Terazosin

Product NDC
69452-332
Requested package NDC
69452-332-20
11-digit product format
694520332
Labeler code
69452
Product ID
69452-332_29b9921b-6884-e5bb-e063-6394a90aecf6
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
Terazosin
Dosage form
CAPSULE
Route
ORAL
Labeler
Bionpharma Inc.
Application
ANDA075667
Marketing category
ANDA
Marketing start
2024-03-11
Substance
TERAZOSIN HYDROCHLORIDE
Active strength
5 mg/1
Pharmacologic classes
Adrenergic alpha-Antagonists [MoA], alpha-Adrenergic Blocker [EPC]
NDC exclude flag
No
Listing certified through
2026-12-31
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
A075667-001TERAZOSIN HYDROCHLORIDETERAZOSIN HYDROCHLORIDEEQ 1MG BASECAPSULE / ORALAB2000-07-28
A075667-002TERAZOSIN HYDROCHLORIDETERAZOSIN HYDROCHLORIDEEQ 2MG BASECAPSULE / ORALAB2000-07-28
A075667-003TERAZOSIN HYDROCHLORIDETERAZOSIN HYDROCHLORIDEEQ 5MG BASECAPSULE / ORALAB2000-07-28
A075667-004TERAZOSIN HYDROCHLORIDETERAZOSIN HYDROCHLORIDEEQ 10MG BASECAPSULE / ORALAB2000-07-28

Therapeutic equivalence codes#

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

Application-product, TE code table
Application-productTE code
A075667-001AB
A075667-002AB
A075667-003AB
A075667-004AB

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 UTC2026-02A075667-001TERAZOSIN HYDROCHLORIDEEQ 1MG BASECAPSULE / ORALAB2000-07-28011fe1cb6892…
2026-02-19 14:30 UTC2026-02A075667-002TERAZOSIN HYDROCHLORIDEEQ 2MG BASECAPSULE / ORALAB2000-07-28011fe1cb6892…
2026-02-19 14:30 UTC2026-02A075667-003TERAZOSIN HYDROCHLORIDEEQ 5MG BASECAPSULE / ORALAB2000-07-28011fe1cb6892…
2026-02-19 14:30 UTC2026-02A075667-004TERAZOSIN HYDROCHLORIDEEQ 10MG BASECAPSULE / ORALAB2000-07-28011fe1cb6892…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A075667-001TERAZOSIN HYDROCHLORIDEEQ 1MG BASECAPSULE / ORALAB2000-07-2831067a03dcf5…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A075667-002TERAZOSIN HYDROCHLORIDEEQ 2MG BASECAPSULE / ORALAB2000-07-2831067a03dcf5…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A075667-003TERAZOSIN HYDROCHLORIDEEQ 5MG BASECAPSULE / ORALAB2000-07-2831067a03dcf5…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A075667-004TERAZOSIN HYDROCHLORIDEEQ 10MG BASECAPSULE / ORALAB2000-07-2831067a03dcf5…
2025-08-23 18:47 UTC2025-08A075667-001TERAZOSIN HYDROCHLORIDEEQ 1MG BASECAPSULE / ORALAB2000-07-286a471c1ec25d…
2025-08-23 18:47 UTC2025-08A075667-002TERAZOSIN HYDROCHLORIDEEQ 2MG BASECAPSULE / ORALAB2000-07-286a471c1ec25d…
2025-08-23 18:47 UTC2025-08A075667-003TERAZOSIN HYDROCHLORIDEEQ 5MG BASECAPSULE / ORALAB2000-07-286a471c1ec25d…
2025-08-23 18:47 UTC2025-08A075667-004TERAZOSIN HYDROCHLORIDEEQ 10MG BASECAPSULE / ORALAB2000-07-286a471c1ec25d…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03A075667-001TERAZOSIN HYDROCHLORIDEEQ 1MG BASECAPSULE / ORALAB2000-07-28fd3edfee7708…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03A075667-002TERAZOSIN HYDROCHLORIDEEQ 2MG BASECAPSULE / ORALAB2000-07-28fd3edfee7708…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03A075667-003TERAZOSIN HYDROCHLORIDEEQ 5MG BASECAPSULE / ORALAB2000-07-28fd3edfee7708…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03A075667-004TERAZOSIN HYDROCHLORIDEEQ 10MG BASECAPSULE / ORALAB2000-07-28fd3edfee7708…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02A075667-001TERAZOSIN HYDROCHLORIDEEQ 1MG BASECAPSULE / ORALAB2000-07-28b8a1b40f171c…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02A075667-002TERAZOSIN HYDROCHLORIDEEQ 2MG BASECAPSULE / ORALAB2000-07-28b8a1b40f171c…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02A075667-003TERAZOSIN HYDROCHLORIDEEQ 5MG BASECAPSULE / ORALAB2000-07-28b8a1b40f171c…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02A075667-004TERAZOSIN HYDROCHLORIDEEQ 10MG BASECAPSULE / ORALAB2000-07-28b8a1b40f171c…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01A075667-001TERAZOSIN HYDROCHLORIDEEQ 1MG BASECAPSULE / ORALAB2000-07-2803ed91905a0d…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01A075667-002TERAZOSIN HYDROCHLORIDEEQ 2MG BASECAPSULE / ORALAB2000-07-2803ed91905a0d…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01A075667-003TERAZOSIN HYDROCHLORIDEEQ 5MG BASECAPSULE / ORALAB2000-07-2803ed91905a0d…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01A075667-004TERAZOSIN HYDROCHLORIDEEQ 10MG BASECAPSULE / ORALAB2000-07-2803ed91905a0d…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12A075667-001TERAZOSIN HYDROCHLORIDEEQ 1MG BASECAPSULE / ORALAB2000-07-282680178bc6a6…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12A075667-002TERAZOSIN HYDROCHLORIDEEQ 2MG BASECAPSULE / ORALAB2000-07-282680178bc6a6…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12A075667-003TERAZOSIN HYDROCHLORIDEEQ 5MG BASECAPSULE / ORALAB2000-07-282680178bc6a6…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12A075667-004TERAZOSIN HYDROCHLORIDEEQ 10MG BASECAPSULE / ORALAB2000-07-282680178bc6a6…
2024-09-14 05:58 UTC · 2 captures of this ZIP2024-09A075667-001TERAZOSIN HYDROCHLORIDEEQ 1MG BASECAPSULE / ORALAB2000-07-285bbf6a4d5a75…
2024-09-14 05:58 UTC · 2 captures of this ZIP2024-09A075667-002TERAZOSIN HYDROCHLORIDEEQ 2MG BASECAPSULE / ORALAB2000-07-285bbf6a4d5a75…
2024-09-14 05:58 UTC · 2 captures of this ZIP2024-09A075667-003TERAZOSIN HYDROCHLORIDEEQ 5MG BASECAPSULE / ORALAB2000-07-285bbf6a4d5a75…
2024-09-14 05:58 UTC · 2 captures of this ZIP2024-09A075667-004TERAZOSIN HYDROCHLORIDEEQ 10MG BASECAPSULE / ORALAB2000-07-285bbf6a4d5a75…
2024-11-08 22:44 UTC · 3 captures of this ZIP2024-11A075667-001TERAZOSIN HYDROCHLORIDEEQ 1MG BASECAPSULE / ORALAB2000-07-28d8e5a09893c0…
2024-11-08 22:44 UTC · 3 captures of this ZIP2024-11A075667-002TERAZOSIN HYDROCHLORIDEEQ 2MG BASECAPSULE / ORALAB2000-07-28d8e5a09893c0…
2024-11-08 22:44 UTC · 3 captures of this ZIP2024-11A075667-003TERAZOSIN HYDROCHLORIDEEQ 5MG BASECAPSULE / ORALAB2000-07-28d8e5a09893c0…
2024-11-08 22:44 UTC · 3 captures of this ZIP2024-11A075667-004TERAZOSIN HYDROCHLORIDEEQ 10MG BASECAPSULE / ORALAB2000-07-28d8e5a09893c0…
2024-10-29 15:01 UTC2024-10A075667-001TERAZOSIN HYDROCHLORIDEEQ 1MG BASECAPSULE / ORALAB2000-07-28d06236e962d9…
2024-10-29 15:01 UTC2024-10A075667-002TERAZOSIN HYDROCHLORIDEEQ 2MG BASECAPSULE / ORALAB2000-07-28d06236e962d9…
2024-10-29 15:01 UTC2024-10A075667-003TERAZOSIN HYDROCHLORIDEEQ 5MG BASECAPSULE / ORALAB2000-07-28d06236e962d9…
2024-10-29 15:01 UTC2024-10A075667-004TERAZOSIN HYDROCHLORIDEEQ 10MG BASECAPSULE / ORALAB2000-07-28d06236e962d9…

Observed Orange Book normalized TE history#

Normalized TE history page 1 of 2 · 68 observed states.

Captured, Edition, Application-product table
CapturedEditionApplication-productTE codeOrderSource SHA-256
2026-02-19 14:30 UTC2026-02A075667-001AB1011fe1cb6892…
2026-02-19 14:30 UTC2026-02A075667-002AB1011fe1cb6892…
2026-02-19 14:30 UTC2026-02A075667-003AB1011fe1cb6892…
2026-02-19 14:30 UTC2026-02A075667-004AB1011fe1cb6892…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A075667-001AB131067a03dcf5…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A075667-002AB131067a03dcf5…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A075667-003AB131067a03dcf5…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A075667-004AB131067a03dcf5…
2025-08-23 18:47 UTC2025-08A075667-001AB16a471c1ec25d…
2025-08-23 18:47 UTC2025-08A075667-002AB16a471c1ec25d…
2025-08-23 18:47 UTC2025-08A075667-003AB16a471c1ec25d…
2025-08-23 18:47 UTC2025-08A075667-004AB16a471c1ec25d…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03A075667-001AB1fd3edfee7708…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03A075667-002AB1fd3edfee7708…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03A075667-003AB1fd3edfee7708…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03A075667-004AB1fd3edfee7708…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02A075667-001AB1b8a1b40f171c…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02A075667-002AB1b8a1b40f171c…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02A075667-003AB1b8a1b40f171c…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02A075667-004AB1b8a1b40f171c…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01A075667-001AB103ed91905a0d…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01A075667-002AB103ed91905a0d…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01A075667-003AB103ed91905a0d…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01A075667-004AB103ed91905a0d…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12A075667-001AB12680178bc6a6…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12A075667-002AB12680178bc6a6…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12A075667-003AB12680178bc6a6…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12A075667-004AB12680178bc6a6…
2024-09-14 05:58 UTC · 2 captures of this ZIP2024-09A075667-001AB15bbf6a4d5a75…
2024-09-14 05:58 UTC · 2 captures of this ZIP2024-09A075667-002AB15bbf6a4d5a75…
2024-09-14 05:58 UTC · 2 captures of this ZIP2024-09A075667-003AB15bbf6a4d5a75…
2024-09-14 05:58 UTC · 2 captures of this ZIP2024-09A075667-004AB15bbf6a4d5a75…
2024-11-08 22:44 UTC · 3 captures of this ZIP2024-11A075667-001AB1d8e5a09893c0…
2024-11-08 22:44 UTC · 3 captures of this ZIP2024-11A075667-002AB1d8e5a09893c0…
2024-11-08 22:44 UTC · 3 captures of this ZIP2024-11A075667-003AB1d8e5a09893c0…
2024-11-08 22:44 UTC · 3 captures of this ZIP2024-11A075667-004AB1d8e5a09893c0…
2024-10-29 15:01 UTC2024-10A075667-001AB1d06236e962d9…
2024-10-29 15:01 UTC2024-10A075667-002AB1d06236e962d9…
2024-10-29 15:01 UTC2024-10A075667-003AB1d06236e962d9…
2024-10-29 15:01 UTC2024-10A075667-004AB1d06236e962d9…

Additional Listing Data#

Finished product
Yes
Brand name base
Terazosin
Listing expiration
2026-12-31

Active Ingredients#

Ingredient, Strength table
IngredientStrength
TERAZOSIN HYDROCHLORIDE5 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
130c84dc-b598-660f-e063-6294a90a8e46Available 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
69452-332-20Terazosin100 in 1 BOTTLECAPSULE1002
69452-332-32Terazosin1000 in 1 BOTTLECAPSULE10002

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
69452-332-20EA - Each69452-3327779eaf5-e6b7-4672-b8d4-84f8ca2611c712024-05-16
69452-332-32EA - Each69452-33229c14222-c3d2-4926-a541-c4b99d5ab20112025-02-10

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
69452-332TERAZOSIN CAPSULE [BIONPHARMA INC.]2Current NDC, 2 package rows20241222_130c84dc-b598-660f-e063-6294a90a8e46.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 · 6 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
TerazosinTERAZOSINBryant Ranch Prepackb77a4a38-edb1-412e-97af-d49e862b32c12026-05-21Warnings, Adverse reactionsExact identifier
application applno (ANDA): 075667
application number: ANDA075667
TerazosinTERAZOSINBryant Ranch Prepackf0b4c58a-13ad-48d9-9796-b27fedab62492026-04-20Warnings, Adverse reactionsExact identifier
application applno (ANDA): 075667
application number: ANDA075667
TerazosinTERAZOSINBryant Ranch Prepack5c55d942-35c1-46f6-af89-2a0f68f3ea992026-02-06Warnings, Adverse reactionsExact identifier
application applno (ANDA): 075667
application number: ANDA075667
TerazosinTERAZOSINPreferred Pharmaceuticals Inc.d1718217-ddab-4a3a-a862-8c952fd5a2742026-01-28Warnings, Adverse reactionsExact identifier
application applno (ANDA): 075667
application number: ANDA075667
TerazosinTERAZOSINREMEDYREPACK INC.a16abe41-98e7-4e60-8c1b-911c6a29f0a22026-01-14Warnings, Adverse reactionsExact identifier
application applno (ANDA): 075667
application number: ANDA075667
TerazosinTERAZOSINBionpharma Inc.130c84dc-b598-660f-e063-6294a90a8e462024-12-20Warnings, Adverse reactionsExact identifier
application applno (ANDA): 075667
application number: ANDA075667
ndc (package): 69452-332-20
ndc (product): 69452-332
ndc11 (package): 69452033220

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
313215terazosin HCl 1 MG Oral CapsulePSN130c84dc-b598-660f-e063-6294a90a8e462
260376terazosin HCl 10 MG Oral CapsulePSN130c84dc-b598-660f-e063-6294a90a8e462
313217terazosin HCl 2 MG Oral CapsulePSN130c84dc-b598-660f-e063-6294a90a8e462
313219terazosin HCl 5 MG Oral CapsulePSN130c84dc-b598-660f-e063-6294a90a8e462
313215terazosin 1 MG Oral CapsuleSCD130c84dc-b598-660f-e063-6294a90a8e462
260376terazosin 10 MG Oral CapsuleSCD130c84dc-b598-660f-e063-6294a90a8e462
313217terazosin 2 MG Oral CapsuleSCD130c84dc-b598-660f-e063-6294a90a8e462
313219terazosin 5 MG Oral CapsuleSCD130c84dc-b598-660f-e063-6294a90a8e462
313215terazosin (as terazosin HCl) 1 MG Oral CapsuleSY130c84dc-b598-660f-e063-6294a90a8e462
260376terazosin (as terazosin HCl) 10 MG Oral CapsuleSY130c84dc-b598-660f-e063-6294a90a8e462
313217terazosin (as terazosin HCl) 2 MG Oral CapsuleSY130c84dc-b598-660f-e063-6294a90a8e462
313219terazosin (as terazosin hydrochloride) 5 MG Oral CapsuleSY130c84dc-b598-660f-e063-6294a90a8e462
313219terazosin HCl 5 MG Oral CapsulePSNb77a4a38-edb1-412e-97af-d49e862b32c11
313219terazosin 5 MG Oral CapsuleSCDb77a4a38-edb1-412e-97af-d49e862b32c11
313219terazosin (as terazosin hydrochloride) 5 MG Oral CapsuleSYb77a4a38-edb1-412e-97af-d49e862b32c11

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startSampleExclude flagStatus
69452-332-2069452033220100 CAPSULE in 1 BOTTLE (69452-332-20) 100 capsule2024-03-11NoNoCurrent