Home NDC 70710-1926 Sodium phenylacetate and Sodium benzoate
Product NDC 70710-1926
11-digit product format 707101926
Labeler code 70710
Product ID 70710-1926_fd646c47-7fcd-4d60-8f6c-29e13f611c6d
Type HUMAN PRESCRIPTION DRUG
Nonproprietary name Sodium phenylacetate and Sodium benzoate
Dosage form INJECTION, SOLUTION, CONCENTRATE
Route INTRAVENOUS
Labeler Zydus Pharmaceuticals USA Inc.
Application ANDA217526
Marketing category ANDA
Marketing start 2023-09-19
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 A217526-001 SODIUM PHENYLACETATE AND SODIUM BENZOATE SODIUM BENZOATE; SODIUM PHENYLACETATE 10%;10% (2GM/20ML; 2GM/20ML) SOLUTION / INTRAVENOUS AP 2023-07-14
Therapeutic equivalence codes# Current TE-code rows page 1 of 1 · 1 matching rows.
Application-product, TE code table Application-product TE code A217526-001 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 2026-09-14 22:38:34 2026-08 A217526-001 SODIUM PHENYLACETATE AND SODIUM BENZOATE 10%;10% (2GM/20ML; 2GM/20ML) SOLUTION / INTRAVENOUS AP 2023-07-14 84e616aacf4f…2026-08-18 06:07:40 2026-07 A217526-001 SODIUM PHENYLACETATE AND SODIUM BENZOATE 10%;10% (2GM/20ML; 2GM/20ML) SOLUTION / INTRAVENOUS AP 2023-07-14 caaa826d4ba7…2026-02-19 14:30 UTC 2026-02 A217526-001 SODIUM PHENYLACETATE AND SODIUM BENZOATE 10%;10% (2GM/20ML; 2GM/20ML) SOLUTION / INTRAVENOUS AP 2023-07-14 011fe1cb6892…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 A217526-001 SODIUM PHENYLACETATE AND SODIUM BENZOATE 10%;10% (2GM/20ML; 2GM/20ML) SOLUTION / INTRAVENOUS AP 2023-07-14 31067a03dcf5…2025-08-23 18:47 UTC 2025-08 A217526-001 SODIUM PHENYLACETATE AND SODIUM BENZOATE 10%;10% (2GM/20ML; 2GM/20ML) SOLUTION / INTRAVENOUS AP 2023-07-14 6a471c1ec25d…2025-03-22 03:13 UTC · 3 captures of this ZIP 2025-03 A217526-001 SODIUM PHENYLACETATE AND SODIUM BENZOATE 10%;10% (2GM/20ML; 2GM/20ML) SOLUTION / INTRAVENOUS AP 2023-07-14 fd3edfee7708…2025-02-26 10:13 UTC · 3 captures of this ZIP 2025-02 A217526-001 SODIUM PHENYLACETATE AND SODIUM BENZOATE 10%;10% (2GM/20ML; 2GM/20ML) SOLUTION / INTRAVENOUS AP 2023-07-14 b8a1b40f171c…2025-01-19 17:59 UTC · 7 captures of this ZIP 2025-01 A217526-001 SODIUM PHENYLACETATE AND SODIUM BENZOATE 10%;10% (2GM/20ML; 2GM/20ML) SOLUTION / INTRAVENOUS AP 2023-07-14 03ed91905a0d…2024-12-13 21:23 UTC · 2 captures of this ZIP 2024-12 A217526-001 SODIUM PHENYLACETATE AND SODIUM BENZOATE 10%;10% (2GM/20ML; 2GM/20ML) SOLUTION / INTRAVENOUS AP 2023-07-14 2680178bc6a6…2024-09-14 05:58 UTC · 2 captures of this ZIP 2024-09 A217526-001 SODIUM PHENYLACETATE AND SODIUM BENZOATE 10%;10% (2GM/20ML; 2GM/20ML) SOLUTION / INTRAVENOUS AP 2023-07-14 5bbf6a4d5a75…2024-11-08 22:44 UTC · 3 captures of this ZIP 2024-11 A217526-001 SODIUM PHENYLACETATE AND SODIUM BENZOATE 10%;10% (2GM/20ML; 2GM/20ML) SOLUTION / INTRAVENOUS AP 2023-07-14 d8e5a09893c0…2024-10-29 15:01 UTC 2024-10 A217526-001 SODIUM PHENYLACETATE AND SODIUM BENZOATE 10%;10% (2GM/20ML; 2GM/20ML) SOLUTION / INTRAVENOUS AP 2023-07-14 d06236e962d9…2024-08-13 05:28 UTC · 3 captures of this ZIP 2024-08 A217526-001 SODIUM PHENYLACETATE AND SODIUM BENZOATE 10%;10% (2GM/20ML; 2GM/20ML) SOLUTION / INTRAVENOUS AP 2023-07-14 79d66fd596c7…2024-07-13 05:37 UTC · 2 captures of this ZIP 2024-07 A217526-001 SODIUM PHENYLACETATE AND SODIUM BENZOATE 10%;10% (2GM/20ML; 2GM/20ML) SOLUTION / INTRAVENOUS AP 2023-07-14 301d65b070ca…2024-06-18 03:08 UTC · 5 captures of this ZIP 2024-06 A217526-001 SODIUM PHENYLACETATE AND SODIUM BENZOATE 10%;10% (2GM/20ML; 2GM/20ML) SOLUTION / INTRAVENOUS AP 2023-07-14 1e350fbaab3a…2024-05-31 18:47 UTC 2024-05 A217526-001 SODIUM PHENYLACETATE AND SODIUM BENZOATE 10%;10% (2GM/20ML; 2GM/20ML) SOLUTION / INTRAVENOUS AP 2023-07-14 8072bd15b7f6…2024-03-16 18:09 UTC · 4 captures of this ZIP 2024-03 A217526-001 SODIUM PHENYLACETATE AND SODIUM BENZOATE 10%;10% (2GM/20ML; 2GM/20ML) SOLUTION / INTRAVENOUS AP 2023-07-14 6a51e52b5d6a…2024-02-18 07:12 UTC 2024-02 A217526-001 SODIUM PHENYLACETATE AND SODIUM BENZOATE 10%;10% (2GM/20ML; 2GM/20ML) SOLUTION / INTRAVENOUS AP 2023-07-14 1c564ffb4f44…2023-12-20 04:57 UTC 2023-12 A217526-001 SODIUM PHENYLACETATE AND SODIUM BENZOATE 10%;10% (2GM/20ML; 2GM/20ML) SOLUTION / INTRAVENOUS AP 2023-07-14 ea1830bbd6c7…2023-11-28 05:40 UTC · 2 captures of this ZIP 2023-11 A217526-001 SODIUM PHENYLACETATE AND SODIUM BENZOATE 10%;10% (2GM/20ML; 2GM/20ML) SOLUTION / INTRAVENOUS AP 2023-07-14 a72a2bbeb626…2023-10-25 00:34 UTC · 2 captures of this ZIP 2023-10 A217526-001 SODIUM PHENYLACETATE AND SODIUM BENZOATE 10%;10% (2GM/20ML; 2GM/20ML) SOLUTION / INTRAVENOUS AP 2023-07-14 9b2671bbb829…2026-07-26 02:55 UTC · 3 captures of this ZIP 2026-06 A217526-001 SODIUM PHENYLACETATE AND SODIUM BENZOATE 10%;10% (2GM/20ML; 2GM/20ML) SOLUTION / INTRAVENOUS AP 2023-07-14 a50c72e98297…
Observed Orange Book normalized TE history# Observed Orange Book exclusivity history# Captured, Edition, Application-product table Captured Edition Application-product Exclusivity code Expiration Source SHA-256 2025-01-19 17:59 UTC · 7 captures of this ZIP 2025-01 A217526-001 CGT 2024-03-17 03ed91905a0d…2024-12-13 21:23 UTC · 2 captures of this ZIP 2024-12 A217526-001 CGT 2024-03-17 2680178bc6a6…2024-09-14 05:58 UTC · 2 captures of this ZIP 2024-09 A217526-001 CGT 2024-03-17 5bbf6a4d5a75…2024-11-08 22:44 UTC · 3 captures of this ZIP 2024-11 A217526-001 CGT 2024-03-17 d8e5a09893c0…2024-10-29 15:01 UTC 2024-10 A217526-001 CGT 2024-03-17 d06236e962d9…2024-08-13 05:28 UTC · 3 captures of this ZIP 2024-08 A217526-001 CGT 2024-03-17 79d66fd596c7…2024-07-13 05:37 UTC · 2 captures of this ZIP 2024-07 A217526-001 CGT 2024-03-17 301d65b070ca…2024-06-18 03:08 UTC · 5 captures of this ZIP 2024-06 A217526-001 CGT 2024-03-17 1e350fbaab3a…2024-05-31 18:47 UTC 2024-05 A217526-001 CGT 2024-03-17 8072bd15b7f6…2024-03-16 18:09 UTC · 4 captures of this ZIP 2024-03 A217526-001 CGT 2024-03-17 6a51e52b5d6a…2024-02-18 07:12 UTC 2024-02 A217526-001 CGT 2024-03-17 1c564ffb4f44…2023-12-20 04:57 UTC 2023-12 A217526-001 CGT 2024-03-17 ea1830bbd6c7…2023-11-28 05:40 UTC · 2 captures of this ZIP 2023-11 A217526-001 CGT 2024-03-17 a72a2bbeb626…2023-10-25 00:34 UTC · 2 captures of this ZIP 2023-10 A217526-001 CGT 2024-03-17 9b2671bbb829…
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 2560228 Internal RxNorm lookup
Harmonized SPL set identifiers# SPL set identifiers page 1 of 1 · 1 matching rows.
DailyMed Product Concepts# DailyMed Package Descriptions# Package NDC, Product, Description table Package NDC Product Description Form Quantity Strength SPL version 70710-1926-1 Sodium phenylacetate and Sodium benzoate 1 in 1 CARTON INJECTION, SOLUTION, CONCENTRATE 1 5 70710-1926-1 Sodium phenylacetate and Sodium benzoate 20 mL in 1 VIAL INJECTION, SOLUTION, CONCENTRATE 20 5
DailyMed Dashboard NDC Coverage# NDC, Dashboard title, SPL version table NDC Dashboard title SPL version Validation Dashboard ZIP 70710-1926 SODIUM PHENYLACETATE AND SODIUM BENZOATE INJECTION, SOLUTION, CONCENTRATE [ZYDUS PHARMACEUTICALS USA INC.] 5 Current NDC, 2 package rows 20231101_0f17c50f-3761-4470-bf3b-63837a287b8a.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.
DailyMed RxNorm Mappings# Packages# Package NDC, 11-digit format, Description table Package NDC 11-digit format Description Units Marketing start Sample Exclude flag Status 70710-1926-1 70710192601 1 VIAL in 1 CARTON (70710-1926-1) / 20 mL in 1 VIAL 1 vial 2023-09-19 No No Current