Home NDC 62332-045 Valsartan
Product NDC 62332-045
11-digit product format 623320045
Labeler code 62332
Product ID 62332-045_d9c3b1ac-bbb0-4974-b337-88e247093c72
Type HUMAN PRESCRIPTION DRUG
Nonproprietary name Valsartan
Dosage form TABLET
Route ORAL
Labeler Alembic Pharmaceuticals Inc.
Application ANDA091367
Marketing category ANDA
Marketing start 2016-05-20
Substance VALSARTAN
Active strength 80 mg/1
Pharmacologic classes Angiotensin 2 Receptor Antagonists [MoA], Angiotensin 2 Receptor Blocker [EPC]
NDC exclude flag No
Listing certified through 2026-12-31
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 · 4 matching rows.
Application-product, Trade name, Ingredient table Application-product Trade name Ingredient Strength Dosage form / route TE codes RLD / RS Approval date A091367-001 VALSARTAN VALSARTAN 40MG TABLET / ORAL AB 2015-01-05 A091367-002 VALSARTAN VALSARTAN 80MG TABLET / ORAL AB 2015-01-05 A091367-003 VALSARTAN VALSARTAN 160MG TABLET / ORAL AB 2015-01-05 A091367-004 VALSARTAN VALSARTAN 320MG TABLET / ORAL AB 2015-01-05
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 5 · 164 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 A091367-001 VALSARTAN 40MG TABLET / ORAL AB 2015-01-05 011fe1cb6892…2026-02-19 14:30 UTC 2026-02 A091367-002 VALSARTAN 80MG TABLET / ORAL AB 2015-01-05 011fe1cb6892…2026-02-19 14:30 UTC 2026-02 A091367-003 VALSARTAN 160MG TABLET / ORAL AB 2015-01-05 011fe1cb6892…2026-02-19 14:30 UTC 2026-02 A091367-004 VALSARTAN 320MG TABLET / ORAL AB 2015-01-05 011fe1cb6892…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 A091367-001 VALSARTAN 40MG TABLET / ORAL AB 2015-01-05 31067a03dcf5…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 A091367-002 VALSARTAN 80MG TABLET / ORAL AB 2015-01-05 31067a03dcf5…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 A091367-003 VALSARTAN 160MG TABLET / ORAL AB 2015-01-05 31067a03dcf5…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 A091367-004 VALSARTAN 320MG TABLET / ORAL AB 2015-01-05 31067a03dcf5…2025-08-23 18:47 UTC 2025-08 A091367-001 VALSARTAN 40MG TABLET / ORAL AB 2015-01-05 6a471c1ec25d…2025-08-23 18:47 UTC 2025-08 A091367-002 VALSARTAN 80MG TABLET / ORAL AB 2015-01-05 6a471c1ec25d…2025-08-23 18:47 UTC 2025-08 A091367-003 VALSARTAN 160MG TABLET / ORAL AB 2015-01-05 6a471c1ec25d…2025-08-23 18:47 UTC 2025-08 A091367-004 VALSARTAN 320MG TABLET / ORAL AB 2015-01-05 6a471c1ec25d…2025-03-22 03:13 UTC · 3 captures of this ZIP 2025-03 A091367-001 VALSARTAN 40MG TABLET / ORAL AB 2015-01-05 fd3edfee7708…2025-03-22 03:13 UTC · 3 captures of this ZIP 2025-03 A091367-002 VALSARTAN 80MG TABLET / ORAL AB 2015-01-05 fd3edfee7708…2025-03-22 03:13 UTC · 3 captures of this ZIP 2025-03 A091367-003 VALSARTAN 160MG TABLET / ORAL AB 2015-01-05 fd3edfee7708…2025-03-22 03:13 UTC · 3 captures of this ZIP 2025-03 A091367-004 VALSARTAN 320MG TABLET / ORAL AB 2015-01-05 fd3edfee7708…2025-02-26 10:13 UTC · 3 captures of this ZIP 2025-02 A091367-001 VALSARTAN 40MG TABLET / ORAL AB 2015-01-05 b8a1b40f171c…2025-02-26 10:13 UTC · 3 captures of this ZIP 2025-02 A091367-002 VALSARTAN 80MG TABLET / ORAL AB 2015-01-05 b8a1b40f171c…2025-02-26 10:13 UTC · 3 captures of this ZIP 2025-02 A091367-003 VALSARTAN 160MG TABLET / ORAL AB 2015-01-05 b8a1b40f171c…2025-02-26 10:13 UTC · 3 captures of this ZIP 2025-02 A091367-004 VALSARTAN 320MG TABLET / ORAL AB 2015-01-05 b8a1b40f171c…2025-01-19 17:59 UTC · 7 captures of this ZIP 2025-01 A091367-001 VALSARTAN 40MG TABLET / ORAL AB 2015-01-05 03ed91905a0d…2025-01-19 17:59 UTC · 7 captures of this ZIP 2025-01 A091367-002 VALSARTAN 80MG TABLET / ORAL AB 2015-01-05 03ed91905a0d…2025-01-19 17:59 UTC · 7 captures of this ZIP 2025-01 A091367-003 VALSARTAN 160MG TABLET / ORAL AB 2015-01-05 03ed91905a0d…2025-01-19 17:59 UTC · 7 captures of this ZIP 2025-01 A091367-004 VALSARTAN 320MG TABLET / ORAL AB 2015-01-05 03ed91905a0d…2024-12-13 21:23 UTC · 2 captures of this ZIP 2024-12 A091367-001 VALSARTAN 40MG TABLET / ORAL AB 2015-01-05 2680178bc6a6…2024-12-13 21:23 UTC · 2 captures of this ZIP 2024-12 A091367-002 VALSARTAN 80MG TABLET / ORAL AB 2015-01-05 2680178bc6a6…2024-12-13 21:23 UTC · 2 captures of this ZIP 2024-12 A091367-003 VALSARTAN 160MG TABLET / ORAL AB 2015-01-05 2680178bc6a6…2024-12-13 21:23 UTC · 2 captures of this ZIP 2024-12 A091367-004 VALSARTAN 320MG TABLET / ORAL AB 2015-01-05 2680178bc6a6…2024-09-14 05:58 UTC · 2 captures of this ZIP 2024-09 A091367-001 VALSARTAN 40MG TABLET / ORAL AB 2015-01-05 5bbf6a4d5a75…2024-09-14 05:58 UTC · 2 captures of this ZIP 2024-09 A091367-002 VALSARTAN 80MG TABLET / ORAL AB 2015-01-05 5bbf6a4d5a75…2024-09-14 05:58 UTC · 2 captures of this ZIP 2024-09 A091367-003 VALSARTAN 160MG TABLET / ORAL AB 2015-01-05 5bbf6a4d5a75…2024-09-14 05:58 UTC · 2 captures of this ZIP 2024-09 A091367-004 VALSARTAN 320MG TABLET / ORAL AB 2015-01-05 5bbf6a4d5a75…2024-11-08 22:44 UTC · 3 captures of this ZIP 2024-11 A091367-001 VALSARTAN 40MG TABLET / ORAL AB 2015-01-05 d8e5a09893c0…2024-11-08 22:44 UTC · 3 captures of this ZIP 2024-11 A091367-002 VALSARTAN 80MG TABLET / ORAL AB 2015-01-05 d8e5a09893c0…2024-11-08 22:44 UTC · 3 captures of this ZIP 2024-11 A091367-003 VALSARTAN 160MG TABLET / ORAL AB 2015-01-05 d8e5a09893c0…2024-11-08 22:44 UTC · 3 captures of this ZIP 2024-11 A091367-004 VALSARTAN 320MG TABLET / ORAL AB 2015-01-05 d8e5a09893c0…2024-10-29 15:01 UTC 2024-10 A091367-001 VALSARTAN 40MG TABLET / ORAL AB 2015-01-05 d06236e962d9…2024-10-29 15:01 UTC 2024-10 A091367-002 VALSARTAN 80MG TABLET / ORAL AB 2015-01-05 d06236e962d9…2024-10-29 15:01 UTC 2024-10 A091367-003 VALSARTAN 160MG TABLET / ORAL AB 2015-01-05 d06236e962d9…2024-10-29 15:01 UTC 2024-10 A091367-004 VALSARTAN 320MG TABLET / ORAL AB 2015-01-05 d06236e962d9…
Observed Orange Book normalized TE history# Normalized TE history page 1 of 5 · 164 observed states.
Additional Listing Data#
Finished product Yes
Brand name base Valsartan
Listing expiration 2026-12-31 Active Ingredients# Ingredient, Strength table Ingredient Strength VALSARTAN 80 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 · 4 matching rows.
Identifier, FDA.report destination table Identifier FDA.report destination 349199 Internal RxNorm lookup 349200 Internal RxNorm lookup 349201 Internal RxNorm lookup 349483 Internal RxNorm lookup
Harmonized SPL set identifiers# SPL set identifiers page 1 of 1 · 1 matching rows.
DailyMed Product Concepts# DailyMed Package Descriptions# DailyMed Dashboard NDC Coverage# NDC, Dashboard title, SPL version table NDC Dashboard title SPL version Validation Dashboard ZIP 62332-045 VALSARTAN TABLET [ALEMBIC PHARMACEUTICALS INC.] 14 Current NDC, Legacy NDC, 5 package rows 20210828_8478a05f-38fd-412d-af49-69a73a787c8f.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 · 2 matching rows.
DailyMed RxNorm Mappings# Packages# Package NDC, 11-digit format, Description table Package NDC 11-digit format Description Units Marketing start Marketing end Sample Exclude flag Status 62332-045-10 62332004510 100 TABLET in 1 CARTON (62332-045-10) 100 tablet 2016-05-20 0000-00-00 No No Current 62332-045-30 62332004530 30 TABLET in 1 BOTTLE (62332-045-30) 30 tablet 2016-05-20 0000-00-00 No No Current 62332-045-71 62332004571 500 TABLET in 1 BOTTLE (62332-045-71) 500 tablet 2016-05-20 0000-00-00 No No Current 62332-045-90 62332004590 90 TABLET in 1 BOTTLE (62332-045-90) 90 tablet 2016-05-20 0000-00-00 No No Current 62332-045-91 62332004591 1000 TABLET in 1 BOTTLE (62332-045-91) 1000 tablet 2016-05-20 0000-00-00 No No Current