Home NDC 62592-720 Ammonul
Product NDC 62592-720
11-digit product format 625920720
Labeler code 62592
Product ID 62592-720_6295e473-526f-1f28-e053-2a91aa0a3a83
Type HUMAN PRESCRIPTION DRUG
Nonproprietary name sodium phenylacetate and sodium benzoate
Dosage form INJECTION, SOLUTION, CONCENTRATE
Route INTRAVENOUS
Labeler Ucyclyd Pharma Inc.
Application NDA020645
Marketing category NDA
Marketing start 2005-02-17
Marketing end 0000-00-00
Substance SODIUM PHENYLACETATE; SODIUM BENZOATE
Active strength 100 mg/mL; mg/mL
Pharmacologic classes Ammonium Ion Binding Activity [MoA],Nitrogen Binding Agent [EPC],Ammonium Ion Binding Activity [MoA],Nitrogen Binding Agent [EPC]
NDC exclude flag No
Listing certified through 2019-12-31
Current FDA listing Historical FDA.report record 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 · 42 matching rows.
View current auxiliary records. · View the auxiliary file history.
Captured / source date, Dataset, Scope table Captured / source date Dataset Scope Package NDC Snapshot Source SHA-256 2025-12-14 17:58 UTC · source 2025-12-05 excluded product product d630ba8d3edf…732f749b63fb…2025-12-14 17:58 UTC · source 2025-12-05 excluded package package 62592-720-50 d630ba8d3edf…732f749b63fb…2025-08-27 00:01 UTC · source 2025-08-26 excluded product product f5e01cc5f278…a2eaf40c39c3…2025-08-27 00:01 UTC · source 2025-08-26 excluded package package 62592-720-50 f5e01cc5f278…a2eaf40c39c3…2025-04-01 02:39 UTC · source 2025-03-31 excluded product product 2ef7874e63bc…57b86245f4fa…2025-04-01 02:39 UTC · source 2025-03-31 excluded package package 62592-720-50 2ef7874e63bc…57b86245f4fa…2025-03-28 20:22 UTC · source 2025-03-28 excluded product product a1b67e2a42f9…c4cf2c586c0d…2025-03-28 20:22 UTC · source 2025-03-28 excluded package package 62592-720-50 a1b67e2a42f9…c4cf2c586c0d…2025-03-22 03:12 UTC · source 2025-03-21 excluded product product cfe11265f3b6…090c488252e2…2025-03-22 03:12 UTC · source 2025-03-21 excluded package package 62592-720-50 cfe11265f3b6…090c488252e2…2025-03-10 12:48 UTC · source 2025-03-10 excluded product product cdf11ea48f46…ba0047e9e063…2025-03-10 12:48 UTC · source 2025-03-10 excluded package package 62592-720-50 cdf11ea48f46…ba0047e9e063…2025-02-02 03:52 UTC · source 2025-01-31 excluded product product 302b2466d912…e7b80fea0513…2025-02-02 03:52 UTC · source 2025-01-31 excluded package package 62592-720-50 302b2466d912…e7b80fea0513…2025-01-20 13:05 UTC · source 2025-01-20 excluded product product ed331223b511…672a5bd82f5f…2025-01-20 13:05 UTC · source 2025-01-20 excluded package package 62592-720-50 ed331223b511…672a5bd82f5f…2025-01-11 03:41 UTC · source 2025-01-10 excluded product product 0efc9e666f02…f202fb6c5f17…2025-01-11 03:41 UTC · source 2025-01-10 excluded package package 62592-720-50 0efc9e666f02…f202fb6c5f17…2024-11-09 02:27 UTC · source 2024-11-08 excluded product product ad56d346431e…cc804d4bbf1e…2024-11-09 02:27 UTC · source 2024-11-08 excluded package package 62592-720-50 ad56d346431e…cc804d4bbf1e…2024-10-04 04:10 UTC · source 2024-10-03 excluded product product 367a005e9d99…383a685ebd0f…2024-10-04 04:10 UTC · source 2024-10-03 excluded package package 62592-720-50 367a005e9d99…383a685ebd0f…2024-07-10 04:00 UTC · source 2024-07-09 excluded product product 557ba5c1ecfa…9c80585c8c6e…2024-07-10 04:00 UTC · source 2024-07-09 excluded package package 62592-720-50 557ba5c1ecfa…9c80585c8c6e…2024-05-28 21:12 UTC · source 2024-05-28 excluded product product 8af77b9d5b6f…d9bbb34c5368…2024-05-28 21:12 UTC · source 2024-05-28 excluded package package 62592-720-50 8af77b9d5b6f…d9bbb34c5368…2024-05-15 03:39 UTC · source 2024-05-14 excluded product product 834df4deac94…adcc014656a3…2024-05-15 03:39 UTC · source 2024-05-14 excluded package package 62592-720-50 834df4deac94…adcc014656a3…2024-03-11 06:39 UTC · source 2024-03-08 excluded product product 1332a3947898…d4bfe170f9cd…2024-03-11 06:39 UTC · source 2024-03-08 excluded package package 62592-720-50 1332a3947898…d4bfe170f9cd…2022-08-30 03:57 UTC · source 2022-08-29 excluded product product fb8cb913e6d1…eb8c232b6be0…2022-08-30 03:57 UTC · source 2022-08-29 excluded package package 62592-720-50 fb8cb913e6d1…eb8c232b6be0…2022-04-09 23:13 UTC · source 2022-04-08 excluded product product 86f5da6cb304…a595104c45d7…2022-04-09 23:13 UTC · source 2022-04-08 excluded package package 62592-720-50 86f5da6cb304…a595104c45d7…2022-04-04 05:40 UTC · source 2022-04-01 excluded product product bd6a592717d7…303034d00443…2022-04-04 05:40 UTC · source 2022-04-01 excluded package package 62592-720-50 bd6a592717d7…303034d00443…2021-12-27 23:28 UTC · source 2021-12-27 excluded product product 8dfbde2a14a4…c9ff85d89658…2021-12-27 23:28 UTC · source 2021-12-27 excluded package package 62592-720-50 8dfbde2a14a4…c9ff85d89658…2020-12-18 03:04 UTC · source 2020-12-17 excluded product product e2bbac7714bc…27bdfed8d636…2020-12-18 03:04 UTC · source 2020-12-17 excluded package package 62592-720-50 e2bbac7714bc…27bdfed8d636…2020-06-10 20:45 UTC · source 2020-06-10 excluded product product 9bebd1f3094a…5416666fcb17…2020-06-10 20:45 UTC · source 2020-06-10 excluded package package 62592-720-50 9bebd1f3094a…5416666fcb17…
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 N020645-001 AMMONUL SODIUM BENZOATE; SODIUM PHENYLACETATE 10%;10% (5GM/50ML;5GM/50ML) **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** SOLUTION / INTRAVENOUS RLD 2005-02-17
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 · 41 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 2026-02-19 14:30 UTC 2026-02 N020645-001 AMMONUL 10%;10% (5GM/50ML;5GM/50ML) **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** SOLUTION / INTRAVENOUS RLD 2005-02-17 011fe1cb6892…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 N020645-001 AMMONUL 10%;10% (5GM/50ML;5GM/50ML) **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** SOLUTION / INTRAVENOUS RLD 2005-02-17 31067a03dcf5…2025-08-23 18:47 UTC 2025-08 N020645-001 AMMONUL 10%;10% (5GM/50ML;5GM/50ML) **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** SOLUTION / INTRAVENOUS RLD 2005-02-17 6a471c1ec25d…2025-03-22 03:13 UTC · 3 captures of this ZIP 2025-03 N020645-001 AMMONUL 10%;10% (5GM/50ML;5GM/50ML) SOLUTION / INTRAVENOUS RLD 2005-02-17 fd3edfee7708…2025-02-26 10:13 UTC · 3 captures of this ZIP 2025-02 N020645-001 AMMONUL 10%;10% (5GM/50ML;5GM/50ML) SOLUTION / INTRAVENOUS RLD 2005-02-17 b8a1b40f171c…2025-01-19 17:59 UTC · 7 captures of this ZIP 2025-01 N020645-001 AMMONUL 10%;10% (5GM/50ML;5GM/50ML) SOLUTION / INTRAVENOUS RLD 2005-02-17 03ed91905a0d…2024-12-13 21:23 UTC · 2 captures of this ZIP 2024-12 N020645-001 AMMONUL 10%;10% (5GM/50ML;5GM/50ML) SOLUTION / INTRAVENOUS RLD 2005-02-17 2680178bc6a6…2024-09-14 05:58 UTC · 2 captures of this ZIP 2024-09 N020645-001 AMMONUL 10%;10% (5GM/50ML;5GM/50ML) SOLUTION / INTRAVENOUS RLD 2005-02-17 5bbf6a4d5a75…2024-11-08 22:44 UTC · 3 captures of this ZIP 2024-11 N020645-001 AMMONUL 10%;10% (5GM/50ML;5GM/50ML) SOLUTION / INTRAVENOUS RLD 2005-02-17 d8e5a09893c0…2024-10-29 15:01 UTC 2024-10 N020645-001 AMMONUL 10%;10% (5GM/50ML;5GM/50ML) SOLUTION / INTRAVENOUS RLD 2005-02-17 d06236e962d9…2024-08-13 05:28 UTC · 3 captures of this ZIP 2024-08 N020645-001 AMMONUL 10%;10% (5GM/50ML;5GM/50ML) SOLUTION / INTRAVENOUS RLD 2005-02-17 79d66fd596c7…2024-07-13 05:37 UTC · 2 captures of this ZIP 2024-07 N020645-001 AMMONUL 10%;10% (5GM/50ML;5GM/50ML) SOLUTION / INTRAVENOUS AP RLD, RS 2005-02-17 301d65b070ca…2024-06-18 03:08 UTC · 5 captures of this ZIP 2024-06 N020645-001 AMMONUL 10%;10% (5GM/50ML;5GM/50ML) SOLUTION / INTRAVENOUS AP RLD, RS 2005-02-17 1e350fbaab3a…2024-05-31 18:47 UTC 2024-05 N020645-001 AMMONUL 10%;10% (5GM/50ML;5GM/50ML) SOLUTION / INTRAVENOUS AP RLD, RS 2005-02-17 8072bd15b7f6…2022-06-29 02:47 UTC · 2 captures of this ZIP 2022-06 N020645-001 AMMONUL 10%;10% (5GM/50ML;5GM/50ML) SOLUTION / INTRAVENOUS AP RLD, RS 2005-02-17 5c6f7cd8ea54…2022-04-08 23:34 UTC 2022-04 N020645-001 AMMONUL 10%;10% (5GM/50ML;5GM/50ML) SOLUTION / INTRAVENOUS AP RLD, RS 2005-02-17 5d02ea3f76ae…2022-04-04 05:41 UTC 2022-04 N020645-001 AMMONUL 10%;10% (5GM/50ML;5GM/50ML) SOLUTION / INTRAVENOUS AP RLD, RS 2005-02-17 4b0b4de00fa7…2019-12-13 00:20 UTC 2019-12 N020645-001 AMMONUL 10%;10% (5GM/50ML;5GM/50ML) SOLUTION / INTRAVENOUS AP RLD, RS 2005-02-17 74a2ff9319b5…2022-03-09 01:35 UTC 2022-03 N020645-001 AMMONUL 10%;10% (5GM/50ML;5GM/50ML) SOLUTION / INTRAVENOUS AP RLD, RS 2005-02-17 bb7c543d1eb4…2021-12-28 21:50 UTC 2021-12 N020645-001 AMMONUL 10%;10% (5GM/50ML;5GM/50ML) SOLUTION / INTRAVENOUS AP RLD, RS 2005-02-17 782e0a99824c…2021-05-05 16:15 UTC · 3 captures of this ZIP 2021-05 N020645-001 AMMONUL 10%;10% (5GM/50ML;5GM/50ML) SOLUTION / INTRAVENOUS AP RLD, RS 2005-02-17 87673890dc5c…2021-03-12 10:30 UTC 2021-03 N020645-001 AMMONUL 10%;10% (5GM/50ML;5GM/50ML) SOLUTION / INTRAVENOUS AP RLD, RS 2005-02-17 5aa47cf7b7d7…2020-12-22 03:56 UTC 2020-12 N020645-001 AMMONUL 10%;10% (5GM/50ML;5GM/50ML) SOLUTION / INTRAVENOUS AP RLD, RS 2005-02-17 8869cabd3fbd…2020-11-12 02:37 UTC 2020-11 N020645-001 AMMONUL 10%;10% (5GM/50ML;5GM/50ML) SOLUTION / INTRAVENOUS AP RLD, RS 2005-02-17 c0c555d07b60…2019-12-14 00:12 UTC 2019-12 N020645-001 AMMONUL 10%;10% (5GM/50ML;5GM/50ML) SOLUTION / INTRAVENOUS AP RLD, RS 2005-02-17 3f01610625f2…2019-09-15 20:21 UTC 2019-09 N020645-001 AMMONUL 10%;10% (5GM/50ML;5GM/50ML) SOLUTION / INTRAVENOUS AP RLD, RS 2005-02-17 b00525d2431f…2019-07-19 19:46 UTC 2019-07 N020645-001 AMMONUL 10%;10% (5GM/50ML;5GM/50ML) SOLUTION / INTRAVENOUS AP RLD, RS 2005-02-17 ea99ee380514…2024-03-16 18:09 UTC · 4 captures of this ZIP 2024-03 N020645-001 AMMONUL 10%;10% (5GM/50ML;5GM/50ML) SOLUTION / INTRAVENOUS AP RLD, RS 2005-02-17 6a51e52b5d6a…2024-02-18 07:12 UTC 2024-02 N020645-001 AMMONUL 10%;10% (5GM/50ML;5GM/50ML) SOLUTION / INTRAVENOUS AP RLD, RS 2005-02-17 1c564ffb4f44…2023-12-20 04:57 UTC 2023-12 N020645-001 AMMONUL 10%;10% (5GM/50ML;5GM/50ML) SOLUTION / INTRAVENOUS AP RLD, RS 2005-02-17 ea1830bbd6c7…2023-11-28 05:40 UTC · 2 captures of this ZIP 2023-11 N020645-001 AMMONUL 10%;10% (5GM/50ML;5GM/50ML) SOLUTION / INTRAVENOUS AP RLD, RS 2005-02-17 a72a2bbeb626…2023-10-25 00:34 UTC · 2 captures of this ZIP 2023-10 N020645-001 AMMONUL 10%;10% (5GM/50ML;5GM/50ML) SOLUTION / INTRAVENOUS AP RLD, RS 2005-02-17 9b2671bbb829…2023-07-15 15:27 UTC · 2 captures of this ZIP 2023-07 N020645-001 AMMONUL 10%;10% (5GM/50ML;5GM/50ML) SOLUTION / INTRAVENOUS AP RLD, RS 2005-02-17 a67488948f0b…2023-06-13 01:57 UTC · 3 captures of this ZIP 2023-06 N020645-001 AMMONUL 10%;10% (5GM/50ML;5GM/50ML) SOLUTION / INTRAVENOUS AP RLD, RS 2005-02-17 3f0d92c62455…2023-05-13 08:27 UTC 2023-05 N020645-001 AMMONUL 10%;10% (5GM/50ML;5GM/50ML) SOLUTION / INTRAVENOUS AP RLD, RS 2005-02-17 053a50430f4f…2023-01-26 05:58 UTC 2023-01 N020645-001 AMMONUL 10%;10% (5GM/50ML;5GM/50ML) SOLUTION / INTRAVENOUS AP RLD, RS 2005-02-17 3bdfa0b2c4d7…2022-11-12 20:34 UTC · 5 captures of this ZIP 2022-11 N020645-001 AMMONUL 10%;10% (5GM/50ML;5GM/50ML) SOLUTION / INTRAVENOUS AP RLD, RS 2005-02-17 3a93d1ddd44b…2022-10-28 04:53 UTC 2022-10 N020645-001 AMMONUL 10%;10% (5GM/50ML;5GM/50ML) SOLUTION / INTRAVENOUS AP RLD, RS 2005-02-17 f41ea6bd6efb…2022-09-29 23:25 UTC 2022-09 N020645-001 AMMONUL 10%;10% (5GM/50ML;5GM/50ML) SOLUTION / INTRAVENOUS AP RLD, RS 2005-02-17 e64feba35796…2022-07-09 03:26 UTC · 3 captures of this ZIP 2022-07 N020645-001 AMMONUL 10%;10% (5GM/50ML;5GM/50ML) SOLUTION / INTRAVENOUS AP RLD, RS 2005-02-17 cb3db0bc1861…
Observed Orange Book normalized TE history# DailyMed Product Concepts# FDA-Initiated Inactive NDC Indexing# DailyMed Package Descriptions# Package NDC, Product, Description table Package NDC Product Description Form Quantity Strength SPL version 62592-720-50 Ammonul 1 in 1 CARTON INJECTION, SOLUTION, CONCENTRATE 1 7 62592-720-50 Ammonul 50 mL in 1 VIAL, SINGLE-USE INJECTION, SOLUTION, CONCENTRATE 50 7
DailyMed Socrata Ingredients# Ingredient, Type, UNII table Ingredient Type UNII DailyMed label SPL version Uploaded sodium benzoate ACTIVE INGREDIENT OJ245FE5EU AMMONUL (SODIUM PHENYLACETATE AND SODIUM BENZOATE) INJECTION, SOLUTION, CONCENTRATE [UCYCLYD PHARMA INC.] 6 sodium phenylacetate ACTIVE INGREDIENT 48N6U1781G AMMONUL (SODIUM PHENYLACETATE AND SODIUM BENZOATE) INJECTION, SOLUTION, CONCENTRATE [UCYCLYD PHARMA INC.] 6 benzoic acid ACTIVE MOIETY 8SKN0B0MIM AMMONUL (SODIUM PHENYLACETATE AND SODIUM BENZOATE) INJECTION, SOLUTION, CONCENTRATE [UCYCLYD PHARMA INC.] 6 phenylacetic acid ACTIVE MOIETY ER5I1W795A AMMONUL (SODIUM PHENYLACETATE AND SODIUM BENZOATE) INJECTION, SOLUTION, CONCENTRATE [UCYCLYD PHARMA INC.] 6 hydrochloric acid INACTIVE INGREDIENT QTT17582CB AMMONUL (SODIUM PHENYLACETATE AND SODIUM BENZOATE) INJECTION, SOLUTION, CONCENTRATE [UCYCLYD PHARMA INC.] 6 sodium hydroxide INACTIVE INGREDIENT 55X04QC32I AMMONUL (SODIUM PHENYLACETATE AND SODIUM BENZOATE) INJECTION, SOLUTION, CONCENTRATE [UCYCLYD PHARMA INC.] 6 water INACTIVE INGREDIENT 059QF0KO0R AMMONUL (SODIUM PHENYLACETATE AND SODIUM BENZOATE) INJECTION, SOLUTION, CONCENTRATE [UCYCLYD PHARMA INC.] 6
DailyMed Dashboard NDC Coverage# NDC, Dashboard title, SPL version table NDC Dashboard title SPL version Validation Dashboard ZIP 62592-720 AMMONUL (SODIUM PHENYLACETATE AND SODIUM BENZOATE) INJECTION, SOLUTION, CONCENTRATE [UCYCLYD PHARMA INC.] 7 Legacy NDC, 2 package rows 20180115_d564f2b1-9fc7-4201-8066-d745ac3a671f.zip
DailyMed RxNorm Mappings# Packages# Package NDC, 11-digit format, Description table Package NDC 11-digit format Description Status 62592-720-50 62592072050 1 in 1 CARTON Historical