Home NDC 0187-0010 Ammonul
Product NDC 0187-0010
11-digit product format 001870010
Labeler code 0187
Product ID 0187-0010_de82ac73-cc5f-4e5d-8dfb-9cb98c625bdd
Type HUMAN PRESCRIPTION DRUG
Nonproprietary name sodium phenylacetate and sodium benzoate
Dosage form INJECTION, SOLUTION, CONCENTRATE
Route INTRAVENOUS
Labeler Bausch Health US LLC
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 2022-12-31
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 · 4 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 0187-0010-50 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 0187-0010-50 f5e01cc5f278…a2eaf40c39c3…
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SODIUM PHENYLACETATE 10%;10% (5GM/50ML;5GM/50ML) **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** SOLUTION / INTRAVENOUS RLD 2005-02-17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 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 [VALEANT PHARMACEUTICALS NORTH AMERICA LLC] 1 sodium phenylacetate ACTIVE INGREDIENT 48N6U1781G AMMONUL (SODIUM PHENYLACETATE AND SODIUM BENZOATE) INJECTION, SOLUTION, CONCENTRATE [VALEANT PHARMACEUTICALS NORTH AMERICA LLC] 1 benzoic acid ACTIVE MOIETY 8SKN0B0MIM AMMONUL (SODIUM PHENYLACETATE AND SODIUM BENZOATE) INJECTION, SOLUTION, CONCENTRATE [VALEANT PHARMACEUTICALS NORTH AMERICA LLC] 1 phenylacetic acid ACTIVE MOIETY ER5I1W795A AMMONUL (SODIUM PHENYLACETATE AND SODIUM BENZOATE) INJECTION, SOLUTION, CONCENTRATE [VALEANT PHARMACEUTICALS NORTH AMERICA LLC] 1 hydrochloric acid INACTIVE INGREDIENT QTT17582CB AMMONUL (SODIUM PHENYLACETATE AND SODIUM BENZOATE) INJECTION, SOLUTION, CONCENTRATE [VALEANT PHARMACEUTICALS NORTH AMERICA LLC] 1 sodium hydroxide INACTIVE INGREDIENT 55X04QC32I AMMONUL (SODIUM PHENYLACETATE AND SODIUM BENZOATE) INJECTION, SOLUTION, CONCENTRATE [VALEANT PHARMACEUTICALS NORTH AMERICA LLC] 1 water INACTIVE INGREDIENT 059QF0KO0R AMMONUL (SODIUM PHENYLACETATE AND SODIUM BENZOATE) INJECTION, SOLUTION, CONCENTRATE [VALEANT PHARMACEUTICALS NORTH AMERICA LLC] 1
DailyMed Dashboard NDC Coverage# NDC, Dashboard title, SPL version table NDC Dashboard title SPL version Validation Dashboard ZIP 0187-0010 AMMONUL (SODIUM PHENYLACETATE AND SODIUM BENZOATE) INJECTION, SOLUTION, CONCENTRATE [BAUSCH HEALTH US LLC] 12 Legacy NDC 20250410_e00521d3-84f1-4586-b4a8-9dc17ffffcb1.zip
Packages# Package NDC, 11-digit format, Description table Package NDC 11-digit format Description Marketing start Marketing end Sample Exclude flag Status 0187-0010-50 00187001050 1 VIAL, SINGLE-USE in 1 CARTON (0187-0010-50) > 50 mL in 1 VIAL, SINGLE-USE 2005-02-17 0000-00-00 No No Current