Home NDC 0404-9936 Potassium Chloride
Product NDC 0404-9936
11-digit product format 004049936
Labeler code 0404
Product ID 0404-9936_86d210da-05db-45c6-b2fd-4d6aa79484fa
Type HUMAN PRESCRIPTION DRUG
Nonproprietary name Potassium Chloride
Dosage form INJECTION, SOLUTION, CONCENTRATE
Route INTRAVENOUS
Labeler Henry Schein, Inc.
Application ANDA088901
Marketing category ANDA
Marketing start 2022-01-13
Substance POTASSIUM CHLORIDE
Active strength 2 meq/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 · 1 matching rows.
Application-product, Trade name, Ingredient table Application-product Trade name Ingredient Strength Dosage form / route TE codes RLD / RS Approval date A088901-001 POTASSIUM CHLORIDE IN PLASTIC CONTAINER POTASSIUM CHLORIDE 2MEQ/ML INJECTABLE / INJECTION AP 1985-01-25
Therapeutic equivalence codes# Current TE-code rows page 1 of 1 · 1 matching rows.
Application-product, TE code table Application-product TE code A088901-001 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 2 · 41 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 A088901-001 POTASSIUM CHLORIDE IN PLASTIC CONTAINER 2MEQ/ML INJECTABLE / INJECTION AP 1985-01-25 011fe1cb6892…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 A088901-001 POTASSIUM CHLORIDE IN PLASTIC CONTAINER 2MEQ/ML INJECTABLE / INJECTION AP 1985-01-25 31067a03dcf5…2025-08-23 18:47 UTC 2025-08 A088901-001 POTASSIUM CHLORIDE IN PLASTIC CONTAINER 2MEQ/ML INJECTABLE / INJECTION AP 1985-01-25 6a471c1ec25d…2025-03-22 03:13 UTC · 3 captures of this ZIP 2025-03 A088901-001 POTASSIUM CHLORIDE IN PLASTIC CONTAINER 2MEQ/ML INJECTABLE / INJECTION AP 1985-01-25 fd3edfee7708…2025-02-26 10:13 UTC · 3 captures of this ZIP 2025-02 A088901-001 POTASSIUM CHLORIDE IN PLASTIC CONTAINER 2MEQ/ML INJECTABLE / INJECTION AP 1985-01-25 b8a1b40f171c…2025-01-19 17:59 UTC · 7 captures of this ZIP 2025-01 A088901-001 POTASSIUM CHLORIDE IN PLASTIC CONTAINER 2MEQ/ML INJECTABLE / INJECTION AP 1985-01-25 03ed91905a0d…2024-12-13 21:23 UTC · 2 captures of this ZIP 2024-12 A088901-001 POTASSIUM CHLORIDE IN PLASTIC CONTAINER 2MEQ/ML INJECTABLE / INJECTION AP 1985-01-25 2680178bc6a6…2024-09-14 05:58 UTC · 2 captures of this ZIP 2024-09 A088901-001 POTASSIUM CHLORIDE IN PLASTIC CONTAINER 2MEQ/ML INJECTABLE / INJECTION AP 1985-01-25 5bbf6a4d5a75…2024-11-08 22:44 UTC · 3 captures of this ZIP 2024-11 A088901-001 POTASSIUM CHLORIDE IN PLASTIC CONTAINER 2MEQ/ML INJECTABLE / INJECTION AP 1985-01-25 d8e5a09893c0…2024-10-29 15:01 UTC 2024-10 A088901-001 POTASSIUM CHLORIDE IN PLASTIC CONTAINER 2MEQ/ML INJECTABLE / INJECTION AP 1985-01-25 d06236e962d9…2024-08-13 05:28 UTC · 3 captures of this ZIP 2024-08 A088901-001 POTASSIUM CHLORIDE IN PLASTIC CONTAINER 2MEQ/ML INJECTABLE / INJECTION AP 1985-01-25 79d66fd596c7…2024-07-13 05:37 UTC · 2 captures of this ZIP 2024-07 A088901-001 POTASSIUM CHLORIDE IN PLASTIC CONTAINER 2MEQ/ML INJECTABLE / INJECTION AP 1985-01-25 301d65b070ca…2024-06-18 03:08 UTC · 5 captures of this ZIP 2024-06 A088901-001 POTASSIUM CHLORIDE IN PLASTIC CONTAINER 2MEQ/ML INJECTABLE / INJECTION AP 1985-01-25 1e350fbaab3a…2024-05-31 18:47 UTC 2024-05 A088901-001 POTASSIUM CHLORIDE IN PLASTIC CONTAINER 2MEQ/ML INJECTABLE / INJECTION AP 1985-01-25 8072bd15b7f6…2022-06-29 02:47 UTC · 2 captures of this ZIP 2022-06 A088901-001 POTASSIUM CHLORIDE IN PLASTIC CONTAINER 2MEQ/ML INJECTABLE / INJECTION AP 1985-01-25 5c6f7cd8ea54…2022-04-08 23:34 UTC 2022-04 A088901-001 POTASSIUM CHLORIDE IN PLASTIC CONTAINER 2MEQ/ML INJECTABLE / INJECTION AP 1985-01-25 5d02ea3f76ae…2022-04-04 05:41 UTC 2022-04 A088901-001 POTASSIUM CHLORIDE IN PLASTIC CONTAINER 2MEQ/ML INJECTABLE / INJECTION AP 1985-01-25 4b0b4de00fa7…2019-12-13 00:20 UTC 2019-12 A088901-001 POTASSIUM CHLORIDE IN PLASTIC CONTAINER 2MEQ/ML INJECTABLE / INJECTION AP 1985-01-25 74a2ff9319b5…2022-03-09 01:35 UTC 2022-03 A088901-001 POTASSIUM CHLORIDE IN PLASTIC CONTAINER 2MEQ/ML INJECTABLE / INJECTION AP 1985-01-25 bb7c543d1eb4…2021-12-28 21:50 UTC 2021-12 A088901-001 POTASSIUM CHLORIDE IN PLASTIC CONTAINER 2MEQ/ML INJECTABLE / INJECTION AP 1985-01-25 782e0a99824c…2021-05-05 16:15 UTC · 3 captures of this ZIP 2021-05 A088901-001 POTASSIUM CHLORIDE IN PLASTIC CONTAINER 2MEQ/ML INJECTABLE / INJECTION AP 1985-01-25 87673890dc5c…2021-03-12 10:30 UTC 2021-03 A088901-001 POTASSIUM CHLORIDE IN PLASTIC CONTAINER 2MEQ/ML INJECTABLE / INJECTION AP 1985-01-25 5aa47cf7b7d7…2020-12-22 03:56 UTC 2020-12 A088901-001 POTASSIUM CHLORIDE IN PLASTIC CONTAINER 2MEQ/ML INJECTABLE / INJECTION AP 1985-01-25 8869cabd3fbd…2020-11-12 02:37 UTC 2020-11 A088901-001 POTASSIUM CHLORIDE IN PLASTIC CONTAINER 2MEQ/ML INJECTABLE / INJECTION AP 1985-01-25 c0c555d07b60…2019-12-14 00:12 UTC 2019-12 A088901-001 POTASSIUM CHLORIDE IN PLASTIC CONTAINER 2MEQ/ML INJECTABLE / INJECTION AP 1985-01-25 3f01610625f2…2019-09-15 20:21 UTC 2019-09 A088901-001 POTASSIUM CHLORIDE IN PLASTIC CONTAINER 2MEQ/ML INJECTABLE / INJECTION AP 1985-01-25 b00525d2431f…2019-07-19 19:46 UTC 2019-07 A088901-001 POTASSIUM CHLORIDE IN PLASTIC CONTAINER 2MEQ/ML INJECTABLE / INJECTION AP 1985-01-25 ea99ee380514…2024-03-16 18:09 UTC · 4 captures of this ZIP 2024-03 A088901-001 POTASSIUM CHLORIDE IN PLASTIC CONTAINER 2MEQ/ML INJECTABLE / INJECTION AP 1985-01-25 6a51e52b5d6a…2024-02-18 07:12 UTC 2024-02 A088901-001 POTASSIUM CHLORIDE IN PLASTIC CONTAINER 2MEQ/ML INJECTABLE / INJECTION AP 1985-01-25 1c564ffb4f44…2023-12-20 04:57 UTC 2023-12 A088901-001 POTASSIUM CHLORIDE IN PLASTIC CONTAINER 2MEQ/ML INJECTABLE / INJECTION AP 1985-01-25 ea1830bbd6c7…2023-11-28 05:40 UTC · 2 captures of this ZIP 2023-11 A088901-001 POTASSIUM CHLORIDE IN PLASTIC CONTAINER 2MEQ/ML INJECTABLE / INJECTION AP 1985-01-25 a72a2bbeb626…2023-10-25 00:34 UTC · 2 captures of this ZIP 2023-10 A088901-001 POTASSIUM CHLORIDE IN PLASTIC CONTAINER 2MEQ/ML INJECTABLE / INJECTION AP 1985-01-25 9b2671bbb829…2023-07-15 15:27 UTC · 2 captures of this ZIP 2023-07 A088901-001 POTASSIUM CHLORIDE IN PLASTIC CONTAINER 2MEQ/ML INJECTABLE / INJECTION AP 1985-01-25 a67488948f0b…2023-06-13 01:57 UTC · 3 captures of this ZIP 2023-06 A088901-001 POTASSIUM CHLORIDE IN PLASTIC CONTAINER 2MEQ/ML INJECTABLE / INJECTION AP 1985-01-25 3f0d92c62455…2023-05-13 08:27 UTC 2023-05 A088901-001 POTASSIUM CHLORIDE IN PLASTIC CONTAINER 2MEQ/ML INJECTABLE / INJECTION AP 1985-01-25 053a50430f4f…2023-01-26 05:58 UTC 2023-01 A088901-001 POTASSIUM CHLORIDE IN PLASTIC CONTAINER 2MEQ/ML INJECTABLE / INJECTION AP 1985-01-25 3bdfa0b2c4d7…2022-11-12 20:34 UTC · 5 captures of this ZIP 2022-11 A088901-001 POTASSIUM CHLORIDE IN PLASTIC CONTAINER 2MEQ/ML INJECTABLE / INJECTION AP 1985-01-25 3a93d1ddd44b…2022-10-28 04:53 UTC 2022-10 A088901-001 POTASSIUM CHLORIDE IN PLASTIC CONTAINER 2MEQ/ML INJECTABLE / INJECTION AP 1985-01-25 f41ea6bd6efb…2022-09-29 23:25 UTC 2022-09 A088901-001 POTASSIUM CHLORIDE IN PLASTIC CONTAINER 2MEQ/ML INJECTABLE / INJECTION AP 1985-01-25 e64feba35796…2022-07-09 03:26 UTC · 3 captures of this ZIP 2022-07 A088901-001 POTASSIUM CHLORIDE IN PLASTIC CONTAINER 2MEQ/ML INJECTABLE / INJECTION AP 1985-01-25 cb3db0bc1861…
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 2 meq/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 · 2 matching rows.
Identifier, FDA.report destination table Identifier FDA.report destination 1860132 Internal RxNorm lookup 1860139 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 0404-9936-10 Potassium Chloride 5 mL in 1 VIAL, SINGLE-DOSE INJECTION, SOLUTION, CONCENTRATE 5 5 0404-9936-10 Potassium Chloride 1 in 1 BAG INJECTION, SOLUTION, CONCENTRATE 1 5 0404-9936-20 Potassium Chloride 1 in 1 BAG INJECTION, SOLUTION, CONCENTRATE 1 5 0404-9936-20 Potassium Chloride 20 mL in 1 VIAL, SINGLE-DOSE INJECTION, SOLUTION, CONCENTRATE 20 5
DailyMed Dashboard NDC Coverage# NDC, Dashboard title, SPL version table NDC Dashboard title SPL version Validation Dashboard ZIP 0404-9936 POTASSIUM CHLORIDE INJECTION, SOLUTION, CONCENTRATE [HENRY SCHEIN, INC.] 4 Current NDC, Legacy NDC, 4 package rows 20240518_bf8e8ac7-e6a8-4571-a0ea-7bcab89290f6.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 Marketing start Marketing end Sample Exclude flag Status 0404-9936-10 00404993610 1 VIAL, SINGLE-DOSE in 1 BAG (0404-9936-10) / 5 mL in 1 VIAL, SINGLE-DOSE 2022-01-13 0000-00-00 No No Current 0404-9936-20 00404993620 1 VIAL, SINGLE-DOSE in 1 BAG (0404-9936-20) / 20 mL in 1 VIAL, SINGLE-DOSE 2022-01-13 0000-00-00 No No Current