Home DailyMed ed11e22b-60f5-4ad7-a7a4-aa8d643a122b National Council for Prescription Drug Programs indexing - billing unit Drug label information. FDA.report displays public Structured Product Labeling data from DailyMed and legacy FDA.report DailyMed cache rows. This page is not medical advice, prescribing advice, or a substitute for the official label reviewed by a qualified healthcare professional. Labeling can change; when a current hydrated DailyMed SPL record is available, FDA.report shows that newer record before legacy cached files.
Manufacturer National Council for Prescription Drug Programs
Effective date 2012-07-24
Label type Indexing - Billing Unit
Version 1
Source full-release
Hydrated at 2026-06-05 02:46:46 Orange Book application contexts# All distinct exact application/product contexts derived from this label’s complete NDC list are paginated below.
Orange Book application contexts page 1 of 1 · 1 matching rows.
Source provenance: Browse the complete Orange Book source catalog · source snapshot 43 .
Orange Book products# Current product rows page 1 of 1 · 5 matching rows.
Application-product, Trade name, Ingredient table Application-product Trade name Ingredient Strength Dosage form / route TE codes RLD / RS Approval date N020818-001 DIOVAN HCT HYDROCHLOROTHIAZIDE; VALSARTAN 12.5MG;80MG TABLET / ORAL AB RLD 1998-03-06 N020818-002 DIOVAN HCT HYDROCHLOROTHIAZIDE; VALSARTAN 12.5MG;160MG TABLET / ORAL AB RLD 1998-03-06 N020818-003 DIOVAN HCT HYDROCHLOROTHIAZIDE; VALSARTAN 25MG;160MG TABLET / ORAL AB RLD 2002-01-17 N020818-004 DIOVAN HCT HYDROCHLOROTHIAZIDE; VALSARTAN 12.5MG;320MG TABLET / ORAL AB RLD 2006-04-28 N020818-005 DIOVAN HCT HYDROCHLOROTHIAZIDE; VALSARTAN 25MG;320MG TABLET / ORAL AB RLD, RS 2006-04-28
Therapeutic equivalence codes# Current TE-code rows page 1 of 1 · 5 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 6 · 215 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 N020818-001 DIOVAN HCT 12.5MG;80MG TABLET / ORAL AB RLD 1998-03-06 84e616aacf4f…2026-09-14 22:38:34 2026-08 N020818-002 DIOVAN HCT 12.5MG;160MG TABLET / ORAL AB RLD 1998-03-06 84e616aacf4f…2026-09-14 22:38:34 2026-08 N020818-003 DIOVAN HCT 25MG;160MG TABLET / ORAL AB RLD 2002-01-17 84e616aacf4f…2026-09-14 22:38:34 2026-08 N020818-004 DIOVAN HCT 12.5MG;320MG TABLET / ORAL AB RLD 2006-04-28 84e616aacf4f…2026-09-14 22:38:34 2026-08 N020818-005 DIOVAN HCT 25MG;320MG TABLET / ORAL AB RLD, RS 2006-04-28 84e616aacf4f…2026-08-18 06:07:40 2026-07 N020818-001 DIOVAN HCT 12.5MG;80MG TABLET / ORAL AB RLD 1998-03-06 caaa826d4ba7…2026-08-18 06:07:40 2026-07 N020818-002 DIOVAN HCT 12.5MG;160MG TABLET / ORAL AB RLD 1998-03-06 caaa826d4ba7…2026-08-18 06:07:40 2026-07 N020818-003 DIOVAN HCT 25MG;160MG TABLET / ORAL AB RLD 2002-01-17 caaa826d4ba7…2026-08-18 06:07:40 2026-07 N020818-004 DIOVAN HCT 12.5MG;320MG TABLET / ORAL AB RLD 2006-04-28 caaa826d4ba7…2026-08-18 06:07:40 2026-07 N020818-005 DIOVAN HCT 25MG;320MG TABLET / ORAL AB RLD, RS 2006-04-28 caaa826d4ba7…2026-02-19 14:30 UTC 2026-02 N020818-001 DIOVAN HCT 12.5MG;80MG TABLET / ORAL AB RLD 1998-03-06 011fe1cb6892…2026-02-19 14:30 UTC 2026-02 N020818-002 DIOVAN HCT 12.5MG;160MG TABLET / ORAL AB RLD 1998-03-06 011fe1cb6892…2026-02-19 14:30 UTC 2026-02 N020818-003 DIOVAN HCT 25MG;160MG TABLET / ORAL AB RLD 2002-01-17 011fe1cb6892…2026-02-19 14:30 UTC 2026-02 N020818-004 DIOVAN HCT 12.5MG;320MG TABLET / ORAL AB RLD 2006-04-28 011fe1cb6892…2026-02-19 14:30 UTC 2026-02 N020818-005 DIOVAN HCT 25MG;320MG TABLET / ORAL AB RLD, RS 2006-04-28 011fe1cb6892…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 N020818-001 DIOVAN HCT 12.5MG;80MG TABLET / ORAL AB RLD 1998-03-06 31067a03dcf5…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 N020818-002 DIOVAN HCT 12.5MG;160MG TABLET / ORAL AB RLD 1998-03-06 31067a03dcf5…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 N020818-003 DIOVAN HCT 25MG;160MG TABLET / ORAL AB RLD 2002-01-17 31067a03dcf5…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 N020818-004 DIOVAN HCT 12.5MG;320MG TABLET / ORAL AB RLD 2006-04-28 31067a03dcf5…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 N020818-005 DIOVAN HCT 25MG;320MG TABLET / ORAL AB RLD, RS 2006-04-28 31067a03dcf5…2025-08-23 18:47 UTC 2025-08 N020818-001 DIOVAN HCT 12.5MG;80MG TABLET / ORAL AB RLD 1998-03-06 6a471c1ec25d…2025-08-23 18:47 UTC 2025-08 N020818-002 DIOVAN HCT 12.5MG;160MG TABLET / ORAL AB RLD 1998-03-06 6a471c1ec25d…2025-08-23 18:47 UTC 2025-08 N020818-003 DIOVAN HCT 25MG;160MG TABLET / ORAL AB RLD 2002-01-17 6a471c1ec25d…2025-08-23 18:47 UTC 2025-08 N020818-004 DIOVAN HCT 12.5MG;320MG TABLET / ORAL AB RLD 2006-04-28 6a471c1ec25d…2025-08-23 18:47 UTC 2025-08 N020818-005 DIOVAN HCT 25MG;320MG TABLET / ORAL AB RLD, RS 2006-04-28 6a471c1ec25d…2025-03-22 03:13 UTC · 3 captures of this ZIP 2025-03 N020818-001 DIOVAN HCT 12.5MG;80MG TABLET / ORAL AB RLD 1998-03-06 fd3edfee7708…2025-03-22 03:13 UTC · 3 captures of this ZIP 2025-03 N020818-002 DIOVAN HCT 12.5MG;160MG TABLET / ORAL AB RLD 1998-03-06 fd3edfee7708…2025-03-22 03:13 UTC · 3 captures of this ZIP 2025-03 N020818-003 DIOVAN HCT 25MG;160MG TABLET / ORAL AB RLD 2002-01-17 fd3edfee7708…2025-03-22 03:13 UTC · 3 captures of this ZIP 2025-03 N020818-004 DIOVAN HCT 12.5MG;320MG TABLET / ORAL AB RLD 2006-04-28 fd3edfee7708…2025-03-22 03:13 UTC · 3 captures of this ZIP 2025-03 N020818-005 DIOVAN HCT 25MG;320MG TABLET / ORAL AB RLD, RS 2006-04-28 fd3edfee7708…2025-02-26 10:13 UTC · 3 captures of this ZIP 2025-02 N020818-001 DIOVAN HCT 12.5MG;80MG TABLET / ORAL AB RLD 1998-03-06 b8a1b40f171c…2025-02-26 10:13 UTC · 3 captures of this ZIP 2025-02 N020818-002 DIOVAN HCT 12.5MG;160MG TABLET / ORAL AB RLD 1998-03-06 b8a1b40f171c…2025-02-26 10:13 UTC · 3 captures of this ZIP 2025-02 N020818-003 DIOVAN HCT 25MG;160MG TABLET / ORAL AB RLD 2002-01-17 b8a1b40f171c…2025-02-26 10:13 UTC · 3 captures of this ZIP 2025-02 N020818-004 DIOVAN HCT 12.5MG;320MG TABLET / ORAL AB RLD 2006-04-28 b8a1b40f171c…2025-02-26 10:13 UTC · 3 captures of this ZIP 2025-02 N020818-005 DIOVAN HCT 25MG;320MG TABLET / ORAL AB RLD, RS 2006-04-28 b8a1b40f171c…2025-01-19 17:59 UTC · 7 captures of this ZIP 2025-01 N020818-001 DIOVAN HCT 12.5MG;80MG TABLET / ORAL AB RLD 1998-03-06 03ed91905a0d…2025-01-19 17:59 UTC · 7 captures of this ZIP 2025-01 N020818-002 DIOVAN HCT 12.5MG;160MG TABLET / ORAL AB RLD 1998-03-06 03ed91905a0d…2025-01-19 17:59 UTC · 7 captures of this ZIP 2025-01 N020818-003 DIOVAN HCT 25MG;160MG TABLET / ORAL AB RLD 2002-01-17 03ed91905a0d…2025-01-19 17:59 UTC · 7 captures of this ZIP 2025-01 N020818-004 DIOVAN HCT 12.5MG;320MG TABLET / ORAL AB RLD 2006-04-28 03ed91905a0d…2025-01-19 17:59 UTC · 7 captures of this ZIP 2025-01 N020818-005 DIOVAN HCT 25MG;320MG TABLET / ORAL AB RLD, RS 2006-04-28 03ed91905a0d…
Observed Orange Book normalized TE history# Normalized TE history page 1 of 6 · 215 observed states.
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 HCT VALSARTAN AND HYDROCHLOROTHIAZIDE Novartis Pharmaceuticals Corporation d76a0419-05ee-437e-884c-65807aea9569 2026-02-13 Boxed warning, Warnings, Adverse reactions Exact identifier ndc (package): 0078-0472-34 ndc11 (package): 00078047234
Reported adverse events (FAERS/openFDA)# Adverse event summaries are temporarily unavailable. Other product information remains available.