Potassium Acetate

Product NDC: 51754-2001
11-digit product format: 517542001
Labeler code: 51754
Product ID: 51754-2001_9ed8665b-91b9-4a6d-a7cc-177040e35e35
Type: HUMAN PRESCRIPTION DRUG
Nonproprietary name: POTASSIUM ACETATE
Dosage form: INJECTION, SOLUTION, CONCENTRATE
Route: INTRAVENOUS
Labeler: Exela Pharma Sciences, LLC
Application: ANDA206203
Marketing category: ANDA
Marketing start: 2016-01-07
Marketing end: 0000-00-00
Substance: POTASSIUM ACETATE
Active strength: 4 g/20mL
Pharmacologic classes: Potassium Compounds [CS],Potassium Salt [EPC],Osmotic Laxative [EPC],Increased Large Intestinal Motility [PE],Inhibition Large Intestine Fluid/Electrolyte Absorption [PE],Osmotic Activity [MoA]
NDC exclude flag: No
Listing certified through: 2021-12-31
Current FDA listing: Historical FDA.report record

NDC auxiliary status#

These records are reproduced from FDA’s unfinished, excluded, and compounder listings. They describe what appeared in the source files; a missing record does not establish a regulatory status. View all current auxiliary records, including entries without an NDC. · View the auxiliary file history.

Current NDC status page 1 of 1 · 2 matching rows.

Dataset, Scope, Product NDC table
Dataset	Scope	Product NDC	Package NDC	Code	Status	Reporting period	Source date
excluded product	product	51754-2001		I	Inactivated by FDA		2026-08-17
excluded package	package	51754-2001	51754-2001-4	I	Inactivated by FDA		2026-08-17

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	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#

Captured, Edition, Application-product table
Captured	Edition	Application-product	TE code	Order	Source SHA-256
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A206203-001	AP	1	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	A206203-001	AP	1	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A206203-001	AP	1	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A206203-001	AP	1	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A206203-001	AP	1	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A206203-001	AP	1	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A206203-001	AP	1	`5bbf6a4d5a75…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A206203-001	AP	1	`d8e5a09893c0…`
2024-10-29 15:01 UTC	2024-10	A206203-001	AP	1	`d06236e962d9…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A206203-001	AP	1	`79d66fd596c7…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A206203-001	AP	1	`301d65b070ca…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A206203-001	AP	1	`1e350fbaab3a…`
2024-05-31 18:47 UTC	2024-05	A206203-001	AP	1	`8072bd15b7f6…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	A206203-001	AP	1	`5c6f7cd8ea54…`
2022-04-08 23:34 UTC	2022-04	A206203-001	AP	1	`5d02ea3f76ae…`
2022-04-04 05:41 UTC	2022-04	A206203-001	AP	1	`4b0b4de00fa7…`
2019-12-13 00:20 UTC	2019-12	A206203-001	AP	1	`74a2ff9319b5…`
2022-03-09 01:35 UTC	2022-03	A206203-001	AP	1	`bb7c543d1eb4…`
2021-12-28 21:50 UTC	2021-12	A206203-001	AP	1	`782e0a99824c…`
2021-05-05 16:15 UTC · 3 captures of this ZIP	2021-05	A206203-001	AP	1	`87673890dc5c…`
2021-03-12 10:30 UTC	2021-03	A206203-001	AP	1	`5aa47cf7b7d7…`
2020-12-22 03:56 UTC	2020-12	A206203-001	AP	1	`8869cabd3fbd…`
2020-11-12 02:37 UTC	2020-11	A206203-001	AP	1	`c0c555d07b60…`
2019-12-14 00:12 UTC	2019-12	A206203-001	AP	1	`3f01610625f2…`
2019-09-15 20:21 UTC	2019-09	A206203-001	AP	1	`b00525d2431f…`
2019-07-19 19:46 UTC	2019-07	A206203-001	AP	1	`ea99ee380514…`
2024-03-16 18:09 UTC · 4 captures of this ZIP	2024-03	A206203-001	AP	1	`6a51e52b5d6a…`
2024-02-18 07:12 UTC	2024-02	A206203-001	AP	1	`1c564ffb4f44…`
2023-12-20 04:57 UTC	2023-12	A206203-001	AP	1	`ea1830bbd6c7…`
2023-11-28 05:40 UTC · 2 captures of this ZIP	2023-11	A206203-001	AP	1	`a72a2bbeb626…`
2023-10-25 00:34 UTC · 2 captures of this ZIP	2023-10	A206203-001	AP	1	`9b2671bbb829…`
2023-07-15 15:27 UTC · 2 captures of this ZIP	2023-07	A206203-001	AP	1	`a67488948f0b…`
2023-06-13 01:57 UTC · 3 captures of this ZIP	2023-06	A206203-001	AP	1	`3f0d92c62455…`
2023-05-13 08:27 UTC	2023-05	A206203-001	AP	1	`053a50430f4f…`
2023-01-26 05:58 UTC	2023-01	A206203-001	AP	1	`3bdfa0b2c4d7…`
2022-11-12 20:34 UTC · 5 captures of this ZIP	2022-11	A206203-001	AP	1	`3a93d1ddd44b…`
2022-10-28 04:53 UTC	2022-10	A206203-001	AP	1	`f41ea6bd6efb…`
2022-09-29 23:25 UTC	2022-09	A206203-001	AP	1	`e64feba35796…`
2022-07-09 03:26 UTC · 3 captures of this ZIP	2022-07	A206203-001	AP	1	`cb3db0bc1861…`

DailyMed Product Concepts#

Product concept, Relation, Version table
Product concept	Relation	Version	Effective
9e37788c-b1bf-42ae-aac9-b60601606144	Product name	8	20260122
95250459-30e4-45c1-b08a-993044f49109	Product name	2	20250805
d9771140-739b-484b-ae64-b79528ff1211	Product name	3	20250801
efd58dcf-540a-4531-8766-e713129ca6f2	Product name	1	20250307
1527ac37-808d-43be-a63e-74e1258dbe46	Product name	9	20250219
bed0530e-f939-4541-956b-6928a2f6404f	Product name	1	20241008
cefa60e2-a5b5-493e-9c54-24735b7dc509	Product name	6	20240814
362d7abb-94e6-4c60-9a58-266894157713	Product name	1	20231023
9fcb7a91-de07-4f00-aabf-e4d6fda403d5	Product name	8	20230322
6bd95106-a412-1dad-b9cc-4cb74bfb27ce	Product name	2	20230315
9badc7be-250a-44ab-aa36-926af3f02679	Product name	1	20210527
0ec3537a-6c9b-432a-896c-b9ea8723049a	Product name	9	20200701
444b3e50-f226-46ef-bfca-2e7035d140cd	Product name	1	20190611
816b97af-edc5-4060-aff1-b814bdbcad50	Product name	1	20190415
7cda52fc-125f-421c-8fea-bc1974370c49	Product name	2	20180703
7916de40-e296-41f0-b811-6d0df1a33e2c	Product name	9	20180627
48747306-602a-42cc-957b-5b0c69158eee	Product name	1	20180604
cefa60e2-a5b5-493e-9c54-24735b7dc509	Product name	2	20171212
419aab54-5d5a-4146-9453-026d4a9991be	Product name	2	20170525
26acd337-b838-40ac-bcbc-05c3b81c8712	Product name	1	20170323
d5e51f11-ad28-caa4-4b49-4143974782ad	Product name	1	20150831
290f523a-f9db-9774-b5a9-e1f908ac1782	Product name	1	20150828
0ca1d589-929b-4b33-bc5b-1d84abdafa6a	Product name	1	20150324
fc363c46-397b-4476-ac0f-70e43e8e4592	Product name	1	20150324
89dac932-b90a-4410-9ab1-84c53e57de25	Product name	1	20150316
5668b646-cd56-c3c7-bdea-3f6b1a8840db	Product name	1	20140508
810ab97e-f109-f41c-7c83-6a652a9cbf43	Product name	1	20140508
87711080-88eb-65c5-b2dd-bf99e700a372	Product name	1	20140508
8dbefedf-0a0d-a224-5a3c-66dc9e11c2dd	Product name	1	20140508
c6b65c52-69c7-df49-550a-a50c137f6218	Product name	1	20140508
db5ebcdb-b6ae-21cd-4dc5-76cd84b5578b	Product name	1	20140508
ec2149b3-5c6d-5344-f757-c86411073075	Product name	1	20140508
ed912195-5da0-0f2f-6f4b-3ef17710cbe3	Product name	1	20140508

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDC	Product	Description	Form	Quantity	Strength	SPL version
51754-2001-4	Potassium Acetate	25 in 1 CARTON	INJECTION, SOLUTION, CONCENTRATE	25		5
51754-2001-4	Potassium Acetate	20 mL in 1 VIAL, SINGLE-DOSE	INJECTION, SOLUTION, CONCENTRATE	20		5

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDC	Billing unit	Product NDC	DailyMed indexing SPL	SPL version	Effective
51754-2001-4	ML - Milliliter	51754-2001	03988ea0-77aa-4eb0-9488-18d2fcd25a36	1	2016-02-04

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDC	Dashboard title	SPL version	Validation	Dashboard ZIP
51754-2001	POTASSIUM ACETATE INJECTION, SOLUTION, CONCENTRATE [EXELA PHARMA SCIENCES, LLC]	5	Legacy NDC, 2 package rows	20200303_a9485880-933d-4f82-9728-22397126a1d4.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.

Brand, Generic, Manufacturer table
Brand	Generic	Manufacturer	SPL set ID	Effective date	Available safety fields	Join
Potassium Acetate	POTASSIUM ACETATE	Exela Pharma Sciences, LLC	d5f6dc05-9fb0-4a89-8c54-46112df10abd	2019-11-15	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 206203 application number: ANDA206203

UNII, Preferred term, Registry number table
UNII	Preferred term	Registry number	Matched term
M911911U02	POTASSIUM ACETATE	127-08-2	POTASSIUM ACETATE

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUI	RxNorm string	TTY	DailyMed	SPL version
1871155	potassium acetate 40 MEQ in 20 ML Injection	PSN	a9485880-933d-4f82-9728-22397126a1d4	5
1871155	20 ML potassium acetate 2 MEQ/ML Injection	SCD	a9485880-933d-4f82-9728-22397126a1d4	5
1871155	20 ML K+ Acetate 2 MEQ/ML Injection	SY	a9485880-933d-4f82-9728-22397126a1d4	5
1871155	20 ML Pot Acetate 2 MEQ/ML Injection	SY	a9485880-933d-4f82-9728-22397126a1d4	5
1871155	potassium acetate 3.93 GM per 20 ML Injection	SY	a9485880-933d-4f82-9728-22397126a1d4	5
1871155	potassium acetate 40 MEQ per 20 ML Injection	SY	a9485880-933d-4f82-9728-22397126a1d4	5

Packages#

Package NDC, 11-digit format, Description table
Package NDC	11-digit format	Description	Marketing start	Marketing end	Sample	Exclude flag	Status
51754-2001-4	51754200104	25 VIAL, SINGLE-DOSE in 1 CARTON (51754-2001-4) > 20 mL in 1 VIAL, SINGLE-DOSE	2016-01-07	0000-00-00	No	No	Current

Title, Manufacturer, Effective date table
Title	Manufacturer	Effective date	Type	Version
Potassium Acetate Injection USP	Exela Pharma Sciences, LLC	2016-01-07	HUMAN PRESCRIPTION DRUG LABEL	5