Sodium Phenylacetate and Sodium Benzoate

Product NDC: 72266-236
11-digit product format: 722660236
Labeler code: 72266
Product ID: 72266-236_18084634-4c12-58ee-e063-6294a90ac7d3
Type: HUMAN PRESCRIPTION DRUG
Nonproprietary name: Sodium Phenylacetate and Sodium Benzoate
Dosage form: INJECTION
Route: INTRAVENOUS
Labeler: FOSUN PHARMA USA INC
Application: NDA215025
Marketing category: NDA
Marketing start: 2021-11-14
Substance: SODIUM BENZOATE; SODIUM PHENYLACETATE
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 1.

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
N215025-001	SODIUM PHENYLACETATE AND SODIUM BENZOATE	SODIUM BENZOATE; SODIUM PHENYLACETATE	10%;10% (2GM/20ML;2GM/20ML)	SOLUTION / INTRAVENOUS	AP	RLD, RS	2021-06-10

Therapeutic equivalence codes#

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

Application-product, TE code table
Application-product	TE code
N215025-001	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.

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
2026-02-19 14:30 UTC	2026-02	N215025-001	SODIUM PHENYLACETATE AND SODIUM BENZOATE	10%;10% (2GM/20ML;2GM/20ML)	SOLUTION / INTRAVENOUS	AP	RLD, RS	2021-06-10	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	N215025-001	SODIUM PHENYLACETATE AND SODIUM BENZOATE	10%;10% (2GM/20ML;2GM/20ML)	SOLUTION / INTRAVENOUS	AP	RLD, RS	2021-06-10	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	N215025-001	SODIUM PHENYLACETATE AND SODIUM BENZOATE	10%;10% (2GM/20ML;2GM/20ML)	SOLUTION / INTRAVENOUS	AP	RLD, RS	2021-06-10	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	N215025-001	SODIUM PHENYLACETATE AND SODIUM BENZOATE	10%;10% (2GM/20ML;2GM/20ML)	SOLUTION / INTRAVENOUS	AP	RLD, RS	2021-06-10	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	N215025-001	SODIUM PHENYLACETATE AND SODIUM BENZOATE	10%;10% (2GM/20ML;2GM/20ML)	SOLUTION / INTRAVENOUS	AP	RLD, RS	2021-06-10	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	N215025-001	SODIUM PHENYLACETATE AND SODIUM BENZOATE	10%;10% (2GM/20ML;2GM/20ML)	SOLUTION / INTRAVENOUS	AP	RLD, RS	2021-06-10	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	N215025-001	SODIUM PHENYLACETATE AND SODIUM BENZOATE	10%;10% (2GM/20ML;2GM/20ML)	SOLUTION / INTRAVENOUS	AP	RLD, RS	2021-06-10	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	N215025-001	SODIUM PHENYLACETATE AND SODIUM BENZOATE	10%;10% (2GM/20ML;2GM/20ML)	SOLUTION / INTRAVENOUS	AP	RLD, RS	2021-06-10	`5bbf6a4d5a75…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	N215025-001	SODIUM PHENYLACETATE AND SODIUM BENZOATE	10%;10% (2GM/20ML;2GM/20ML)	SOLUTION / INTRAVENOUS	AP	RLD, RS	2021-06-10	`d8e5a09893c0…`
2024-10-29 15:01 UTC	2024-10	N215025-001	SODIUM PHENYLACETATE AND SODIUM BENZOATE	10%;10% (2GM/20ML;2GM/20ML)	SOLUTION / INTRAVENOUS	AP	RLD, RS	2021-06-10	`d06236e962d9…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	N215025-001	SODIUM PHENYLACETATE AND SODIUM BENZOATE	10%;10% (2GM/20ML;2GM/20ML)	SOLUTION / INTRAVENOUS	AP	RLD, RS	2021-06-10	`79d66fd596c7…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	N215025-001	SODIUM PHENYLACETATE AND SODIUM BENZOATE	10%;10% (2GM/20ML;2GM/20ML)	SOLUTION / INTRAVENOUS	AP	RLD, RS	2021-06-10	`301d65b070ca…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	N215025-001	SODIUM PHENYLACETATE AND SODIUM BENZOATE	10%;10% (2GM/20ML;2GM/20ML)	SOLUTION / INTRAVENOUS	AP	RLD, RS	2021-06-10	`1e350fbaab3a…`
2024-05-31 18:47 UTC	2024-05	N215025-001	SODIUM PHENYLACETATE AND SODIUM BENZOATE	10%;10% (2GM/20ML;2GM/20ML)	SOLUTION / INTRAVENOUS	AP	RLD, RS	2021-06-10	`8072bd15b7f6…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	N215025-001	SODIUM PHENYLACETATE AND SODIUM BENZOATE	10%;10% (2GM/20ML;2GM/20ML)	SOLUTION / INTRAVENOUS		RLD, RS	2021-06-10	`5c6f7cd8ea54…`
2022-04-08 23:34 UTC	2022-04	N215025-001	SODIUM PHENYLACETATE AND SODIUM BENZOATE	10%;10% (2GM/20ML;2GM/20ML)	SOLUTION / INTRAVENOUS		RLD, RS	2021-06-10	`5d02ea3f76ae…`
2022-04-04 05:41 UTC	2022-04	N215025-001	SODIUM PHENYLACETATE AND SODIUM BENZOATE	10%;10% (2GM/20ML;2GM/20ML)	SOLUTION / INTRAVENOUS		RLD, RS	2021-06-10	`4b0b4de00fa7…`
2022-03-09 01:35 UTC	2022-03	N215025-001	SODIUM PHENYLACETATE AND SODIUM BENZOATE	10%;10% (2GM/20ML;2GM/20ML)	SOLUTION / INTRAVENOUS		RLD, RS	2021-06-10	`bb7c543d1eb4…`
2021-12-28 21:50 UTC	2021-12	N215025-001	SODIUM PHENYLACETATE AND SODIUM BENZOATE	10%;10% (2GM/20ML;2GM/20ML)	SOLUTION / INTRAVENOUS		RLD, RS	2021-06-10	`782e0a99824c…`
2024-03-16 18:09 UTC · 4 captures of this ZIP	2024-03	N215025-001	SODIUM PHENYLACETATE AND SODIUM BENZOATE	10%;10% (2GM/20ML;2GM/20ML)	SOLUTION / INTRAVENOUS	AP	RLD, RS	2021-06-10	`6a51e52b5d6a…`
2024-02-18 07:12 UTC	2024-02	N215025-001	SODIUM PHENYLACETATE AND SODIUM BENZOATE	10%;10% (2GM/20ML;2GM/20ML)	SOLUTION / INTRAVENOUS	AP	RLD, RS	2021-06-10	`1c564ffb4f44…`
2023-12-20 04:57 UTC	2023-12	N215025-001	SODIUM PHENYLACETATE AND SODIUM BENZOATE	10%;10% (2GM/20ML;2GM/20ML)	SOLUTION / INTRAVENOUS	AP	RLD, RS	2021-06-10	`ea1830bbd6c7…`
2023-11-28 05:40 UTC · 2 captures of this ZIP	2023-11	N215025-001	SODIUM PHENYLACETATE AND SODIUM BENZOATE	10%;10% (2GM/20ML;2GM/20ML)	SOLUTION / INTRAVENOUS	AP	RLD, RS	2021-06-10	`a72a2bbeb626…`
2023-10-25 00:34 UTC · 2 captures of this ZIP	2023-10	N215025-001	SODIUM PHENYLACETATE AND SODIUM BENZOATE	10%;10% (2GM/20ML;2GM/20ML)	SOLUTION / INTRAVENOUS	AP	RLD, RS	2021-06-10	`9b2671bbb829…`
2023-07-15 15:27 UTC · 2 captures of this ZIP	2023-07	N215025-001	SODIUM PHENYLACETATE AND SODIUM BENZOATE	10%;10% (2GM/20ML;2GM/20ML)	SOLUTION / INTRAVENOUS		RLD, RS	2021-06-10	`a67488948f0b…`
2023-06-13 01:57 UTC · 3 captures of this ZIP	2023-06	N215025-001	SODIUM PHENYLACETATE AND SODIUM BENZOATE	10%;10% (2GM/20ML;2GM/20ML)	SOLUTION / INTRAVENOUS		RLD, RS	2021-06-10	`3f0d92c62455…`
2023-05-13 08:27 UTC	2023-05	N215025-001	SODIUM PHENYLACETATE AND SODIUM BENZOATE	10%;10% (2GM/20ML;2GM/20ML)	SOLUTION / INTRAVENOUS		RLD, RS	2021-06-10	`053a50430f4f…`
2023-01-26 05:58 UTC	2023-01	N215025-001	SODIUM PHENYLACETATE AND SODIUM BENZOATE	10%;10% (2GM/20ML;2GM/20ML)	SOLUTION / INTRAVENOUS		RLD, RS	2021-06-10	`3bdfa0b2c4d7…`
2022-11-12 20:34 UTC · 5 captures of this ZIP	2022-11	N215025-001	SODIUM PHENYLACETATE AND SODIUM BENZOATE	10%;10% (2GM/20ML;2GM/20ML)	SOLUTION / INTRAVENOUS		RLD, RS	2021-06-10	`3a93d1ddd44b…`
2022-10-28 04:53 UTC	2022-10	N215025-001	SODIUM PHENYLACETATE AND SODIUM BENZOATE	10%;10% (2GM/20ML;2GM/20ML)	SOLUTION / INTRAVENOUS		RLD, RS	2021-06-10	`f41ea6bd6efb…`
2022-09-29 23:25 UTC	2022-09	N215025-001	SODIUM PHENYLACETATE AND SODIUM BENZOATE	10%;10% (2GM/20ML;2GM/20ML)	SOLUTION / INTRAVENOUS		RLD, RS	2021-06-10	`e64feba35796…`
2022-07-09 03:26 UTC · 3 captures of this ZIP	2022-07	N215025-001	SODIUM PHENYLACETATE AND SODIUM BENZOATE	10%;10% (2GM/20ML;2GM/20ML)	SOLUTION / INTRAVENOUS		RLD, RS	2021-06-10	`cb3db0bc1861…`
2026-07-26 02:55 UTC · 3 captures of this ZIP	2026-06	N215025-001	SODIUM PHENYLACETATE AND SODIUM BENZOATE	10%;10% (2GM/20ML;2GM/20ML)	SOLUTION / INTRAVENOUS	AP	RLD, RS	2021-06-10	`a50c72e98297…`

Observed Orange Book normalized TE history#

Captured, Edition, Application-product table
Captured	Edition	Application-product	TE code	Order	Source SHA-256
2026-02-19 14:30 UTC	2026-02	N215025-001	AP	1	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	N215025-001	AP	1	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	N215025-001	AP	1	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	N215025-001	AP	1	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	N215025-001	AP	1	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	N215025-001	AP	1	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	N215025-001	AP	1	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	N215025-001	AP	1	`5bbf6a4d5a75…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	N215025-001	AP	1	`d8e5a09893c0…`
2024-10-29 15:01 UTC	2024-10	N215025-001	AP	1	`d06236e962d9…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	N215025-001	AP	1	`79d66fd596c7…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	N215025-001	AP	1	`301d65b070ca…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	N215025-001	AP	1	`1e350fbaab3a…`
2024-05-31 18:47 UTC	2024-05	N215025-001	AP	1	`8072bd15b7f6…`
2024-03-16 18:09 UTC · 4 captures of this ZIP	2024-03	N215025-001	AP	1	`6a51e52b5d6a…`
2024-02-18 07:12 UTC	2024-02	N215025-001	AP	1	`1c564ffb4f44…`
2023-12-20 04:57 UTC	2023-12	N215025-001	AP	1	`ea1830bbd6c7…`
2023-11-28 05:40 UTC · 2 captures of this ZIP	2023-11	N215025-001	AP	1	`a72a2bbeb626…`
2023-10-25 00:34 UTC · 2 captures of this ZIP	2023-10	N215025-001	AP	1	`9b2671bbb829…`
2026-07-26 02:55 UTC · 3 captures of this ZIP	2026-06	N215025-001	AP	1	`a50c72e98297…`

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
2560228	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
cee1e9a2-bbe5-2419-e053-2a95a90ac3ef	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
72266-236-01	Sodium Phenylacetate and Sodium Benzoate	1 in 1 CARTON	INJECTION	1		2
72266-236-01	Sodium Phenylacetate and Sodium Benzoate	20 mL in 1 VIAL, SINGLE-DOSE	INJECTION	20		2

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDC	Billing unit	Product NDC	DailyMed indexing SPL	SPL version	Effective
72266-236-01	ML - Milliliter	72266-236	589842ce-d775-4282-9e5a-7cb56792b5a8	1	2022-01-06

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDC	Dashboard title	SPL version	Validation	Dashboard ZIP
72266-236	SODIUM PHENYLACETATE AND SODIUM BENZOATE INJECTION [FOSUN PHARMA USA INC]	2	Current NDC, Legacy NDC, 2 package rows	20240510_cee1e9a2-bbe5-2419-e053-2a95a90ac3ef.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 · 2 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	FOSUN PHARMA USA INC	cee1e9a2-bbe5-2419-e053-2a95a90ac3ef	2024-05-09	Warnings, Adverse reactions	Exact identifier application applno (NDA): 215025 application number: NDA215025 ndc (product): 72266-236
Sodium Phenylacetate and Sodium Benzoate	SODIUM PHENYLACETATE AND SODIUM BENZOATE	MAIA PHARMACEUTICALS	ab40b62b-9f8d-4394-92d5-09d9f1941eaa	2023-01-16	Warnings, Adverse reactions	Exact identifier application applno (NDA): 215025 application number: NDA215025

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

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUI	RxNorm string	TTY	DailyMed	SPL version
2560228	sodium benzoate 10 % / sodium phenylacetate 10 % in 20 ML Injection	PSN	cee1e9a2-bbe5-2419-e053-2a95a90ac3ef	2
2560228	20 ML sodium benzoate 100 MG/ML / sodium phenylacetate 100 MG/ML Injection	SCD	cee1e9a2-bbe5-2419-e053-2a95a90ac3ef	2
2560228	sodium benzoate 10 % / sodium phenylacetate 10 % per 20 ML Injection	SY	cee1e9a2-bbe5-2419-e053-2a95a90ac3ef	2

Packages#

Package NDC, 11-digit format, Description table
Package NDC	11-digit format	Description	Marketing start	Marketing end	Sample	Exclude flag	Status
72266-236-01	72266023601	1 VIAL, SINGLE-DOSE in 1 CARTON (72266-236-01) / 20 mL in 1 VIAL, SINGLE-DOSE	2021-11-14	0000-00-00	No	No	Current

Title, Manufacturer, Effective date table
Title	Manufacturer	Effective date	Type	Version
Sodium Phenylacetate and Sodium Benzoate	FOSUN PHARMA USA INC	2024-05-09	HUMAN PRESCRIPTION DRUG LABEL	2