…2025-08-23 18:47 UTC 2025-08 A080205-003 POTASSIUM CHLORIDE 1MEQ/ML INJECTABLE / INJECTION Approved before 1982 6a471c1ec25d…2025-08-23 18:47 UTC 2025-08 A080205-004 POTASSIUM CHLORIDE 2.4MEQ/ML INJECTABLE / INJECTION Approved before 1982 6a471c1ec25d…2025-08-23 18:47 UTC 2025-08 A080205-005 POTASSIUM CHLORIDE 3.2MEQ/ML INJECTABLE / INJECTION Approved before 1982 6a471c1ec25d…2025-03-22 03:13 UTC · 3 captures of this ZIP 2025-03 A080205-001 POTASSIUM CHLORIDE 2MEQ/ML INJECTABLE / INJECTION AP RLD, RS, Approved before 1982 fd3edfee7708…2025-03-22 03:13 UTC · 3 captures of this ZIP 2025-03 A080205-003 POTASSIUM CHLORIDE 1MEQ/ML INJECTABLE / INJECTION Approved before 1982 fd3edfee7708…2025-03-22 03:13 UTC · 3 captures of this ZIP 2025-03 A080205-004 POTASSIUM CHLORIDE 2.4MEQ/ML INJECTABLE / INJECTION Approved before 1982 fd3edfee7708…2025-03-22 03:13 UTC · 3 captures of this ZIP 2025-03 A080205-005 POTASSIUM CHLORIDE 3.2MEQ/ML INJECTABLE / INJECTION Approved before 1982 fd3edfee7708…2025-02-26 10:13 UTC · 3 captures of this ZIP 2025-02 A080205-001 POTASSIUM CHLORIDE 2MEQ/ML INJECTABLE / INJECTION AP RLD, RS, Approved before 1982 b8a1b40f171c…2025-02-26 10:13 UTC · 3 captures of this ZIP 2025-02 A080205-003 POTASSIUM CHLORIDE 1MEQ/ML INJECTABLE / INJECTION Approved before 1982 b8a1b40f171c…2025-02-26 10:13 UTC · 3 captures of this ZIP 2025-02 A080205-004 POTASSIUM CHLORIDE 2.4MEQ/ML INJECTABLE / INJECTION Approved before 1982 b8a1b40f171c…2025-02-26 10:13 UTC · 3 captures of this ZIP 2025-02 A080205-005 POTASSIUM CHLORIDE 3.2MEQ/ML INJECTABLE / INJECTION Approved before 1982 b8a1b40f171c…2025-01-19 17:59 UTC · 7 captures of this ZIP 2025-01 A080205-001 POTASSIUM CHLORIDE 2MEQ/ML INJECTABLE / INJECTION AP RLD, RS, Approved before 1982 03ed91905a0d…2025-01-19 17:59 UTC · 7 captures of this ZIP 2025-01 A080205-003 POTASSIUM CHLORIDE 1MEQ/ML INJECTABLE / INJECTION Approved before 1982 03ed91905a0d…2025-01-19 17:59 UTC · 7 captures of this ZIP 2025-01 A080205-004 POTASSIUM CHLORIDE 2.4MEQ/ML INJECTABLE / INJECTION Approved before 1982 03ed91905a0d…2025-01-19 17:59 UTC · 7 captures of this ZIP 2025-01 A080205-005 POTASSIUM CHLORIDE 3.2MEQ/ML INJECTABLE / INJECTION Approved before 1982 03ed91905a0d…2024-12-13 21:23 UTC · 2 captures of this ZIP 2024-12 A080205-001 POTASSIUM CHLORIDE 2MEQ/ML INJECTABLE / INJECTION AP RLD, RS, Approved before 1982 2680178bc6a6…2024-12-13 21:23 UTC · 2 captures of this ZIP 2024-12 A080205-003 POTASSIUM CHLORIDE 1MEQ/ML INJECTABLE / INJECTION Approved before 1982 2680178bc6a6…2024-12-13 21:23 UTC · 2 captures of this ZIP 2024-12 A080205-004 POTASSIUM CHLORIDE 2.4MEQ/ML INJECTABLE / INJECTION Approved before 1982 2680178bc6a6…2024-12-13 21:23 UTC · 2 captures of this ZIP 2024-12 A080205-005 POTASSIUM CHLORIDE 3.2MEQ/ML INJECTABLE / INJECTION Approved before 1982 2680178bc6a6…2024-09-14 05:58 UTC · 2 captures of this ZIP 2024-09 A080205-001 POTASSIUM CHLORIDE 2MEQ/ML INJECTABLE / INJECTION AP RLD, RS, Approved before 1982 5bbf6a4d5a75…2024-09-14 05:58 UTC · 2 captures of this ZIP 2024-09 A080205-003 POTASSIUM CHLORIDE 1MEQ/ML INJECTABLE / INJECTION Approved before 1982 5bbf6a4d5a75…2024-09-14 05:58 UTC · 2 captures of this ZIP 2024-09 A080205-004 POTASSIUM CHLORIDE 2.4MEQ/ML INJECTABLE / INJECTION Approved before 1982 5bbf6a4d5a75…2024-09-14 05:58 UTC · 2 captures of this ZIP 2024-09 A080205-005 POTASSIUM CHLORIDE 3.2MEQ/ML INJECTABLE / INJECTION Approved before 1982 5bbf6a4d5a75…2024-11-08 22:44 UTC · 3 captures of this ZIP 2024-11 A080205-001 POTASSIUM CHLORIDE 2MEQ/ML INJECTABLE / INJECTION AP RLD, RS, Approved before 1982 d8e5a09893c0…2024-11-08 22:44 UTC · 3 captures of this ZIP 2024-11 A080205-003 POTASSIUM CHLORIDE 1MEQ/ML INJECTABLE / INJECTION Approved before 1982 d8e5a09893c0…2024-11-08 22:44 UTC · 3 captures of this ZIP 2024-11 A080205-004 POTASSIUM CHLORIDE 2.4MEQ/ML INJECTABLE / INJECTION Approved before 1982 d8e5a09893c0…2024-11-08 22:44 UTC · 3 captures of this ZIP 2024-11 A080205-005 POTASSIUM CHLORIDE 3.2MEQ/ML INJECTABLE / INJECTION Approved before 1982 d8e5a09893c0…2024-10-29 15:01 UTC 2024-10 A080205-001 POTASSIUM CHLORIDE 2MEQ/ML INJECTABLE / INJECTION AP RLD, RS, Approved before 1982 d06236e962d9…2024-10-29 15:01 UTC 2024-10 A080205-003 POTASSIUM CHLORIDE 1MEQ/ML INJECTABLE / INJECTION Approved before 1982 d06236e962d9…2024-10-29 15:01 UTC 2024-10 A080205-004 POTASSIUM CHLORIDE 2.4MEQ/ML INJECTABLE / INJECTION Approved before 1982 d06236e962d9…2024-10-29 15:01 UTC 2024-10 A080205-005 POTASSIUM CHLORIDE 3.2MEQ/ML INJECTABLE / INJECTION Approved before 1982 d06236e962d9…
Observed Orange Book normalized TE history# Normalized TE history page 1 of 2 · 41 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 149 mg/mL
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 1860136 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 0404-9937-10 Potassium Chloride 1 mL in 1 VIAL, SINGLE-DOSE INJECTION, SOLUTION, CONCENTRATE 1 7 0404-9937-10 Potassium Chloride 1 in 1 BAG INJECTION, SOLUTION, CONCENTRATE 1 7
DailyMed Dashboard NDC Coverage# NDC, Dashboard title, SPL version table NDC Dashboard title SPL version Validation Dashboard ZIP 0404-9937 POTASSIUM CHLORIDE INJECTION, SOLUTION, CONCENTRATE [HENRY SCHEIN, INC.] 6 Current NDC, Legacy NDC, 2 package rows 20240518_8367a2ae-dfd9-4515-838c-529920291ca0.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.
Brand, Generic, Manufacturer table Brand Generic Manufacturer SPL set ID Effective date Available safety fields Join POTASSIUM CHLORIDE POTASSIUM CHLORIDE Hospira, Inc. 559a0a8c-a8fe-40a5-b196-21f9308780ab 2026-07-01 Warnings, Adverse reactions Exact identifier application applno (ANDA): 080205 application number: ANDA080205 Potassium Chloride POTASSIUM CHLORIDE Henry Schein, Inc. 8367a2ae-dfd9-4515-838c-529920291ca0 2025-11-07 Warnings, Adverse reactions Exact identifier application applno (ANDA): 080205 application number: ANDA080205 ndc (product): 0404-9937 POTASSIUM CHLORIDE POTASSIUM CHLORIDE HF Acquisition Co LLC, DBA HealthFirst 9508355e-e1ed-412b-e053-2a95a90aac8e 2025-01-08 Warnings, Adverse reactions Exact identifier application applno (ANDA): 080205 application number: ANDA080205 POTASSIUM CHLORIDE POTASSIUM CHLORIDE HF Acquisition Co LLC, DBA HealthFirst 951ffdc3-d54f-d5e1-e053-2a95a90a79e6 2025-01-08 Warnings, Adverse reactions Exact identifier application applno (ANDA): 080205 application number: ANDA080205
DailyMed RxNorm Mappings# Packages# Package NDC, 11-digit format, Description table Package NDC 11-digit format Description Marketing start Marketing end Sample Exclude flag Status 0404-9937-10 00404993710 1 VIAL, SINGLE-DOSE in 1 BAG (0404-9937-10) / 1 mL in 1 VIAL, SINGLE-DOSE 2022-01-13 0000-00-00 No No Current