Terazosin Hydrochloride

Product NDC
0781-2054
11-digit product format
007812054
Labeler code
0781
Product ID
0781-2054_7d3db2e2-2f65-45df-9259-2b8e54eddb87
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
Terazosin Hydrochloride
Dosage form
CAPSULE
Route
ORAL
Labeler
Sandoz Inc
Application
ANDA074823
Marketing category
ANDA
Marketing start
1998-03-30
Marketing end
2021-08-31
Substance
TERAZOSIN HYDROCHLORIDE
Active strength
10 mg/1
Pharmacologic classes
Adrenergic alpha-Antagonists [MoA],alpha-Adrenergic Blocker [EPC]
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 · 3 matching rows.

Dataset, Scope, Product NDC table
DatasetScopeProduct NDCPackage NDCCodeStatusReporting periodSource date
excluded productproduct0781-2054DDiscontinued by firm2026-08-11
excluded packagepackage0781-20540781-2054-01DDiscontinued by firm2026-08-11
excluded packagepackage0781-20540781-2054-05DDiscontinued by firm2026-08-11

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 · 36 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 packagepackage0781-2054-01d630ba8d3edf…732f749b63fb…
2025-12-14 17:58 UTC · source 2025-12-05excluded packagepackage0781-2054-05d630ba8d3edf…732f749b63fb…
2025-08-27 00:01 UTC · source 2025-08-26excluded productproductf5e01cc5f278…a2eaf40c39c3…
2025-08-27 00:01 UTC · source 2025-08-26excluded packagepackage0781-2054-01f5e01cc5f278…a2eaf40c39c3…
2025-08-27 00:01 UTC · source 2025-08-26excluded packagepackage0781-2054-05f5e01cc5f278…a2eaf40c39c3…
2025-04-01 02:39 UTC · source 2025-03-31excluded productproduct2ef7874e63bc…57b86245f4fa…
2025-04-01 02:39 UTC · source 2025-03-31excluded packagepackage0781-2054-012ef7874e63bc…57b86245f4fa…
2025-04-01 02:39 UTC · source 2025-03-31excluded packagepackage0781-2054-052ef7874e63bc…57b86245f4fa…
2025-03-28 20:22 UTC · source 2025-03-28excluded productproducta1b67e2a42f9…c4cf2c586c0d…
2025-03-28 20:22 UTC · source 2025-03-28excluded packagepackage0781-2054-01a1b67e2a42f9…c4cf2c586c0d…
2025-03-28 20:22 UTC · source 2025-03-28excluded packagepackage0781-2054-05a1b67e2a42f9…c4cf2c586c0d…
2025-03-22 03:12 UTC · source 2025-03-21excluded productproductcfe11265f3b6…090c488252e2…
2025-03-22 03:12 UTC · source 2025-03-21excluded packagepackage0781-2054-01cfe11265f3b6…090c488252e2…
2025-03-22 03:12 UTC · source 2025-03-21excluded packagepackage0781-2054-05cfe11265f3b6…090c488252e2…
2025-03-10 12:48 UTC · source 2025-03-10excluded productproductcdf11ea48f46…ba0047e9e063…
2025-03-10 12:48 UTC · source 2025-03-10excluded packagepackage0781-2054-01cdf11ea48f46…ba0047e9e063…
2025-03-10 12:48 UTC · source 2025-03-10excluded packagepackage0781-2054-05cdf11ea48f46…ba0047e9e063…
2025-02-02 03:52 UTC · source 2025-01-31excluded productproduct302b2466d912…e7b80fea0513…
2025-02-02 03:52 UTC · source 2025-01-31excluded packagepackage0781-2054-01302b2466d912…e7b80fea0513…
2025-02-02 03:52 UTC · source 2025-01-31excluded packagepackage0781-2054-05302b2466d912…e7b80fea0513…
2025-01-20 13:05 UTC · source 2025-01-20excluded productproducted331223b511…672a5bd82f5f…
2025-01-20 13:05 UTC · source 2025-01-20excluded packagepackage0781-2054-01ed331223b511…672a5bd82f5f…
2025-01-20 13:05 UTC · source 2025-01-20excluded packagepackage0781-2054-05ed331223b511…672a5bd82f5f…
2025-01-11 03:41 UTC · source 2025-01-10excluded productproduct0efc9e666f02…f202fb6c5f17…
2025-01-11 03:41 UTC · source 2025-01-10excluded packagepackage0781-2054-010efc9e666f02…f202fb6c5f17…
2025-01-11 03:41 UTC · source 2025-01-10excluded packagepackage0781-2054-050efc9e666f02…f202fb6c5f17…
2024-11-09 02:27 UTC · source 2024-11-08excluded productproductad56d346431e…cc804d4bbf1e…
2024-11-09 02:27 UTC · source 2024-11-08excluded packagepackage0781-2054-01ad56d346431e…cc804d4bbf1e…
2024-11-09 02:27 UTC · source 2024-11-08excluded packagepackage0781-2054-05ad56d346431e…cc804d4bbf1e…
2024-10-04 04:10 UTC · source 2024-10-03excluded productproduct367a005e9d99…383a685ebd0f…
2024-10-04 04:10 UTC · source 2024-10-03excluded packagepackage0781-2054-01367a005e9d99…383a685ebd0f…
2024-10-04 04:10 UTC · source 2024-10-03excluded packagepackage0781-2054-05367a005e9d99…383a685ebd0f…
2024-07-10 04:00 UTC · source 2024-07-09excluded productproduct557ba5c1ecfa…9c80585c8c6e…
2024-07-10 04:00 UTC · source 2024-07-09excluded packagepackage0781-2054-01557ba5c1ecfa…9c80585c8c6e…
2024-07-10 04:00 UTC · source 2024-07-09excluded packagepackage0781-2054-05557ba5c1ecfa…9c80585c8c6e…

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
A074823-001TERAZOSIN HYDROCHLORIDETERAZOSIN HYDROCHLORIDEEQ 1MG BASECAPSULE / ORALAB1998-03-30
A074823-002TERAZOSIN HYDROCHLORIDETERAZOSIN HYDROCHLORIDEEQ 2MG BASECAPSULE / ORALAB1998-03-30
A074823-003TERAZOSIN HYDROCHLORIDETERAZOSIN HYDROCHLORIDEEQ 5MG BASECAPSULE / ORALAB1998-03-30
A074823-004TERAZOSIN HYDROCHLORIDETERAZOSIN HYDROCHLORIDEEQ 10MG BASECAPSULE / ORALAB1998-03-30

Therapeutic equivalence codes#

Current TE-code rows page 1 of 1 · 4 matching rows.

Application-product, TE code table
Application-productTE code
A074823-001AB
A074823-002AB
A074823-003AB
A074823-004AB

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 UTC2026-02A074823-001TERAZOSIN HYDROCHLORIDEEQ 1MG BASECAPSULE / ORALAB1998-03-30011fe1cb6892…
2026-02-19 14:30 UTC2026-02A074823-002TERAZOSIN HYDROCHLORIDEEQ 2MG BASECAPSULE / ORALAB1998-03-30011fe1cb6892…
2026-02-19 14:30 UTC2026-02A074823-003TERAZOSIN HYDROCHLORIDEEQ 5MG BASECAPSULE / ORALAB1998-03-30011fe1cb6892…
2026-02-19 14:30 UTC2026-02A074823-004TERAZOSIN HYDROCHLORIDEEQ 10MG BASECAPSULE / ORALAB1998-03-30011fe1cb6892…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A074823-001TERAZOSIN HYDROCHLORIDEEQ 1MG BASECAPSULE / ORALAB1998-03-3031067a03dcf5…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A074823-002TERAZOSIN HYDROCHLORIDEEQ 2MG BASECAPSULE / ORALAB1998-03-3031067a03dcf5…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A074823-003TERAZOSIN HYDROCHLORIDEEQ 5MG BASECAPSULE / ORALAB1998-03-3031067a03dcf5…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A074823-004TERAZOSIN HYDROCHLORIDEEQ 10MG BASECAPSULE / ORALAB1998-03-3031067a03dcf5…
2025-08-23 18:47 UTC2025-08A074823-001TERAZOSIN HYDROCHLORIDEEQ 1MG BASECAPSULE / ORALAB1998-03-306a471c1ec25d…
2025-08-23 18:47 UTC2025-08A074823-002TERAZOSIN HYDROCHLORIDEEQ 2MG BASECAPSULE / ORALAB1998-03-306a471c1ec25d…
2025-08-23 18:47 UTC2025-08A074823-003TERAZOSIN HYDROCHLORIDEEQ 5MG BASECAPSULE / ORALAB1998-03-306a471c1ec25d…
2025-08-23 18:47 UTC2025-08A074823-004TERAZOSIN HYDROCHLORIDEEQ 10MG BASECAPSULE / ORALAB1998-03-306a471c1ec25d…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03A074823-001TERAZOSIN HYDROCHLORIDEEQ 1MG BASECAPSULE / ORALAB1998-03-30fd3edfee7708…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03A074823-002TERAZOSIN HYDROCHLORIDEEQ 2MG BASECAPSULE / ORALAB1998-03-30fd3edfee7708…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03A074823-003TERAZOSIN HYDROCHLORIDEEQ 5MG BASECAPSULE / ORALAB1998-03-30fd3edfee7708…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03A074823-004TERAZOSIN HYDROCHLORIDEEQ 10MG BASECAPSULE / ORALAB1998-03-30fd3edfee7708…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02A074823-001TERAZOSIN HYDROCHLORIDEEQ 1MG BASECAPSULE / ORALAB1998-03-30b8a1b40f171c…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02A074823-002TERAZOSIN HYDROCHLORIDEEQ 2MG BASECAPSULE / ORALAB1998-03-30b8a1b40f171c…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02A074823-003TERAZOSIN HYDROCHLORIDEEQ 5MG BASECAPSULE / ORALAB1998-03-30b8a1b40f171c…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02A074823-004TERAZOSIN HYDROCHLORIDEEQ 10MG BASECAPSULE / ORALAB1998-03-30b8a1b40f171c…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01A074823-001TERAZOSIN HYDROCHLORIDEEQ 1MG BASECAPSULE / ORALAB1998-03-3003ed91905a0d…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01A074823-002TERAZOSIN HYDROCHLORIDEEQ 2MG BASECAPSULE / ORALAB1998-03-3003ed91905a0d…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01A074823-003TERAZOSIN HYDROCHLORIDEEQ 5MG BASECAPSULE / ORALAB1998-03-3003ed91905a0d…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01A074823-004TERAZOSIN HYDROCHLORIDEEQ 10MG BASECAPSULE / ORALAB1998-03-3003ed91905a0d…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12A074823-001TERAZOSIN HYDROCHLORIDEEQ 1MG BASECAPSULE / ORALAB1998-03-302680178bc6a6…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12A074823-002TERAZOSIN HYDROCHLORIDEEQ 2MG BASECAPSULE / ORALAB1998-03-302680178bc6a6…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12A074823-003TERAZOSIN HYDROCHLORIDEEQ 5MG BASECAPSULE / ORALAB1998-03-302680178bc6a6…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12A074823-004TERAZOSIN HYDROCHLORIDEEQ 10MG BASECAPSULE / ORALAB1998-03-302680178bc6a6…
2024-09-14 05:58 UTC · 2 captures of this ZIP2024-09A074823-001TERAZOSIN HYDROCHLORIDEEQ 1MG BASECAPSULE / ORALAB1998-03-305bbf6a4d5a75…
2024-09-14 05:58 UTC · 2 captures of this ZIP2024-09A074823-002TERAZOSIN HYDROCHLORIDEEQ 2MG BASECAPSULE / ORALAB1998-03-305bbf6a4d5a75…
2024-09-14 05:58 UTC · 2 captures of this ZIP2024-09A074823-003TERAZOSIN HYDROCHLORIDEEQ 5MG BASECAPSULE / ORALAB1998-03-305bbf6a4d5a75…
2024-09-14 05:58 UTC · 2 captures of this ZIP2024-09A074823-004TERAZOSIN HYDROCHLORIDEEQ 10MG BASECAPSULE / ORALAB1998-03-305bbf6a4d5a75…
2024-11-08 22:44 UTC · 3 captures of this ZIP2024-11A074823-001TERAZOSIN HYDROCHLORIDEEQ 1MG BASECAPSULE / ORALAB1998-03-30d8e5a09893c0…
2024-11-08 22:44 UTC · 3 captures of this ZIP2024-11A074823-002TERAZOSIN HYDROCHLORIDEEQ 2MG BASECAPSULE / ORALAB1998-03-30d8e5a09893c0…
2024-11-08 22:44 UTC · 3 captures of this ZIP2024-11A074823-003TERAZOSIN HYDROCHLORIDEEQ 5MG BASECAPSULE / ORALAB1998-03-30d8e5a09893c0…
2024-11-08 22:44 UTC · 3 captures of this ZIP2024-11A074823-004TERAZOSIN HYDROCHLORIDEEQ 10MG BASECAPSULE / ORALAB1998-03-30d8e5a09893c0…
2024-10-29 15:01 UTC2024-10A074823-001TERAZOSIN HYDROCHLORIDEEQ 1MG BASECAPSULE / ORALAB1998-03-30d06236e962d9…
2024-10-29 15:01 UTC2024-10A074823-002TERAZOSIN HYDROCHLORIDEEQ 2MG BASECAPSULE / ORALAB1998-03-30d06236e962d9…
2024-10-29 15:01 UTC2024-10A074823-003TERAZOSIN HYDROCHLORIDEEQ 5MG BASECAPSULE / ORALAB1998-03-30d06236e962d9…
2024-10-29 15:01 UTC2024-10A074823-004TERAZOSIN HYDROCHLORIDEEQ 10MG BASECAPSULE / ORALAB1998-03-30d06236e962d9…

Observed Orange Book normalized TE history#

Normalized TE history page 1 of 5 · 164 observed states.

Captured, Edition, Application-product table
CapturedEditionApplication-productTE codeOrderSource SHA-256
2026-02-19 14:30 UTC2026-02A074823-001AB1011fe1cb6892…
2026-02-19 14:30 UTC2026-02A074823-002AB1011fe1cb6892…
2026-02-19 14:30 UTC2026-02A074823-003AB1011fe1cb6892…
2026-02-19 14:30 UTC2026-02A074823-004AB1011fe1cb6892…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A074823-001AB131067a03dcf5…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A074823-002AB131067a03dcf5…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A074823-003AB131067a03dcf5…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A074823-004AB131067a03dcf5…
2025-08-23 18:47 UTC2025-08A074823-001AB16a471c1ec25d…
2025-08-23 18:47 UTC2025-08A074823-002AB16a471c1ec25d…
2025-08-23 18:47 UTC2025-08A074823-003AB16a471c1ec25d…
2025-08-23 18:47 UTC2025-08A074823-004AB16a471c1ec25d…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03A074823-001AB1fd3edfee7708…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03A074823-002AB1fd3edfee7708…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03A074823-003AB1fd3edfee7708…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03A074823-004AB1fd3edfee7708…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02A074823-001AB1b8a1b40f171c…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02A074823-002AB1b8a1b40f171c…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02A074823-003AB1b8a1b40f171c…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02A074823-004AB1b8a1b40f171c…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01A074823-001AB103ed91905a0d…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01A074823-002AB103ed91905a0d…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01A074823-003AB103ed91905a0d…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01A074823-004AB103ed91905a0d…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12A074823-001AB12680178bc6a6…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12A074823-002AB12680178bc6a6…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12A074823-003AB12680178bc6a6…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12A074823-004AB12680178bc6a6…
2024-09-14 05:58 UTC · 2 captures of this ZIP2024-09A074823-001AB15bbf6a4d5a75…
2024-09-14 05:58 UTC · 2 captures of this ZIP2024-09A074823-002AB15bbf6a4d5a75…
2024-09-14 05:58 UTC · 2 captures of this ZIP2024-09A074823-003AB15bbf6a4d5a75…
2024-09-14 05:58 UTC · 2 captures of this ZIP2024-09A074823-004AB15bbf6a4d5a75…
2024-11-08 22:44 UTC · 3 captures of this ZIP2024-11A074823-001AB1d8e5a09893c0…
2024-11-08 22:44 UTC · 3 captures of this ZIP2024-11A074823-002AB1d8e5a09893c0…
2024-11-08 22:44 UTC · 3 captures of this ZIP2024-11A074823-003AB1d8e5a09893c0…
2024-11-08 22:44 UTC · 3 captures of this ZIP2024-11A074823-004AB1d8e5a09893c0…
2024-10-29 15:01 UTC2024-10A074823-001AB1d06236e962d9…
2024-10-29 15:01 UTC2024-10A074823-002AB1d06236e962d9…
2024-10-29 15:01 UTC2024-10A074823-003AB1d06236e962d9…
2024-10-29 15:01 UTC2024-10A074823-004AB1d06236e962d9…

DailyMed Product Concepts#

Product concept, Relation, Version table
Product conceptRelationVersionEffective
975cd6e7-95ee-60f8-7c38-135ffbb09240Product name220260223
1bc6d1ac-ef0f-4fc6-8704-c443f03b274aProduct name120250311
8adc9826-3fee-6091-f1ee-af9fd6f9caf8Product name120140508

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
0781-2054-01EA - Each0781-20547c636fd0-33de-41dc-9fdf-26e02f1ef1a112012-07-24
0781-2054-05EA - Each0781-2054f005be0d-8f9e-4fd9-8df0-ab2d9ba6b9a612012-07-24

DailyMed Socrata Ingredients#

Ingredient, Type, UNII table
IngredientTypeUNIIDailyMed labelSPL versionUploaded
TERAZOSIN HYDROCHLORIDEACTIVE INGREDIENTD32S14F082TERAZOSIN HYDROCHLORIDE CAPSULE [SANDOZ INC]13
TERAZOSINACTIVE MOIETY8L5014XET7TERAZOSIN HYDROCHLORIDE CAPSULE [SANDOZ INC]13
CELLULOSE, MICROCRYSTALLINEINACTIVE INGREDIENTOP1R32D61UTERAZOSIN HYDROCHLORIDE CAPSULE [SANDOZ INC]13
CROSPOVIDONEINACTIVE INGREDIENT68401960MKTERAZOSIN HYDROCHLORIDE CAPSULE [SANDOZ INC]13
D&C RED NO. 28INACTIVE INGREDIENT767IP0Y5NHTERAZOSIN HYDROCHLORIDE CAPSULE [SANDOZ INC]13
D&C YELLOW NO. 10INACTIVE INGREDIENT35SW5USQ3GTERAZOSIN HYDROCHLORIDE CAPSULE [SANDOZ INC]13
FD&C BLUE NO. 1INACTIVE INGREDIENTH3R47K3TBDTERAZOSIN HYDROCHLORIDE CAPSULE [SANDOZ INC]13
FD&C BLUE NO. 2INACTIVE INGREDIENTL06K8R7DQKTERAZOSIN HYDROCHLORIDE CAPSULE [SANDOZ INC]13
FD&C RED NO. 40INACTIVE INGREDIENTWZB9127XOATERAZOSIN HYDROCHLORIDE CAPSULE [SANDOZ INC]13
FERROSOFERRIC OXIDEINACTIVE INGREDIENTXM0M87F357TERAZOSIN HYDROCHLORIDE CAPSULE [SANDOZ INC]13
GELATININACTIVE INGREDIENT2G86QN327LTERAZOSIN HYDROCHLORIDE CAPSULE [SANDOZ INC]13
LACTOSE MONOHYDRATEINACTIVE INGREDIENTEWQ57Q8I5XTERAZOSIN HYDROCHLORIDE CAPSULE [SANDOZ INC]13
MAGNESIUM STEARATEINACTIVE INGREDIENT70097M6I30TERAZOSIN HYDROCHLORIDE CAPSULE [SANDOZ INC]13
PROPYLENE GLYCOLINACTIVE INGREDIENT6DC9Q167V3TERAZOSIN HYDROCHLORIDE CAPSULE [SANDOZ INC]13
SHELLACINACTIVE INGREDIENT46N107B71OTERAZOSIN HYDROCHLORIDE CAPSULE [SANDOZ INC]13
STARCH, CORNINACTIVE INGREDIENTO8232NY3SJTERAZOSIN HYDROCHLORIDE CAPSULE [SANDOZ INC]13
TITANIUM DIOXIDEINACTIVE INGREDIENT15FIX9V2JPTERAZOSIN HYDROCHLORIDE CAPSULE [SANDOZ INC]13
TERAZOSIN HYDROCHLORIDEACTIVE INGREDIENTD32S14F082TERAZOSIN HYDROCHLORIDE CAPSULE [PHYSICIANS TOTAL CARE, INC.]6
TERAZOSINACTIVE MOIETY8L5014XET7TERAZOSIN HYDROCHLORIDE CAPSULE [PHYSICIANS TOTAL CARE, INC.]6
CELLULOSE, MICROCRYSTALLINEINACTIVE INGREDIENTOP1R32D61UTERAZOSIN HYDROCHLORIDE CAPSULE [PHYSICIANS TOTAL CARE, INC.]6
CROSPOVIDONEINACTIVE INGREDIENT68401960MKTERAZOSIN HYDROCHLORIDE CAPSULE [PHYSICIANS TOTAL CARE, INC.]6
D&C RED NO. 28INACTIVE INGREDIENT767IP0Y5NHTERAZOSIN HYDROCHLORIDE CAPSULE [PHYSICIANS TOTAL CARE, INC.]6
D&C YELLOW NO. 10INACTIVE INGREDIENT35SW5USQ3GTERAZOSIN HYDROCHLORIDE CAPSULE [PHYSICIANS TOTAL CARE, INC.]6
FD&C BLUE NO. 1INACTIVE INGREDIENTH3R47K3TBDTERAZOSIN HYDROCHLORIDE CAPSULE [PHYSICIANS TOTAL CARE, INC.]6
FD&C BLUE NO. 2INACTIVE INGREDIENTL06K8R7DQKTERAZOSIN HYDROCHLORIDE CAPSULE [PHYSICIANS TOTAL CARE, INC.]6
FD&C RED NO. 40INACTIVE INGREDIENTWZB9127XOATERAZOSIN HYDROCHLORIDE CAPSULE [PHYSICIANS TOTAL CARE, INC.]6
FERROSOFERRIC OXIDEINACTIVE INGREDIENTXM0M87F357TERAZOSIN HYDROCHLORIDE CAPSULE [PHYSICIANS TOTAL CARE, INC.]6
GELATININACTIVE INGREDIENT2G86QN327LTERAZOSIN HYDROCHLORIDE CAPSULE [PHYSICIANS TOTAL CARE, INC.]6
LACTOSE MONOHYDRATEINACTIVE INGREDIENTEWQ57Q8I5XTERAZOSIN HYDROCHLORIDE CAPSULE [PHYSICIANS TOTAL CARE, INC.]6
MAGNESIUM STEARATEINACTIVE INGREDIENT70097M6I30TERAZOSIN HYDROCHLORIDE CAPSULE [PHYSICIANS TOTAL CARE, INC.]6
PROPYLENE GLYCOLINACTIVE INGREDIENT6DC9Q167V3TERAZOSIN HYDROCHLORIDE CAPSULE [PHYSICIANS TOTAL CARE, INC.]6
SHELLACINACTIVE INGREDIENT46N107B71OTERAZOSIN HYDROCHLORIDE CAPSULE [PHYSICIANS TOTAL CARE, INC.]6
STARCH, CORNINACTIVE INGREDIENTO8232NY3SJTERAZOSIN HYDROCHLORIDE CAPSULE [PHYSICIANS TOTAL CARE, INC.]6
TITANIUM DIOXIDEINACTIVE INGREDIENT15FIX9V2JPTERAZOSIN HYDROCHLORIDE CAPSULE [PHYSICIANS TOTAL CARE, INC.]6

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 · 5 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
Terazosin HydrochlorideTERAZOSIN HYDROCHLORIDEAmerisyn, LLC5680d373-0f61-baf8-e063-6394a90ab8a62026-07-13Warnings, Adverse reactionsExact identifier
application applno (ANDA): 074823
application number: ANDA074823
Terazosin HydrochlorideTERAZOSIN HYDROCHLORIDEAmici Pharma, Inc.4007dbd3-e850-43e7-8a56-8735e31063cd2026-05-20Warnings, Adverse reactionsExact identifier
application applno (ANDA): 074823
application number: ANDA074823
Terazosin HydrochlorideTERAZOSIN HYDROCHLORIDEAphena Pharma Solutions - Tennessee, LLC214d9b06-8d23-3ee8-e063-6394a90a15212024-09-04Warnings, Adverse reactionsExact identifier
application applno (ANDA): 074823
application number: ANDA074823
Terazosin HydrochlorideTERAZOSIN HYDROCHLORIDEAphena Pharma Solutions - Tennessee, LLC9199083d-403f-4c9e-90e1-713ed0a079032023-04-05Warnings, Adverse reactionsExact identifier
application applno (ANDA): 074823
application number: ANDA074823
Terazosin HydrochlorideTERAZOSIN HYDROCHLORIDEAphena Pharma Solutions - Tennessee, LLCe5507ea6-bdb3-4363-a68b-0478cbb25f4a2021-08-26Warnings, Adverse reactionsExact identifier
application applno (ANDA): 074823
application number: ANDA074823

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
260376terazosin HCl 10 MG Oral CapsulePSN40369190-10a4-4af5-a5f2-ed38562b443c23
313219terazosin HCl 5 MG Oral CapsulePSN40369190-10a4-4af5-a5f2-ed38562b443c23
260376terazosin 10 MG Oral CapsuleSCD40369190-10a4-4af5-a5f2-ed38562b443c23
313219terazosin 5 MG Oral CapsuleSCD40369190-10a4-4af5-a5f2-ed38562b443c23
260376terazosin (as terazosin HCl) 10 MG Oral CapsuleSY40369190-10a4-4af5-a5f2-ed38562b443c23
313219terazosin (as terazosin hydrochloride) 5 MG Oral CapsuleSY40369190-10a4-4af5-a5f2-ed38562b443c23
313215terazosin HCl 1 MG Oral CapsulePSN88ac2dc1-062f-42c4-93ba-8a09116dbaed6
260376terazosin HCl 10 MG Oral CapsulePSN88ac2dc1-062f-42c4-93ba-8a09116dbaed6
313217terazosin HCl 2 MG Oral CapsulePSN88ac2dc1-062f-42c4-93ba-8a09116dbaed6
313219terazosin HCl 5 MG Oral CapsulePSN88ac2dc1-062f-42c4-93ba-8a09116dbaed6
313215terazosin 1 MG Oral CapsuleSCD88ac2dc1-062f-42c4-93ba-8a09116dbaed6
260376terazosin 10 MG Oral CapsuleSCD88ac2dc1-062f-42c4-93ba-8a09116dbaed6
313217terazosin 2 MG Oral CapsuleSCD88ac2dc1-062f-42c4-93ba-8a09116dbaed6
313219terazosin 5 MG Oral CapsuleSCD88ac2dc1-062f-42c4-93ba-8a09116dbaed6
313215terazosin (as terazosin HCl) 1 MG Oral CapsuleSY88ac2dc1-062f-42c4-93ba-8a09116dbaed6
260376terazosin (as terazosin HCl) 10 MG Oral CapsuleSY88ac2dc1-062f-42c4-93ba-8a09116dbaed6
313217terazosin (as terazosin HCl) 2 MG Oral CapsuleSY88ac2dc1-062f-42c4-93ba-8a09116dbaed6
313219terazosin (as terazosin hydrochloride) 5 MG Oral CapsuleSY88ac2dc1-062f-42c4-93ba-8a09116dbaed6

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
0781-2054-0100781205401100 CAPSULE in 1 BOTTLE (0781-2054-01) 100 capsule1998-03-302021-07-31NoNoCurrent