Home NDC 0078-0423 Diovan
Product NDC 0078-0423
11-digit product format 000780423
Labeler code 0078
Product ID 0078-0423_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 40 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 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 · 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 0078-0423-15 Diovan 30 in 1 BOTTLE TABLET 30 31
DailyMed Socrata Ingredients# Ingredient, Type, UNII table Ingredient Type UNII DailyMed label SPL version Uploaded VALSARTAN ACTIVE INGREDIENT 80M03YXJ7I DIOVAN (VALSARTAN) TABLET [NOVARTIS PHARMACEUTICALS CORPORATION] 15 VALSARTAN ACTIVE MOIETY 80M03YXJ7I DIOVAN (VALSARTAN) TABLET [NOVARTIS PHARMACEUTICALS CORPORATION] 15 CELLULOSE, MICROCRYSTALLINE INACTIVE INGREDIENT OP1R32D61U DIOVAN (VALSARTAN) TABLET [NOVARTIS PHARMACEUTICALS CORPORATION] 15 CROSPOVIDONE INACTIVE INGREDIENT 68401960MK DIOVAN (VALSARTAN) TABLET [NOVARTIS PHARMACEUTICALS CORPORATION] 15 FERRIC OXIDE RED INACTIVE INGREDIENT 1K09F3G675 DIOVAN (VALSARTAN) TABLET [NOVARTIS PHARMACEUTICALS CORPORATION] 15 FERRIC OXIDE YELLOW INACTIVE INGREDIENT EX438O2MRT DIOVAN (VALSARTAN) TABLET [NOVARTIS PHARMACEUTICALS CORPORATION] 15 FERROSOFERRIC OXIDE INACTIVE INGREDIENT XM0M87F357 DIOVAN (VALSARTAN) TABLET [NOVARTIS PHARMACEUTICALS CORPORATION] 15 HYPROMELLOSES INACTIVE INGREDIENT 3NXW29V3WO DIOVAN (VALSARTAN) TABLET [NOVARTIS PHARMACEUTICALS CORPORATION] 15 MAGNESIUM STEARATE INACTIVE INGREDIENT 70097M6I30 DIOVAN (VALSARTAN) TABLET [NOVARTIS PHARMACEUTICALS CORPORATION] 15 POLYETHYLENE GLYCOL 8000 INACTIVE INGREDIENT Q662QK8M3B DIOVAN (VALSARTAN) TABLET [NOVARTIS PHARMACEUTICALS CORPORATION] 15 SILICON DIOXIDE INACTIVE INGREDIENT ETJ7Z6XBU4 DIOVAN (VALSARTAN) TABLET [NOVARTIS PHARMACEUTICALS CORPORATION] 15 TITANIUM DIOXIDE INACTIVE INGREDIENT 15FIX9V2JP DIOVAN (VALSARTAN) TABLET [NOVARTIS PHARMACEUTICALS CORPORATION] 15 VALSARTAN ACTIVE INGREDIENT 80M03YXJ7I DIOVAN (VALSARTAN) TABLET [PHYSICIANS TOTAL CARE, INC.] 3 VALSARTAN ACTIVE MOIETY 80M03YXJ7I DIOVAN (VALSARTAN) TABLET [PHYSICIANS TOTAL CARE, INC.] 3 CELLULOSE, MICROCRYSTALLINE INACTIVE INGREDIENT OP1R32D61U DIOVAN (VALSARTAN) TABLET [PHYSICIANS TOTAL CARE, INC.] 3 CROSPOVIDONE INACTIVE INGREDIENT 68401960MK DIOVAN (VALSARTAN) TABLET [PHYSICIANS TOTAL CARE, INC.] 3 FERRIC OXIDE RED INACTIVE INGREDIENT 1K09F3G675 DIOVAN (VALSARTAN) TABLET [PHYSICIANS TOTAL CARE, INC.] 3 FERRIC OXIDE YELLOW INACTIVE INGREDIENT EX438O2MRT DIOVAN (VALSARTAN) TABLET [PHYSICIANS TOTAL CARE, INC.] 3 FERROSOFERRIC OXIDE INACTIVE INGREDIENT XM0M87F357 DIOVAN (VALSARTAN) TABLET [PHYSICIANS TOTAL CARE, INC.] 3 HYPROMELLOSES INACTIVE INGREDIENT 3NXW29V3WO DIOVAN (VALSARTAN) TABLET [PHYSICIANS TOTAL CARE, INC.] 3 MAGNESIUM STEARATE INACTIVE INGREDIENT 70097M6I30 DIOVAN (VALSARTAN) TABLET [PHYSICIANS TOTAL CARE, INC.] 3 POLYETHYLENE GLYCOL 8000 INACTIVE INGREDIENT Q662QK8M3B DIOVAN (VALSARTAN) TABLET [PHYSICIANS TOTAL CARE, INC.] 3 SILICON DIOXIDE INACTIVE INGREDIENT ETJ7Z6XBU4 DIOVAN (VALSARTAN) TABLET [PHYSICIANS TOTAL CARE, INC.] 3 TITANIUM DIOXIDE INACTIVE INGREDIENT 15FIX9V2JP DIOVAN (VALSARTAN) TABLET [PHYSICIANS TOTAL CARE, INC.] 3 VALSARTAN ACTIVE INGREDIENT 80M03YXJ7I DIOVAN (VALSARTAN) TABLET [CARILION MATERIALS MANAGEMENT] 2 VALSARTAN ACTIVE MOIETY 80M03YXJ7I DIOVAN (VALSARTAN) TABLET [CARILION MATERIALS MANAGEMENT] 2 CELLULOSE, MICROCRYSTALLINE INACTIVE INGREDIENT OP1R32D61U DIOVAN (VALSARTAN) TABLET [CARILION MATERIALS MANAGEMENT] 2 CROSPOVIDONE INACTIVE INGREDIENT 68401960MK DIOVAN (VALSARTAN) TABLET [CARILION MATERIALS MANAGEMENT] 2 FERRIC OXIDE YELLOW INACTIVE INGREDIENT EX438O2MRT DIOVAN (VALSARTAN) TABLET [CARILION MATERIALS MANAGEMENT] 2 HYPROMELLOSES INACTIVE INGREDIENT 3NXW29V3WO DIOVAN (VALSARTAN) TABLET [CARILION MATERIALS MANAGEMENT] 2 MAGNESIUM STEARATE INACTIVE INGREDIENT 70097M6I30 DIOVAN (VALSARTAN) TABLET [CARILION MATERIALS MANAGEMENT] 2 POLYETHYLENE GLYCOL 8000 INACTIVE INGREDIENT Q662QK8M3B DIOVAN (VALSARTAN) TABLET [CARILION MATERIALS MANAGEMENT] 2 SILICON DIOXIDE INACTIVE INGREDIENT ETJ7Z6XBU4 DIOVAN (VALSARTAN) TABLET [CARILION MATERIALS MANAGEMENT] 2 TITANIUM DIOXIDE INACTIVE INGREDIENT 15FIX9V2JP DIOVAN (VALSARTAN) TABLET [CARILION MATERIALS MANAGEMENT] 2
DailyMed Dashboard NDC Coverage# NDC, Dashboard title, SPL version table NDC Dashboard title SPL version Validation Dashboard ZIP 0078-0423 DIOVAN (VALSARTAN) TABLET [NOVARTIS PHARMACEUTICALS CORPORATION] 29 Current NDC, Legacy NDC, 1 package rows 20250110_5ddba454-f3e6-43c2-a7a6-58365d297213.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 Diovan VALSARTAN Novartis Pharmaceuticals Corporation 5ddba454-f3e6-43c2-a7a6-58365d297213 2025-12-22 Boxed warning, Warnings, Adverse reactions Exact identifier application applno (NDA): 021283 application number: NDA021283 ndc (product): 0078-0423
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 0078-0423-15 00078042315 30 TABLET in 1 BOTTLE (0078-0423-15) 30 tablet 2001-07-01 0000-00-00 No No Current