Home NDC 10544-198 Hydrochlorothiazide
Product NDC 10544-198
11-digit product format 105440198
Labeler code 10544
Product ID 10544-198_118f7c88-dd6f-25d5-e054-00144ff88e88
Type HUMAN PRESCRIPTION DRUG
Nonproprietary name Hydrochlorothiazide
Dosage form TABLET
Route ORAL
Labeler Blenheim Pharmacal, Inc.
Application NDA020504
Marketing category NDA AUTHORIZED GENERIC
Marketing start 2010-04-08
Marketing end 0000-00-00
Substance HYDROCHLOROTHIAZIDE
Active strength 25 mg/1
Pharmacologic classes Increased Diuresis [PE],Thiazide Diuretic [EPC],Thiazides [CS]
NDC exclude flag E
Listing certified through 2017-12-31
Current FDA listing Historical FDA.report record 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 · 44 matching rows.
View current auxiliary records. · View the auxiliary file history.
Captured / source date, Dataset, Scope table Captured / source date Dataset Scope Package NDC Code Status Snapshot Source SHA-256 2025-12-14 17:58 UTC · source 2025-12-05 excluded product product I Inactivated by FDA d630ba8d3edf…732f749b63fb…2025-12-14 17:58 UTC · source 2025-12-05 excluded package package 10544-198-30 I Inactivated by FDA d630ba8d3edf…732f749b63fb…2025-08-27 00:01 UTC · source 2025-08-26 excluded product product I Inactivated by FDA f5e01cc5f278…a2eaf40c39c3…2025-08-27 00:01 UTC · source 2025-08-26 excluded package package 10544-198-30 I Inactivated by FDA f5e01cc5f278…a2eaf40c39c3…2025-04-01 02:39 UTC · source 2025-03-31 excluded product product I Inactivated by FDA 2ef7874e63bc…57b86245f4fa…2025-04-01 02:39 UTC · source 2025-03-31 excluded package package 10544-198-30 I Inactivated by FDA 2ef7874e63bc…57b86245f4fa…2025-03-28 20:22 UTC · source 2025-03-28 excluded product product I Inactivated by FDA a1b67e2a42f9…c4cf2c586c0d…2025-03-28 20:22 UTC · source 2025-03-28 excluded package package 10544-198-30 I Inactivated by FDA a1b67e2a42f9…c4cf2c586c0d…2025-03-22 03:12 UTC · source 2025-03-21 excluded product product I Inactivated by FDA cfe11265f3b6…090c488252e2…2025-03-22 03:12 UTC · source 2025-03-21 excluded package package 10544-198-30 I Inactivated by FDA cfe11265f3b6…090c488252e2…2025-03-10 12:48 UTC · source 2025-03-10 excluded product product I Inactivated by FDA cdf11ea48f46…ba0047e9e063…2025-03-10 12:48 UTC · source 2025-03-10 excluded package package 10544-198-30 I Inactivated by FDA cdf11ea48f46…ba0047e9e063…2025-02-02 03:52 UTC · source 2025-01-31 excluded product product I Inactivated by FDA 302b2466d912…e7b80fea0513…2025-02-02 03:52 UTC · source 2025-01-31 excluded package package 10544-198-30 I Inactivated by FDA 302b2466d912…e7b80fea0513…2025-01-20 13:05 UTC · source 2025-01-20 excluded product product I Inactivated by FDA ed331223b511…672a5bd82f5f…2025-01-20 13:05 UTC · source 2025-01-20 excluded package package 10544-198-30 I Inactivated by FDA ed331223b511…672a5bd82f5f…2025-01-11 03:41 UTC · source 2025-01-10 excluded product product I Inactivated by FDA 0efc9e666f02…f202fb6c5f17…2025-01-11 03:41 UTC · source 2025-01-10 excluded package package 10544-198-30 I Inactivated by FDA 0efc9e666f02…f202fb6c5f17…2024-11-09 02:27 UTC · source 2024-11-08 excluded product product I Inactivated by FDA ad56d346431e…cc804d4bbf1e…2024-11-09 02:27 UTC · source 2024-11-08 excluded package package 10544-198-30 I Inactivated by FDA ad56d346431e…cc804d4bbf1e…2024-10-04 04:10 UTC · source 2024-10-03 excluded product product I Inactivated by FDA 367a005e9d99…383a685ebd0f…2024-10-04 04:10 UTC · source 2024-10-03 excluded package package 10544-198-30 I Inactivated by FDA 367a005e9d99…383a685ebd0f…2024-07-10 04:00 UTC · source 2024-07-09 excluded product product I Inactivated by FDA 557ba5c1ecfa…9c80585c8c6e…2024-07-10 04:00 UTC · source 2024-07-09 excluded package package 10544-198-30 I Inactivated by FDA 557ba5c1ecfa…9c80585c8c6e…2024-05-28 21:12 UTC · source 2024-05-28 excluded product product I Inactivated by FDA 8af77b9d5b6f…d9bbb34c5368…2024-05-28 21:12 UTC · source 2024-05-28 excluded package package 10544-198-30 I Inactivated by FDA 8af77b9d5b6f…d9bbb34c5368…2024-05-15 03:39 UTC · source 2024-05-14 excluded product product I Inactivated by FDA 834df4deac94…adcc014656a3…2024-05-15 03:39 UTC · source 2024-05-14 excluded package package 10544-198-30 I Inactivated by FDA 834df4deac94…adcc014656a3…2024-03-11 06:39 UTC · source 2024-03-08 excluded product product I Inactivated by FDA 1332a3947898…d4bfe170f9cd…2024-03-11 06:39 UTC · source 2024-03-08 excluded package package 10544-198-30 I Inactivated by FDA 1332a3947898…d4bfe170f9cd…2022-08-30 03:57 UTC · source 2022-08-29 excluded product product I Inactivated by FDA fb8cb913e6d1…eb8c232b6be0…2022-08-30 03:57 UTC · source 2022-08-29 excluded package package 10544-198-30 I Inactivated by FDA fb8cb913e6d1…eb8c232b6be0…2022-04-09 23:13 UTC · source 2022-04-08 excluded product product I Inactivated by FDA 86f5da6cb304…a595104c45d7…2022-04-09 23:13 UTC · source 2022-04-08 excluded package package 10544-198-30 I Inactivated by FDA 86f5da6cb304…a595104c45d7…2022-04-04 05:40 UTC · source 2022-04-01 excluded product product I Inactivated by FDA bd6a592717d7…303034d00443…2022-04-04 05:40 UTC · source 2022-04-01 excluded package package 10544-198-30 I Inactivated by FDA bd6a592717d7…303034d00443…2021-12-27 23:28 UTC · source 2021-12-27 excluded product product I Inactivated by FDA 8dfbde2a14a4…c9ff85d89658…2021-12-27 23:28 UTC · source 2021-12-27 excluded package package 10544-198-30 I Inactivated by FDA 8dfbde2a14a4…c9ff85d89658…2020-12-18 03:04 UTC · source 2020-12-17 excluded product product I Inactivated by FDA e2bbac7714bc…27bdfed8d636…2020-12-18 03:04 UTC · source 2020-12-17 excluded package package 10544-198-30 I Inactivated by FDA e2bbac7714bc…27bdfed8d636…2020-06-10 20:45 UTC · source 2020-06-10 excluded product product I Inactivated by FDA 9bebd1f3094a…5416666fcb17…2020-06-10 20:45 UTC · source 2020-06-10 excluded package package 10544-198-30 I Inactivated by FDA 9bebd1f3094a…5416666fcb17…2019-12-08 06:16 UTC · source 2019-12-05 excluded product product E Excluded after deficient or non-compliant submission was not corrected 110d247fa046…a55b01930146…2019-12-08 06:16 UTC · source 2019-12-05 excluded package package 10544-198-30 E Excluded after deficient or non-compliant submission was not corrected 110d247fa046…a55b01930146…
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 N020504-001 MICROZIDE HYDROCHLOROTHIAZIDE 12.5MG CAPSULE / ORAL AB RLD, RS 1996-12-27
Therapeutic equivalence codes# Current TE-code rows page 1 of 1 · 1 matching rows.
Application-product, TE code table Application-product TE code N020504-001 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 N020504-001 MICROZIDE 12.5MG CAPSULE / ORAL AB RLD, RS 1996-12-27 84e616aacf4f…2026-08-18 06:07:40 2026-07 N020504-001 MICROZIDE 12.5MG CAPSULE / ORAL AB RLD, RS 1996-12-27 caaa826d4ba7…2026-02-19 14:30 UTC 2026-02 N020504-001 MICROZIDE 12.5MG CAPSULE / ORAL AB RLD, RS 1996-12-27 011fe1cb6892…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 N020504-001 MICROZIDE 12.5MG CAPSULE / ORAL AB RLD, RS 1996-12-27 31067a03dcf5…2025-08-23 18:47 UTC 2025-08 N020504-001 MICROZIDE 12.5MG CAPSULE / ORAL AB RLD, RS 1996-12-27 6a471c1ec25d…2025-03-22 03:13 UTC · 3 captures of this ZIP 2025-03 N020504-001 MICROZIDE 12.5MG CAPSULE / ORAL AB RLD, RS 1996-12-27 fd3edfee7708…2025-02-26 10:13 UTC · 3 captures of this ZIP 2025-02 N020504-001 MICROZIDE 12.5MG CAPSULE / ORAL AB RLD, RS 1996-12-27 b8a1b40f171c…2025-01-19 17:59 UTC · 7 captures of this ZIP 2025-01 N020504-001 MICROZIDE 12.5MG CAPSULE / ORAL AB RLD, RS 1996-12-27 03ed91905a0d…2024-12-13 21:23 UTC · 2 captures of this ZIP 2024-12 N020504-001 MICROZIDE 12.5MG CAPSULE / ORAL AB RLD, RS 1996-12-27 2680178bc6a6…2024-09-14 05:58 UTC · 2 captures of this ZIP 2024-09 N020504-001 MICROZIDE 12.5MG CAPSULE / ORAL AB RLD, RS 1996-12-27 5bbf6a4d5a75…2024-11-08 22:44 UTC · 3 captures of this ZIP 2024-11 N020504-001 MICROZIDE 12.5MG CAPSULE / ORAL AB RLD, RS 1996-12-27 d8e5a09893c0…2024-10-29 15:01 UTC 2024-10 N020504-001 MICROZIDE 12.5MG CAPSULE / ORAL AB RLD, RS 1996-12-27 d06236e962d9…2024-08-13 05:28 UTC · 3 captures of this ZIP 2024-08 N020504-001 MICROZIDE 12.5MG CAPSULE / ORAL AB RLD, RS 1996-12-27 79d66fd596c7…2024-07-13 05:37 UTC · 2 captures of this ZIP 2024-07 N020504-001 MICROZIDE 12.5MG CAPSULE / ORAL AB RLD, RS 1996-12-27 301d65b070ca…2024-06-18 03:08 UTC · 5 captures of this ZIP 2024-06 N020504-001 MICROZIDE 12.5MG CAPSULE / ORAL AB RLD, RS 1996-12-27 1e350fbaab3a…2024-05-31 18:47 UTC 2024-05 N020504-001 MICROZIDE 12.5MG CAPSULE / ORAL AB RLD, RS 1996-12-27 8072bd15b7f6…2022-06-29 02:47 UTC · 2 captures of this ZIP 2022-06 N020504-001 MICROZIDE 12.5MG CAPSULE / ORAL AB RLD, RS 1996-12-27 5c6f7cd8ea54…2022-04-08 23:34 UTC 2022-04 N020504-001 MICROZIDE 12.5MG CAPSULE / ORAL AB RLD, RS 1996-12-27 5d02ea3f76ae…2022-04-04 05:41 UTC 2022-04 N020504-001 MICROZIDE 12.5MG CAPSULE / ORAL AB RLD, RS 1996-12-27 4b0b4de00fa7…2019-12-13 00:20 UTC 2019-12 N020504-001 MICROZIDE 12.5MG CAPSULE / ORAL AB RLD, RS 1996-12-27 74a2ff9319b5…2022-03-09 01:35 UTC 2022-03 N020504-001 MICROZIDE 12.5MG CAPSULE / ORAL AB RLD, RS 1996-12-27 bb7c543d1eb4…2021-12-28 21:50 UTC 2021-12 N020504-001 MICROZIDE 12.5MG CAPSULE / ORAL AB RLD, RS 1996-12-27 782e0a99824c…2021-05-05 16:15 UTC · 3 captures of this ZIP 2021-05 N020504-001 MICROZIDE 12.5MG CAPSULE / ORAL AB RLD, RS 1996-12-27 87673890dc5c…2021-03-12 10:30 UTC 2021-03 N020504-001 MICROZIDE 12.5MG CAPSULE / ORAL AB RLD, RS 1996-12-27 5aa47cf7b7d7…2020-12-22 03:56 UTC 2020-12 N020504-001 MICROZIDE 12.5MG CAPSULE / ORAL AB RLD, RS 1996-12-27 8869cabd3fbd…2020-11-12 02:37 UTC 2020-11 N020504-001 MICROZIDE 12.5MG CAPSULE / ORAL AB RLD, RS 1996-12-27 c0c555d07b60…2019-12-14 00:12 UTC 2019-12 N020504-001 MICROZIDE 12.5MG CAPSULE / ORAL AB RLD, RS 1996-12-27 3f01610625f2…2019-09-15 20:21 UTC 2019-09 N020504-001 MICROZIDE 12.5MG CAPSULE / ORAL AB RLD, RS 1996-12-27 b00525d2431f…2019-07-19 19:46 UTC 2019-07 N020504-001 MICROZIDE 12.5MG CAPSULE / ORAL AB RLD, RS 1996-12-27 ea99ee380514…2024-03-16 18:09 UTC · 4 captures of this ZIP 2024-03 N020504-001 MICROZIDE 12.5MG CAPSULE / ORAL AB RLD, RS 1996-12-27 6a51e52b5d6a…2024-02-18 07:12 UTC 2024-02 N020504-001 MICROZIDE 12.5MG CAPSULE / ORAL AB RLD, RS 1996-12-27 1c564ffb4f44…2023-12-20 04:57 UTC 2023-12 N020504-001 MICROZIDE 12.5MG CAPSULE / ORAL AB RLD, RS 1996-12-27 ea1830bbd6c7…2023-11-28 05:40 UTC · 2 captures of this ZIP 2023-11 N020504-001 MICROZIDE 12.5MG CAPSULE / ORAL AB RLD, RS 1996-12-27 a72a2bbeb626…2023-10-25 00:34 UTC · 2 captures of this ZIP 2023-10 N020504-001 MICROZIDE 12.5MG CAPSULE / ORAL AB RLD, RS 1996-12-27 9b2671bbb829…2023-07-15 15:27 UTC · 2 captures of this ZIP 2023-07 N020504-001 MICROZIDE 12.5MG CAPSULE / ORAL AB RLD, RS 1996-12-27 a67488948f0b…2023-06-13 01:57 UTC · 3 captures of this ZIP 2023-06 N020504-001 MICROZIDE 12.5MG CAPSULE / ORAL AB RLD, RS 1996-12-27 3f0d92c62455…2023-05-13 08:27 UTC 2023-05 N020504-001 MICROZIDE 12.5MG CAPSULE / ORAL AB RLD, RS 1996-12-27 053a50430f4f…2023-01-26 05:58 UTC 2023-01 N020504-001 MICROZIDE 12.5MG CAPSULE / ORAL AB RLD, RS 1996-12-27 3bdfa0b2c4d7…2022-11-12 20:34 UTC · 5 captures of this ZIP 2022-11 N020504-001 MICROZIDE 12.5MG CAPSULE / ORAL AB RLD, RS 1996-12-27 3a93d1ddd44b…2022-10-28 04:53 UTC 2022-10 N020504-001 MICROZIDE 12.5MG CAPSULE / ORAL AB RLD, RS 1996-12-27 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.
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 10544-198-30 Hydrochlorothiazide 30 in 1 BOTTLE TABLET 30 1
DailyMed Socrata Ingredients# Ingredient, Type, UNII table Ingredient Type UNII DailyMed label SPL version Uploaded HYDROCHLOROTHIAZIDE ACTIVE INGREDIENT 0J48LPH2TH HYDROCHLOROTHIAZIDE TABLET [BLENHEIM PHARMACAL, INC.] 1 HYDROCHLOROTHIAZIDE ACTIVE MOIETY 0J48LPH2TH HYDROCHLOROTHIAZIDE TABLET [BLENHEIM PHARMACAL, INC.] 1 D&C RED NO. 28 INACTIVE INGREDIENT 767IP0Y5NH HYDROCHLOROTHIAZIDE TABLET [BLENHEIM PHARMACAL, INC.] 1 D&C YELLOW NO. 10 INACTIVE INGREDIENT 35SW5USQ3G HYDROCHLOROTHIAZIDE TABLET [BLENHEIM PHARMACAL, INC.] 1 FD&C BLUE NO. 1 INACTIVE INGREDIENT H3R47K3TBD HYDROCHLOROTHIAZIDE TABLET [BLENHEIM PHARMACAL, INC.] 1 FD&C BLUE NO. 2 INACTIVE INGREDIENT L06K8R7DQK HYDROCHLOROTHIAZIDE TABLET [BLENHEIM PHARMACAL, INC.] 1 FD&C RED NO. 40 INACTIVE INGREDIENT WZB9127XOA HYDROCHLOROTHIAZIDE TABLET [BLENHEIM PHARMACAL, INC.] 1 FERROSOFERRIC OXIDE INACTIVE INGREDIENT XM0M87F357 HYDROCHLOROTHIAZIDE TABLET [BLENHEIM PHARMACAL, INC.] 1 GELATIN INACTIVE INGREDIENT 2G86QN327L HYDROCHLOROTHIAZIDE TABLET [BLENHEIM PHARMACAL, INC.] 1 LACTOSE MONOHYDRATE INACTIVE INGREDIENT EWQ57Q8I5X HYDROCHLOROTHIAZIDE TABLET [BLENHEIM PHARMACAL, INC.] 1 MAGNESIUM STEARATE INACTIVE INGREDIENT 70097M6I30 HYDROCHLOROTHIAZIDE TABLET [BLENHEIM PHARMACAL, INC.] 1 SILICON DIOXIDE INACTIVE INGREDIENT ETJ7Z6XBU4 HYDROCHLOROTHIAZIDE TABLET [BLENHEIM PHARMACAL, INC.] 1 STARCH, CORN INACTIVE INGREDIENT O8232NY3SJ HYDROCHLOROTHIAZIDE TABLET [BLENHEIM PHARMACAL, INC.] 1 TITANIUM DIOXIDE INACTIVE INGREDIENT 15FIX9V2JP HYDROCHLOROTHIAZIDE TABLET [BLENHEIM PHARMACAL, INC.] 1
DailyMed Dashboard NDC Coverage# NDC, Dashboard title, SPL version table NDC Dashboard title SPL version Validation Dashboard ZIP 10544-198 HYDROCHLOROTHIAZIDE TABLET [BLENHEIM PHARMACAL, INC.] 1 Legacy NDC, 1 package rows 20150318_118f7c88-dd6e-25d5-e054-00144ff88e88.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 Status 10544-198-30 10544019830 30 in 1 BOTTLE Historical