Home NDC 68071-3443-3 Hydrochlorothiazide
Product NDC 68071-3443
Requested package NDC 68071-3443-3
11-digit product format 680713443
Labeler code 68071
Product ID 68071-3443_339e8633-2e2a-26d1-e063-6394a90aa72e
Type HUMAN PRESCRIPTION DRUG
Nonproprietary name Hydrochlorothiazide
Dosage form TABLET
Route ORAL
Labeler NuCare Pharmaceuticals,Inc.
Application ANDA040707
Marketing category ANDA
Marketing start 2007-03-12
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 2026-12-31
Current FDA listing Yes Observed NDC auxiliary status history# This history shows the information present in each captured FDA auxiliary file. It is not a continuous regulatory timeline, and a missing record does not establish a status.
Historic NDC status page 1 of 1 · 3 matching rows.
View current auxiliary records. · View the auxiliary file history.
Captured / source date, Dataset, Scope table Captured / source date Dataset Scope Product NDC Package NDC Code Status Reporting period Archive Snapshot Source SHA-256 2025-02-02 03:52 UTC · source 2025-01-31 excluded package package 68071-3443 68071-3443-3 U Excluded because listing certification expired excluded / ndc_excluded.zip 302b2466d912…e7b80fea0513…2025-01-20 13:05 UTC · source 2025-01-20 excluded package package 68071-3443 68071-3443-3 U Excluded because listing certification expired excluded / ndc_excluded.zip ed331223b511…672a5bd82f5f…2025-01-11 03:41 UTC · source 2025-01-10 excluded package package 68071-3443 68071-3443-3 U Excluded because listing certification expired excluded / ndc_excluded.zip 0efc9e666f02…f202fb6c5f17…
Source provenance: Browse the complete Orange Book source catalog · source snapshot 43 .
Orange Book products# Current product rows page 1 of 1 · 1 matching rows.
Application-product, Trade name, Ingredient table Application-product Trade name Ingredient Strength Dosage form / route TE codes RLD / RS Approval date A040707-001 HYDROCHLOROTHIAZIDE HYDROCHLOROTHIAZIDE 12.5MG TABLET / ORAL AB 2007-02-27
Therapeutic equivalence codes# Current TE-code rows page 1 of 1 · 1 matching rows.
Application-product, TE code table Application-product TE code A040707-001 AB
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 2 · 43 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 A040707-001 HYDROCHLOROTHIAZIDE 12.5MG TABLET / ORAL AB 2007-02-27 84e616aacf4f…2026-08-18 06:07:40 2026-07 A040707-001 HYDROCHLOROTHIAZIDE 12.5MG TABLET / ORAL AB 2007-02-27 caaa826d4ba7…2026-02-19 14:30 UTC 2026-02 A040707-001 HYDROCHLOROTHIAZIDE 12.5MG TABLET / ORAL AB 2007-02-27 011fe1cb6892…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 A040707-001 HYDROCHLOROTHIAZIDE 12.5MG TABLET / ORAL AB 2007-02-27 31067a03dcf5…2025-08-23 18:47 UTC 2025-08 A040707-001 HYDROCHLOROTHIAZIDE 12.5MG TABLET / ORAL AB 2007-02-27 6a471c1ec25d…2025-03-22 03:13 UTC · 3 captures of this ZIP 2025-03 A040707-001 HYDROCHLOROTHIAZIDE 12.5MG TABLET / ORAL AB 2007-02-27 fd3edfee7708…2025-02-26 10:13 UTC · 3 captures of this ZIP 2025-02 A040707-001 HYDROCHLOROTHIAZIDE 12.5MG TABLET / ORAL AB 2007-02-27 b8a1b40f171c…2025-01-19 17:59 UTC · 7 captures of this ZIP 2025-01 A040707-001 HYDROCHLOROTHIAZIDE 12.5MG TABLET / ORAL AB 2007-02-27 03ed91905a0d…2024-12-13 21:23 UTC · 2 captures of this ZIP 2024-12 A040707-001 HYDROCHLOROTHIAZIDE 12.5MG TABLET / ORAL AB 2007-02-27 2680178bc6a6…2024-09-14 05:58 UTC · 2 captures of this ZIP 2024-09 A040707-001 HYDROCHLOROTHIAZIDE 12.5MG TABLET / ORAL AB 2007-02-27 5bbf6a4d5a75…2024-11-08 22:44 UTC · 3 captures of this ZIP 2024-11 A040707-001 HYDROCHLOROTHIAZIDE 12.5MG TABLET / ORAL AB 2007-02-27 d8e5a09893c0…2024-10-29 15:01 UTC 2024-10 A040707-001 HYDROCHLOROTHIAZIDE 12.5MG TABLET / ORAL AB 2007-02-27 d06236e962d9…2024-08-13 05:28 UTC · 3 captures of this ZIP 2024-08 A040707-001 HYDROCHLOROTHIAZIDE 12.5MG TABLET / ORAL AB 2007-02-27 79d66fd596c7…2024-07-13 05:37 UTC · 2 captures of this ZIP 2024-07 A040707-001 HYDROCHLOROTHIAZIDE 12.5MG TABLET / ORAL AB 2007-02-27 301d65b070ca…2024-06-18 03:08 UTC · 5 captures of this ZIP 2024-06 A040707-001 HYDROCHLOROTHIAZIDE 12.5MG TABLET / ORAL AB 2007-02-27 1e350fbaab3a…2024-05-31 18:47 UTC 2024-05 A040707-001 HYDROCHLOROTHIAZIDE 12.5MG TABLET / ORAL AB 2007-02-27 8072bd15b7f6…2022-06-29 02:47 UTC · 2 captures of this ZIP 2022-06 A040707-001 HYDROCHLOROTHIAZIDE 12.5MG TABLET / ORAL AB 2007-02-27 5c6f7cd8ea54…2022-04-08 23:34 UTC 2022-04 A040707-001 HYDROCHLOROTHIAZIDE 12.5MG TABLET / ORAL AB 2007-02-27 5d02ea3f76ae…2022-04-04 05:41 UTC 2022-04 A040707-001 HYDROCHLOROTHIAZIDE 12.5MG TABLET / ORAL AB 2007-02-27 4b0b4de00fa7…2019-12-13 00:20 UTC 2019-12 A040707-001 HYDROCHLOROTHIAZIDE 12.5MG TABLET / ORAL AB 2007-02-27 74a2ff9319b5…2022-03-09 01:35 UTC 2022-03 A040707-001 HYDROCHLOROTHIAZIDE 12.5MG TABLET / ORAL AB 2007-02-27 bb7c543d1eb4…2021-12-28 21:50 UTC 2021-12 A040707-001 HYDROCHLOROTHIAZIDE 12.5MG TABLET / ORAL AB 2007-02-27 782e0a99824c…2021-05-05 16:15 UTC · 3 captures of this ZIP 2021-05 A040707-001 HYDROCHLOROTHIAZIDE 12.5MG TABLET / ORAL AB 2007-02-27 87673890dc5c…2021-03-12 10:30 UTC 2021-03 A040707-001 HYDROCHLOROTHIAZIDE 12.5MG TABLET / ORAL AB 2007-02-27 5aa47cf7b7d7…2020-12-22 03:56 UTC 2020-12 A040707-001 HYDROCHLOROTHIAZIDE 12.5MG TABLET / ORAL AB 2007-02-27 8869cabd3fbd…2020-11-12 02:37 UTC 2020-11 A040707-001 HYDROCHLOROTHIAZIDE 12.5MG TABLET / ORAL AB 2007-02-27 c0c555d07b60…2019-12-14 00:12 UTC 2019-12 A040707-001 HYDROCHLOROTHIAZIDE 12.5MG TABLET / ORAL AB 2007-02-27 3f01610625f2…2019-09-15 20:21 UTC 2019-09 A040707-001 HYDROCHLOROTHIAZIDE 12.5MG TABLET / ORAL AB 2007-02-27 b00525d2431f…2019-07-19 19:46 UTC 2019-07 A040707-001 HYDROCHLOROTHIAZIDE 12.5MG TABLET / ORAL AB 2007-02-27 ea99ee380514…2024-03-16 18:09 UTC · 4 captures of this ZIP 2024-03 A040707-001 HYDROCHLOROTHIAZIDE 12.5MG TABLET / ORAL AB 2007-02-27 6a51e52b5d6a…2024-02-18 07:12 UTC 2024-02 A040707-001 HYDROCHLOROTHIAZIDE 12.5MG TABLET / ORAL AB 2007-02-27 1c564ffb4f44…2023-12-20 04:57 UTC 2023-12 A040707-001 HYDROCHLOROTHIAZIDE 12.5MG TABLET / ORAL AB 2007-02-27 ea1830bbd6c7…2023-11-28 05:40 UTC · 2 captures of this ZIP 2023-11 A040707-001 HYDROCHLOROTHIAZIDE 12.5MG TABLET / ORAL AB 2007-02-27 a72a2bbeb626…2023-10-25 00:34 UTC · 2 captures of this ZIP 2023-10 A040707-001 HYDROCHLOROTHIAZIDE 12.5MG TABLET / ORAL AB 2007-02-27 9b2671bbb829…2023-07-15 15:27 UTC · 2 captures of this ZIP 2023-07 A040707-001 HYDROCHLOROTHIAZIDE 12.5MG TABLET / ORAL AB 2007-02-27 a67488948f0b…2023-06-13 01:57 UTC · 3 captures of this ZIP 2023-06 A040707-001 HYDROCHLOROTHIAZIDE 12.5MG TABLET / ORAL AB 2007-02-27 3f0d92c62455…2023-05-13 08:27 UTC 2023-05 A040707-001 HYDROCHLOROTHIAZIDE 12.5MG TABLET / ORAL AB 2007-02-27 053a50430f4f…2023-01-26 05:58 UTC 2023-01 A040707-001 HYDROCHLOROTHIAZIDE 12.5MG TABLET / ORAL AB 2007-02-27 3bdfa0b2c4d7…2022-11-12 20:34 UTC · 5 captures of this ZIP 2022-11 A040707-001 HYDROCHLOROTHIAZIDE 12.5MG TABLET / ORAL AB 2007-02-27 3a93d1ddd44b…2022-10-28 04:53 UTC 2022-10 A040707-001 HYDROCHLOROTHIAZIDE 12.5MG TABLET / ORAL AB 2007-02-27 f41ea6bd6efb…
Observed Orange Book normalized TE history# Normalized TE history page 1 of 2 · 43 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 2026-12-31 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# FDA-Initiated Inactive NDC Indexing# DailyMed Package Descriptions# Package NDC, Product, Description table Package NDC Product Description Form Quantity Strength SPL version 68071-3443-3 Hydrochlorothiazide 30 in 1 BOTTLE TABLET 30 3
DailyMed Dashboard NDC Coverage# NDC, Dashboard title, SPL version table NDC Dashboard title SPL version Validation Dashboard ZIP 68071-3443 HYDROCHLOROTHIAZIDE TABLET [NUCARE PHARMACEUTICALS,INC.] 3 Current NDC, 1 package rows 20250427_fea5a353-9b13-9b87-e053-6394a90a627d.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 · 3 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 68071-3443-3 68071344303 30 TABLET in 1 BOTTLE (68071-3443-3) 30 tablet 2023-06-21 No No Current