Terazosin

Product NDC
33261-212
11-digit product format
332610212
Labeler code
33261
Product ID
33261-212_ce7c1472-b399-493e-a419-e71701b04acc
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
Terazosin
Dosage form
CAPSULE
Route
ORAL
Labeler
Aidarex Pharmaceuticals LLC
Application
ANDA075498
Marketing category
ANDA
Marketing start
2001-04-12
Marketing end
0000-00-00
Substance
TERAZOSIN HYDROCHLORIDE
Active strength
2 mg/1
Pharmacologic classes
Adrenergic alpha-Antagonists [MoA],alpha-Adrenergic Blocker [EPC]
NDC exclude flag
No
Listing certified through
2019-12-31
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 productproduct33261-212IInactivated by FDA2026-08-11
excluded packagepackage33261-21233261-212-30IInactivated by FDA2026-08-11

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 · 42 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 packagepackage33261-212-30d630ba8d3edf…732f749b63fb…
2025-08-27 00:01 UTC · source 2025-08-26excluded productproductf5e01cc5f278…a2eaf40c39c3…
2025-08-27 00:01 UTC · source 2025-08-26excluded packagepackage33261-212-30f5e01cc5f278…a2eaf40c39c3…
2025-04-01 02:39 UTC · source 2025-03-31excluded productproduct2ef7874e63bc…57b86245f4fa…
2025-04-01 02:39 UTC · source 2025-03-31excluded packagepackage33261-212-302ef7874e63bc…57b86245f4fa…
2025-03-28 20:22 UTC · source 2025-03-28excluded productproducta1b67e2a42f9…c4cf2c586c0d…
2025-03-28 20:22 UTC · source 2025-03-28excluded packagepackage33261-212-30a1b67e2a42f9…c4cf2c586c0d…
2025-03-22 03:12 UTC · source 2025-03-21excluded productproductcfe11265f3b6…090c488252e2…
2025-03-22 03:12 UTC · source 2025-03-21excluded packagepackage33261-212-30cfe11265f3b6…090c488252e2…
2025-03-10 12:48 UTC · source 2025-03-10excluded productproductcdf11ea48f46…ba0047e9e063…
2025-03-10 12:48 UTC · source 2025-03-10excluded packagepackage33261-212-30cdf11ea48f46…ba0047e9e063…
2025-02-02 03:52 UTC · source 2025-01-31excluded productproduct302b2466d912…e7b80fea0513…
2025-02-02 03:52 UTC · source 2025-01-31excluded packagepackage33261-212-30302b2466d912…e7b80fea0513…
2025-01-20 13:05 UTC · source 2025-01-20excluded productproducted331223b511…672a5bd82f5f…
2025-01-20 13:05 UTC · source 2025-01-20excluded packagepackage33261-212-30ed331223b511…672a5bd82f5f…
2025-01-11 03:41 UTC · source 2025-01-10excluded productproduct0efc9e666f02…f202fb6c5f17…
2025-01-11 03:41 UTC · source 2025-01-10excluded packagepackage33261-212-300efc9e666f02…f202fb6c5f17…
2024-11-09 02:27 UTC · source 2024-11-08excluded productproductad56d346431e…cc804d4bbf1e…
2024-11-09 02:27 UTC · source 2024-11-08excluded packagepackage33261-212-30ad56d346431e…cc804d4bbf1e…
2024-10-04 04:10 UTC · source 2024-10-03excluded productproduct367a005e9d99…383a685ebd0f…
2024-10-04 04:10 UTC · source 2024-10-03excluded packagepackage33261-212-30367a005e9d99…383a685ebd0f…
2024-07-10 04:00 UTC · source 2024-07-09excluded productproduct557ba5c1ecfa…9c80585c8c6e…
2024-07-10 04:00 UTC · source 2024-07-09excluded packagepackage33261-212-30557ba5c1ecfa…9c80585c8c6e…
2024-05-28 21:12 UTC · source 2024-05-28excluded productproduct8af77b9d5b6f…d9bbb34c5368…
2024-05-28 21:12 UTC · source 2024-05-28excluded packagepackage33261-212-308af77b9d5b6f…d9bbb34c5368…
2024-05-15 03:39 UTC · source 2024-05-14excluded productproduct834df4deac94…adcc014656a3…
2024-05-15 03:39 UTC · source 2024-05-14excluded packagepackage33261-212-30834df4deac94…adcc014656a3…
2024-03-11 06:39 UTC · source 2024-03-08excluded productproduct1332a3947898…d4bfe170f9cd…
2024-03-11 06:39 UTC · source 2024-03-08excluded packagepackage33261-212-301332a3947898…d4bfe170f9cd…
2022-08-30 03:57 UTC · source 2022-08-29excluded productproductfb8cb913e6d1…eb8c232b6be0…
2022-08-30 03:57 UTC · source 2022-08-29excluded packagepackage33261-212-30fb8cb913e6d1…eb8c232b6be0…
2022-04-09 23:13 UTC · source 2022-04-08excluded productproduct86f5da6cb304…a595104c45d7…
2022-04-09 23:13 UTC · source 2022-04-08excluded packagepackage33261-212-3086f5da6cb304…a595104c45d7…
2022-04-04 05:40 UTC · source 2022-04-01excluded productproductbd6a592717d7…303034d00443…
2022-04-04 05:40 UTC · source 2022-04-01excluded packagepackage33261-212-30bd6a592717d7…303034d00443…
2021-12-27 23:28 UTC · source 2021-12-27excluded productproduct8dfbde2a14a4…c9ff85d89658…
2021-12-27 23:28 UTC · source 2021-12-27excluded packagepackage33261-212-308dfbde2a14a4…c9ff85d89658…
2020-12-18 03:04 UTC · source 2020-12-17excluded productproducte2bbac7714bc…27bdfed8d636…
2020-12-18 03:04 UTC · source 2020-12-17excluded packagepackage33261-212-30e2bbac7714bc…27bdfed8d636…
2020-06-10 20:45 UTC · source 2020-06-10excluded productproduct9bebd1f3094a…5416666fcb17…
2020-06-10 20:45 UTC · source 2020-06-10excluded packagepackage33261-212-309bebd1f3094a…5416666fcb17…

Source provenance: Browse the complete Orange Book source catalog · source snapshot 1.

Orange Book products#

Current product rows page 1 of 1 · 4 matching rows.

Application-product, Trade name, Ingredient table
Application-productTrade nameIngredientStrengthDosage form / routeTE codesRLD / RSApproval date
A075498-001TERAZOSIN HYDROCHLORIDETERAZOSIN HYDROCHLORIDEEQ 1MG BASECAPSULE / ORAL2001-04-12
A075498-002TERAZOSIN HYDROCHLORIDETERAZOSIN HYDROCHLORIDEEQ 2MG BASECAPSULE / ORAL2001-04-12
A075498-003TERAZOSIN HYDROCHLORIDETERAZOSIN HYDROCHLORIDEEQ 5MG BASECAPSULE / ORAL2001-04-12
A075498-004TERAZOSIN HYDROCHLORIDETERAZOSIN HYDROCHLORIDEEQ 10MG BASECAPSULE / ORAL2001-04-12

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 5 · 164 observed states.

Captured, Edition, Application-product table
CapturedEditionApplication-productTrade nameStrengthDosage form / routeProduct TE source textRLD / RSApproval dateSource SHA-256
2026-02-19 14:30 UTC2026-02A075498-001TERAZOSIN HYDROCHLORIDEEQ 1MG BASECAPSULE / ORAL2001-04-12011fe1cb6892…
2026-02-19 14:30 UTC2026-02A075498-002TERAZOSIN HYDROCHLORIDEEQ 2MG BASECAPSULE / ORAL2001-04-12011fe1cb6892…
2026-02-19 14:30 UTC2026-02A075498-003TERAZOSIN HYDROCHLORIDEEQ 5MG BASECAPSULE / ORAL2001-04-12011fe1cb6892…
2026-02-19 14:30 UTC2026-02A075498-004TERAZOSIN HYDROCHLORIDEEQ 10MG BASECAPSULE / ORAL2001-04-12011fe1cb6892…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A075498-001TERAZOSIN HYDROCHLORIDEEQ 1MG BASECAPSULE / ORAL2001-04-1231067a03dcf5…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A075498-002TERAZOSIN HYDROCHLORIDEEQ 2MG BASECAPSULE / ORAL2001-04-1231067a03dcf5…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A075498-003TERAZOSIN HYDROCHLORIDEEQ 5MG BASECAPSULE / ORAL2001-04-1231067a03dcf5…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A075498-004TERAZOSIN HYDROCHLORIDEEQ 10MG BASECAPSULE / ORAL2001-04-1231067a03dcf5…
2025-08-23 18:47 UTC2025-08A075498-001TERAZOSIN HYDROCHLORIDEEQ 1MG BASECAPSULE / ORAL2001-04-126a471c1ec25d…
2025-08-23 18:47 UTC2025-08A075498-002TERAZOSIN HYDROCHLORIDEEQ 2MG BASECAPSULE / ORAL2001-04-126a471c1ec25d…
2025-08-23 18:47 UTC2025-08A075498-003TERAZOSIN HYDROCHLORIDEEQ 5MG BASECAPSULE / ORAL2001-04-126a471c1ec25d…
2025-08-23 18:47 UTC2025-08A075498-004TERAZOSIN HYDROCHLORIDEEQ 10MG BASECAPSULE / ORAL2001-04-126a471c1ec25d…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03A075498-001TERAZOSIN HYDROCHLORIDEEQ 1MG BASECAPSULE / ORAL2001-04-12fd3edfee7708…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03A075498-002TERAZOSIN HYDROCHLORIDEEQ 2MG BASECAPSULE / ORAL2001-04-12fd3edfee7708…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03A075498-003TERAZOSIN HYDROCHLORIDEEQ 5MG BASECAPSULE / ORAL2001-04-12fd3edfee7708…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03A075498-004TERAZOSIN HYDROCHLORIDEEQ 10MG BASECAPSULE / ORAL2001-04-12fd3edfee7708…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02A075498-001TERAZOSIN HYDROCHLORIDEEQ 1MG BASECAPSULE / ORAL2001-04-12b8a1b40f171c…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02A075498-002TERAZOSIN HYDROCHLORIDEEQ 2MG BASECAPSULE / ORAL2001-04-12b8a1b40f171c…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02A075498-003TERAZOSIN HYDROCHLORIDEEQ 5MG BASECAPSULE / ORAL2001-04-12b8a1b40f171c…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02A075498-004TERAZOSIN HYDROCHLORIDEEQ 10MG BASECAPSULE / ORAL2001-04-12b8a1b40f171c…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01A075498-001TERAZOSIN HYDROCHLORIDEEQ 1MG BASECAPSULE / ORAL2001-04-1203ed91905a0d…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01A075498-002TERAZOSIN HYDROCHLORIDEEQ 2MG BASECAPSULE / ORAL2001-04-1203ed91905a0d…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01A075498-003TERAZOSIN HYDROCHLORIDEEQ 5MG BASECAPSULE / ORAL2001-04-1203ed91905a0d…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01A075498-004TERAZOSIN HYDROCHLORIDEEQ 10MG BASECAPSULE / ORAL2001-04-1203ed91905a0d…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12A075498-001TERAZOSIN HYDROCHLORIDEEQ 1MG BASECAPSULE / ORAL2001-04-122680178bc6a6…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12A075498-002TERAZOSIN HYDROCHLORIDEEQ 2MG BASECAPSULE / ORAL2001-04-122680178bc6a6…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12A075498-003TERAZOSIN HYDROCHLORIDEEQ 5MG BASECAPSULE / ORAL2001-04-122680178bc6a6…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12A075498-004TERAZOSIN HYDROCHLORIDEEQ 10MG BASECAPSULE / ORAL2001-04-122680178bc6a6…
2024-09-14 05:58 UTC · 2 captures of this ZIP2024-09A075498-001TERAZOSIN HYDROCHLORIDEEQ 1MG BASECAPSULE / ORAL2001-04-125bbf6a4d5a75…
2024-09-14 05:58 UTC · 2 captures of this ZIP2024-09A075498-002TERAZOSIN HYDROCHLORIDEEQ 2MG BASECAPSULE / ORAL2001-04-125bbf6a4d5a75…
2024-09-14 05:58 UTC · 2 captures of this ZIP2024-09A075498-003TERAZOSIN HYDROCHLORIDEEQ 5MG BASECAPSULE / ORAL2001-04-125bbf6a4d5a75…
2024-09-14 05:58 UTC · 2 captures of this ZIP2024-09A075498-004TERAZOSIN HYDROCHLORIDEEQ 10MG BASECAPSULE / ORAL2001-04-125bbf6a4d5a75…
2024-11-08 22:44 UTC · 3 captures of this ZIP2024-11A075498-001TERAZOSIN HYDROCHLORIDEEQ 1MG BASECAPSULE / ORAL2001-04-12d8e5a09893c0…
2024-11-08 22:44 UTC · 3 captures of this ZIP2024-11A075498-002TERAZOSIN HYDROCHLORIDEEQ 2MG BASECAPSULE / ORAL2001-04-12d8e5a09893c0…
2024-11-08 22:44 UTC · 3 captures of this ZIP2024-11A075498-003TERAZOSIN HYDROCHLORIDEEQ 5MG BASECAPSULE / ORAL2001-04-12d8e5a09893c0…
2024-11-08 22:44 UTC · 3 captures of this ZIP2024-11A075498-004TERAZOSIN HYDROCHLORIDEEQ 10MG BASECAPSULE / ORAL2001-04-12d8e5a09893c0…
2024-10-29 15:01 UTC2024-10A075498-001TERAZOSIN HYDROCHLORIDEEQ 1MG BASECAPSULE / ORAL2001-04-12d06236e962d9…
2024-10-29 15:01 UTC2024-10A075498-002TERAZOSIN HYDROCHLORIDEEQ 2MG BASECAPSULE / ORAL2001-04-12d06236e962d9…
2024-10-29 15:01 UTC2024-10A075498-003TERAZOSIN HYDROCHLORIDEEQ 5MG BASECAPSULE / ORAL2001-04-12d06236e962d9…
2024-10-29 15:01 UTC2024-10A075498-004TERAZOSIN HYDROCHLORIDEEQ 10MG BASECAPSULE / ORAL2001-04-12d06236e962d9…

Observed Orange Book normalized TE history#

Captured, Edition, Application-product table
CapturedEditionApplication-productTE codeOrderSource SHA-256
2019-12-13 00:20 UTC2019-12A075498-001AB174a2ff9319b5…
2019-12-13 00:20 UTC2019-12A075498-002AB174a2ff9319b5…
2019-12-13 00:20 UTC2019-12A075498-003AB174a2ff9319b5…
2019-12-13 00:20 UTC2019-12A075498-004AB174a2ff9319b5…
2019-12-14 00:12 UTC2019-12A075498-001AB13f01610625f2…
2019-12-14 00:12 UTC2019-12A075498-002AB13f01610625f2…
2019-12-14 00:12 UTC2019-12A075498-003AB13f01610625f2…
2019-12-14 00:12 UTC2019-12A075498-004AB13f01610625f2…
2019-09-15 20:21 UTC2019-09A075498-001AB1b00525d2431f…
2019-09-15 20:21 UTC2019-09A075498-002AB1b00525d2431f…
2019-09-15 20:21 UTC2019-09A075498-003AB1b00525d2431f…
2019-09-15 20:21 UTC2019-09A075498-004AB1b00525d2431f…
2019-07-19 19:46 UTC2019-07A075498-001AB1ea99ee380514…
2019-07-19 19:46 UTC2019-07A075498-002AB1ea99ee380514…
2019-07-19 19:46 UTC2019-07A075498-003AB1ea99ee380514…
2019-07-19 19:46 UTC2019-07A075498-004AB1ea99ee380514…

DailyMed Product Concepts#

Product concept, Relation, Version table
Product conceptRelationVersionEffective
975cd6e7-95ee-60f8-7c38-135ffbb09240Product name220260223
1bc6d1ac-ef0f-4fc6-8704-c443f03b274aProduct name120250311
594e2c86-3079-4e6e-96c9-48f7a8afc78dProduct name120230718
8adc9826-3fee-6091-f1ee-af9fd6f9caf8Product name120140508

FDA-Initiated Inactive NDC Indexing#

NDC, Effective, Action table
NDCEffectiveActionDocumentIndexing SPLRelated label
33261-212-302020-01-31C16284748780-19d75b9d0-cdb7-f424-e053-dadaa90a57ceTerazosin Capsules, 1mg, 2mg, 5mg and 10 mg

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
33261-212-30Terazosin30 in 1 BOTTLE, PLASTICCAPSULE301

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
33261-212-30EA - Each33261-212168cd971-6cbb-4916-beb9-fc9d86a78f8812015-10-02

DailyMed Socrata Ingredients#

Ingredient, Type, UNII table
IngredientTypeUNIIDailyMed labelSPL versionUploaded
TERAZOSIN HYDROCHLORIDEACTIVE INGREDIENTD32S14F082TERAZOSIN CAPSULE [AIDAREX PHARMACEUTICALS LLC]1
TERAZOSINACTIVE MOIETY8L5014XET7TERAZOSIN CAPSULE [AIDAREX PHARMACEUTICALS LLC]1
AMMONIAINACTIVE INGREDIENT5138Q19F1XTERAZOSIN CAPSULE [AIDAREX PHARMACEUTICALS LLC]1
D&C RED NO. 28INACTIVE INGREDIENT767IP0Y5NHTERAZOSIN CAPSULE [AIDAREX PHARMACEUTICALS LLC]1
D&C YELLOW NO. 10INACTIVE INGREDIENT35SW5USQ3GTERAZOSIN CAPSULE [AIDAREX PHARMACEUTICALS LLC]1
FD&C BLUE NO. 1INACTIVE INGREDIENTH3R47K3TBDTERAZOSIN CAPSULE [AIDAREX PHARMACEUTICALS LLC]1
FD&C RED NO. 40INACTIVE INGREDIENTWZB9127XOATERAZOSIN CAPSULE [AIDAREX PHARMACEUTICALS LLC]1
FERRIC OXIDE YELLOWINACTIVE INGREDIENTEX438O2MRTTERAZOSIN CAPSULE [AIDAREX PHARMACEUTICALS LLC]1
FERROSOFERRIC OXIDEINACTIVE INGREDIENTXM0M87F357TERAZOSIN CAPSULE [AIDAREX PHARMACEUTICALS LLC]1
GELATININACTIVE INGREDIENT2G86QN327LTERAZOSIN CAPSULE [AIDAREX PHARMACEUTICALS LLC]1
LACTOSE MONOHYDRATEINACTIVE INGREDIENTEWQ57Q8I5XTERAZOSIN CAPSULE [AIDAREX PHARMACEUTICALS LLC]1
POTASSIUM HYDROXIDEINACTIVE INGREDIENTWZH3C48M4TTERAZOSIN CAPSULE [AIDAREX PHARMACEUTICALS LLC]1
PROPYLENE GLYCOLINACTIVE INGREDIENT6DC9Q167V3TERAZOSIN CAPSULE [AIDAREX PHARMACEUTICALS LLC]1
SHELLACINACTIVE INGREDIENT46N107B71OTERAZOSIN CAPSULE [AIDAREX PHARMACEUTICALS LLC]1
STARCH, CORNINACTIVE INGREDIENTO8232NY3SJTERAZOSIN CAPSULE [AIDAREX PHARMACEUTICALS LLC]1
STEARIC ACIDINACTIVE INGREDIENT4ELV7Z65APTERAZOSIN CAPSULE [AIDAREX PHARMACEUTICALS LLC]1
TALCINACTIVE INGREDIENT7SEV7J4R1UTERAZOSIN CAPSULE [AIDAREX PHARMACEUTICALS LLC]1
TITANIUM DIOXIDEINACTIVE INGREDIENT15FIX9V2JPTERAZOSIN CAPSULE [AIDAREX PHARMACEUTICALS LLC]1

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
33261-212TERAZOSIN CAPSULE [AIDAREX PHARMACEUTICALS LLC]1Legacy NDC, 1 package rows20140213_06234cba-c474-4f53-8efa-fa688b6913b6.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
313215terazosin HCl 1 MG Oral CapsulePSN06234cba-c474-4f53-8efa-fa688b6913b61
260376terazosin HCl 10 MG Oral CapsulePSN06234cba-c474-4f53-8efa-fa688b6913b61
313217terazosin HCl 2 MG Oral CapsulePSN06234cba-c474-4f53-8efa-fa688b6913b61
313215terazosin 1 MG Oral CapsuleSCD06234cba-c474-4f53-8efa-fa688b6913b61
260376terazosin 10 MG Oral CapsuleSCD06234cba-c474-4f53-8efa-fa688b6913b61
313217terazosin 2 MG Oral CapsuleSCD06234cba-c474-4f53-8efa-fa688b6913b61
313215terazosin (as terazosin HCl) 1 MG Oral CapsuleSY06234cba-c474-4f53-8efa-fa688b6913b61
260376terazosin (as terazosin HCl) 10 MG Oral CapsuleSY06234cba-c474-4f53-8efa-fa688b6913b61
313217terazosin (as terazosin HCl) 2 MG Oral CapsuleSY06234cba-c474-4f53-8efa-fa688b6913b61

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionStatus
33261-212-303326102123030 in 1 BOTTLE, PLASTICHistorical