Home NDC 25208-100 PREXXARTAN
Product NDC 25208-100
11-digit product format 252080100
Labeler code 25208
Product ID 25208-100_7ad4ad18-919e-48fe-b630-213ead75a8b6
Type HUMAN PRESCRIPTION DRUG
Nonproprietary name PREXXARTAN
Dosage form SOLUTION
Route ORAL
Labeler Medicure International Inc.
Application NDA209139
Marketing category NDA
Marketing start 2018-01-02
Marketing end 0000-00-00
Substance VALSARTAN
Active strength 4 mg/mL
Pharmacologic classes Angiotensin 2 Receptor Antagonists [MoA],Angiotensin 2 Receptor Blocker [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 2 · 84 matching rows.
View current auxiliary records. · View the auxiliary file history.
Source provenance: Browse the complete Orange Book source catalog · source snapshot 44 .
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date N209139-001 PREXXARTAN VALSARTAN 4MG/ML **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** SOLUTION / ORAL AB RLD 2017-12-19
Therapeutic equivalence codes# Current TE-code rows page 1 of 1 · 1 matching rows.
Application-product, TE code table Application-product TE code N209139-001 AB
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 3 · 81 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 2026-10-15 13:18:30 2026-09 N209139-001 PREXXARTAN 4MG/ML **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** SOLUTION / ORAL AB RLD 2017-12-19 c2088c7a36db…2026-09-14 22:38:34 2026-08 N209139-001 PREXXARTAN 4MG/ML **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** SOLUTION / ORAL AB RLD 2017-12-19 84e616aacf4f…2026-08-18 06:07:40 2026-07 N209139-001 PREXXARTAN 4MG/ML **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** SOLUTION / ORAL AB RLD 2017-12-19 caaa826d4ba7…2026-02-19 14:30 UTC 2026-02 N209139-001 PREXXARTAN 4MG/ML **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** SOLUTION / ORAL RLD 2017-12-19 011fe1cb6892…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 N209139-001 PREXXARTAN 4MG/ML **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** SOLUTION / ORAL RLD 2017-12-19 31067a03dcf5…2025-08-23 18:47 UTC 2025-08 N209139-001 PREXXARTAN 4MG/ML **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** SOLUTION / ORAL RLD 2017-12-19 6a471c1ec25d…2025-03-22 03:13 UTC · 3 captures of this ZIP 2025-03 N209139-001 PREXXARTAN 20MG/5ML **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** SOLUTION / ORAL RLD 2017-12-19 fd3edfee7708…2025-03-22 03:13 UTC · 3 captures of this ZIP 2025-03 N209139-002 PREXXARTAN 80MG/20ML **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** SOLUTION / ORAL RLD 2017-12-19 fd3edfee7708…2025-02-26 10:13 UTC · 3 captures of this ZIP 2025-02 N209139-001 PREXXARTAN 20MG/5ML **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** SOLUTION / ORAL RLD 2017-12-19 b8a1b40f171c…2025-02-26 10:13 UTC · 3 captures of this ZIP 2025-02 N209139-002 PREXXARTAN 80MG/20ML **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** SOLUTION / ORAL RLD 2017-12-19 b8a1b40f171c…2025-01-19 17:59 UTC · 7 captures of this ZIP 2025-01 N209139-001 PREXXARTAN 20MG/5ML **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** SOLUTION / ORAL RLD 2017-12-19 03ed91905a0d…2025-01-19 17:59 UTC · 7 captures of this ZIP 2025-01 N209139-002 PREXXARTAN 80MG/20ML **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** SOLUTION / ORAL RLD 2017-12-19 03ed91905a0d…2024-12-13 21:23 UTC · 2 captures of this ZIP 2024-12 N209139-001 PREXXARTAN 20MG/5ML **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** SOLUTION / ORAL RLD 2017-12-19 2680178bc6a6…2024-12-13 21:23 UTC · 2 captures of this ZIP 2024-12 N209139-002 PREXXARTAN 80MG/20ML **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** SOLUTION / ORAL RLD 2017-12-19 2680178bc6a6…2024-09-14 05:58 UTC · 2 captures of this ZIP 2024-09 N209139-001 PREXXARTAN 20MG/5ML **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** SOLUTION / ORAL RLD 2017-12-19 5bbf6a4d5a75…2024-09-14 05:58 UTC · 2 captures of this ZIP 2024-09 N209139-002 PREXXARTAN 80MG/20ML **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** SOLUTION / ORAL RLD 2017-12-19 5bbf6a4d5a75…2024-11-08 22:44 UTC · 3 captures of this ZIP 2024-11 N209139-001 PREXXARTAN 20MG/5ML **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** SOLUTION / ORAL RLD 2017-12-19 d8e5a09893c0…2024-11-08 22:44 UTC · 3 captures of this ZIP 2024-11 N209139-002 PREXXARTAN 80MG/20ML **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** SOLUTION / ORAL RLD 2017-12-19 d8e5a09893c0…2024-10-29 15:01 UTC 2024-10 N209139-001 PREXXARTAN 20MG/5ML **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** SOLUTION / ORAL RLD 2017-12-19 d06236e962d9…2024-10-29 15:01 UTC 2024-10 N209139-002 PREXXARTAN 80MG/20ML **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** SOLUTION / ORAL RLD 2017-12-19 d06236e962d9…2024-08-13 05:28 UTC · 3 captures of this ZIP 2024-08 N209139-001 PREXXARTAN 20MG/5ML **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** SOLUTION / ORAL RLD 2017-12-19 79d66fd596c7…2024-08-13 05:28 UTC · 3 captures of this ZIP 2024-08 N209139-002 PREXXARTAN 80MG/20ML **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** SOLUTION / ORAL RLD 2017-12-19 79d66fd596c7…2024-07-13 05:37 UTC · 2 captures of this ZIP 2024-07 N209139-001 PREXXARTAN 20MG/5ML **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** SOLUTION / ORAL RLD 2017-12-19 301d65b070ca…2024-07-13 05:37 UTC · 2 captures of this ZIP 2024-07 N209139-002 PREXXARTAN 80MG/20ML **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** SOLUTION / ORAL RLD 2017-12-19 301d65b070ca…2024-06-18 03:08 UTC · 5 captures of this ZIP 2024-06 N209139-001 PREXXARTAN 20MG/5ML **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** SOLUTION / ORAL RLD 2017-12-19 1e350fbaab3a…2024-06-18 03:08 UTC · 5 captures of this ZIP 2024-06 N209139-002 PREXXARTAN 80MG/20ML **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** SOLUTION / ORAL RLD 2017-12-19 1e350fbaab3a…2024-05-31 18:47 UTC 2024-05 N209139-001 PREXXARTAN 20MG/5ML **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** SOLUTION / ORAL RLD 2017-12-19 8072bd15b7f6…2024-05-31 18:47 UTC 2024-05 N209139-002 PREXXARTAN 80MG/20ML **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** SOLUTION / ORAL RLD 2017-12-19 8072bd15b7f6…2022-06-29 02:47 UTC · 2 captures of this ZIP 2022-06 N209139-001 PREXXARTAN 20MG/5ML SOLUTION / ORAL RLD 2017-12-19 5c6f7cd8ea54…2022-06-29 02:47 UTC · 2 captures of this ZIP 2022-06 N209139-002 PREXXARTAN 80MG/20ML SOLUTION / ORAL RLD 2017-12-19 5c6f7cd8ea54…2022-04-08 23:34 UTC 2022-04 N209139-001 PREXXARTAN 20MG/5ML SOLUTION / ORAL RLD 2017-12-19 5d02ea3f76ae…2022-04-08 23:34 UTC 2022-04 N209139-002 PREXXARTAN 80MG/20ML SOLUTION / ORAL RLD 2017-12-19 5d02ea3f76ae…2022-04-04 05:41 UTC 2022-04 N209139-001 PREXXARTAN 20MG/5ML SOLUTION / ORAL RLD 2017-12-19 4b0b4de00fa7…2022-04-04 05:41 UTC 2022-04 N209139-002 PREXXARTAN 80MG/20ML SOLUTION / ORAL RLD 2017-12-19 4b0b4de00fa7…2019-12-13 00:20 UTC 2019-12 N209139-001 PREXXARTAN 20MG/5ML SOLUTION / ORAL RLD 2017-12-19 74a2ff9319b5…2019-12-13 00:20 UTC 2019-12 N209139-002 PREXXARTAN 80MG/20ML SOLUTION / ORAL RLD 2017-12-19 74a2ff9319b5…2022-03-09 01:35 UTC 2022-03 N209139-001 PREXXARTAN 20MG/5ML SOLUTION / ORAL RLD 2017-12-19 bb7c543d1eb4…2022-03-09 01:35 UTC 2022-03 N209139-002 PREXXARTAN 80MG/20ML SOLUTION / ORAL RLD 2017-12-19 bb7c543d1eb4…2021-12-28 21:50 UTC 2021-12 N209139-001 PREXXARTAN 20MG/5ML SOLUTION / ORAL RLD 2017-12-19 782e0a99824c…2021-12-28 21:50 UTC 2021-12 N209139-002 PREXXARTAN 80MG/20ML SOLUTION / ORAL RLD 2017-12-19 782e0a99824c…
Observed Orange Book normalized TE history# Reported adverse events (FAERS/openFDA)# Adverse event summaries are temporarily unavailable. Other product information remains available.
FDA-Initiated Inactive NDC Indexing# DailyMed Dashboard NDC Coverage# NDC, Dashboard title, SPL version table NDC Dashboard title SPL version Validation Dashboard ZIP 25208-100 PREXXARTAN SOLUTION [MEDICURE INTERNATIONAL INC.] 1 Legacy NDC 20180115_df73d781-65d8-4aaa-9b0f-de4341f639ec.zip