SODIUM PHENYLACETATE and SODIUM BENZOATE

Product NDC
69784-810
11-digit product format
697840810
Labeler code
69784
Product ID
69784-810_c67d4fea-9479-42bf-bfdd-368a520dcbfb
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
sodium phenylacetate and sodium benzoate
Dosage form
INJECTION, SOLUTION, CONCENTRATE
Route
INTRAVENOUS
Labeler
Woodward Pharma Services LLC
Application
ANDA207096
Marketing category
ANDA
Marketing start
2021-05-15
Marketing end
0000-00-00
Substance
SODIUM BENZOATE; SODIUM PHENYLACETATE
Active strength
100 mg/mL; mg/mL
Pharmacologic classes
Ammonium Ion Binding Activity [MoA], Ammonium Ion Binding Activity [MoA], Nitrogen Binding Agent [EPC], Nitrogen Binding Agent [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 · 2 matching rows.

Dataset, Scope, Product NDC table
DatasetScopeProduct NDCPackage NDCCodeStatusReporting periodSource date
excluded productproduct69784-810DDiscontinued by firm2026-08-17
excluded packagepackage69784-81069784-810-01DDiscontinued by firm2026-08-17

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 · 6 matching rows.

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

Captured / source date, Dataset, Scope table
Captured / source dateDatasetScopePackage NDCCodeStatusSnapshotSource SHA-256
2025-12-14 17:58 UTC · source 2025-12-05excluded productproductDDiscontinued by firmd630ba8d3edf…732f749b63fb…
2025-12-14 17:58 UTC · source 2025-12-05excluded packagepackage69784-810-01DDiscontinued by firmd630ba8d3edf…732f749b63fb…
2025-01-11 03:41 UTC · source 2025-01-10excluded productproductUExcluded because listing certification expired0efc9e666f02…f202fb6c5f17…
2025-01-11 03:41 UTC · source 2025-01-10excluded packagepackage69784-810-01UExcluded because listing certification expired0efc9e666f02…f202fb6c5f17…
2022-08-30 03:57 UTC · source 2022-08-29excluded productproductIInactivated by FDAfb8cb913e6d1…eb8c232b6be0…
2022-08-30 03:57 UTC · source 2022-08-29excluded packagepackage69784-810-01IInactivated by FDAfb8cb913e6d1…eb8c232b6be0…

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-productTrade nameIngredientStrengthDosage form / routeTE codesRLD / RSApproval date
A207096-001SODIUM PHENYLACETATE AND SODIUM BENZOATESODIUM BENZOATE; SODIUM PHENYLACETATE10%;10% (5GM/50ML;5GM/50ML)SOLUTION / INTRAVENOUSAPRS2016-02-24

Therapeutic equivalence codes#

Current TE-code rows page 1 of 1 · 1 matching rows.

Application-product, TE code table
Application-productTE code
A207096-001AP

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
CapturedEditionApplication-productTrade nameStrengthDosage form / routeProduct TE source textRLD / RSApproval dateSource SHA-256
2026-08-18 06:07:402026-07A207096-001SODIUM PHENYLACETATE AND SODIUM BENZOATE10%;10% (5GM/50ML;5GM/50ML)SOLUTION / INTRAVENOUSAPRS2016-02-24caaa826d4ba7…
2026-02-19 14:30 UTC2026-02A207096-001SODIUM PHENYLACETATE AND SODIUM BENZOATE10%;10% (5GM/50ML;5GM/50ML)SOLUTION / INTRAVENOUSAPRS2016-02-24011fe1cb6892…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A207096-001SODIUM PHENYLACETATE AND SODIUM BENZOATE10%;10% (5GM/50ML;5GM/50ML)SOLUTION / INTRAVENOUSAPRS2016-02-2431067a03dcf5…
2025-08-23 18:47 UTC2025-08A207096-001SODIUM PHENYLACETATE AND SODIUM BENZOATE10%;10% (5GM/50ML;5GM/50ML)SOLUTION / INTRAVENOUSAPRS2016-02-246a471c1ec25d…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03A207096-001SODIUM PHENYLACETATE AND SODIUM BENZOATE10%;10% (5GM/50ML;5GM/50ML)SOLUTION / INTRAVENOUSAPRS2016-02-24fd3edfee7708…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02A207096-001SODIUM PHENYLACETATE AND SODIUM BENZOATE10%;10% (5GM/50ML;5GM/50ML)SOLUTION / INTRAVENOUSAPRS2016-02-24b8a1b40f171c…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01A207096-001SODIUM PHENYLACETATE AND SODIUM BENZOATE10%;10% (5GM/50ML;5GM/50ML)SOLUTION / INTRAVENOUSAPRS2016-02-2403ed91905a0d…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12A207096-001SODIUM PHENYLACETATE AND SODIUM BENZOATE10%;10% (5GM/50ML;5GM/50ML)SOLUTION / INTRAVENOUSAPRS2016-02-242680178bc6a6…
2024-09-14 05:58 UTC · 2 captures of this ZIP2024-09A207096-001SODIUM PHENYLACETATE AND SODIUM BENZOATE10%;10% (5GM/50ML;5GM/50ML)SOLUTION / INTRAVENOUSAPRS2016-02-245bbf6a4d5a75…
2024-11-08 22:44 UTC · 3 captures of this ZIP2024-11A207096-001SODIUM PHENYLACETATE AND SODIUM BENZOATE10%;10% (5GM/50ML;5GM/50ML)SOLUTION / INTRAVENOUSAPRS2016-02-24d8e5a09893c0…
2024-10-29 15:01 UTC2024-10A207096-001SODIUM PHENYLACETATE AND SODIUM BENZOATE10%;10% (5GM/50ML;5GM/50ML)SOLUTION / INTRAVENOUSAPRS2016-02-24d06236e962d9…
2024-08-13 05:28 UTC · 3 captures of this ZIP2024-08A207096-001SODIUM PHENYLACETATE AND SODIUM BENZOATE10%;10% (5GM/50ML;5GM/50ML)SOLUTION / INTRAVENOUSAPRS2016-02-2479d66fd596c7…
2024-07-13 05:37 UTC · 2 captures of this ZIP2024-07A207096-001SODIUM PHENYLACETATE AND SODIUM BENZOATE10%;10% (5GM/50ML;5GM/50ML)SOLUTION / INTRAVENOUSAP2016-02-24301d65b070ca…
2024-06-18 03:08 UTC · 5 captures of this ZIP2024-06A207096-001SODIUM PHENYLACETATE AND SODIUM BENZOATE10%;10% (5GM/50ML;5GM/50ML)SOLUTION / INTRAVENOUSAP2016-02-241e350fbaab3a…
2024-05-31 18:47 UTC2024-05A207096-001SODIUM PHENYLACETATE AND SODIUM BENZOATE10%;10% (5GM/50ML;5GM/50ML)SOLUTION / INTRAVENOUSAP2016-02-248072bd15b7f6…
2022-06-29 02:47 UTC · 2 captures of this ZIP2022-06A207096-001SODIUM PHENYLACETATE AND SODIUM BENZOATE10%;10% (5GM/50ML;5GM/50ML)SOLUTION / INTRAVENOUSAP2016-02-245c6f7cd8ea54…
2022-04-08 23:34 UTC2022-04A207096-001SODIUM PHENYLACETATE AND SODIUM BENZOATE10%;10% (5GM/50ML;5GM/50ML)SOLUTION / INTRAVENOUSAP2016-02-245d02ea3f76ae…
2022-04-04 05:41 UTC2022-04A207096-001SODIUM PHENYLACETATE AND SODIUM BENZOATE10%;10% (5GM/50ML;5GM/50ML)SOLUTION / INTRAVENOUSAP2016-02-244b0b4de00fa7…
2019-12-13 00:20 UTC2019-12A207096-001SODIUM PHENYLACETATE AND SODIUM BENZOATE10%;10% (5GM/50ML;5GM/50ML)SOLUTION / INTRAVENOUSAP2016-02-2474a2ff9319b5…
2022-03-09 01:35 UTC2022-03A207096-001SODIUM PHENYLACETATE AND SODIUM BENZOATE10%;10% (5GM/50ML;5GM/50ML)SOLUTION / INTRAVENOUSAP2016-02-24bb7c543d1eb4…
2021-12-28 21:50 UTC2021-12A207096-001SODIUM PHENYLACETATE AND SODIUM BENZOATE10%;10% (5GM/50ML;5GM/50ML)SOLUTION / INTRAVENOUSAP2016-02-24782e0a99824c…
2021-05-05 16:15 UTC · 3 captures of this ZIP2021-05A207096-001SODIUM PHENYLACETATE AND SODIUM BENZOATE10%;10% (5GM/50ML;5GM/50ML)SOLUTION / INTRAVENOUSAP2016-02-2487673890dc5c…
2021-03-12 10:30 UTC2021-03A207096-001SODIUM PHENYLACETATE AND SODIUM BENZOATE10%;10% (5GM/50ML;5GM/50ML)SOLUTION / INTRAVENOUSAP2016-02-245aa47cf7b7d7…
2020-12-22 03:56 UTC2020-12A207096-001SODIUM PHENYLACETATE AND SODIUM BENZOATE10%;10% (5GM/50ML;5GM/50ML)SOLUTION / INTRAVENOUSAP2016-02-248869cabd3fbd…
2020-11-12 02:37 UTC2020-11A207096-001SODIUM PHENYLACETATE AND SODIUM BENZOATE10%;10% (5GM/50ML;5GM/50ML)SOLUTION / INTRAVENOUSAP2016-02-24c0c555d07b60…
2019-12-14 00:12 UTC2019-12A207096-001SODIUM PHENYLACETATE AND SODIUM BENZOATE10%;10% (5GM/50ML;5GM/50ML)SOLUTION / INTRAVENOUSAP2016-02-243f01610625f2…
2019-09-15 20:21 UTC2019-09A207096-001SODIUM PHENYLACETATE AND SODIUM BENZOATE10%;10% (5GM/50ML;5GM/50ML)SOLUTION / INTRAVENOUSAP2016-02-24b00525d2431f…
2019-07-19 19:46 UTC2019-07A207096-001SODIUM PHENYLACETATE AND SODIUM BENZOATE10%;10% (5GM/50ML;5GM/50ML)SOLUTION / INTRAVENOUSAP2016-02-24ea99ee380514…
2024-03-16 18:09 UTC · 4 captures of this ZIP2024-03A207096-001SODIUM PHENYLACETATE AND SODIUM BENZOATE10%;10% (5GM/50ML;5GM/50ML)SOLUTION / INTRAVENOUSAP2016-02-246a51e52b5d6a…
2024-02-18 07:12 UTC2024-02A207096-001SODIUM PHENYLACETATE AND SODIUM BENZOATE10%;10% (5GM/50ML;5GM/50ML)SOLUTION / INTRAVENOUSAP2016-02-241c564ffb4f44…
2023-12-20 04:57 UTC2023-12A207096-001SODIUM PHENYLACETATE AND SODIUM BENZOATE10%;10% (5GM/50ML;5GM/50ML)SOLUTION / INTRAVENOUSAP2016-02-24ea1830bbd6c7…
2023-11-28 05:40 UTC · 2 captures of this ZIP2023-11A207096-001SODIUM PHENYLACETATE AND SODIUM BENZOATE10%;10% (5GM/50ML;5GM/50ML)SOLUTION / INTRAVENOUSAP2016-02-24a72a2bbeb626…
2023-10-25 00:34 UTC · 2 captures of this ZIP2023-10A207096-001SODIUM PHENYLACETATE AND SODIUM BENZOATE10%;10% (5GM/50ML;5GM/50ML)SOLUTION / INTRAVENOUSAP2016-02-249b2671bbb829…
2023-07-15 15:27 UTC · 2 captures of this ZIP2023-07A207096-001SODIUM PHENYLACETATE AND SODIUM BENZOATE10%;10% (5GM/50ML;5GM/50ML)SOLUTION / INTRAVENOUSAP2016-02-24a67488948f0b…
2023-06-13 01:57 UTC · 3 captures of this ZIP2023-06A207096-001SODIUM PHENYLACETATE AND SODIUM BENZOATE10%;10% (5GM/50ML;5GM/50ML)SOLUTION / INTRAVENOUSAP2016-02-243f0d92c62455…
2023-05-13 08:27 UTC2023-05A207096-001SODIUM PHENYLACETATE AND SODIUM BENZOATE10%;10% (5GM/50ML;5GM/50ML)SOLUTION / INTRAVENOUSAP2016-02-24053a50430f4f…
2023-01-26 05:58 UTC2023-01A207096-001SODIUM PHENYLACETATE AND SODIUM BENZOATE10%;10% (5GM/50ML;5GM/50ML)SOLUTION / INTRAVENOUSAP2016-02-243bdfa0b2c4d7…
2022-11-12 20:34 UTC · 5 captures of this ZIP2022-11A207096-001SODIUM PHENYLACETATE AND SODIUM BENZOATE10%;10% (5GM/50ML;5GM/50ML)SOLUTION / INTRAVENOUSAP2016-02-243a93d1ddd44b…
2022-10-28 04:53 UTC2022-10A207096-001SODIUM PHENYLACETATE AND SODIUM BENZOATE10%;10% (5GM/50ML;5GM/50ML)SOLUTION / INTRAVENOUSAP2016-02-24f41ea6bd6efb…
2022-09-29 23:25 UTC2022-09A207096-001SODIUM PHENYLACETATE AND SODIUM BENZOATE10%;10% (5GM/50ML;5GM/50ML)SOLUTION / INTRAVENOUSAP2016-02-24e64feba35796…

Observed Orange Book normalized TE history#

Normalized TE history page 1 of 2 · 42 observed states.

Captured, Edition, Application-product table
CapturedEditionApplication-productTE codeOrderSource SHA-256
2026-08-18 06:07:402026-07A207096-001AP1caaa826d4ba7…
2026-02-19 14:30 UTC2026-02A207096-001AP1011fe1cb6892…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A207096-001AP131067a03dcf5…
2025-08-23 18:47 UTC2025-08A207096-001AP16a471c1ec25d…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03A207096-001AP1fd3edfee7708…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02A207096-001AP1b8a1b40f171c…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01A207096-001AP103ed91905a0d…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12A207096-001AP12680178bc6a6…
2024-09-14 05:58 UTC · 2 captures of this ZIP2024-09A207096-001AP15bbf6a4d5a75…
2024-11-08 22:44 UTC · 3 captures of this ZIP2024-11A207096-001AP1d8e5a09893c0…
2024-10-29 15:01 UTC2024-10A207096-001AP1d06236e962d9…
2024-08-13 05:28 UTC · 3 captures of this ZIP2024-08A207096-001AP179d66fd596c7…
2024-07-13 05:37 UTC · 2 captures of this ZIP2024-07A207096-001AP1301d65b070ca…
2024-06-18 03:08 UTC · 5 captures of this ZIP2024-06A207096-001AP11e350fbaab3a…
2024-05-31 18:47 UTC2024-05A207096-001AP18072bd15b7f6…
2022-06-29 02:47 UTC · 2 captures of this ZIP2022-06A207096-001AP15c6f7cd8ea54…
2022-04-08 23:34 UTC2022-04A207096-001AP15d02ea3f76ae…
2022-04-04 05:41 UTC2022-04A207096-001AP14b0b4de00fa7…
2019-12-13 00:20 UTC2019-12A207096-001AP174a2ff9319b5…
2022-03-09 01:35 UTC2022-03A207096-001AP1bb7c543d1eb4…
2021-12-28 21:50 UTC2021-12A207096-001AP1782e0a99824c…
2021-05-05 16:15 UTC · 3 captures of this ZIP2021-05A207096-001AP187673890dc5c…
2021-03-12 10:30 UTC2021-03A207096-001AP15aa47cf7b7d7…
2020-12-22 03:56 UTC2020-12A207096-001AP18869cabd3fbd…
2020-11-12 02:37 UTC2020-11A207096-001AP1c0c555d07b60…
2019-12-14 00:12 UTC2019-12A207096-001AP13f01610625f2…
2019-09-15 20:21 UTC2019-09A207096-001AP1b00525d2431f…
2019-07-19 19:46 UTC2019-07A207096-001AP1ea99ee380514…
2024-03-16 18:09 UTC · 4 captures of this ZIP2024-03A207096-001AP16a51e52b5d6a…
2024-02-18 07:12 UTC2024-02A207096-001AP11c564ffb4f44…
2023-12-20 04:57 UTC2023-12A207096-001AP1ea1830bbd6c7…
2023-11-28 05:40 UTC · 2 captures of this ZIP2023-11A207096-001AP1a72a2bbeb626…
2023-10-25 00:34 UTC · 2 captures of this ZIP2023-10A207096-001AP19b2671bbb829…
2023-07-15 15:27 UTC · 2 captures of this ZIP2023-07A207096-001AP1a67488948f0b…
2023-06-13 01:57 UTC · 3 captures of this ZIP2023-06A207096-001AP13f0d92c62455…
2023-05-13 08:27 UTC2023-05A207096-001AP1053a50430f4f…
2023-01-26 05:58 UTC2023-01A207096-001AP13bdfa0b2c4d7…
2022-11-12 20:34 UTC · 5 captures of this ZIP2022-11A207096-001AP13a93d1ddd44b…
2022-10-28 04:53 UTC2022-10A207096-001AP1f41ea6bd6efb…
2022-09-29 23:25 UTC2022-09A207096-001AP1e64feba35796…

FDA-Initiated Inactive NDC Indexing#

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
69784-810-01ML - Milliliter69784-81053e27b10-c7c9-4fe1-bc7d-0cee75cb93fe12021-07-15

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
69784-810SODIUM PHENYLACETATE AND SODIUM BENZOATE INJECTION, SOLUTION, CONCENTRATE [WOODWARD PHARMA SERVICES LLC]3Legacy NDC20250114_901cb61d-a3eb-44b3-a2ce-855ae0495aff.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 · 3 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
SODIUM PHENYLACETATE and SODIUM BENZOATESODIUM PHENYLACETATE AND SODIUM BENZOATEOmnivium Pharmaceuticals LLC8fafc39b-69db-40f3-8a09-ee859e8cef192025-05-15Warnings, Adverse reactionsExact identifier
application applno (ANDA): 207096
application number: ANDA207096
SODIUM PHENYLACETATE and SODIUM BENZOATESODIUM PHENYLACETATE AND SODIUM BENZOATEAilex Pharmaceuticals, LLC329655ae-c3c0-46b2-a925-e49777f2076b2025-03-30Warnings, Adverse reactionsExact identifier
application applno (ANDA): 207096
application number: ANDA207096
SODIUM PHENYLACETATE and SODIUM BENZOATESODIUM PHENYLACETATE AND SODIUM BENZOATEOmnivium Pharmaceuticals LLC9067c301-74f9-457a-9b0f-b7e9b06a35082025-02-15Warnings, Adverse reactionsExact identifier
application applno (ANDA): 207096
application number: ANDA207096

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionMarketing startMarketing endSampleExclude flagStatus
69784-810-01697840810011 VIAL, SINGLE-DOSE in 1 CARTON (69784-810-01) > 50 mL in 1 VIAL, SINGLE-DOSE2021-05-150000-00-00NoNoCurrent