Home NDC 65219-510-20 Potassium Acetate
Product NDC 65219-510
Requested package NDC 65219-510-20
11-digit product format 652190510
Labeler code 65219
Product ID 65219-510_67c83f58-73cd-47d2-8dbc-e0fd8331c6e7
Type HUMAN PRESCRIPTION DRUG
Nonproprietary name POTASSIUM ACETATE
Dosage form INJECTION, SOLUTION, CONCENTRATE
Route INTRAVENOUS
Labeler Fresenius Kabi USA, LLC
Application ANDA217515
Marketing category ANDA
Marketing start 2024-11-27
Substance POTASSIUM ACETATE
Active strength 3.93 g/20mL
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 A217515-001 POTASSIUM ACETATE POTASSIUM ACETATE 2MEQ/ML INJECTABLE / INJECTION AP 2024-11-27
Therapeutic equivalence codes# Current TE-code rows page 1 of 1 · 1 matching rows.
Application-product, TE code table Application-product TE code A217515-001 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.
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 A217515-001 POTASSIUM ACETATE 2MEQ/ML INJECTABLE / INJECTION AP 2024-11-27 011fe1cb6892…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 A217515-001 POTASSIUM ACETATE 2MEQ/ML INJECTABLE / INJECTION AP 2024-11-27 31067a03dcf5…2025-08-23 18:47 UTC 2025-08 A217515-001 POTASSIUM ACETATE 2MEQ/ML INJECTABLE / INJECTION AP 2024-11-27 6a471c1ec25d…2025-03-22 03:13 UTC · 3 captures of this ZIP 2025-03 A217515-001 POTASSIUM ACETATE 2MEQ/ML INJECTABLE / INJECTION AP 2024-11-27 fd3edfee7708…2025-02-26 10:13 UTC · 3 captures of this ZIP 2025-02 A217515-001 POTASSIUM ACETATE 2MEQ/ML INJECTABLE / INJECTION AP 2024-11-27 b8a1b40f171c…2025-01-19 17:59 UTC · 7 captures of this ZIP 2025-01 A217515-001 POTASSIUM ACETATE 2MEQ/ML INJECTABLE / INJECTION AP 2024-11-27 03ed91905a0d…2024-12-13 21:23 UTC · 2 captures of this ZIP 2024-12 A217515-001 POTASSIUM ACETATE 2MEQ/ML INJECTABLE / INJECTION AP 2024-11-27 2680178bc6a6…2026-07-26 02:55 UTC · 3 captures of this ZIP 2026-06 A217515-001 POTASSIUM ACETATE 2MEQ/ML INJECTABLE / INJECTION AP 2024-11-27 a50c72e98297…
Observed Orange Book normalized TE history# Additional Listing Data#
Finished product Yes
Brand name base Potassium Acetate
Listing expiration 2026-12-31 Active Ingredients# Ingredient, Strength table Ingredient Strength POTASSIUM ACETATE 3.93 g/20mL
Harmonized UNII identifiers# UNII identifiers page 1 of 1 · 1 matching rows.
Identifier, FDA.report destination table Identifier FDA.report destination M911911U02 Internal UNII lookup
Harmonized RxCUI identifiers# RxCUI identifiers page 1 of 1 · 1 matching rows.
Identifier, FDA.report destination table Identifier FDA.report destination 1871155 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 65219-510-02 Potassium Acetate 20 mL in 1 VIAL, SINGLE-DOSE INJECTION, SOLUTION, CONCENTRATE 20 1 65219-510-20 Potassium Acetate 25 in 1 TRAY INJECTION, SOLUTION, CONCENTRATE 25 1
DailyMed Dashboard NDC Coverage# NDC, Dashboard title, SPL version table NDC Dashboard title SPL version Validation Dashboard ZIP 65219-510 POTASSIUM ACETATE (POTASSIUM ACETATE) INJECTION, SOLUTION, CONCENTRATE [FRESENIUS KABI USA, LLC
] 1 Current NDC, 2 package rows 20241213_bf4dc488-d6f3-41f8-ac8d-37b27f25b8db.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 Sample Exclude flag Status 65219-510-20 65219051020 25 VIAL, SINGLE-DOSE in 1 TRAY (65219-510-20) / 20 mL in 1 VIAL, SINGLE-DOSE (65219-510-02) 2024-11-27 No No Current