Terazosin

Product NDC
59746-386
11-digit product format
597460386
Labeler code
59746
Product ID
59746-386_cc58b113-b1c4-4147-a20b-473c30aa7041
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
Terazosin Hydrochloride
Dosage form
CAPSULE
Route
ORAL
Labeler
Jubilant Cadista Pharmaceuticals Inc.
Application
ANDA075317
Marketing category
ANDA
Marketing start
2004-12-20
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
2027-12-31
Current FDA listing
Yes

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
A075317-001TERAZOSIN HYDROCHLORIDETERAZOSIN HYDROCHLORIDEEQ 1MG BASECAPSULE / ORALABRS2004-12-20
A075317-002TERAZOSIN HYDROCHLORIDETERAZOSIN HYDROCHLORIDEEQ 2MG BASECAPSULE / ORALAB2004-12-20
A075317-003TERAZOSIN HYDROCHLORIDETERAZOSIN HYDROCHLORIDEEQ 5MG BASECAPSULE / ORALAB2004-12-20
A075317-004TERAZOSIN HYDROCHLORIDETERAZOSIN HYDROCHLORIDEEQ 10MG BASECAPSULE / ORALAB2004-12-20

Therapeutic equivalence codes#

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

Application-product, TE code table
Application-productTE code
A075317-001AB
A075317-002AB
A075317-003AB
A075317-004AB

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 UTC2026-02A075317-001TERAZOSIN HYDROCHLORIDEEQ 1MG BASECAPSULE / ORALABRS2004-12-20011fe1cb6892…
2026-02-19 14:30 UTC2026-02A075317-002TERAZOSIN HYDROCHLORIDEEQ 2MG BASECAPSULE / ORALAB2004-12-20011fe1cb6892…
2026-02-19 14:30 UTC2026-02A075317-003TERAZOSIN HYDROCHLORIDEEQ 5MG BASECAPSULE / ORALAB2004-12-20011fe1cb6892…
2026-02-19 14:30 UTC2026-02A075317-004TERAZOSIN HYDROCHLORIDEEQ 10MG BASECAPSULE / ORALAB2004-12-20011fe1cb6892…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A075317-001TERAZOSIN HYDROCHLORIDEEQ 1MG BASECAPSULE / ORALABRS2004-12-2031067a03dcf5…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A075317-002TERAZOSIN HYDROCHLORIDEEQ 2MG BASECAPSULE / ORALAB2004-12-2031067a03dcf5…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A075317-003TERAZOSIN HYDROCHLORIDEEQ 5MG BASECAPSULE / ORALAB2004-12-2031067a03dcf5…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A075317-004TERAZOSIN HYDROCHLORIDEEQ 10MG BASECAPSULE / ORALAB2004-12-2031067a03dcf5…
2025-08-23 18:47 UTC2025-08A075317-001TERAZOSIN HYDROCHLORIDEEQ 1MG BASECAPSULE / ORALABRS2004-12-206a471c1ec25d…
2025-08-23 18:47 UTC2025-08A075317-002TERAZOSIN HYDROCHLORIDEEQ 2MG BASECAPSULE / ORALAB2004-12-206a471c1ec25d…
2025-08-23 18:47 UTC2025-08A075317-003TERAZOSIN HYDROCHLORIDEEQ 5MG BASECAPSULE / ORALAB2004-12-206a471c1ec25d…
2025-08-23 18:47 UTC2025-08A075317-004TERAZOSIN HYDROCHLORIDEEQ 10MG BASECAPSULE / ORALAB2004-12-206a471c1ec25d…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03A075317-001TERAZOSIN HYDROCHLORIDEEQ 1MG BASECAPSULE / ORALABRS2004-12-20fd3edfee7708…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03A075317-002TERAZOSIN HYDROCHLORIDEEQ 2MG BASECAPSULE / ORALAB2004-12-20fd3edfee7708…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03A075317-003TERAZOSIN HYDROCHLORIDEEQ 5MG BASECAPSULE / ORALAB2004-12-20fd3edfee7708…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03A075317-004TERAZOSIN HYDROCHLORIDEEQ 10MG BASECAPSULE / ORALAB2004-12-20fd3edfee7708…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02A075317-001TERAZOSIN HYDROCHLORIDEEQ 1MG BASECAPSULE / ORALABRS2004-12-20b8a1b40f171c…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02A075317-002TERAZOSIN HYDROCHLORIDEEQ 2MG BASECAPSULE / ORALAB2004-12-20b8a1b40f171c…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02A075317-003TERAZOSIN HYDROCHLORIDEEQ 5MG BASECAPSULE / ORALAB2004-12-20b8a1b40f171c…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02A075317-004TERAZOSIN HYDROCHLORIDEEQ 10MG BASECAPSULE / ORALAB2004-12-20b8a1b40f171c…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01A075317-001TERAZOSIN HYDROCHLORIDEEQ 1MG BASECAPSULE / ORALABRS2004-12-2003ed91905a0d…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01A075317-002TERAZOSIN HYDROCHLORIDEEQ 2MG BASECAPSULE / ORALAB2004-12-2003ed91905a0d…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01A075317-003TERAZOSIN HYDROCHLORIDEEQ 5MG BASECAPSULE / ORALAB2004-12-2003ed91905a0d…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01A075317-004TERAZOSIN HYDROCHLORIDEEQ 10MG BASECAPSULE / ORALAB2004-12-2003ed91905a0d…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12A075317-001TERAZOSIN HYDROCHLORIDEEQ 1MG BASECAPSULE / ORALABRS2004-12-202680178bc6a6…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12A075317-002TERAZOSIN HYDROCHLORIDEEQ 2MG BASECAPSULE / ORALAB2004-12-202680178bc6a6…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12A075317-003TERAZOSIN HYDROCHLORIDEEQ 5MG BASECAPSULE / ORALAB2004-12-202680178bc6a6…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12A075317-004TERAZOSIN HYDROCHLORIDEEQ 10MG BASECAPSULE / ORALAB2004-12-202680178bc6a6…
2024-09-14 05:58 UTC · 2 captures of this ZIP2024-09A075317-001TERAZOSIN HYDROCHLORIDEEQ 1MG BASECAPSULE / ORALABRS2004-12-205bbf6a4d5a75…
2024-09-14 05:58 UTC · 2 captures of this ZIP2024-09A075317-002TERAZOSIN HYDROCHLORIDEEQ 2MG BASECAPSULE / ORALAB2004-12-205bbf6a4d5a75…
2024-09-14 05:58 UTC · 2 captures of this ZIP2024-09A075317-003TERAZOSIN HYDROCHLORIDEEQ 5MG BASECAPSULE / ORALAB2004-12-205bbf6a4d5a75…
2024-09-14 05:58 UTC · 2 captures of this ZIP2024-09A075317-004TERAZOSIN HYDROCHLORIDEEQ 10MG BASECAPSULE / ORALAB2004-12-205bbf6a4d5a75…
2024-11-08 22:44 UTC · 3 captures of this ZIP2024-11A075317-001TERAZOSIN HYDROCHLORIDEEQ 1MG BASECAPSULE / ORALABRS2004-12-20d8e5a09893c0…
2024-11-08 22:44 UTC · 3 captures of this ZIP2024-11A075317-002TERAZOSIN HYDROCHLORIDEEQ 2MG BASECAPSULE / ORALAB2004-12-20d8e5a09893c0…
2024-11-08 22:44 UTC · 3 captures of this ZIP2024-11A075317-003TERAZOSIN HYDROCHLORIDEEQ 5MG BASECAPSULE / ORALAB2004-12-20d8e5a09893c0…
2024-11-08 22:44 UTC · 3 captures of this ZIP2024-11A075317-004TERAZOSIN HYDROCHLORIDEEQ 10MG BASECAPSULE / ORALAB2004-12-20d8e5a09893c0…
2024-10-29 15:01 UTC2024-10A075317-001TERAZOSIN HYDROCHLORIDEEQ 1MG BASECAPSULE / ORALABRS2004-12-20d06236e962d9…
2024-10-29 15:01 UTC2024-10A075317-002TERAZOSIN HYDROCHLORIDEEQ 2MG BASECAPSULE / ORALAB2004-12-20d06236e962d9…
2024-10-29 15:01 UTC2024-10A075317-003TERAZOSIN HYDROCHLORIDEEQ 5MG BASECAPSULE / ORALAB2004-12-20d06236e962d9…
2024-10-29 15:01 UTC2024-10A075317-004TERAZOSIN HYDROCHLORIDEEQ 10MG BASECAPSULE / ORALAB2004-12-20d06236e962d9…

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 UTC2026-02A075317-001AB1011fe1cb6892…
2026-02-19 14:30 UTC2026-02A075317-002AB1011fe1cb6892…
2026-02-19 14:30 UTC2026-02A075317-003AB1011fe1cb6892…
2026-02-19 14:30 UTC2026-02A075317-004AB1011fe1cb6892…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A075317-001AB131067a03dcf5…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A075317-002AB131067a03dcf5…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A075317-003AB131067a03dcf5…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A075317-004AB131067a03dcf5…
2025-08-23 18:47 UTC2025-08A075317-001AB16a471c1ec25d…
2025-08-23 18:47 UTC2025-08A075317-002AB16a471c1ec25d…
2025-08-23 18:47 UTC2025-08A075317-003AB16a471c1ec25d…
2025-08-23 18:47 UTC2025-08A075317-004AB16a471c1ec25d…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03A075317-001AB1fd3edfee7708…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03A075317-002AB1fd3edfee7708…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03A075317-003AB1fd3edfee7708…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03A075317-004AB1fd3edfee7708…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02A075317-001AB1b8a1b40f171c…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02A075317-002AB1b8a1b40f171c…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02A075317-003AB1b8a1b40f171c…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02A075317-004AB1b8a1b40f171c…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01A075317-001AB103ed91905a0d…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01A075317-002AB103ed91905a0d…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01A075317-003AB103ed91905a0d…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01A075317-004AB103ed91905a0d…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12A075317-001AB12680178bc6a6…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12A075317-002AB12680178bc6a6…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12A075317-003AB12680178bc6a6…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12A075317-004AB12680178bc6a6…
2024-09-14 05:58 UTC · 2 captures of this ZIP2024-09A075317-001AB15bbf6a4d5a75…
2024-09-14 05:58 UTC · 2 captures of this ZIP2024-09A075317-002AB15bbf6a4d5a75…
2024-09-14 05:58 UTC · 2 captures of this ZIP2024-09A075317-003AB15bbf6a4d5a75…
2024-09-14 05:58 UTC · 2 captures of this ZIP2024-09A075317-004AB15bbf6a4d5a75…
2024-11-08 22:44 UTC · 3 captures of this ZIP2024-11A075317-001AB1d8e5a09893c0…
2024-11-08 22:44 UTC · 3 captures of this ZIP2024-11A075317-002AB1d8e5a09893c0…
2024-11-08 22:44 UTC · 3 captures of this ZIP2024-11A075317-003AB1d8e5a09893c0…
2024-11-08 22:44 UTC · 3 captures of this ZIP2024-11A075317-004AB1d8e5a09893c0…
2024-10-29 15:01 UTC2024-10A075317-001AB1d06236e962d9…
2024-10-29 15:01 UTC2024-10A075317-002AB1d06236e962d9…
2024-10-29 15:01 UTC2024-10A075317-003AB1d06236e962d9…
2024-10-29 15:01 UTC2024-10A075317-004AB1d06236e962d9…

Additional Listing Data#

Finished product
Yes
Brand name base
Terazosin
Listing expiration
2027-12-31

Active Ingredients#

Ingredient, Strength table
IngredientStrength
TERAZOSIN HYDROCHLORIDE10 mg/1

Harmonized UNII identifiers#

UNII identifiers page 1 of 1 · 1 matching rows.

Identifier, FDA.report destination table
IdentifierFDA.report destination
D32S14F082Internal UNII lookup

Harmonized RxCUI identifiers#

RxCUI identifiers page 1 of 1 · 4 matching rows.

Identifier, FDA.report destination table
IdentifierFDA.report destination
260376Internal RxNorm lookup
313215Internal RxNorm lookup
313217Internal RxNorm lookup
313219Internal RxNorm lookup

Harmonized SPL set identifiers#

SPL set identifiers page 1 of 1 · 1 matching rows.

Identifier, FDA.report destination table
IdentifierFDA.report destination
43e92495-2cf2-46dd-a80c-f0c3c88c7b73Available on FDA.report

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 Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
59746-386-06Terazosin100 in 1 BOTTLECAPSULE1008
59746-386-09Terazosin500 in 1 BOTTLECAPSULE5008
59746-386-10Terazosin1000 in 1 BOTTLECAPSULE10008
59746-386-90Terazosin90 in 1 BOTTLECAPSULE908

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
59746-386-06EA - Each59746-386a95641be-d090-4277-8d64-4c187784c66512012-07-24
59746-386-09EA - Each59746-3863cd54982-a247-4c7e-bcc7-a9ecbeea158c12012-07-24
59746-386-10EA - Each59746-386992cc5ae-db3c-4a04-9928-53bced543e5612012-07-24

DailyMed Socrata Ingredients#

Ingredient, Type, UNII table
IngredientTypeUNIIDailyMed labelSPL versionUploaded
TERAZOSIN HYDROCHLORIDEACTIVE INGREDIENTD32S14F082TERAZOSIN (TERAZOSIN HYDROCHLORIDE) CAPSULE [BRYANT RANCH PREPACK]1000
TERAZOSINACTIVE MOIETY8L5014XET7TERAZOSIN (TERAZOSIN HYDROCHLORIDE) CAPSULE [BRYANT RANCH PREPACK]1000
D&C YELLOW NO. 10INACTIVE INGREDIENT35SW5USQ3GTERAZOSIN (TERAZOSIN HYDROCHLORIDE) CAPSULE [BRYANT RANCH PREPACK]1000
FD&C GREEN NO. 3INACTIVE INGREDIENT3P3ONR6O1STERAZOSIN (TERAZOSIN HYDROCHLORIDE) CAPSULE [BRYANT RANCH PREPACK]1000
GELATININACTIVE INGREDIENT2G86QN327LTERAZOSIN (TERAZOSIN HYDROCHLORIDE) CAPSULE [BRYANT RANCH PREPACK]1000
LACTOSE MONOHYDRATEINACTIVE INGREDIENTEWQ57Q8I5XTERAZOSIN (TERAZOSIN HYDROCHLORIDE) CAPSULE [BRYANT RANCH PREPACK]1000
MAGNESIUM STEARATEINACTIVE INGREDIENT70097M6I30TERAZOSIN (TERAZOSIN HYDROCHLORIDE) CAPSULE [BRYANT RANCH PREPACK]1000
SILICON DIOXIDEINACTIVE INGREDIENTETJ7Z6XBU4TERAZOSIN (TERAZOSIN HYDROCHLORIDE) CAPSULE [BRYANT RANCH PREPACK]1000
SODIUM LAURYL SULFATEINACTIVE INGREDIENT368GB5141JTERAZOSIN (TERAZOSIN HYDROCHLORIDE) CAPSULE [BRYANT RANCH PREPACK]1000
STARCH, CORNINACTIVE INGREDIENTO8232NY3SJTERAZOSIN (TERAZOSIN HYDROCHLORIDE) CAPSULE [BRYANT RANCH PREPACK]1000
TITANIUM DIOXIDEINACTIVE INGREDIENT15FIX9V2JPTERAZOSIN (TERAZOSIN HYDROCHLORIDE) CAPSULE [BRYANT RANCH PREPACK]1000
Terazosin HydrochlorideACTIVE INGREDIENTD32S14F082TERAZOSIN (TERAZOSIN HYDROCHLORIDE) CAPSULE [JUBILANT CADISTA PHARMACEUTICALS INC.]3
TerazosinACTIVE MOIETY8L5014XET7TERAZOSIN (TERAZOSIN HYDROCHLORIDE) CAPSULE [JUBILANT CADISTA PHARMACEUTICALS INC.]3
D&c Red No. 28INACTIVE INGREDIENT767IP0Y5NHTERAZOSIN (TERAZOSIN HYDROCHLORIDE) CAPSULE [JUBILANT CADISTA PHARMACEUTICALS INC.]3
D&c Yellow No. 10INACTIVE INGREDIENT35SW5USQ3GTERAZOSIN (TERAZOSIN HYDROCHLORIDE) CAPSULE [JUBILANT CADISTA PHARMACEUTICALS INC.]3
Fd&c Green No. 3INACTIVE INGREDIENT3P3ONR6O1STERAZOSIN (TERAZOSIN HYDROCHLORIDE) CAPSULE [JUBILANT CADISTA PHARMACEUTICALS INC.]3
Fd&c Red No. 40INACTIVE INGREDIENTWZB9127XOATERAZOSIN (TERAZOSIN HYDROCHLORIDE) CAPSULE [JUBILANT CADISTA PHARMACEUTICALS INC.]3
Ferrosoferric OxideINACTIVE INGREDIENTXM0M87F357TERAZOSIN (TERAZOSIN HYDROCHLORIDE) CAPSULE [JUBILANT CADISTA PHARMACEUTICALS INC.]3
GelatinINACTIVE INGREDIENT2G86QN327LTERAZOSIN (TERAZOSIN HYDROCHLORIDE) CAPSULE [JUBILANT CADISTA PHARMACEUTICALS INC.]3
Lactose MonohydrateINACTIVE INGREDIENTEWQ57Q8I5XTERAZOSIN (TERAZOSIN HYDROCHLORIDE) CAPSULE [JUBILANT CADISTA PHARMACEUTICALS INC.]3
Magnesium StearateINACTIVE INGREDIENT70097M6I30TERAZOSIN (TERAZOSIN HYDROCHLORIDE) CAPSULE [JUBILANT CADISTA PHARMACEUTICALS INC.]3
Silicon DioxideINACTIVE INGREDIENTETJ7Z6XBU4TERAZOSIN (TERAZOSIN HYDROCHLORIDE) CAPSULE [JUBILANT CADISTA PHARMACEUTICALS INC.]3
Sodium Lauryl SulfateINACTIVE INGREDIENT368GB5141JTERAZOSIN (TERAZOSIN HYDROCHLORIDE) CAPSULE [JUBILANT CADISTA PHARMACEUTICALS INC.]3
Starch, CornINACTIVE INGREDIENTO8232NY3SJTERAZOSIN (TERAZOSIN HYDROCHLORIDE) CAPSULE [JUBILANT CADISTA PHARMACEUTICALS INC.]3
Titanium DioxideINACTIVE INGREDIENT15FIX9V2JPTERAZOSIN (TERAZOSIN HYDROCHLORIDE) CAPSULE [JUBILANT CADISTA PHARMACEUTICALS INC.]3
Terazosin HydrochlorideACTIVE INGREDIENTD32S14F082TERAZOSIN HYDROCHLORIDE (TERAZOSIN HYDROCHLORIDE) CAPSULE TERAZOSIN HYDROCHLORIDE CAPSULE [APHENA PHARMA SOLUTIONS - TENNESSEE, LLC]2
TerazosinACTIVE MOIETY8L5014XET7TERAZOSIN HYDROCHLORIDE (TERAZOSIN HYDROCHLORIDE) CAPSULE TERAZOSIN HYDROCHLORIDE CAPSULE [APHENA PHARMA SOLUTIONS - TENNESSEE, LLC]2
D&c Red No. 28INACTIVE INGREDIENT767IP0Y5NHTERAZOSIN HYDROCHLORIDE (TERAZOSIN HYDROCHLORIDE) CAPSULE TERAZOSIN HYDROCHLORIDE CAPSULE [APHENA PHARMA SOLUTIONS - TENNESSEE, LLC]2
D&c Yellow No. 10INACTIVE INGREDIENT35SW5USQ3GTERAZOSIN HYDROCHLORIDE (TERAZOSIN HYDROCHLORIDE) CAPSULE TERAZOSIN HYDROCHLORIDE CAPSULE [APHENA PHARMA SOLUTIONS - TENNESSEE, LLC]2
Fd&c Green No. 3INACTIVE INGREDIENT3P3ONR6O1STERAZOSIN HYDROCHLORIDE (TERAZOSIN HYDROCHLORIDE) CAPSULE TERAZOSIN HYDROCHLORIDE CAPSULE [APHENA PHARMA SOLUTIONS - TENNESSEE, LLC]2
Fd&c Red No. 40INACTIVE INGREDIENTWZB9127XOATERAZOSIN HYDROCHLORIDE (TERAZOSIN HYDROCHLORIDE) CAPSULE TERAZOSIN HYDROCHLORIDE CAPSULE [APHENA PHARMA SOLUTIONS - TENNESSEE, LLC]2
Ferrosoferric OxideINACTIVE INGREDIENTXM0M87F357TERAZOSIN HYDROCHLORIDE (TERAZOSIN HYDROCHLORIDE) CAPSULE TERAZOSIN HYDROCHLORIDE CAPSULE [APHENA PHARMA SOLUTIONS - TENNESSEE, LLC]2
GelatinINACTIVE INGREDIENT2G86QN327LTERAZOSIN HYDROCHLORIDE (TERAZOSIN HYDROCHLORIDE) CAPSULE TERAZOSIN HYDROCHLORIDE CAPSULE [APHENA PHARMA SOLUTIONS - TENNESSEE, LLC]2
Lactose MonohydrateINACTIVE INGREDIENTEWQ57Q8I5XTERAZOSIN HYDROCHLORIDE (TERAZOSIN HYDROCHLORIDE) CAPSULE TERAZOSIN HYDROCHLORIDE CAPSULE [APHENA PHARMA SOLUTIONS - TENNESSEE, LLC]2
Magnesium StearateINACTIVE INGREDIENT70097M6I30TERAZOSIN HYDROCHLORIDE (TERAZOSIN HYDROCHLORIDE) CAPSULE TERAZOSIN HYDROCHLORIDE CAPSULE [APHENA PHARMA SOLUTIONS - TENNESSEE, LLC]2
Silicon DioxideINACTIVE INGREDIENTETJ7Z6XBU4TERAZOSIN HYDROCHLORIDE (TERAZOSIN HYDROCHLORIDE) CAPSULE TERAZOSIN HYDROCHLORIDE CAPSULE [APHENA PHARMA SOLUTIONS - TENNESSEE, LLC]2
Sodium Lauryl SulfateINACTIVE INGREDIENT368GB5141JTERAZOSIN HYDROCHLORIDE (TERAZOSIN HYDROCHLORIDE) CAPSULE TERAZOSIN HYDROCHLORIDE CAPSULE [APHENA PHARMA SOLUTIONS - TENNESSEE, LLC]2
Starch, CornINACTIVE INGREDIENTO8232NY3SJTERAZOSIN HYDROCHLORIDE (TERAZOSIN HYDROCHLORIDE) CAPSULE TERAZOSIN HYDROCHLORIDE CAPSULE [APHENA PHARMA SOLUTIONS - TENNESSEE, LLC]2
Titanium DioxideINACTIVE INGREDIENT15FIX9V2JPTERAZOSIN HYDROCHLORIDE (TERAZOSIN HYDROCHLORIDE) CAPSULE TERAZOSIN HYDROCHLORIDE CAPSULE [APHENA PHARMA SOLUTIONS - TENNESSEE, LLC]2

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
59746-386TERAZOSIN (TERAZOSIN HYDROCHLORIDE) CAPSULE [JUBILANT CADISTA PHARMACEUTICALS INC.]6Current NDC, Legacy NDC, 4 package rows20180502_43e92495-2cf2-46dd-a80c-f0c3c88c7b73.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 2 · 25 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
TerazosinTERAZOSIN HYDROCHLORIDEBryant Ranch Prepack458b4a60-b2d6-445a-8638-7fcd07decf662026-06-30Warnings, Adverse reactionsExact identifier
application applno (ANDA): 075317
application number: ANDA075317
TerazosinTERAZOSIN HYDROCHLORIDEREMEDYREPACK INC.a3a5901a-6395-4030-a27b-1fb17cd973152026-05-19Warnings, Adverse reactionsExact identifier
application applno (ANDA): 075317
application number: ANDA075317
TerazosinTERAZOSIN HYDROCHLORIDEREMEDYREPACK INC.242589f0-0c79-4ea1-b900-10bccfec2b822026-05-19Warnings, Adverse reactionsExact identifier
application applno (ANDA): 075317
application number: ANDA075317
TerazosinTERAZOSIN HYDROCHLORIDEJubilant Cadista Pharmaceuticals Inc.43e92495-2cf2-46dd-a80c-f0c3c88c7b732026-05-05Warnings, Adverse reactionsExact identifier
application applno (ANDA): 075317
application number: ANDA075317
ndc (product): 59746-386
TERAZOSIN HYDROCHLORIDETERAZOSIN HYDROCHLORIDEBryant Ranch Prepack2c42171e-1b44-4d34-b6ca-5b6a94f0e6942026-03-10Warnings, Adverse reactionsExact identifier
application applno (ANDA): 075317
application number: ANDA075317
Terazosin HydrochlorideTERAZOSIN HYDROCHLORIDEBryant Ranch Prepackd971811c-d327-4e63-808c-8d553ee471e72026-03-05Warnings, Adverse reactionsExact identifier
application applno (ANDA): 075317
application number: ANDA075317
TerazosinTERAZOSIN HYDROCHLORIDEREMEDYREPACK INC.854b64ff-c138-45af-9cdf-6c23323d84902026-01-08Warnings, Adverse reactionsExact identifier
application applno (ANDA): 075317
application number: ANDA075317
TerazosinTERAZOSIN HYDROCHLORIDECoupler LLC4614e8cc-c922-4c0f-e063-6394a90a85012025-12-16Warnings, Adverse reactionsExact identifier
application applno (ANDA): 075317
application number: ANDA075317
TerazosinTERAZOSIN HYDROCHLORIDEBryant Ranch Prepack3822068f-f160-4493-a207-4d75dad6af732025-11-05Warnings, Adverse reactionsExact identifier
application applno (ANDA): 075317
application number: ANDA075317
TerazosinTERAZOSIN HYDROCHLORIDEBryant Ranch Prepackbb88f0d9-e010-4d4d-8465-bcccce0bef6e2025-11-05Warnings, Adverse reactionsExact identifier
application applno (ANDA): 075317
application number: ANDA075317
Terazosin hydrochlorideTERAZOSIN HYDROCHLORIDEPreferred Pharmaceuticals, Inc9d8fd052-b478-447e-a884-74fcd21275bb2025-09-30Warnings, Adverse reactionsExact identifier
application applno (ANDA): 075317
application number: ANDA075317
TerazosinTERAZOSIN HYDROCHLORIDEBryant Ranch Prepack521e4aad-c6ec-4410-867f-dd9ecc08d5b22025-09-04Warnings, Adverse reactionsExact identifier
application applno (ANDA): 075317
application number: ANDA075317
TerazosinTERAZOSIN HYDROCHLORIDEBryant Ranch Prepack33699a94-4561-455f-9e5d-48856369aa072025-09-04Warnings, Adverse reactionsExact identifier
application applno (ANDA): 075317
application number: ANDA075317
TerazosinTERAZOSIN HYDROCHLORIDEAvKAREa2137488-8554-e84f-e053-2995a90a796c2025-07-23Warnings, Adverse reactionsExact identifier
application applno (ANDA): 075317
application number: ANDA075317
TerazosinTERAZOSIN HYDROCHLORIDEAvPAK9e7b27a6-cc09-407e-e053-2a95a90a17b32025-07-02Warnings, Adverse reactionsExact identifier
application applno (ANDA): 075317
application number: ANDA075317
TerazosinTERAZOSIN HYDROCHLORIDEA-S Medication Solutions4b195327-10d4-477f-ada2-d62c7f835e6c2024-11-07Warnings, Adverse reactionsExact identifier
application applno (ANDA): 075317
application number: ANDA075317
TerazosinTERAZOSIN HYDROCHLORIDENuCare Pharmaceuticals, Inc.40e5ae44-708a-15a3-e054-00144ff8d46c2024-08-14Warnings, Adverse reactionsExact identifier
application applno (ANDA): 075317
application number: ANDA075317
TerazosinTERAZOSIN HYDROCHLORIDEAphena Pharma Solutions - Tennessee, LLC363a6c85-e5e9-4521-9065-37a7c45bb5252024-02-06Warnings, Adverse reactionsExact identifier
application applno (ANDA): 075317
application number: ANDA075317
TerazosinTERAZOSIN HYDROCHLORIDEAphena Pharma Solutions - Tennessee, LLC85e450c2-1bc3-49f4-ac2b-5aeedc154bba2024-02-01Warnings, Adverse reactionsExact identifier
application applno (ANDA): 075317
application number: ANDA075317
TerazosinTERAZOSIN HYDROCHLORIDEAphena Pharma Solutions - Tennessee, LLC0574d9ae-04da-4cb2-b124-9d920012c4112023-07-20Warnings, Adverse reactionsExact identifier
application applno (ANDA): 075317
application number: ANDA075317

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
260376terazosin HCl 10 MG Oral CapsulePSN521e4aad-c6ec-4410-867f-dd9ecc08d5b21012
313217terazosin HCl 2 MG Oral CapsulePSN521e4aad-c6ec-4410-867f-dd9ecc08d5b21012
260376terazosin 10 MG Oral CapsuleSCD521e4aad-c6ec-4410-867f-dd9ecc08d5b21012
313217terazosin 2 MG Oral CapsuleSCD521e4aad-c6ec-4410-867f-dd9ecc08d5b21012
260376terazosin (as terazosin HCl) 10 MG Oral CapsuleSY521e4aad-c6ec-4410-867f-dd9ecc08d5b21012
313217terazosin (as terazosin HCl) 2 MG Oral CapsuleSY521e4aad-c6ec-4410-867f-dd9ecc08d5b21012
260376terazosin HCl 10 MG Oral CapsulePSN458b4a60-b2d6-445a-8638-7fcd07decf66103
260376terazosin HCl 10 MG Oral CapsulePSN33699a94-4561-455f-9e5d-48856369aa07103
260376terazosin 10 MG Oral CapsuleSCD33699a94-4561-455f-9e5d-48856369aa07103
260376terazosin 10 MG Oral CapsuleSCD458b4a60-b2d6-445a-8638-7fcd07decf66103
260376terazosin (as terazosin HCl) 10 MG Oral CapsuleSY458b4a60-b2d6-445a-8638-7fcd07decf66103
260376terazosin (as terazosin HCl) 10 MG Oral CapsuleSY33699a94-4561-455f-9e5d-48856369aa07103
260376terazosin HCl 10 MG Oral CapsulePSN83bf40fa-6ae1-4811-8dc1-e8c0bcd63d7831
313217terazosin HCl 2 MG Oral CapsulePSN83bf40fa-6ae1-4811-8dc1-e8c0bcd63d7831
313219terazosin HCl 5 MG Oral CapsulePSN83bf40fa-6ae1-4811-8dc1-e8c0bcd63d7831
260376terazosin 10 MG Oral CapsuleSCD83bf40fa-6ae1-4811-8dc1-e8c0bcd63d7831
313217terazosin 2 MG Oral CapsuleSCD83bf40fa-6ae1-4811-8dc1-e8c0bcd63d7831
313219terazosin 5 MG Oral CapsuleSCD83bf40fa-6ae1-4811-8dc1-e8c0bcd63d7831
260376terazosin (as terazosin HCl) 10 MG Oral CapsuleSY83bf40fa-6ae1-4811-8dc1-e8c0bcd63d7831
313217terazosin (as terazosin HCl) 2 MG Oral CapsuleSY83bf40fa-6ae1-4811-8dc1-e8c0bcd63d7831
313219terazosin (as terazosin hydrochloride) 5 MG Oral CapsuleSY83bf40fa-6ae1-4811-8dc1-e8c0bcd63d7831
313215terazosin HCl 1 MG Oral CapsulePSNec962052-7bea-4aeb-ac49-0072fdc7738510
260376terazosin HCl 10 MG Oral CapsulePSNec962052-7bea-4aeb-ac49-0072fdc7738510
313217terazosin HCl 2 MG Oral CapsulePSNec962052-7bea-4aeb-ac49-0072fdc7738510
313219terazosin HCl 5 MG Oral CapsulePSNec962052-7bea-4aeb-ac49-0072fdc7738510
313215terazosin 1 MG Oral CapsuleSCDec962052-7bea-4aeb-ac49-0072fdc7738510
260376terazosin 10 MG Oral CapsuleSCDec962052-7bea-4aeb-ac49-0072fdc7738510
313217terazosin 2 MG Oral CapsuleSCDec962052-7bea-4aeb-ac49-0072fdc7738510
313219terazosin 5 MG Oral CapsuleSCDec962052-7bea-4aeb-ac49-0072fdc7738510
313215terazosin (as terazosin HCl) 1 MG Oral CapsuleSYec962052-7bea-4aeb-ac49-0072fdc7738510
260376terazosin (as terazosin HCl) 10 MG Oral CapsuleSYec962052-7bea-4aeb-ac49-0072fdc7738510
313217terazosin (as terazosin HCl) 2 MG Oral CapsuleSYec962052-7bea-4aeb-ac49-0072fdc7738510
313219terazosin (as terazosin hydrochloride) 5 MG Oral CapsuleSYec962052-7bea-4aeb-ac49-0072fdc7738510
313215terazosin HCl 1 MG Oral CapsulePSN43e92495-2cf2-46dd-a80c-f0c3c88c7b738
260376terazosin HCl 10 MG Oral CapsulePSN43e92495-2cf2-46dd-a80c-f0c3c88c7b738
313217terazosin HCl 2 MG Oral CapsulePSN43e92495-2cf2-46dd-a80c-f0c3c88c7b738
313219terazosin HCl 5 MG Oral CapsulePSN43e92495-2cf2-46dd-a80c-f0c3c88c7b738
313215terazosin 1 MG Oral CapsuleSCD43e92495-2cf2-46dd-a80c-f0c3c88c7b738
260376terazosin 10 MG Oral CapsuleSCD43e92495-2cf2-46dd-a80c-f0c3c88c7b738
313217terazosin 2 MG Oral CapsuleSCD43e92495-2cf2-46dd-a80c-f0c3c88c7b738
313219terazosin 5 MG Oral CapsuleSCD43e92495-2cf2-46dd-a80c-f0c3c88c7b738
313215terazosin (as terazosin HCl) 1 MG Oral CapsuleSY43e92495-2cf2-46dd-a80c-f0c3c88c7b738
260376terazosin (as terazosin HCl) 10 MG Oral CapsuleSY43e92495-2cf2-46dd-a80c-f0c3c88c7b738
313217terazosin (as terazosin HCl) 2 MG Oral CapsuleSY43e92495-2cf2-46dd-a80c-f0c3c88c7b738
313219terazosin (as terazosin hydrochloride) 5 MG Oral CapsuleSY43e92495-2cf2-46dd-a80c-f0c3c88c7b738
313215terazosin HCl 1 MG Oral CapsulePSN9e7b27a6-cc09-407e-e053-2a95a90a17b35
260376terazosin HCl 10 MG Oral CapsulePSN9e7b27a6-cc09-407e-e053-2a95a90a17b35
313217terazosin HCl 2 MG Oral CapsulePSN9e7b27a6-cc09-407e-e053-2a95a90a17b35
313219terazosin HCl 5 MG Oral CapsulePSN9e7b27a6-cc09-407e-e053-2a95a90a17b35
313215terazosin 1 MG Oral CapsuleSCD9e7b27a6-cc09-407e-e053-2a95a90a17b35
260376terazosin 10 MG Oral CapsuleSCD9e7b27a6-cc09-407e-e053-2a95a90a17b35
313217terazosin 2 MG Oral CapsuleSCD9e7b27a6-cc09-407e-e053-2a95a90a17b35
313219terazosin 5 MG Oral CapsuleSCD9e7b27a6-cc09-407e-e053-2a95a90a17b35
313215terazosin (as terazosin HCl) 1 MG Oral CapsuleSY9e7b27a6-cc09-407e-e053-2a95a90a17b35
260376terazosin (as terazosin HCl) 10 MG Oral CapsuleSY9e7b27a6-cc09-407e-e053-2a95a90a17b35
313217terazosin (as terazosin HCl) 2 MG Oral CapsuleSY9e7b27a6-cc09-407e-e053-2a95a90a17b35
313219terazosin (as terazosin hydrochloride) 5 MG Oral CapsuleSY9e7b27a6-cc09-407e-e053-2a95a90a17b35
313215terazosin HCl 1 MG Oral CapsulePSNa2137488-8554-e84f-e053-2995a90a796c4
260376terazosin HCl 10 MG Oral CapsulePSN27f8952a-189d-4687-854e-c51da619bf3d4
260376terazosin HCl 10 MG Oral CapsulePSNa2137488-8554-e84f-e053-2995a90a796c4
313217terazosin HCl 2 MG Oral CapsulePSNa2137488-8554-e84f-e053-2995a90a796c4
313219terazosin HCl 5 MG Oral CapsulePSNa2137488-8554-e84f-e053-2995a90a796c4
313215terazosin 1 MG Oral CapsuleSCDa2137488-8554-e84f-e053-2995a90a796c4
260376terazosin 10 MG Oral CapsuleSCD27f8952a-189d-4687-854e-c51da619bf3d4
260376terazosin 10 MG Oral CapsuleSCDa2137488-8554-e84f-e053-2995a90a796c4
313217terazosin 2 MG Oral CapsuleSCDa2137488-8554-e84f-e053-2995a90a796c4
313219terazosin 5 MG Oral CapsuleSCDa2137488-8554-e84f-e053-2995a90a796c4
313215terazosin (as terazosin HCl) 1 MG Oral CapsuleSYa2137488-8554-e84f-e053-2995a90a796c4
260376terazosin (as terazosin HCl) 10 MG Oral CapsuleSY27f8952a-189d-4687-854e-c51da619bf3d4
260376terazosin (as terazosin HCl) 10 MG Oral CapsuleSYa2137488-8554-e84f-e053-2995a90a796c4
313217terazosin (as terazosin HCl) 2 MG Oral CapsuleSYa2137488-8554-e84f-e053-2995a90a796c4
313219terazosin (as terazosin hydrochloride) 5 MG Oral CapsuleSYa2137488-8554-e84f-e053-2995a90a796c4
313215terazosin HCl 1 MG Oral CapsulePSN21c6bec7-4767-4113-8561-38497dae50d03
260376terazosin HCl 10 MG Oral CapsulePSN21c6bec7-4767-4113-8561-38497dae50d03
313217terazosin HCl 2 MG Oral CapsulePSN21c6bec7-4767-4113-8561-38497dae50d03
313219terazosin HCl 5 MG Oral CapsulePSN21c6bec7-4767-4113-8561-38497dae50d03
313215terazosin 1 MG Oral CapsuleSCD21c6bec7-4767-4113-8561-38497dae50d03
260376terazosin 10 MG Oral CapsuleSCD21c6bec7-4767-4113-8561-38497dae50d03
313217terazosin 2 MG Oral CapsuleSCD21c6bec7-4767-4113-8561-38497dae50d03
313219terazosin 5 MG Oral CapsuleSCD21c6bec7-4767-4113-8561-38497dae50d03

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
59746-386-0659746038606100 CAPSULE in 1 BOTTLE (59746-386-06) 100 capsule2004-12-200000-00-00NoNoCurrent
59746-386-0959746038609500 CAPSULE in 1 BOTTLE (59746-386-09) 500 capsule2004-12-200000-00-00NoNoCurrent
59746-386-10597460386101000 CAPSULE in 1 BOTTLE (59746-386-10) 1000 capsule2004-12-200000-00-00NoNoCurrent
59746-386-905974603869090 CAPSULE in 1 BOTTLE (59746-386-90) 90 capsule2006-12-200000-00-00NoNoCurrent