Home NDC 72789-553-90 Valsartan
Product NDC 72789-553
Requested package NDC 72789-553-90
11-digit product format 727890553
Labeler code 72789
Product ID 72789-553_4c4a5a50-2972-acf1-e063-6294a90ab318
Type HUMAN PRESCRIPTION DRUG
Nonproprietary name Valsartan
Dosage form TABLET, FILM COATED
Route ORAL
Labeler PD-Rx Pharmaceuticals, Inc.
Application ANDA218991
Marketing category ANDA
Marketing start 2024-08-30
Substance VALSARTAN
Active strength 40 mg/1
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 43 .
Orange Book products# Current product rows page 1 of 1 · 4 matching rows.
Application-product, Trade name, Ingredient table Application-product Trade name Ingredient Strength Dosage form / route TE codes RLD / RS Approval date A218991-001 VALSARTAN VALSARTAN 40MG TABLET / ORAL AB 2024-07-22 A218991-002 VALSARTAN VALSARTAN 80MG TABLET / ORAL AB 2024-07-22 A218991-003 VALSARTAN VALSARTAN 160MG TABLET / ORAL AB 2024-07-22 A218991-004 VALSARTAN VALSARTAN 320MG TABLET / ORAL AB 2024-07-22
Therapeutic equivalence codes# Current TE-code rows page 1 of 1 · 4 matching rows.
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 · 56 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 2026-09-14 22:38:34 2026-08 A218991-001 VALSARTAN 40MG TABLET / ORAL AB 2024-07-22 84e616aacf4f…2026-09-14 22:38:34 2026-08 A218991-002 VALSARTAN 80MG TABLET / ORAL AB 2024-07-22 84e616aacf4f…2026-09-14 22:38:34 2026-08 A218991-003 VALSARTAN 160MG TABLET / ORAL AB 2024-07-22 84e616aacf4f…2026-09-14 22:38:34 2026-08 A218991-004 VALSARTAN 320MG TABLET / ORAL AB 2024-07-22 84e616aacf4f…2026-08-18 06:07:40 2026-07 A218991-001 VALSARTAN 40MG TABLET / ORAL AB 2024-07-22 caaa826d4ba7…2026-08-18 06:07:40 2026-07 A218991-002 VALSARTAN 80MG TABLET / ORAL AB 2024-07-22 caaa826d4ba7…2026-08-18 06:07:40 2026-07 A218991-003 VALSARTAN 160MG TABLET / ORAL AB 2024-07-22 caaa826d4ba7…2026-08-18 06:07:40 2026-07 A218991-004 VALSARTAN 320MG TABLET / ORAL AB 2024-07-22 caaa826d4ba7…2026-02-19 14:30 UTC 2026-02 A218991-001 VALSARTAN 40MG TABLET / ORAL AB 2024-07-22 011fe1cb6892…2026-02-19 14:30 UTC 2026-02 A218991-002 VALSARTAN 80MG TABLET / ORAL AB 2024-07-22 011fe1cb6892…2026-02-19 14:30 UTC 2026-02 A218991-003 VALSARTAN 160MG TABLET / ORAL AB 2024-07-22 011fe1cb6892…2026-02-19 14:30 UTC 2026-02 A218991-004 VALSARTAN 320MG TABLET / ORAL AB 2024-07-22 011fe1cb6892…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 A218991-001 VALSARTAN 40MG TABLET / ORAL AB 2024-07-22 31067a03dcf5…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 A218991-002 VALSARTAN 80MG TABLET / ORAL AB 2024-07-22 31067a03dcf5…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 A218991-003 VALSARTAN 160MG TABLET / ORAL AB 2024-07-22 31067a03dcf5…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 A218991-004 VALSARTAN 320MG TABLET / ORAL AB 2024-07-22 31067a03dcf5…2025-08-23 18:47 UTC 2025-08 A218991-001 VALSARTAN 40MG TABLET / ORAL AB 2024-07-22 6a471c1ec25d…2025-08-23 18:47 UTC 2025-08 A218991-002 VALSARTAN 80MG TABLET / ORAL AB 2024-07-22 6a471c1ec25d…2025-08-23 18:47 UTC 2025-08 A218991-003 VALSARTAN 160MG TABLET / ORAL AB 2024-07-22 6a471c1ec25d…2025-08-23 18:47 UTC 2025-08 A218991-004 VALSARTAN 320MG TABLET / ORAL AB 2024-07-22 6a471c1ec25d…2025-03-22 03:13 UTC · 3 captures of this ZIP 2025-03 A218991-001 VALSARTAN 40MG TABLET / ORAL AB 2024-07-22 fd3edfee7708…2025-03-22 03:13 UTC · 3 captures of this ZIP 2025-03 A218991-002 VALSARTAN 80MG TABLET / ORAL AB 2024-07-22 fd3edfee7708…2025-03-22 03:13 UTC · 3 captures of this ZIP 2025-03 A218991-003 VALSARTAN 160MG TABLET / ORAL AB 2024-07-22 fd3edfee7708…2025-03-22 03:13 UTC · 3 captures of this ZIP 2025-03 A218991-004 VALSARTAN 320MG TABLET / ORAL AB 2024-07-22 fd3edfee7708…2025-02-26 10:13 UTC · 3 captures of this ZIP 2025-02 A218991-001 VALSARTAN 40MG TABLET / ORAL AB 2024-07-22 b8a1b40f171c…2025-02-26 10:13 UTC · 3 captures of this ZIP 2025-02 A218991-002 VALSARTAN 80MG TABLET / ORAL AB 2024-07-22 b8a1b40f171c…2025-02-26 10:13 UTC · 3 captures of this ZIP 2025-02 A218991-003 VALSARTAN 160MG TABLET / ORAL AB 2024-07-22 b8a1b40f171c…2025-02-26 10:13 UTC · 3 captures of this ZIP 2025-02 A218991-004 VALSARTAN 320MG TABLET / ORAL AB 2024-07-22 b8a1b40f171c…2025-01-19 17:59 UTC · 7 captures of this ZIP 2025-01 A218991-001 VALSARTAN 40MG TABLET / ORAL AB 2024-07-22 03ed91905a0d…2025-01-19 17:59 UTC · 7 captures of this ZIP 2025-01 A218991-002 VALSARTAN 80MG TABLET / ORAL AB 2024-07-22 03ed91905a0d…2025-01-19 17:59 UTC · 7 captures of this ZIP 2025-01 A218991-003 VALSARTAN 160MG TABLET / ORAL AB 2024-07-22 03ed91905a0d…2025-01-19 17:59 UTC · 7 captures of this ZIP 2025-01 A218991-004 VALSARTAN 320MG TABLET / ORAL AB 2024-07-22 03ed91905a0d…2024-12-13 21:23 UTC · 2 captures of this ZIP 2024-12 A218991-001 VALSARTAN 40MG TABLET / ORAL AB 2024-07-22 2680178bc6a6…2024-12-13 21:23 UTC · 2 captures of this ZIP 2024-12 A218991-002 VALSARTAN 80MG TABLET / ORAL AB 2024-07-22 2680178bc6a6…2024-12-13 21:23 UTC · 2 captures of this ZIP 2024-12 A218991-003 VALSARTAN 160MG TABLET / ORAL AB 2024-07-22 2680178bc6a6…2024-12-13 21:23 UTC · 2 captures of this ZIP 2024-12 A218991-004 VALSARTAN 320MG TABLET / ORAL AB 2024-07-22 2680178bc6a6…2024-09-14 05:58 UTC · 2 captures of this ZIP 2024-09 A218991-001 VALSARTAN 40MG TABLET / ORAL AB 2024-07-22 5bbf6a4d5a75…2024-09-14 05:58 UTC · 2 captures of this ZIP 2024-09 A218991-002 VALSARTAN 80MG TABLET / ORAL AB 2024-07-22 5bbf6a4d5a75…2024-09-14 05:58 UTC · 2 captures of this ZIP 2024-09 A218991-003 VALSARTAN 160MG TABLET / ORAL AB 2024-07-22 5bbf6a4d5a75…2024-09-14 05:58 UTC · 2 captures of this ZIP 2024-09 A218991-004 VALSARTAN 320MG TABLET / ORAL AB 2024-07-22 5bbf6a4d5a75…
Observed Orange Book normalized TE history# Normalized TE history page 1 of 2 · 56 observed states.
Reported adverse events (FAERS/openFDA)# Adverse event summaries are temporarily unavailable. Other product information remains available.
Additional Listing Data#
Finished product Yes
Brand name base Valsartan
Listing expiration 2027-12-31 Active Ingredients# Ingredient, Strength table Ingredient Strength VALSARTAN 40 mg/1
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 349483 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 72789-553-90 Valsartan 90 in 1 BOTTLE, PLASTIC TABLET, FILM COATED 90 2
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 · 3 matching rows.
DailyMed RxNorm Mappings# Packages# Package NDC, 11-digit format, Description table Package NDC 11-digit format Description Marketing start Sample Exclude flag Status 72789-553-90 72789055390 90 TABLET, FILM COATED in 1 BOTTLE, PLASTIC (72789-553-90) 2026-03-05 No No Current