SODIUM PHENYLACETATE and SODIUM BENZOATE

Product NDC: 81665-204
11-digit product format: 816650204
Labeler code: 81665
Product ID: 81665-204_03dcc78e-b47c-46dc-b7be-b6e6dcb0d071
Type: HUMAN PRESCRIPTION DRUG
Nonproprietary name: sodium phenylacetate and sodium benzoate
Dosage form: INJECTION, SOLUTION, CONCENTRATE
Route: INTRAVENOUS
Labeler: Omnivium Pharmaceuticals LLC
Application: ANDA207096
Marketing category: ANDA
Marketing start: 2025-05-15
Substance: SODIUM PHENYLACETATE; SODIUM BENZOATE
Active strength: 100; 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: 2026-12-31
Current FDA listing: Yes

Source provenance: Browse the complete Orange Book source catalog · source snapshot 43.

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
A207096-001	SODIUM PHENYLACETATE AND SODIUM BENZOATE	SODIUM BENZOATE; SODIUM PHENYLACETATE	10%;10% (5GM/50ML;5GM/50ML)	SOLUTION / INTRAVENOUS	AP	RS	2016-02-24

Therapeutic equivalence codes#

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

Application-product, TE code table
Application-product	TE code
A207096-001	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.

Product history page 1 of 2 · 43 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
2026-09-14 22:38:34	2026-08	A207096-001	SODIUM PHENYLACETATE AND SODIUM BENZOATE	10%;10% (5GM/50ML;5GM/50ML)	SOLUTION / INTRAVENOUS	AP	RS	2016-02-24	`84e616aacf4f…`
2026-08-18 06:07:40	2026-07	A207096-001	SODIUM PHENYLACETATE AND SODIUM BENZOATE	10%;10% (5GM/50ML;5GM/50ML)	SOLUTION / INTRAVENOUS	AP	RS	2016-02-24	`caaa826d4ba7…`
2026-02-19 14:30 UTC	2026-02	A207096-001	SODIUM PHENYLACETATE AND SODIUM BENZOATE	10%;10% (5GM/50ML;5GM/50ML)	SOLUTION / INTRAVENOUS	AP	RS	2016-02-24	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A207096-001	SODIUM PHENYLACETATE AND SODIUM BENZOATE	10%;10% (5GM/50ML;5GM/50ML)	SOLUTION / INTRAVENOUS	AP	RS	2016-02-24	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	A207096-001	SODIUM PHENYLACETATE AND SODIUM BENZOATE	10%;10% (5GM/50ML;5GM/50ML)	SOLUTION / INTRAVENOUS	AP	RS	2016-02-24	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A207096-001	SODIUM PHENYLACETATE AND SODIUM BENZOATE	10%;10% (5GM/50ML;5GM/50ML)	SOLUTION / INTRAVENOUS	AP	RS	2016-02-24	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A207096-001	SODIUM PHENYLACETATE AND SODIUM BENZOATE	10%;10% (5GM/50ML;5GM/50ML)	SOLUTION / INTRAVENOUS	AP	RS	2016-02-24	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A207096-001	SODIUM PHENYLACETATE AND SODIUM BENZOATE	10%;10% (5GM/50ML;5GM/50ML)	SOLUTION / INTRAVENOUS	AP	RS	2016-02-24	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A207096-001	SODIUM PHENYLACETATE AND SODIUM BENZOATE	10%;10% (5GM/50ML;5GM/50ML)	SOLUTION / INTRAVENOUS	AP	RS	2016-02-24	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A207096-001	SODIUM PHENYLACETATE AND SODIUM BENZOATE	10%;10% (5GM/50ML;5GM/50ML)	SOLUTION / INTRAVENOUS	AP	RS	2016-02-24	`5bbf6a4d5a75…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A207096-001	SODIUM PHENYLACETATE AND SODIUM BENZOATE	10%;10% (5GM/50ML;5GM/50ML)	SOLUTION / INTRAVENOUS	AP	RS	2016-02-24	`d8e5a09893c0…`
2024-10-29 15:01 UTC	2024-10	A207096-001	SODIUM PHENYLACETATE AND SODIUM BENZOATE	10%;10% (5GM/50ML;5GM/50ML)	SOLUTION / INTRAVENOUS	AP	RS	2016-02-24	`d06236e962d9…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A207096-001	SODIUM PHENYLACETATE AND SODIUM BENZOATE	10%;10% (5GM/50ML;5GM/50ML)	SOLUTION / INTRAVENOUS	AP	RS	2016-02-24	`79d66fd596c7…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A207096-001	SODIUM PHENYLACETATE AND SODIUM BENZOATE	10%;10% (5GM/50ML;5GM/50ML)	SOLUTION / INTRAVENOUS	AP		2016-02-24	`301d65b070ca…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A207096-001	SODIUM PHENYLACETATE AND SODIUM BENZOATE	10%;10% (5GM/50ML;5GM/50ML)	SOLUTION / INTRAVENOUS	AP		2016-02-24	`1e350fbaab3a…`
2024-05-31 18:47 UTC	2024-05	A207096-001	SODIUM PHENYLACETATE AND SODIUM BENZOATE	10%;10% (5GM/50ML;5GM/50ML)	SOLUTION / INTRAVENOUS	AP		2016-02-24	`8072bd15b7f6…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	A207096-001	SODIUM PHENYLACETATE AND SODIUM BENZOATE	10%;10% (5GM/50ML;5GM/50ML)	SOLUTION / INTRAVENOUS	AP		2016-02-24	`5c6f7cd8ea54…`
2022-04-08 23:34 UTC	2022-04	A207096-001	SODIUM PHENYLACETATE AND SODIUM BENZOATE	10%;10% (5GM/50ML;5GM/50ML)	SOLUTION / INTRAVENOUS	AP		2016-02-24	`5d02ea3f76ae…`
2022-04-04 05:41 UTC	2022-04	A207096-001	SODIUM PHENYLACETATE AND SODIUM BENZOATE	10%;10% (5GM/50ML;5GM/50ML)	SOLUTION / INTRAVENOUS	AP		2016-02-24	`4b0b4de00fa7…`
2019-12-13 00:20 UTC	2019-12	A207096-001	SODIUM PHENYLACETATE AND SODIUM BENZOATE	10%;10% (5GM/50ML;5GM/50ML)	SOLUTION / INTRAVENOUS	AP		2016-02-24	`74a2ff9319b5…`
2022-03-09 01:35 UTC	2022-03	A207096-001	SODIUM PHENYLACETATE AND SODIUM BENZOATE	10%;10% (5GM/50ML;5GM/50ML)	SOLUTION / INTRAVENOUS	AP		2016-02-24	`bb7c543d1eb4…`
2021-12-28 21:50 UTC	2021-12	A207096-001	SODIUM PHENYLACETATE AND SODIUM BENZOATE	10%;10% (5GM/50ML;5GM/50ML)	SOLUTION / INTRAVENOUS	AP		2016-02-24	`782e0a99824c…`
2021-05-05 16:15 UTC · 3 captures of this ZIP	2021-05	A207096-001	SODIUM PHENYLACETATE AND SODIUM BENZOATE	10%;10% (5GM/50ML;5GM/50ML)	SOLUTION / INTRAVENOUS	AP		2016-02-24	`87673890dc5c…`
2021-03-12 10:30 UTC	2021-03	A207096-001	SODIUM PHENYLACETATE AND SODIUM BENZOATE	10%;10% (5GM/50ML;5GM/50ML)	SOLUTION / INTRAVENOUS	AP		2016-02-24	`5aa47cf7b7d7…`
2020-12-22 03:56 UTC	2020-12	A207096-001	SODIUM PHENYLACETATE AND SODIUM BENZOATE	10%;10% (5GM/50ML;5GM/50ML)	SOLUTION / INTRAVENOUS	AP		2016-02-24	`8869cabd3fbd…`
2020-11-12 02:37 UTC	2020-11	A207096-001	SODIUM PHENYLACETATE AND SODIUM BENZOATE	10%;10% (5GM/50ML;5GM/50ML)	SOLUTION / INTRAVENOUS	AP		2016-02-24	`c0c555d07b60…`
2019-12-14 00:12 UTC	2019-12	A207096-001	SODIUM PHENYLACETATE AND SODIUM BENZOATE	10%;10% (5GM/50ML;5GM/50ML)	SOLUTION / INTRAVENOUS	AP		2016-02-24	`3f01610625f2…`
2019-09-15 20:21 UTC	2019-09	A207096-001	SODIUM PHENYLACETATE AND SODIUM BENZOATE	10%;10% (5GM/50ML;5GM/50ML)	SOLUTION / INTRAVENOUS	AP		2016-02-24	`b00525d2431f…`
2019-07-19 19:46 UTC	2019-07	A207096-001	SODIUM PHENYLACETATE AND SODIUM BENZOATE	10%;10% (5GM/50ML;5GM/50ML)	SOLUTION / INTRAVENOUS	AP		2016-02-24	`ea99ee380514…`
2024-03-16 18:09 UTC · 4 captures of this ZIP	2024-03	A207096-001	SODIUM PHENYLACETATE AND SODIUM BENZOATE	10%;10% (5GM/50ML;5GM/50ML)	SOLUTION / INTRAVENOUS	AP		2016-02-24	`6a51e52b5d6a…`
2024-02-18 07:12 UTC	2024-02	A207096-001	SODIUM PHENYLACETATE AND SODIUM BENZOATE	10%;10% (5GM/50ML;5GM/50ML)	SOLUTION / INTRAVENOUS	AP		2016-02-24	`1c564ffb4f44…`
2023-12-20 04:57 UTC	2023-12	A207096-001	SODIUM PHENYLACETATE AND SODIUM BENZOATE	10%;10% (5GM/50ML;5GM/50ML)	SOLUTION / INTRAVENOUS	AP		2016-02-24	`ea1830bbd6c7…`
2023-11-28 05:40 UTC · 2 captures of this ZIP	2023-11	A207096-001	SODIUM PHENYLACETATE AND SODIUM BENZOATE	10%;10% (5GM/50ML;5GM/50ML)	SOLUTION / INTRAVENOUS	AP		2016-02-24	`a72a2bbeb626…`
2023-10-25 00:34 UTC · 2 captures of this ZIP	2023-10	A207096-001	SODIUM PHENYLACETATE AND SODIUM BENZOATE	10%;10% (5GM/50ML;5GM/50ML)	SOLUTION / INTRAVENOUS	AP		2016-02-24	`9b2671bbb829…`
2023-07-15 15:27 UTC · 2 captures of this ZIP	2023-07	A207096-001	SODIUM PHENYLACETATE AND SODIUM BENZOATE	10%;10% (5GM/50ML;5GM/50ML)	SOLUTION / INTRAVENOUS	AP		2016-02-24	`a67488948f0b…`
2023-06-13 01:57 UTC · 3 captures of this ZIP	2023-06	A207096-001	SODIUM PHENYLACETATE AND SODIUM BENZOATE	10%;10% (5GM/50ML;5GM/50ML)	SOLUTION / INTRAVENOUS	AP		2016-02-24	`3f0d92c62455…`
2023-05-13 08:27 UTC	2023-05	A207096-001	SODIUM PHENYLACETATE AND SODIUM BENZOATE	10%;10% (5GM/50ML;5GM/50ML)	SOLUTION / INTRAVENOUS	AP		2016-02-24	`053a50430f4f…`
2023-01-26 05:58 UTC	2023-01	A207096-001	SODIUM PHENYLACETATE AND SODIUM BENZOATE	10%;10% (5GM/50ML;5GM/50ML)	SOLUTION / INTRAVENOUS	AP		2016-02-24	`3bdfa0b2c4d7…`
2022-11-12 20:34 UTC · 5 captures of this ZIP	2022-11	A207096-001	SODIUM PHENYLACETATE AND SODIUM BENZOATE	10%;10% (5GM/50ML;5GM/50ML)	SOLUTION / INTRAVENOUS	AP		2016-02-24	`3a93d1ddd44b…`
2022-10-28 04:53 UTC	2022-10	A207096-001	SODIUM PHENYLACETATE AND SODIUM BENZOATE	10%;10% (5GM/50ML;5GM/50ML)	SOLUTION / INTRAVENOUS	AP		2016-02-24	`f41ea6bd6efb…`

Observed Orange Book normalized TE history#

Normalized TE history page 1 of 2 · 43 observed states.

Captured, Edition, Application-product table
Captured	Edition	Application-product	TE code	Order	Source SHA-256
2026-09-14 22:38:34	2026-08	A207096-001	AP	1	`84e616aacf4f…`
2026-08-18 06:07:40	2026-07	A207096-001	AP	1	`caaa826d4ba7…`
2026-02-19 14:30 UTC	2026-02	A207096-001	AP	1	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A207096-001	AP	1	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	A207096-001	AP	1	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A207096-001	AP	1	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A207096-001	AP	1	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A207096-001	AP	1	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A207096-001	AP	1	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A207096-001	AP	1	`5bbf6a4d5a75…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A207096-001	AP	1	`d8e5a09893c0…`
2024-10-29 15:01 UTC	2024-10	A207096-001	AP	1	`d06236e962d9…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A207096-001	AP	1	`79d66fd596c7…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A207096-001	AP	1	`301d65b070ca…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A207096-001	AP	1	`1e350fbaab3a…`
2024-05-31 18:47 UTC	2024-05	A207096-001	AP	1	`8072bd15b7f6…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	A207096-001	AP	1	`5c6f7cd8ea54…`
2022-04-08 23:34 UTC	2022-04	A207096-001	AP	1	`5d02ea3f76ae…`
2022-04-04 05:41 UTC	2022-04	A207096-001	AP	1	`4b0b4de00fa7…`
2019-12-13 00:20 UTC	2019-12	A207096-001	AP	1	`74a2ff9319b5…`
2022-03-09 01:35 UTC	2022-03	A207096-001	AP	1	`bb7c543d1eb4…`
2021-12-28 21:50 UTC	2021-12	A207096-001	AP	1	`782e0a99824c…`
2021-05-05 16:15 UTC · 3 captures of this ZIP	2021-05	A207096-001	AP	1	`87673890dc5c…`
2021-03-12 10:30 UTC	2021-03	A207096-001	AP	1	`5aa47cf7b7d7…`
2020-12-22 03:56 UTC	2020-12	A207096-001	AP	1	`8869cabd3fbd…`
2020-11-12 02:37 UTC	2020-11	A207096-001	AP	1	`c0c555d07b60…`
2019-12-14 00:12 UTC	2019-12	A207096-001	AP	1	`3f01610625f2…`
2019-09-15 20:21 UTC	2019-09	A207096-001	AP	1	`b00525d2431f…`
2019-07-19 19:46 UTC	2019-07	A207096-001	AP	1	`ea99ee380514…`
2024-03-16 18:09 UTC · 4 captures of this ZIP	2024-03	A207096-001	AP	1	`6a51e52b5d6a…`
2024-02-18 07:12 UTC	2024-02	A207096-001	AP	1	`1c564ffb4f44…`
2023-12-20 04:57 UTC	2023-12	A207096-001	AP	1	`ea1830bbd6c7…`
2023-11-28 05:40 UTC · 2 captures of this ZIP	2023-11	A207096-001	AP	1	`a72a2bbeb626…`
2023-10-25 00:34 UTC · 2 captures of this ZIP	2023-10	A207096-001	AP	1	`9b2671bbb829…`
2023-07-15 15:27 UTC · 2 captures of this ZIP	2023-07	A207096-001	AP	1	`a67488948f0b…`
2023-06-13 01:57 UTC · 3 captures of this ZIP	2023-06	A207096-001	AP	1	`3f0d92c62455…`
2023-05-13 08:27 UTC	2023-05	A207096-001	AP	1	`053a50430f4f…`
2023-01-26 05:58 UTC	2023-01	A207096-001	AP	1	`3bdfa0b2c4d7…`
2022-11-12 20:34 UTC · 5 captures of this ZIP	2022-11	A207096-001	AP	1	`3a93d1ddd44b…`
2022-10-28 04:53 UTC	2022-10	A207096-001	AP	1	`f41ea6bd6efb…`

Reported adverse events (FAERS/openFDA)#

Adverse event summaries are temporarily unavailable. Other product information remains available.

Additional Listing Data#

Finished product: Yes
Brand name base: SODIUM PHENYLACETATE and SODIUM BENZOATE
Listing expiration: 2026-12-31

Active Ingredients#

Ingredient, Strength table
Ingredient	Strength
SODIUM PHENYLACETATE	100 mg/mL
SODIUM BENZOATE	100 mg/mL

Harmonized UNII identifiers#

UNII identifiers page 1 of 1 · 2 matching rows.

Identifier, FDA.report destination table
Identifier	FDA.report destination
48N6U1781G	Internal UNII lookup
OJ245FE5EU	Internal UNII lookup

Harmonized RxCUI identifiers#

RxCUI identifiers page 1 of 1 · 1 matching rows.

Identifier, FDA.report destination table
Identifier	FDA.report destination
984118	Internal RxNorm lookup

Harmonized SPL set identifiers#

SPL set identifiers page 1 of 1 · 1 matching rows.

Identifier, FDA.report destination table
Identifier	FDA.report destination
8fafc39b-69db-40f3-8a09-ee859e8cef19	Available on FDA.report

DailyMed Product Concepts#

Product concept, Relation, Version table
Product concept	Relation	Version	Effective
c6f86816-7da6-43ea-8c25-ac9758311cc5	Product name	1	20220118
252e11b6-1a9a-4283-a242-df2c129c496d	Product name	3	20170717

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDC	Product	Description	Form	Quantity	Strength	SPL version
81665-204-01	SODIUM PHENYLACETATE and SODIUM BENZOATE	1 in 1 CARTON	INJECTION, SOLUTION, CONCENTRATE	1		1
81665-204-01	SODIUM PHENYLACETATE and SODIUM BENZOATE	50 mL in 1 VIAL, SINGLE-DOSE	INJECTION, SOLUTION, CONCENTRATE	50		1

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDC	Billing unit	Product NDC	DailyMed indexing SPL	SPL version	Effective
81665-204-01	ML - Milliliter	81665-204	f634d44d-9136-438e-b63e-e511f809380a	1	2025-09-12

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
Brand	Generic	Manufacturer	SPL set ID	Effective date	Available safety fields	Join
SODIUM PHENYLACETATE and SODIUM BENZOATE	SODIUM PHENYLACETATE AND SODIUM BENZOATE	Omnivium Pharmaceuticals LLC	8fafc39b-69db-40f3-8a09-ee859e8cef19	2025-05-15	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 207096 application number: ANDA207096 ndc (product): 81665-204
SODIUM PHENYLACETATE and SODIUM BENZOATE	SODIUM PHENYLACETATE AND SODIUM BENZOATE	Ailex Pharmaceuticals, LLC	329655ae-c3c0-46b2-a925-e49777f2076b	2025-03-30	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 207096 application number: ANDA207096
SODIUM PHENYLACETATE and SODIUM BENZOATE	SODIUM PHENYLACETATE AND SODIUM BENZOATE	Omnivium Pharmaceuticals LLC	9067c301-74f9-457a-9b0f-b7e9b06a3508	2025-02-15	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 207096 application number: ANDA207096

UNII, Preferred term, Registry number table
UNII	Preferred term	Registry number	Matched term
48N6U1781G	SODIUM PHENYLACETATE	114-70-5	SODIUM PHENYLACETATE
OJ245FE5EU	SODIUM BENZOATE	532-32-1	SODIUM BENZOATE

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUI	RxNorm string	TTY	DailyMed	SPL version
984118	sodium benzoate 10 % / sodium phenylacetate 10 % in 50 ML Injection	PSN	8fafc39b-69db-40f3-8a09-ee859e8cef19	1
984118	50 ML sodium benzoate 100 MG/ML / sodium phenylacetate 100 MG/ML Injection	SCD	8fafc39b-69db-40f3-8a09-ee859e8cef19	1
984118	sodium benzoate 10 % / sodium phenylacetate 10 % per 50 ML Injection	SY	8fafc39b-69db-40f3-8a09-ee859e8cef19	1

Packages#

Package NDC, 11-digit format, Description table
Package NDC	11-digit format	Description	Marketing start	Sample	Exclude flag	Status
81665-204-01	81665020401	1 VIAL, SINGLE-DOSE in 1 CARTON (81665-204-01) / 50 mL in 1 VIAL, SINGLE-DOSE	2025-05-15	No	No	Current

Title, Manufacturer, Effective date table
Title	Manufacturer	Effective date	Type	Version
SODIUM PHENYLACETATE and SODIUM BENZOATE	Omnivium Pharmaceuticals LLC	2025-05-15	HUMAN PRESCRIPTION DRUG LABEL	1