Home NDC 0078-1245-34 Diovan
Product NDC 0078-1245
Requested package NDC 0078-1245-34
11-digit product format 000781245
Labeler code 0078
Product ID 0078-1245_bb542e5b-0b85-45db-8542-e203b9cd8618
Type HUMAN PRESCRIPTION DRUG
Nonproprietary name valsartan
Dosage form TABLET
Route ORAL
Labeler Novartis Pharmaceuticals Corporation
Application NDA021283
Marketing category NDA
Marketing start 2001-07-01
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 N021283-001 DIOVAN VALSARTAN 80MG TABLET / ORAL AB RLD 2001-07-18 N021283-002 DIOVAN VALSARTAN 160MG TABLET / ORAL AB RLD 2001-07-18 N021283-003 DIOVAN VALSARTAN 320MG TABLET / ORAL AB RLD, RS 2001-07-18 N021283-004 DIOVAN VALSARTAN 40MG TABLET / ORAL AB RLD 2002-08-14
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 N021283-001 DIOVAN 80MG TABLET / ORAL AB RLD 2001-07-18 011fe1cb6892…2026-02-19 14:30 UTC 2026-02 N021283-002 DIOVAN 160MG TABLET / ORAL AB RLD 2001-07-18 011fe1cb6892…2026-02-19 14:30 UTC 2026-02 N021283-003 DIOVAN 320MG TABLET / ORAL AB RLD, RS 2001-07-18 011fe1cb6892…2026-02-19 14:30 UTC 2026-02 N021283-004 DIOVAN 40MG TABLET / ORAL AB RLD 2002-08-14 011fe1cb6892…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 N021283-001 DIOVAN 80MG TABLET / ORAL AB RLD 2001-07-18 31067a03dcf5…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 N021283-002 DIOVAN 160MG TABLET / ORAL AB RLD 2001-07-18 31067a03dcf5…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 N021283-003 DIOVAN 320MG TABLET / ORAL AB RLD, RS 2001-07-18 31067a03dcf5…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 N021283-004 DIOVAN 40MG TABLET / ORAL AB RLD 2002-08-14 31067a03dcf5…2025-08-23 18:47 UTC 2025-08 N021283-001 DIOVAN 80MG TABLET / ORAL AB RLD 2001-07-18 6a471c1ec25d…2025-08-23 18:47 UTC 2025-08 N021283-002 DIOVAN 160MG TABLET / ORAL AB RLD 2001-07-18 6a471c1ec25d…2025-08-23 18:47 UTC 2025-08 N021283-003 DIOVAN 320MG TABLET / ORAL AB RLD, RS 2001-07-18 6a471c1ec25d…2025-08-23 18:47 UTC 2025-08 N021283-004 DIOVAN 40MG TABLET / ORAL AB RLD 2002-08-14 6a471c1ec25d…2025-03-22 03:13 UTC · 3 captures of this ZIP 2025-03 N021283-001 DIOVAN 80MG TABLET / ORAL AB RLD 2001-07-18 fd3edfee7708…2025-03-22 03:13 UTC · 3 captures of this ZIP 2025-03 N021283-002 DIOVAN 160MG TABLET / ORAL AB RLD 2001-07-18 fd3edfee7708…2025-03-22 03:13 UTC · 3 captures of this ZIP 2025-03 N021283-003 DIOVAN 320MG TABLET / ORAL AB RLD, RS 2001-07-18 fd3edfee7708…2025-03-22 03:13 UTC · 3 captures of this ZIP 2025-03 N021283-004 DIOVAN 40MG TABLET / ORAL AB RLD 2002-08-14 fd3edfee7708…2025-02-26 10:13 UTC · 3 captures of this ZIP 2025-02 N021283-001 DIOVAN 80MG TABLET / ORAL AB RLD 2001-07-18 b8a1b40f171c…2025-02-26 10:13 UTC · 3 captures of this ZIP 2025-02 N021283-002 DIOVAN 160MG TABLET / ORAL AB RLD 2001-07-18 b8a1b40f171c…2025-02-26 10:13 UTC · 3 captures of this ZIP 2025-02 N021283-003 DIOVAN 320MG TABLET / ORAL AB RLD, RS 2001-07-18 b8a1b40f171c…2025-02-26 10:13 UTC · 3 captures of this ZIP 2025-02 N021283-004 DIOVAN 40MG TABLET / ORAL AB RLD 2002-08-14 b8a1b40f171c…2025-01-19 17:59 UTC · 7 captures of this ZIP 2025-01 N021283-001 DIOVAN 80MG TABLET / ORAL AB RLD 2001-07-18 03ed91905a0d…2025-01-19 17:59 UTC · 7 captures of this ZIP 2025-01 N021283-002 DIOVAN 160MG TABLET / ORAL AB RLD 2001-07-18 03ed91905a0d…2025-01-19 17:59 UTC · 7 captures of this ZIP 2025-01 N021283-003 DIOVAN 320MG TABLET / ORAL AB RLD, RS 2001-07-18 03ed91905a0d…2025-01-19 17:59 UTC · 7 captures of this ZIP 2025-01 N021283-004 DIOVAN 40MG TABLET / ORAL AB RLD 2002-08-14 03ed91905a0d…2024-12-13 21:23 UTC · 2 captures of this ZIP 2024-12 N021283-001 DIOVAN 80MG TABLET / ORAL AB RLD 2001-07-18 2680178bc6a6…2024-12-13 21:23 UTC · 2 captures of this ZIP 2024-12 N021283-002 DIOVAN 160MG TABLET / ORAL AB RLD 2001-07-18 2680178bc6a6…2024-12-13 21:23 UTC · 2 captures of this ZIP 2024-12 N021283-003 DIOVAN 320MG TABLET / ORAL AB RLD, RS 2001-07-18 2680178bc6a6…2024-12-13 21:23 UTC · 2 captures of this ZIP 2024-12 N021283-004 DIOVAN 40MG TABLET / ORAL AB RLD 2002-08-14 2680178bc6a6…2024-09-14 05:58 UTC · 2 captures of this ZIP 2024-09 N021283-001 DIOVAN 80MG TABLET / ORAL AB RLD 2001-07-18 5bbf6a4d5a75…2024-09-14 05:58 UTC · 2 captures of this ZIP 2024-09 N021283-002 DIOVAN 160MG TABLET / ORAL AB RLD 2001-07-18 5bbf6a4d5a75…2024-09-14 05:58 UTC · 2 captures of this ZIP 2024-09 N021283-003 DIOVAN 320MG TABLET / ORAL AB RLD, RS 2001-07-18 5bbf6a4d5a75…2024-09-14 05:58 UTC · 2 captures of this ZIP 2024-09 N021283-004 DIOVAN 40MG TABLET / ORAL AB RLD 2002-08-14 5bbf6a4d5a75…2024-11-08 22:44 UTC · 3 captures of this ZIP 2024-11 N021283-001 DIOVAN 80MG TABLET / ORAL AB RLD 2001-07-18 d8e5a09893c0…2024-11-08 22:44 UTC · 3 captures of this ZIP 2024-11 N021283-002 DIOVAN 160MG TABLET / ORAL AB RLD 2001-07-18 d8e5a09893c0…2024-11-08 22:44 UTC · 3 captures of this ZIP 2024-11 N021283-003 DIOVAN 320MG TABLET / ORAL AB RLD, RS 2001-07-18 d8e5a09893c0…2024-11-08 22:44 UTC · 3 captures of this ZIP 2024-11 N021283-004 DIOVAN 40MG TABLET / ORAL AB RLD 2002-08-14 d8e5a09893c0…2024-10-29 15:01 UTC 2024-10 N021283-001 DIOVAN 80MG TABLET / ORAL AB RLD 2001-07-18 d06236e962d9…2024-10-29 15:01 UTC 2024-10 N021283-002 DIOVAN 160MG TABLET / ORAL AB RLD 2001-07-18 d06236e962d9…2024-10-29 15:01 UTC 2024-10 N021283-003 DIOVAN 320MG TABLET / ORAL AB RLD, RS 2001-07-18 d06236e962d9…2024-10-29 15:01 UTC 2024-10 N021283-004 DIOVAN 40MG TABLET / ORAL AB RLD 2002-08-14 d06236e962d9…
Observed Orange Book normalized TE history# Normalized TE history page 1 of 5 · 164 observed states.
Observed Orange Book exclusivity history# Exclusivity history page 1 of 3 · 81 observed states.
Additional Listing Data#
Finished product Yes
Brand name base Diovan
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 · 8 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 351761 Internal RxNorm lookup 351762 Internal RxNorm lookup 352001 Internal RxNorm lookup 352274 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 0078-1245-34 Diovan 90 in 1 BOTTLE TABLET 90 31
DailyMed Socrata Ingredients# 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 0078-1245-34 00078124534 90 TABLET in 1 BOTTLE (0078-1245-34) 90 tablet 2025-07-21 No No Current