Microzide

Product NDC
52544-622
11-digit product format
525440622
Labeler code
52544
Product ID
52544-622_c21b8dfd-c003-4e72-8bb6-674d6213995d
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
Hydrochlorothiazide
Dosage form
CAPSULE, GELATIN COATED
Route
ORAL
Labeler
Actavis Pharma, Inc.
Application
NDA020504
Marketing category
NDA
Marketing start
1996-12-27
Marketing end
2020-08-31
Substance
HYDROCHLOROTHIAZIDE
Active strength
13 mg/1
Pharmacologic classes
Increased Diuresis [PE],Thiazide Diuretic [EPC],Thiazides [CS]
NDC exclude flag
No
Listing certified through
0000-00-00
Current FDA listing
Historical FDA.report record

NDC auxiliary status#

These records are reproduced from FDA’s unfinished, excluded, and compounder listings. They describe what appeared in the source files; a missing record does not establish a regulatory status. View all current auxiliary records, including entries without an NDC. · View the auxiliary file history.

Current NDC status page 1 of 1 · 2 matching rows.

Dataset, Scope, Product NDC table
DatasetScopeProduct NDCPackage NDCCodeStatusReporting periodSource date
excluded productproduct52544-622DDiscontinued by firm2026-08-17
excluded packagepackage52544-62252544-622-01DDiscontinued by firm2026-08-17

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 · 24 matching rows.

View current auxiliary records. · View the auxiliary file history.

Captured / source date, Dataset, Scope table
Captured / source dateDatasetScopePackage NDCSnapshotSource SHA-256
2025-12-14 17:58 UTC · source 2025-12-05excluded productproductd630ba8d3edf…732f749b63fb…
2025-12-14 17:58 UTC · source 2025-12-05excluded packagepackage52544-622-01d630ba8d3edf…732f749b63fb…
2025-08-27 00:01 UTC · source 2025-08-26excluded productproductf5e01cc5f278…a2eaf40c39c3…
2025-08-27 00:01 UTC · source 2025-08-26excluded packagepackage52544-622-01f5e01cc5f278…a2eaf40c39c3…
2025-04-01 02:39 UTC · source 2025-03-31excluded productproduct2ef7874e63bc…57b86245f4fa…
2025-04-01 02:39 UTC · source 2025-03-31excluded packagepackage52544-622-012ef7874e63bc…57b86245f4fa…
2025-03-28 20:22 UTC · source 2025-03-28excluded productproducta1b67e2a42f9…c4cf2c586c0d…
2025-03-28 20:22 UTC · source 2025-03-28excluded packagepackage52544-622-01a1b67e2a42f9…c4cf2c586c0d…
2025-03-22 03:12 UTC · source 2025-03-21excluded productproductcfe11265f3b6…090c488252e2…
2025-03-22 03:12 UTC · source 2025-03-21excluded packagepackage52544-622-01cfe11265f3b6…090c488252e2…
2025-03-10 12:48 UTC · source 2025-03-10excluded productproductcdf11ea48f46…ba0047e9e063…
2025-03-10 12:48 UTC · source 2025-03-10excluded packagepackage52544-622-01cdf11ea48f46…ba0047e9e063…
2025-02-02 03:52 UTC · source 2025-01-31excluded productproduct302b2466d912…e7b80fea0513…
2025-02-02 03:52 UTC · source 2025-01-31excluded packagepackage52544-622-01302b2466d912…e7b80fea0513…
2025-01-20 13:05 UTC · source 2025-01-20excluded productproducted331223b511…672a5bd82f5f…
2025-01-20 13:05 UTC · source 2025-01-20excluded packagepackage52544-622-01ed331223b511…672a5bd82f5f…
2025-01-11 03:41 UTC · source 2025-01-10excluded productproduct0efc9e666f02…f202fb6c5f17…
2025-01-11 03:41 UTC · source 2025-01-10excluded packagepackage52544-622-010efc9e666f02…f202fb6c5f17…
2024-11-09 02:27 UTC · source 2024-11-08excluded productproductad56d346431e…cc804d4bbf1e…
2024-11-09 02:27 UTC · source 2024-11-08excluded packagepackage52544-622-01ad56d346431e…cc804d4bbf1e…
2024-10-04 04:10 UTC · source 2024-10-03excluded productproduct367a005e9d99…383a685ebd0f…
2024-10-04 04:10 UTC · source 2024-10-03excluded packagepackage52544-622-01367a005e9d99…383a685ebd0f…
2024-07-10 04:00 UTC · source 2024-07-09excluded productproduct557ba5c1ecfa…9c80585c8c6e…
2024-07-10 04:00 UTC · source 2024-07-09excluded packagepackage52544-622-01557ba5c1ecfa…9c80585c8c6e…

Source provenance: Browse the complete Orange Book source catalog · source snapshot 42.

Orange Book products#

Current product rows page 1 of 1 · 1 matching rows.

Application-product, Trade name, Ingredient table
Application-productTrade nameIngredientStrengthDosage form / routeTE codesRLD / RSApproval date
N020504-001MICROZIDEHYDROCHLOROTHIAZIDE12.5MGCAPSULE / ORALABRLD, RS1996-12-27

Therapeutic equivalence codes#

Current TE-code rows page 1 of 1 · 1 matching rows.

Application-product, TE code table
Application-productTE code
N020504-001AB

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 · 42 observed states.

Captured, Edition, Application-product table
CapturedEditionApplication-productTrade nameStrengthDosage form / routeProduct TE source textRLD / RSApproval dateSource SHA-256
2026-08-18 06:07:402026-07N020504-001MICROZIDE12.5MGCAPSULE / ORALABRLD, RS1996-12-27caaa826d4ba7…
2026-02-19 14:30 UTC2026-02N020504-001MICROZIDE12.5MGCAPSULE / ORALABRLD, RS1996-12-27011fe1cb6892…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12N020504-001MICROZIDE12.5MGCAPSULE / ORALABRLD, RS1996-12-2731067a03dcf5…
2025-08-23 18:47 UTC2025-08N020504-001MICROZIDE12.5MGCAPSULE / ORALABRLD, RS1996-12-276a471c1ec25d…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03N020504-001MICROZIDE12.5MGCAPSULE / ORALABRLD, RS1996-12-27fd3edfee7708…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02N020504-001MICROZIDE12.5MGCAPSULE / ORALABRLD, RS1996-12-27b8a1b40f171c…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01N020504-001MICROZIDE12.5MGCAPSULE / ORALABRLD, RS1996-12-2703ed91905a0d…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12N020504-001MICROZIDE12.5MGCAPSULE / ORALABRLD, RS1996-12-272680178bc6a6…
2024-09-14 05:58 UTC · 2 captures of this ZIP2024-09N020504-001MICROZIDE12.5MGCAPSULE / ORALABRLD, RS1996-12-275bbf6a4d5a75…
2024-11-08 22:44 UTC · 3 captures of this ZIP2024-11N020504-001MICROZIDE12.5MGCAPSULE / ORALABRLD, RS1996-12-27d8e5a09893c0…
2024-10-29 15:01 UTC2024-10N020504-001MICROZIDE12.5MGCAPSULE / ORALABRLD, RS1996-12-27d06236e962d9…
2024-08-13 05:28 UTC · 3 captures of this ZIP2024-08N020504-001MICROZIDE12.5MGCAPSULE / ORALABRLD, RS1996-12-2779d66fd596c7…
2024-07-13 05:37 UTC · 2 captures of this ZIP2024-07N020504-001MICROZIDE12.5MGCAPSULE / ORALABRLD, RS1996-12-27301d65b070ca…
2024-06-18 03:08 UTC · 5 captures of this ZIP2024-06N020504-001MICROZIDE12.5MGCAPSULE / ORALABRLD, RS1996-12-271e350fbaab3a…
2024-05-31 18:47 UTC2024-05N020504-001MICROZIDE12.5MGCAPSULE / ORALABRLD, RS1996-12-278072bd15b7f6…
2022-06-29 02:47 UTC · 2 captures of this ZIP2022-06N020504-001MICROZIDE12.5MGCAPSULE / ORALABRLD, RS1996-12-275c6f7cd8ea54…
2022-04-08 23:34 UTC2022-04N020504-001MICROZIDE12.5MGCAPSULE / ORALABRLD, RS1996-12-275d02ea3f76ae…
2022-04-04 05:41 UTC2022-04N020504-001MICROZIDE12.5MGCAPSULE / ORALABRLD, RS1996-12-274b0b4de00fa7…
2019-12-13 00:20 UTC2019-12N020504-001MICROZIDE12.5MGCAPSULE / ORALABRLD, RS1996-12-2774a2ff9319b5…
2022-03-09 01:35 UTC2022-03N020504-001MICROZIDE12.5MGCAPSULE / ORALABRLD, RS1996-12-27bb7c543d1eb4…
2021-12-28 21:50 UTC2021-12N020504-001MICROZIDE12.5MGCAPSULE / ORALABRLD, RS1996-12-27782e0a99824c…
2021-05-05 16:15 UTC · 3 captures of this ZIP2021-05N020504-001MICROZIDE12.5MGCAPSULE / ORALABRLD, RS1996-12-2787673890dc5c…
2021-03-12 10:30 UTC2021-03N020504-001MICROZIDE12.5MGCAPSULE / ORALABRLD, RS1996-12-275aa47cf7b7d7…
2020-12-22 03:56 UTC2020-12N020504-001MICROZIDE12.5MGCAPSULE / ORALABRLD, RS1996-12-278869cabd3fbd…
2020-11-12 02:37 UTC2020-11N020504-001MICROZIDE12.5MGCAPSULE / ORALABRLD, RS1996-12-27c0c555d07b60…
2019-12-14 00:12 UTC2019-12N020504-001MICROZIDE12.5MGCAPSULE / ORALABRLD, RS1996-12-273f01610625f2…
2019-09-15 20:21 UTC2019-09N020504-001MICROZIDE12.5MGCAPSULE / ORALABRLD, RS1996-12-27b00525d2431f…
2019-07-19 19:46 UTC2019-07N020504-001MICROZIDE12.5MGCAPSULE / ORALABRLD, RS1996-12-27ea99ee380514…
2024-03-16 18:09 UTC · 4 captures of this ZIP2024-03N020504-001MICROZIDE12.5MGCAPSULE / ORALABRLD, RS1996-12-276a51e52b5d6a…
2024-02-18 07:12 UTC2024-02N020504-001MICROZIDE12.5MGCAPSULE / ORALABRLD, RS1996-12-271c564ffb4f44…
2023-12-20 04:57 UTC2023-12N020504-001MICROZIDE12.5MGCAPSULE / ORALABRLD, RS1996-12-27ea1830bbd6c7…
2023-11-28 05:40 UTC · 2 captures of this ZIP2023-11N020504-001MICROZIDE12.5MGCAPSULE / ORALABRLD, RS1996-12-27a72a2bbeb626…
2023-10-25 00:34 UTC · 2 captures of this ZIP2023-10N020504-001MICROZIDE12.5MGCAPSULE / ORALABRLD, RS1996-12-279b2671bbb829…
2023-07-15 15:27 UTC · 2 captures of this ZIP2023-07N020504-001MICROZIDE12.5MGCAPSULE / ORALABRLD, RS1996-12-27a67488948f0b…
2023-06-13 01:57 UTC · 3 captures of this ZIP2023-06N020504-001MICROZIDE12.5MGCAPSULE / ORALABRLD, RS1996-12-273f0d92c62455…
2023-05-13 08:27 UTC2023-05N020504-001MICROZIDE12.5MGCAPSULE / ORALABRLD, RS1996-12-27053a50430f4f…
2023-01-26 05:58 UTC2023-01N020504-001MICROZIDE12.5MGCAPSULE / ORALABRLD, RS1996-12-273bdfa0b2c4d7…
2022-11-12 20:34 UTC · 5 captures of this ZIP2022-11N020504-001MICROZIDE12.5MGCAPSULE / ORALABRLD, RS1996-12-273a93d1ddd44b…
2022-10-28 04:53 UTC2022-10N020504-001MICROZIDE12.5MGCAPSULE / ORALABRLD, RS1996-12-27f41ea6bd6efb…
2022-09-29 23:25 UTC2022-09N020504-001MICROZIDE12.5MGCAPSULE / ORALABRLD, RS1996-12-27e64feba35796…

Observed Orange Book normalized TE history#

Normalized TE history page 1 of 2 · 42 observed states.

Captured, Edition, Application-product table
CapturedEditionApplication-productTE codeOrderSource SHA-256
2026-08-18 06:07:402026-07N020504-001AB1caaa826d4ba7…
2026-02-19 14:30 UTC2026-02N020504-001AB1011fe1cb6892…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12N020504-001AB131067a03dcf5…
2025-08-23 18:47 UTC2025-08N020504-001AB16a471c1ec25d…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03N020504-001AB1fd3edfee7708…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02N020504-001AB1b8a1b40f171c…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01N020504-001AB103ed91905a0d…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12N020504-001AB12680178bc6a6…
2024-09-14 05:58 UTC · 2 captures of this ZIP2024-09N020504-001AB15bbf6a4d5a75…
2024-11-08 22:44 UTC · 3 captures of this ZIP2024-11N020504-001AB1d8e5a09893c0…
2024-10-29 15:01 UTC2024-10N020504-001AB1d06236e962d9…
2024-08-13 05:28 UTC · 3 captures of this ZIP2024-08N020504-001AB179d66fd596c7…
2024-07-13 05:37 UTC · 2 captures of this ZIP2024-07N020504-001AB1301d65b070ca…
2024-06-18 03:08 UTC · 5 captures of this ZIP2024-06N020504-001AB11e350fbaab3a…
2024-05-31 18:47 UTC2024-05N020504-001AB18072bd15b7f6…
2022-06-29 02:47 UTC · 2 captures of this ZIP2022-06N020504-001AB15c6f7cd8ea54…
2022-04-08 23:34 UTC2022-04N020504-001AB15d02ea3f76ae…
2022-04-04 05:41 UTC2022-04N020504-001AB14b0b4de00fa7…
2019-12-13 00:20 UTC2019-12N020504-001AB174a2ff9319b5…
2022-03-09 01:35 UTC2022-03N020504-001AB1bb7c543d1eb4…
2021-12-28 21:50 UTC2021-12N020504-001AB1782e0a99824c…
2021-05-05 16:15 UTC · 3 captures of this ZIP2021-05N020504-001AB187673890dc5c…
2021-03-12 10:30 UTC2021-03N020504-001AB15aa47cf7b7d7…
2020-12-22 03:56 UTC2020-12N020504-001AB18869cabd3fbd…
2020-11-12 02:37 UTC2020-11N020504-001AB1c0c555d07b60…
2019-12-14 00:12 UTC2019-12N020504-001AB13f01610625f2…
2019-09-15 20:21 UTC2019-09N020504-001AB1b00525d2431f…
2019-07-19 19:46 UTC2019-07N020504-001AB1ea99ee380514…
2024-03-16 18:09 UTC · 4 captures of this ZIP2024-03N020504-001AB16a51e52b5d6a…
2024-02-18 07:12 UTC2024-02N020504-001AB11c564ffb4f44…
2023-12-20 04:57 UTC2023-12N020504-001AB1ea1830bbd6c7…
2023-11-28 05:40 UTC · 2 captures of this ZIP2023-11N020504-001AB1a72a2bbeb626…
2023-10-25 00:34 UTC · 2 captures of this ZIP2023-10N020504-001AB19b2671bbb829…
2023-07-15 15:27 UTC · 2 captures of this ZIP2023-07N020504-001AB1a67488948f0b…
2023-06-13 01:57 UTC · 3 captures of this ZIP2023-06N020504-001AB13f0d92c62455…
2023-05-13 08:27 UTC2023-05N020504-001AB1053a50430f4f…
2023-01-26 05:58 UTC2023-01N020504-001AB13bdfa0b2c4d7…
2022-11-12 20:34 UTC · 5 captures of this ZIP2022-11N020504-001AB13a93d1ddd44b…
2022-10-28 04:53 UTC2022-10N020504-001AB1f41ea6bd6efb…
2022-09-29 23:25 UTC2022-09N020504-001AB1e64feba35796…

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
52544-622-01EA - Each52544-6220f0df12f-f40d-4cba-b91f-4fc03347293e12012-07-24

DailyMed Socrata Ingredients#

Ingredient, Type, UNII table
IngredientTypeUNIIDailyMed labelSPL versionUploaded
HYDROCHLOROTHIAZIDEACTIVE INGREDIENT0J48LPH2THMICROZIDE (HYDROCHLOROTHIAZIDE) CAPSULE, GELATIN COATED [WATSON PHARMA, INC.]10
HYDROCHLOROTHIAZIDEACTIVE MOIETY0J48LPH2THMICROZIDE (HYDROCHLOROTHIAZIDE) CAPSULE, GELATIN COATED [WATSON PHARMA, INC.]10
D&C RED NO. 28INACTIVE INGREDIENT767IP0Y5NHMICROZIDE (HYDROCHLOROTHIAZIDE) CAPSULE, GELATIN COATED [WATSON PHARMA, INC.]10
D&C YELLOW NO. 10INACTIVE INGREDIENT35SW5USQ3GMICROZIDE (HYDROCHLOROTHIAZIDE) CAPSULE, GELATIN COATED [WATSON PHARMA, INC.]10
FD&C BLUE NO. 1INACTIVE INGREDIENTH3R47K3TBDMICROZIDE (HYDROCHLOROTHIAZIDE) CAPSULE, GELATIN COATED [WATSON PHARMA, INC.]10
FD&C BLUE NO. 2INACTIVE INGREDIENTL06K8R7DQKMICROZIDE (HYDROCHLOROTHIAZIDE) CAPSULE, GELATIN COATED [WATSON PHARMA, INC.]10
FD&C RED NO. 40INACTIVE INGREDIENTWZB9127XOAMICROZIDE (HYDROCHLOROTHIAZIDE) CAPSULE, GELATIN COATED [WATSON PHARMA, INC.]10
FERROSOFERRIC OXIDEINACTIVE INGREDIENTXM0M87F357MICROZIDE (HYDROCHLOROTHIAZIDE) CAPSULE, GELATIN COATED [WATSON PHARMA, INC.]10
GELATININACTIVE INGREDIENT2G86QN327LMICROZIDE (HYDROCHLOROTHIAZIDE) CAPSULE, GELATIN COATED [WATSON PHARMA, INC.]10
LACTOSE MONOHYDRATEINACTIVE INGREDIENTEWQ57Q8I5XMICROZIDE (HYDROCHLOROTHIAZIDE) CAPSULE, GELATIN COATED [WATSON PHARMA, INC.]10
MAGNESIUM STEARATEINACTIVE INGREDIENT70097M6I30MICROZIDE (HYDROCHLOROTHIAZIDE) CAPSULE, GELATIN COATED [WATSON PHARMA, INC.]10
SILICON DIOXIDEINACTIVE INGREDIENTETJ7Z6XBU4MICROZIDE (HYDROCHLOROTHIAZIDE) CAPSULE, GELATIN COATED [WATSON PHARMA, INC.]10
STARCH, CORNINACTIVE INGREDIENTO8232NY3SJMICROZIDE (HYDROCHLOROTHIAZIDE) CAPSULE, GELATIN COATED [WATSON PHARMA, INC.]10
TITANIUM DIOXIDEINACTIVE INGREDIENT15FIX9V2JPMICROZIDE (HYDROCHLOROTHIAZIDE) CAPSULE, GELATIN COATED [WATSON PHARMA, INC.]10

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 · 4 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
HydrochlorothiazideHYDROCHLOROTHIAZIDEQPharma, Inc.5bacc909-6b02-4815-85ef-55fd25b1b1f72025-12-05Warnings, Adverse reactionsExact identifier
application applno (NDA): 020504
application number: NDA020504
HydrochlorothiazideHYDROCHLOROTHIAZIDEActavis Pharma, Inc.a3eb7294-f913-434b-896c-da028bfebc732024-08-01Warnings, Adverse reactionsExact identifier
application applno (NDA): 020504
application number: NDA020504
HydrochlorothiazideHYDROCHLOROTHIAZIDEProficient Rx LPc1052d38-fd75-40c2-a685-0e889009be0b2023-02-01Warnings, Adverse reactionsExact identifier
application applno (NDA): 020504
application number: NDA020504
HydrochlorothiazideHYDROCHLOROTHIAZIDEAphena Pharma Solutions - Tennessee, LLC0f7a608d-748b-49a9-a4b3-b3fdcab53ce02017-12-21Warnings, Adverse reactionsExact identifier
application applno (NDA): 020504
application number: NDA020504