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 42 .
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date N209139-001 PREXXARTAN VALSARTAN 4MG/ML **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** SOLUTION / ORAL AB RLD 2017-12-19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 2 · 79 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 2026-08-18 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N209139-001 PREXXARTAN 4MG/ML **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** SOLUTION / ORAL AB RLD 2017-12-19 caaa826d4ba7…2026-02-19 14:30 UTC 2026-02 N209139-001 PREXXARTAN 4MG/ML **Federal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…2021-05-05 16:15 UTC · 3 captures of this ZIP 2021-05 N209139-001 PREXXARTAN 20MG/5ML SOLUTION / ORAL RLD 2017-12-19 87673890dc5c…2021-05-05 16:15 UTC · 3 captures of this ZIP 2021-05 N209139-002 PREXXARTAN 80MG/20ML SOLUTION / ORAL RLD 2017-12-19 87673890dc5c…
Observed Orange Book normalized TE history# Captured, Edition, Application-product table Captured Edition Application-product TE code Order Source SHA-256 2026-08-18 06:07:40 2026-07 N209139-001 AB 1 caaa826d4ba7…
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
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 · 1 matching rows.
Brand, Generic, Manufacturer table Brand Generic Manufacturer SPL set ID Effective date Available safety fields Join PREXXARTAN PREXXARTAN AptaPharma Inc. 508c5de8-9c70-57f5-e063-6394a90af295 2026-04-27 Boxed warning, Warnings, Adverse reactions Exact identifier application applno (NDA): 209139 application number: NDA209139