Home NDC 67046-1664 Hydrochlorothiazide
Product NDC 67046-1664
11-digit product format 670461664
Labeler code 67046
Product ID 67046-1664_4ee35b9c-c393-279a-e063-6294a90a178c
Type HUMAN PRESCRIPTION DRUG
Nonproprietary name Hydrochlorothiazide
Dosage form TABLET
Route ORAL
Labeler Coupler LLC
Application ANDA040907
Marketing category ANDA
Marketing start 2026-04-07
Substance HYDROCHLOROTHIAZIDE
Active strength 12.5 mg/1
Pharmacologic classes 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 43 .
Orange Book products# Current product rows page 1 of 1 · 3 matching rows.
Application-product, Trade name, Ingredient table Application-product Trade name Ingredient Strength Dosage form / route TE codes RLD / RS Approval date A040907-001 HYDROCHLOROTHIAZIDE HYDROCHLOROTHIAZIDE 25MG TABLET / ORAL AB 2008-08-15 A040907-002 HYDROCHLOROTHIAZIDE HYDROCHLOROTHIAZIDE 50MG TABLET / ORAL AB 2008-08-15 A040907-003 HYDROCHLOROTHIAZIDE HYDROCHLOROTHIAZIDE 12.5MG TABLET / ORAL AB 2025-04-03
Therapeutic equivalence codes# Current TE-code rows page 1 of 1 · 3 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 3 · 92 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 A040907-001 HYDROCHLOROTHIAZIDE 25MG TABLET / ORAL AB 2008-08-15 84e616aacf4f…2026-09-14 22:38:34 2026-08 A040907-002 HYDROCHLOROTHIAZIDE 50MG TABLET / ORAL AB 2008-08-15 84e616aacf4f…2026-09-14 22:38:34 2026-08 A040907-003 HYDROCHLOROTHIAZIDE 12.5MG TABLET / ORAL AB 2025-04-03 84e616aacf4f…2026-08-18 06:07:40 2026-07 A040907-001 HYDROCHLOROTHIAZIDE 25MG TABLET / ORAL AB 2008-08-15 caaa826d4ba7…2026-08-18 06:07:40 2026-07 A040907-002 HYDROCHLOROTHIAZIDE 50MG TABLET / ORAL AB 2008-08-15 caaa826d4ba7…2026-08-18 06:07:40 2026-07 A040907-003 HYDROCHLOROTHIAZIDE 12.5MG TABLET / ORAL AB 2025-04-03 caaa826d4ba7…2026-02-19 14:30 UTC 2026-02 A040907-001 HYDROCHLOROTHIAZIDE 25MG TABLET / ORAL AB 2008-08-15 011fe1cb6892…2026-02-19 14:30 UTC 2026-02 A040907-002 HYDROCHLOROTHIAZIDE 50MG TABLET / ORAL AB 2008-08-15 011fe1cb6892…2026-02-19 14:30 UTC 2026-02 A040907-003 HYDROCHLOROTHIAZIDE 12.5MG TABLET / ORAL AB 2025-04-03 011fe1cb6892…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 A040907-001 HYDROCHLOROTHIAZIDE 25MG TABLET / ORAL AB 2008-08-15 31067a03dcf5…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 A040907-002 HYDROCHLOROTHIAZIDE 50MG TABLET / ORAL AB 2008-08-15 31067a03dcf5…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 A040907-003 HYDROCHLOROTHIAZIDE 12.5MG TABLET / ORAL AB 2025-04-03 31067a03dcf5…2025-08-23 18:47 UTC 2025-08 A040907-001 HYDROCHLOROTHIAZIDE 25MG TABLET / ORAL AB 2008-08-15 6a471c1ec25d…2025-08-23 18:47 UTC 2025-08 A040907-002 HYDROCHLOROTHIAZIDE 50MG TABLET / ORAL AB 2008-08-15 6a471c1ec25d…2025-08-23 18:47 UTC 2025-08 A040907-003 HYDROCHLOROTHIAZIDE 12.5MG TABLET / ORAL AB 2025-04-03 6a471c1ec25d…2025-03-22 03:13 UTC · 3 captures of this ZIP 2025-03 A040907-001 HYDROCHLOROTHIAZIDE 25MG TABLET / ORAL AB 2008-08-15 fd3edfee7708…2025-03-22 03:13 UTC · 3 captures of this ZIP 2025-03 A040907-002 HYDROCHLOROTHIAZIDE 50MG TABLET / ORAL AB 2008-08-15 fd3edfee7708…2025-02-26 10:13 UTC · 3 captures of this ZIP 2025-02 A040907-001 HYDROCHLOROTHIAZIDE 25MG TABLET / ORAL AB 2008-08-15 b8a1b40f171c…2025-02-26 10:13 UTC · 3 captures of this ZIP 2025-02 A040907-002 HYDROCHLOROTHIAZIDE 50MG TABLET / ORAL AB 2008-08-15 b8a1b40f171c…2025-01-19 17:59 UTC · 7 captures of this ZIP 2025-01 A040907-001 HYDROCHLOROTHIAZIDE 25MG TABLET / ORAL AB 2008-08-15 03ed91905a0d…2025-01-19 17:59 UTC · 7 captures of this ZIP 2025-01 A040907-002 HYDROCHLOROTHIAZIDE 50MG TABLET / ORAL AB 2008-08-15 03ed91905a0d…2024-12-13 21:23 UTC · 2 captures of this ZIP 2024-12 A040907-001 HYDROCHLOROTHIAZIDE 25MG TABLET / ORAL AB 2008-08-15 2680178bc6a6…2024-12-13 21:23 UTC · 2 captures of this ZIP 2024-12 A040907-002 HYDROCHLOROTHIAZIDE 50MG TABLET / ORAL AB 2008-08-15 2680178bc6a6…2024-09-14 05:58 UTC · 2 captures of this ZIP 2024-09 A040907-001 HYDROCHLOROTHIAZIDE 25MG TABLET / ORAL AB 2008-08-15 5bbf6a4d5a75…2024-09-14 05:58 UTC · 2 captures of this ZIP 2024-09 A040907-002 HYDROCHLOROTHIAZIDE 50MG TABLET / ORAL AB 2008-08-15 5bbf6a4d5a75…2024-11-08 22:44 UTC · 3 captures of this ZIP 2024-11 A040907-001 HYDROCHLOROTHIAZIDE 25MG TABLET / ORAL AB 2008-08-15 d8e5a09893c0…2024-11-08 22:44 UTC · 3 captures of this ZIP 2024-11 A040907-002 HYDROCHLOROTHIAZIDE 50MG TABLET / ORAL AB 2008-08-15 d8e5a09893c0…2024-10-29 15:01 UTC 2024-10 A040907-001 HYDROCHLOROTHIAZIDE 25MG TABLET / ORAL AB 2008-08-15 d06236e962d9…2024-10-29 15:01 UTC 2024-10 A040907-002 HYDROCHLOROTHIAZIDE 50MG TABLET / ORAL AB 2008-08-15 d06236e962d9…2024-08-13 05:28 UTC · 3 captures of this ZIP 2024-08 A040907-001 HYDROCHLOROTHIAZIDE 25MG TABLET / ORAL AB 2008-08-15 79d66fd596c7…2024-08-13 05:28 UTC · 3 captures of this ZIP 2024-08 A040907-002 HYDROCHLOROTHIAZIDE 50MG TABLET / ORAL AB 2008-08-15 79d66fd596c7…2024-07-13 05:37 UTC · 2 captures of this ZIP 2024-07 A040907-001 HYDROCHLOROTHIAZIDE 25MG TABLET / ORAL AB 2008-08-15 301d65b070ca…2024-07-13 05:37 UTC · 2 captures of this ZIP 2024-07 A040907-002 HYDROCHLOROTHIAZIDE 50MG TABLET / ORAL AB 2008-08-15 301d65b070ca…2024-06-18 03:08 UTC · 5 captures of this ZIP 2024-06 A040907-001 HYDROCHLOROTHIAZIDE 25MG TABLET / ORAL AB 2008-08-15 1e350fbaab3a…2024-06-18 03:08 UTC · 5 captures of this ZIP 2024-06 A040907-002 HYDROCHLOROTHIAZIDE 50MG TABLET / ORAL AB 2008-08-15 1e350fbaab3a…2024-05-31 18:47 UTC 2024-05 A040907-001 HYDROCHLOROTHIAZIDE 25MG TABLET / ORAL AB 2008-08-15 8072bd15b7f6…2024-05-31 18:47 UTC 2024-05 A040907-002 HYDROCHLOROTHIAZIDE 50MG TABLET / ORAL AB 2008-08-15 8072bd15b7f6…2022-06-29 02:47 UTC · 2 captures of this ZIP 2022-06 A040907-001 HYDROCHLOROTHIAZIDE 25MG TABLET / ORAL AB 2008-08-15 5c6f7cd8ea54…2022-06-29 02:47 UTC · 2 captures of this ZIP 2022-06 A040907-002 HYDROCHLOROTHIAZIDE 50MG TABLET / ORAL AB 2008-08-15 5c6f7cd8ea54…2022-04-08 23:34 UTC 2022-04 A040907-001 HYDROCHLOROTHIAZIDE 25MG TABLET / ORAL AB 2008-08-15 5d02ea3f76ae…
Observed Orange Book normalized TE history# Normalized TE history page 1 of 3 · 92 observed states.
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 Hydrochlorothiazide
Listing expiration 2027-12-31 Active Ingredients# Ingredient, Strength table Ingredient Strength HYDROCHLOROTHIAZIDE 12.5 mg/1
Harmonized UNII identifiers# UNII identifiers page 1 of 1 · 1 matching rows.
Identifier, FDA.report destination table Identifier FDA.report destination 0J48LPH2TH Internal UNII lookup
Harmonized RxCUI identifiers# RxCUI identifiers page 1 of 1 · 1 matching rows.
Identifier, FDA.report destination table Identifier FDA.report destination 429503 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 67046-1664-3 Hydrochlorothiazide 30 in 1 BLISTER PACK TABLET 30 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 2 of 2 · 21 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 67046-1664-3 67046166403 30 TABLET in 1 BLISTER PACK (67046-1664-3) 30 tablet 2026-04-07 No No Current