Home NDC 76281-155 PREXXARTAN
Product NDC 76281-155
11-digit product format 762810155
Labeler code 76281
Product ID 76281-155_508c61d6-dbb1-5d06-e063-6394a90aa5ec
Type HUMAN PRESCRIPTION DRUG
Nonproprietary name PREXXARTAN
Dosage form SOLUTION
Route ORAL
Labeler AptaPharma Inc.
Application NDA209139
Marketing category NDA
Marketing start 2026-05-05
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 2027-12-31
Current FDA listing Yes 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date N209139-001 PREXXARTAN VALSARTAN 4MG/ML **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** SOLUTION / ORAL RLD 2017-12-19
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 · 78 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UTC 2026-02 N209139-001 PREXXARTAN 4MG/ML **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** SOLUTION / ORAL RLD 2017-12-19 011fe1cb6892…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 N209139-001 PREXXARTAN 4MG/ML **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** SOLUTION / ORAL RLD 2017-12-19 31067a03dcf5…2025-08-23 18:47 UTC 2025-08 N209139-001 PREXXARTAN 4MG/ML **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** SOLUTION / ORAL RLD 2017-12-19 6a471c1ec25d…2025-03-22 03:13 UTC · 3 captures of this ZIP 2025-03 N209139-001 PREXXARTAN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…2021-03-12 10:30 UTC 2021-03 N209139-001 PREXXARTAN 20MG/5ML SOLUTION / ORAL RLD 2017-12-19 5aa47cf7b7d7…
Additional Listing Data#
Finished product Yes
Brand name base PREXXARTAN
Listing expiration 2027-12-31 Active Ingredients# Ingredient, Strength table Ingredient Strength VALSARTAN 4 mg/mL
Harmonized UNII identifiers# UNII identifiers page 1 of 1 · 1 matching rows.
Identifier, FDA.report destination table Identifier FDA.report destination 80M03YXJ7I Internal UNII lookup
Harmonized RxCUI identifiers# RxCUI identifiers page 1 of 1 · 1 matching rows.
Identifier, FDA.report destination table Identifier FDA.report destination 1996254 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 76281-155-56 PREXXARTAN 20 mL in 1 CUP, UNIT-DOSE SOLUTION 20 1 76281-155-64 PREXXARTAN 120 mL in 1 BOTTLE SOLUTION 120 1 76281-155-82 PREXXARTAN 473 mL in 1 BOTTLE SOLUTION 473 1 76281-155-99 PREXXARTAN 10 in 1 TRAY SOLUTION 10 1
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.
DailyMed RxNorm Mappings# Packages# Package NDC, 11-digit format, Description table Package NDC 11-digit format Description Units Marketing start Sample Exclude flag Status 76281-155-56 76281015556 20 mL in 1 CUP, UNIT-DOSE (76281-155-56) 20 ml 2026-05-05 No No Current 76281-155-64 76281015564 120 mL in 1 BOTTLE (76281-155-64) 120 ml 2026-05-05 No No Current 76281-155-82 76281015582 473 mL in 1 BOTTLE (76281-155-82) 473 ml 2026-05-05 No No Current 76281-155-99 76281015599 10 CUP, UNIT-DOSE in 1 TRAY (76281-155-99) / 20 mL in 1 CUP, UNIT-DOSE (76281-155-56) 2026-05-05 No No Current