Home NDC 51754-2004 Potassium Acetate
Product NDC 51754-2004
11-digit product format 517542004
Labeler code 51754
Product ID 51754-2004_2b86b9e8-48ba-4a72-b705-48c2751016e6
Type HUMAN PRESCRIPTION DRUG
Nonproprietary name Potassium Acetate
Dosage form INJECTION
Route INTRAVENOUS
Labeler Exela Pharma Sciences, LLC
Application ANDA206203
Marketing category ANDA
Marketing start 2023-08-01
Substance POTASSIUM ACETATE
Active strength 200 meq/100mL
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 42 .
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 A206203-001 POTASSIUM ACETATE POTASSIUM ACETATE 2MEQ/ML INJECTABLE / INJECTION 2015-12-29
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 · 42 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 A206203-001 POTASSIUM ACETATE 2MEQ/ML INJECTABLE / INJECTION 2015-12-29 caaa826d4ba7…2026-02-19 14:30 UTC 2026-02 A206203-001 POTASSIUM ACETATE 2MEQ/ML INJECTABLE / INJECTION 2015-12-29 011fe1cb6892…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 A206203-001 POTASSIUM ACETATE 2MEQ/ML INJECTABLE / INJECTION AP 2015-12-29 31067a03dcf5…2025-08-23 18:47 UTC 2025-08 A206203-001 POTASSIUM ACETATE 2MEQ/ML INJECTABLE / INJECTION AP 2015-12-29 6a471c1ec25d…2025-03-22 03:13 UTC · 3 captures of this ZIP 2025-03 A206203-001 POTASSIUM ACETATE 2MEQ/ML INJECTABLE / INJECTION AP 2015-12-29 fd3edfee7708…2025-02-26 10:13 UTC · 3 captures of this ZIP 2025-02 A206203-001 POTASSIUM ACETATE 2MEQ/ML INJECTABLE / INJECTION AP 2015-12-29 b8a1b40f171c…2025-01-19 17:59 UTC · 7 captures of this ZIP 2025-01 A206203-001 POTASSIUM ACETATE 2MEQ/ML INJECTABLE / INJECTION AP 2015-12-29 03ed91905a0d…2024-12-13 21:23 UTC · 2 captures of this ZIP 2024-12 A206203-001 POTASSIUM ACETATE 2MEQ/ML INJECTABLE / INJECTION AP 2015-12-29 2680178bc6a6…2024-09-14 05:58 UTC · 2 captures of this ZIP 2024-09 A206203-001 POTASSIUM ACETATE 2MEQ/ML INJECTABLE / INJECTION AP 2015-12-29 5bbf6a4d5a75…2024-11-08 22:44 UTC · 3 captures of this ZIP 2024-11 A206203-001 POTASSIUM ACETATE 2MEQ/ML INJECTABLE / INJECTION AP 2015-12-29 d8e5a09893c0…2024-10-29 15:01 UTC 2024-10 A206203-001 POTASSIUM ACETATE 2MEQ/ML INJECTABLE / INJECTION AP 2015-12-29 d06236e962d9…2024-08-13 05:28 UTC · 3 captures of this ZIP 2024-08 A206203-001 POTASSIUM ACETATE 2MEQ/ML INJECTABLE / INJECTION AP 2015-12-29 79d66fd596c7…2024-07-13 05:37 UTC · 2 captures of this ZIP 2024-07 A206203-001 POTASSIUM ACETATE 2MEQ/ML INJECTABLE / INJECTION AP 2015-12-29 301d65b070ca…2024-06-18 03:08 UTC · 5 captures of this ZIP 2024-06 A206203-001 POTASSIUM ACETATE 2MEQ/ML INJECTABLE / INJECTION AP 2015-12-29 1e350fbaab3a…2024-05-31 18:47 UTC 2024-05 A206203-001 POTASSIUM ACETATE 2MEQ/ML INJECTABLE / INJECTION AP 2015-12-29 8072bd15b7f6…2022-06-29 02:47 UTC · 2 captures of this ZIP 2022-06 A206203-001 POTASSIUM ACETATE 2MEQ/ML INJECTABLE / INJECTION AP 2015-12-29 5c6f7cd8ea54…2022-04-08 23:34 UTC 2022-04 A206203-001 POTASSIUM ACETATE 2MEQ/ML INJECTABLE / INJECTION AP 2015-12-29 5d02ea3f76ae…2022-04-04 05:41 UTC 2022-04 A206203-001 POTASSIUM ACETATE 2MEQ/ML INJECTABLE / INJECTION AP 2015-12-29 4b0b4de00fa7…2019-12-13 00:20 UTC 2019-12 A206203-001 POTASSIUM ACETATE 2MEQ/ML INJECTABLE / INJECTION AP 2015-12-29 74a2ff9319b5…2022-03-09 01:35 UTC 2022-03 A206203-001 POTASSIUM ACETATE 2MEQ/ML INJECTABLE / INJECTION AP 2015-12-29 bb7c543d1eb4…2021-12-28 21:50 UTC 2021-12 A206203-001 POTASSIUM ACETATE 2MEQ/ML INJECTABLE / INJECTION AP 2015-12-29 782e0a99824c…2021-05-05 16:15 UTC · 3 captures of this ZIP 2021-05 A206203-001 POTASSIUM ACETATE 2MEQ/ML INJECTABLE / INJECTION AP 2015-12-29 87673890dc5c…2021-03-12 10:30 UTC 2021-03 A206203-001 POTASSIUM ACETATE 2MEQ/ML INJECTABLE / INJECTION AP 2015-12-29 5aa47cf7b7d7…2020-12-22 03:56 UTC 2020-12 A206203-001 POTASSIUM ACETATE 2MEQ/ML INJECTABLE / INJECTION AP 2015-12-29 8869cabd3fbd…2020-11-12 02:37 UTC 2020-11 A206203-001 POTASSIUM ACETATE 2MEQ/ML INJECTABLE / INJECTION AP 2015-12-29 c0c555d07b60…2019-12-14 00:12 UTC 2019-12 A206203-001 POTASSIUM ACETATE 2MEQ/ML INJECTABLE / INJECTION AP 2015-12-29 3f01610625f2…2019-09-15 20:21 UTC 2019-09 A206203-001 POTASSIUM ACETATE 2MEQ/ML INJECTABLE / INJECTION AP 2015-12-29 b00525d2431f…2019-07-19 19:46 UTC 2019-07 A206203-001 POTASSIUM ACETATE 2MEQ/ML INJECTABLE / INJECTION AP 2015-12-29 ea99ee380514…2024-03-16 18:09 UTC · 4 captures of this ZIP 2024-03 A206203-001 POTASSIUM ACETATE 2MEQ/ML INJECTABLE / INJECTION AP 2015-12-29 6a51e52b5d6a…2024-02-18 07:12 UTC 2024-02 A206203-001 POTASSIUM ACETATE 2MEQ/ML INJECTABLE / INJECTION AP 2015-12-29 1c564ffb4f44…2023-12-20 04:57 UTC 2023-12 A206203-001 POTASSIUM ACETATE 2MEQ/ML INJECTABLE / INJECTION AP 2015-12-29 ea1830bbd6c7…2023-11-28 05:40 UTC · 2 captures of this ZIP 2023-11 A206203-001 POTASSIUM ACETATE 2MEQ/ML INJECTABLE / INJECTION AP 2015-12-29 a72a2bbeb626…2023-10-25 00:34 UTC · 2 captures of this ZIP 2023-10 A206203-001 POTASSIUM ACETATE 2MEQ/ML INJECTABLE / INJECTION AP 2015-12-29 9b2671bbb829…2023-07-15 15:27 UTC · 2 captures of this ZIP 2023-07 A206203-001 POTASSIUM ACETATE 2MEQ/ML INJECTABLE / INJECTION AP 2015-12-29 a67488948f0b…2023-06-13 01:57 UTC · 3 captures of this ZIP 2023-06 A206203-001 POTASSIUM ACETATE 2MEQ/ML INJECTABLE / INJECTION AP 2015-12-29 3f0d92c62455…2023-05-13 08:27 UTC 2023-05 A206203-001 POTASSIUM ACETATE 2MEQ/ML INJECTABLE / INJECTION AP 2015-12-29 053a50430f4f…2023-01-26 05:58 UTC 2023-01 A206203-001 POTASSIUM ACETATE 2MEQ/ML INJECTABLE / INJECTION AP 2015-12-29 3bdfa0b2c4d7…2022-11-12 20:34 UTC · 5 captures of this ZIP 2022-11 A206203-001 POTASSIUM ACETATE 2MEQ/ML INJECTABLE / INJECTION AP 2015-12-29 3a93d1ddd44b…2022-10-28 04:53 UTC 2022-10 A206203-001 POTASSIUM ACETATE 2MEQ/ML INJECTABLE / INJECTION AP 2015-12-29 f41ea6bd6efb…2022-09-29 23:25 UTC 2022-09 A206203-001 POTASSIUM ACETATE 2MEQ/ML INJECTABLE / INJECTION AP 2015-12-29 e64feba35796…
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 200 meq/100mL
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 237381 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 51754-2004-4 Potassium Acetate 100 mL in 1 VIAL, GLASS INJECTION 100 2 51754-2004-4 Potassium Acetate 25 in 1 CARTON INJECTION 25 2
DailyMed Dashboard NDC Coverage# NDC, Dashboard title, SPL version table NDC Dashboard title SPL version Validation Dashboard ZIP 51754-2004 POTASSIUM ACETATE INJECTION [EXELA PHARMA SCIENCES, LLC] 2 Current NDC, 2 package rows 20230811_d5f6dc05-9fb0-4a89-8c54-46112df10abd.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 · 1 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 51754-2004-4 51754200404 25 VIAL, GLASS in 1 CARTON (51754-2004-4) / 100 mL in 1 VIAL, GLASS 2023-08-01 No No Current