Home NDC 84677-072 VALSARTAN AND HYDROCHLOROTHIAZIDE
Product NDC 84677-072
11-digit product format 846770072
Labeler code 84677
Product ID 84677-072_5ba1085d-7e86-1b54-e063-6394a90a0f36
Type HUMAN PRESCRIPTION DRUG
Nonproprietary name valsartan and hydrochlorothiazide
Dosage form TABLET, FILM COATED
Route ORAL
Labeler Golden State Medical Supply, Inc.
Application ANDA204687
Marketing category ANDA
Marketing start 2026-04-23
Substance VALSARTAN; HYDROCHLOROTHIAZIDE
Active strength 80; 12.5 mg/1; mg/1
Pharmacologic classes Angiotensin 2 Receptor Antagonists [MoA], Angiotensin 2 Receptor Blocker [EPC], Increased Diuresis [PE], Thiazide Diuretic [EPC], Thiazides [CS]
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 44 .
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 A204687-001 VALSARTAN AND HYDROCHLOROTHIAZIDE HYDROCHLOROTHIAZIDE; VALSARTAN 12.5MG;80MG TABLET / ORAL AB 2026-04-23 A204687-002 VALSARTAN AND HYDROCHLOROTHIAZIDE HYDROCHLOROTHIAZIDE; VALSARTAN 12.5MG;160MG TABLET / ORAL AB 2026-04-23 A204687-003 VALSARTAN AND HYDROCHLOROTHIAZIDE HYDROCHLOROTHIAZIDE; VALSARTAN 12.5MG;320MG TABLET / ORAL AB 2026-04-23 A204687-004 VALSARTAN AND HYDROCHLOROTHIAZIDE HYDROCHLOROTHIAZIDE; VALSARTAN 25MG;160MG TABLET / ORAL AB 2026-04-23 A204687-005 VALSARTAN AND HYDROCHLOROTHIAZIDE HYDROCHLOROTHIAZIDE; VALSARTAN 25MG;320MG TABLET / ORAL AB 2026-04-23
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.
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 2026-10-15 13:18:30 2026-09 A204687-001 VALSARTAN AND HYDROCHLOROTHIAZIDE 12.5MG;80MG TABLET / ORAL AB 2026-04-23 c2088c7a36db…2026-10-15 13:18:30 2026-09 A204687-002 VALSARTAN AND HYDROCHLOROTHIAZIDE 12.5MG;160MG TABLET / ORAL AB 2026-04-23 c2088c7a36db…2026-10-15 13:18:30 2026-09 A204687-003 VALSARTAN AND HYDROCHLOROTHIAZIDE 12.5MG;320MG TABLET / ORAL AB 2026-04-23 c2088c7a36db…2026-10-15 13:18:30 2026-09 A204687-004 VALSARTAN AND HYDROCHLOROTHIAZIDE 25MG;160MG TABLET / ORAL AB 2026-04-23 c2088c7a36db…2026-10-15 13:18:30 2026-09 A204687-005 VALSARTAN AND HYDROCHLOROTHIAZIDE 25MG;320MG TABLET / ORAL AB 2026-04-23 c2088c7a36db…2026-09-14 22:38:34 2026-08 A204687-001 VALSARTAN AND HYDROCHLOROTHIAZIDE 12.5MG;80MG TABLET / ORAL AB 2026-04-23 84e616aacf4f…2026-09-14 22:38:34 2026-08 A204687-002 VALSARTAN AND HYDROCHLOROTHIAZIDE 12.5MG;160MG TABLET / ORAL AB 2026-04-23 84e616aacf4f…2026-09-14 22:38:34 2026-08 A204687-003 VALSARTAN AND HYDROCHLOROTHIAZIDE 12.5MG;320MG TABLET / ORAL AB 2026-04-23 84e616aacf4f…2026-09-14 22:38:34 2026-08 A204687-004 VALSARTAN AND HYDROCHLOROTHIAZIDE 25MG;160MG TABLET / ORAL AB 2026-04-23 84e616aacf4f…2026-09-14 22:38:34 2026-08 A204687-005 VALSARTAN AND HYDROCHLOROTHIAZIDE 25MG;320MG TABLET / ORAL AB 2026-04-23 84e616aacf4f…2026-08-18 06:07:40 2026-07 A204687-001 VALSARTAN AND HYDROCHLOROTHIAZIDE 12.5MG;80MG TABLET / ORAL AB 2026-04-23 caaa826d4ba7…2026-08-18 06:07:40 2026-07 A204687-002 VALSARTAN AND HYDROCHLOROTHIAZIDE 12.5MG;160MG TABLET / ORAL AB 2026-04-23 caaa826d4ba7…2026-08-18 06:07:40 2026-07 A204687-003 VALSARTAN AND HYDROCHLOROTHIAZIDE 12.5MG;320MG TABLET / ORAL AB 2026-04-23 caaa826d4ba7…2026-08-18 06:07:40 2026-07 A204687-004 VALSARTAN AND HYDROCHLOROTHIAZIDE 25MG;160MG TABLET / ORAL AB 2026-04-23 caaa826d4ba7…2026-08-18 06:07:40 2026-07 A204687-005 VALSARTAN AND HYDROCHLOROTHIAZIDE 25MG;320MG TABLET / ORAL AB 2026-04-23 caaa826d4ba7…2026-07-26 02:55 UTC · 3 captures of this ZIP 2026-06 A204687-001 VALSARTAN AND HYDROCHLOROTHIAZIDE 12.5MG;80MG TABLET / ORAL AB 2026-04-23 a50c72e98297…2026-07-26 02:55 UTC · 3 captures of this ZIP 2026-06 A204687-002 VALSARTAN AND HYDROCHLOROTHIAZIDE 12.5MG;160MG TABLET / ORAL AB 2026-04-23 a50c72e98297…2026-07-26 02:55 UTC · 3 captures of this ZIP 2026-06 A204687-003 VALSARTAN AND HYDROCHLOROTHIAZIDE 12.5MG;320MG TABLET / ORAL AB 2026-04-23 a50c72e98297…2026-07-26 02:55 UTC · 3 captures of this ZIP 2026-06 A204687-004 VALSARTAN AND HYDROCHLOROTHIAZIDE 25MG;160MG TABLET / ORAL AB 2026-04-23 a50c72e98297…2026-07-26 02:55 UTC · 3 captures of this ZIP 2026-06 A204687-005 VALSARTAN AND HYDROCHLOROTHIAZIDE 25MG;320MG TABLET / ORAL AB 2026-04-23 a50c72e98297…
Observed Orange Book normalized TE history# 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 AND HYDROCHLOROTHIAZIDE
Listing expiration 2027-12-31 Active Ingredients# Ingredient, Strength table Ingredient Strength VALSARTAN 80 mg/1 HYDROCHLOROTHIAZIDE 12.5 mg/1
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.
Packages# Package NDC, 11-digit format, Description table Package NDC 11-digit format Description Marketing start Sample Exclude flag Status 84677-072-90 84677007290 90 TABLET, FILM COATED in 1 BOTTLE (84677-072-90) 2026-08-03 No No Current