FDA.reportPublic FDA data

Sodium Acetate

Product NDC
51754-9995
11-digit product format
517549995
Labeler code
51754
Product ID
51754-9995_e11ab1a1-8cc7-4d3b-ad29-af4c9aaa3ed4
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
Sodium Acetate
Dosage form
INJECTION, SOLUTION
Route
INTRAVENOUS
Labeler
Exela Pharma Sciences, LLC
Marketing category
UNAPPROVED DRUG OTHER
Marketing start
2022-07-01
Marketing end
0000-00-00
Substance
SODIUM ACETATE ANHYDROUS
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]
NDC exclude flag
No
Listing certified through
2023-12-31
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 · 6 matching rows.

Dataset, Scope, Product NDC table
DatasetScopeProduct NDCPackage NDCCodeStatusReporting periodSource date
excluded productproduct51754-9995DDiscontinued by firm2026-08-10
excluded packagepackage51754-999551754-9995-5DDiscontinued by firm2026-08-10
compounderpackage51754-999551754-9995-1COMPOUNDEROutsourcing facility compounded drug report2024-12025-09-25
compounderpackage51754-999551754-9995-1COMPOUNDEROutsourcing facility compounded drug report2024-12026-08-10
compounderpackage51754-999551754-9995-1COMPOUNDEROutsourcing facility compounded drug report2023-12026-08-10
compounderpackage51754-999551754-9995-1COMPOUNDEROutsourcing facility compounded drug report2022-22026-08-10

Observed NDC auxiliary status history#

This history shows the information present in each captured FDA auxiliary file. It is not a continuous regulatory timeline, and a missing record does not establish a status.

Historic NDC status page 1 of 1 · 31 matching rows.

View current auxiliary records. · View the auxiliary file history.

Captured / source date, Dataset, Scope table
Captured / source dateDatasetScopePackage NDCCodeStatusReporting periodArchiveSnapshotSource SHA-256
2025-12-14 17:58 UTC · source 2025-12-05excluded productproductDDiscontinued by firmexcluded / ndc_excluded.zipd630ba8d3edf…732f749b63fb…
2025-12-14 17:58 UTC · source 2025-12-05excluded packagepackage51754-9995-5DDiscontinued by firmexcluded / ndc_excluded.zipd630ba8d3edf…732f749b63fb…
2025-12-16 00:49 UTC · source 2025-09-25compounderpackage51754-9995-1COMPOUNDEROutsourcing facility compounded drug report2024-1compounder / compounders_ndc_directory.zip3f6f48d8db7b…6316a3eebc6a…
2025-08-27 00:01 UTC · source 2025-08-26excluded productproductDDiscontinued by firmexcluded / ndc_excluded.zipf5e01cc5f278…a2eaf40c39c3…
2025-08-27 00:01 UTC · source 2025-08-26excluded packagepackage51754-9995-5DDiscontinued by firmexcluded / ndc_excluded.zipf5e01cc5f278…a2eaf40c39c3…
2025-08-27 00:00 UTC · source 2025-08-20compounderpackage51754-9995-1COMPOUNDEROutsourcing facility compounded drug report2024-1compounder / compounders_ndc_directory.zipaf8e9b524e63…ca326a94a5e9…
2025-08-27 00:00 UTC · source 2025-08-20compounderpackage51754-9995-1COMPOUNDEROutsourcing facility compounded drug report2023-1compounder / compounders_ndc_directory.zipaf8e9b524e63…ca326a94a5e9…
2025-08-27 00:00 UTC · source 2025-08-20compounderpackage51754-9995-1COMPOUNDEROutsourcing facility compounded drug report2022-2compounder / compounders_ndc_directory.zipaf8e9b524e63…ca326a94a5e9…
2025-04-01 02:39 UTC · source 2025-03-31excluded productproductDDiscontinued by firmexcluded / ndc_excluded.zip2ef7874e63bc…57b86245f4fa…
2025-04-01 02:39 UTC · source 2025-03-31excluded packagepackage51754-9995-5DDiscontinued by firmexcluded / ndc_excluded.zip2ef7874e63bc…57b86245f4fa…
2025-03-28 20:22 UTC · source 2025-03-28excluded productproductDDiscontinued by firmexcluded / ndc_excluded.zipa1b67e2a42f9…c4cf2c586c0d…
2025-03-28 20:22 UTC · source 2025-03-28excluded packagepackage51754-9995-5DDiscontinued by firmexcluded / ndc_excluded.zipa1b67e2a42f9…c4cf2c586c0d…
2025-03-22 03:12 UTC · source 2025-03-21excluded productproductDDiscontinued by firmexcluded / ndc_excluded.zipcfe11265f3b6…090c488252e2…
2025-03-22 03:12 UTC · source 2025-03-21excluded packagepackage51754-9995-5DDiscontinued by firmexcluded / ndc_excluded.zipcfe11265f3b6…090c488252e2…
2025-03-10 12:48 UTC · source 2025-03-10excluded productproductDDiscontinued by firmexcluded / ndc_excluded.zipcdf11ea48f46…ba0047e9e063…
2025-03-10 12:48 UTC · source 2025-03-10excluded packagepackage51754-9995-5DDiscontinued by firmexcluded / ndc_excluded.zipcdf11ea48f46…ba0047e9e063…
2025-02-02 03:52 UTC · source 2025-01-31excluded productproductDDiscontinued by firmexcluded / ndc_excluded.zip302b2466d912…e7b80fea0513…
2025-02-02 03:52 UTC · source 2025-01-31excluded packagepackage51754-9995-5DDiscontinued by firmexcluded / ndc_excluded.zip302b2466d912…e7b80fea0513…
2025-01-20 13:05 UTC · source 2025-01-20excluded productproductDDiscontinued by firmexcluded / ndc_excluded.ziped331223b511…672a5bd82f5f…
2025-01-20 13:05 UTC · source 2025-01-20excluded packagepackage51754-9995-5DDiscontinued by firmexcluded / ndc_excluded.ziped331223b511…672a5bd82f5f…
2025-01-11 03:41 UTC · source 2025-01-10excluded productproductDDiscontinued by firmexcluded / ndc_excluded.zip0efc9e666f02…f202fb6c5f17…
2025-01-11 03:41 UTC · source 2025-01-10excluded packagepackage51754-9995-5DDiscontinued by firmexcluded / ndc_excluded.zip0efc9e666f02…f202fb6c5f17…
2025-01-13 04:20 UTC · source 2024-11-20compounderpackage51754-9995-1COMPOUNDEROutsourcing facility compounded drug report2024-1compounder / compounders_ndc_directory.zip85f958c8d153…997044a9741e…
2025-01-13 04:20 UTC · source 2024-11-20compounderpackage51754-9995-1COMPOUNDEROutsourcing facility compounded drug report2023-1compounder / compounders_ndc_directory.zip85f958c8d153…997044a9741e…
2025-01-13 04:20 UTC · source 2024-11-20compounderpackage51754-9995-1COMPOUNDEROutsourcing facility compounded drug report2022-2compounder / compounders_ndc_directory.zip85f958c8d153…997044a9741e…
2024-11-09 02:27 UTC · source 2024-11-08excluded productproductDDiscontinued by firmexcluded / ndc_excluded.zipad56d346431e…cc804d4bbf1e…
2024-11-09 02:27 UTC · source 2024-11-08excluded packagepackage51754-9995-5DDiscontinued by firmexcluded / ndc_excluded.zipad56d346431e…cc804d4bbf1e…
2024-10-04 04:10 UTC · source 2024-10-03excluded productproductDDiscontinued by firmexcluded / ndc_excluded.zip367a005e9d99…383a685ebd0f…
2024-10-04 04:10 UTC · source 2024-10-03excluded packagepackage51754-9995-5DDiscontinued by firmexcluded / ndc_excluded.zip367a005e9d99…383a685ebd0f…
2024-07-10 04:00 UTC · source 2024-07-09excluded productproductDDiscontinued by firmexcluded / ndc_excluded.zip557ba5c1ecfa…9c80585c8c6e…
2024-07-10 04:00 UTC · source 2024-07-09excluded packagepackage51754-9995-5DDiscontinued by firmexcluded / ndc_excluded.zip557ba5c1ecfa…9c80585c8c6e…

Compounder NDC reports#

Browse the complete compounder directory for this NDC · Browse every current compounder row in the unified auxiliary catalog · browse compounder source captures and parsed snapshots.

Establishment, FEI, Product NDC table
EstablishmentFEIProduct NDCPackage NDCProductActive ingredientsReporting periodNormalization
Exela Pharma Sciences, LLC.51754-999551754-9995-1Sodium Acetate200 meq/100 mL2024-1valid
Exela Pharma Sciences, LLC.83127439951754-999551754-9995-1Sodium Acetate200 meq/100 mL2024-1valid
Exela Pharma Sciences, LLC.83127439951754-999551754-9995-1Sodium Acetate200 meq/100 mL2023-1valid
Exela Pharma Sciences, LLC.83127439951754-999551754-9995-1Sodium Acetate200 meq/100 mL2022-2valid

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
51754-9995-55175499950520 VIAL in 1 CARTON (51754-9995-5) > 100 mL in 1 VIAL (51754-9995-1) 20 vial2022-07-010000-00-00NoNoCurrent