Terazosin Hydrochloride

Product NDC
50090-0659
11-digit product format
500900659
Labeler code
50090
Product ID
50090-0659_93817eda-9126-4f77-b9fa-ac3e1afba45d
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
Terazosin Hydrochloride
Dosage form
CAPSULE
Route
ORAL
Labeler
A-S Medication Solutions
Application
ANDA074823
Marketing category
ANDA
Marketing start
1998-03-30
Marketing end
0000-00-00
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
2021-12-31
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 · 3 matching rows.

Dataset, Scope, Product NDC table
DatasetScopeProduct NDCPackage NDCCodeStatusReporting periodSource date
excluded productproduct50090-0659IInactivated by FDA2026-08-11
excluded packagepackage50090-065950090-0659-0DDiscontinued by firm2026-08-11
excluded packagepackage50090-065950090-0659-1IInactivated 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 NDCCodeStatusSnapshotSource SHA-256
2025-12-14 17:58 UTC · source 2025-12-05excluded productproductIInactivated by FDAd630ba8d3edf…732f749b63fb…
2025-12-14 17:58 UTC · source 2025-12-05excluded packagepackage50090-0659-1IInactivated by FDAd630ba8d3edf…732f749b63fb…
2025-12-14 17:58 UTC · source 2025-12-05excluded packagepackage50090-0659-0DDiscontinued by firmd630ba8d3edf…732f749b63fb…
2025-08-27 00:01 UTC · source 2025-08-26excluded productproductIInactivated by FDAf5e01cc5f278…a2eaf40c39c3…
2025-08-27 00:01 UTC · source 2025-08-26excluded packagepackage50090-0659-1IInactivated by FDAf5e01cc5f278…a2eaf40c39c3…
2025-08-27 00:01 UTC · source 2025-08-26excluded packagepackage50090-0659-0DDiscontinued by firmf5e01cc5f278…a2eaf40c39c3…
2025-04-01 02:39 UTC · source 2025-03-31excluded productproductIInactivated by FDA2ef7874e63bc…57b86245f4fa…
2025-04-01 02:39 UTC · source 2025-03-31excluded packagepackage50090-0659-1IInactivated by FDA2ef7874e63bc…57b86245f4fa…
2025-04-01 02:39 UTC · source 2025-03-31excluded packagepackage50090-0659-0DDiscontinued by firm2ef7874e63bc…57b86245f4fa…
2025-03-28 20:22 UTC · source 2025-03-28excluded productproductIInactivated by FDAa1b67e2a42f9…c4cf2c586c0d…
2025-03-28 20:22 UTC · source 2025-03-28excluded packagepackage50090-0659-1IInactivated by FDAa1b67e2a42f9…c4cf2c586c0d…
2025-03-28 20:22 UTC · source 2025-03-28excluded packagepackage50090-0659-0DDiscontinued by firma1b67e2a42f9…c4cf2c586c0d…
2025-03-22 03:12 UTC · source 2025-03-21excluded productproductIInactivated by FDAcfe11265f3b6…090c488252e2…
2025-03-22 03:12 UTC · source 2025-03-21excluded packagepackage50090-0659-1IInactivated by FDAcfe11265f3b6…090c488252e2…
2025-03-22 03:12 UTC · source 2025-03-21excluded packagepackage50090-0659-0DDiscontinued by firmcfe11265f3b6…090c488252e2…
2025-03-10 12:48 UTC · source 2025-03-10excluded productproductIInactivated by FDAcdf11ea48f46…ba0047e9e063…
2025-03-10 12:48 UTC · source 2025-03-10excluded packagepackage50090-0659-1IInactivated by FDAcdf11ea48f46…ba0047e9e063…
2025-03-10 12:48 UTC · source 2025-03-10excluded packagepackage50090-0659-0DDiscontinued by firmcdf11ea48f46…ba0047e9e063…
2025-02-02 03:52 UTC · source 2025-01-31excluded productproductIInactivated by FDA302b2466d912…e7b80fea0513…
2025-02-02 03:52 UTC · source 2025-01-31excluded packagepackage50090-0659-1IInactivated by FDA302b2466d912…e7b80fea0513…
2025-02-02 03:52 UTC · source 2025-01-31excluded packagepackage50090-0659-0DDiscontinued by firm302b2466d912…e7b80fea0513…
2025-01-20 13:05 UTC · source 2025-01-20excluded productproductIInactivated by FDAed331223b511…672a5bd82f5f…
2025-01-20 13:05 UTC · source 2025-01-20excluded packagepackage50090-0659-1IInactivated by FDAed331223b511…672a5bd82f5f…
2025-01-20 13:05 UTC · source 2025-01-20excluded packagepackage50090-0659-0DDiscontinued by firmed331223b511…672a5bd82f5f…
2025-01-11 03:41 UTC · source 2025-01-10excluded productproductIInactivated by FDA0efc9e666f02…f202fb6c5f17…
2025-01-11 03:41 UTC · source 2025-01-10excluded packagepackage50090-0659-1IInactivated by FDA0efc9e666f02…f202fb6c5f17…
2025-01-11 03:41 UTC · source 2025-01-10excluded packagepackage50090-0659-0DDiscontinued by firm0efc9e666f02…f202fb6c5f17…
2024-11-09 02:27 UTC · source 2024-11-08excluded productproductIInactivated by FDAad56d346431e…cc804d4bbf1e…
2024-11-09 02:27 UTC · source 2024-11-08excluded packagepackage50090-0659-1IInactivated by FDAad56d346431e…cc804d4bbf1e…
2024-11-09 02:27 UTC · source 2024-11-08excluded packagepackage50090-0659-0DDiscontinued by firmad56d346431e…cc804d4bbf1e…
2024-10-04 04:10 UTC · source 2024-10-03excluded productproductIInactivated by FDA367a005e9d99…383a685ebd0f…
2024-10-04 04:10 UTC · source 2024-10-03excluded packagepackage50090-0659-1IInactivated by FDA367a005e9d99…383a685ebd0f…
2024-10-04 04:10 UTC · source 2024-10-03excluded packagepackage50090-0659-0DDiscontinued by firm367a005e9d99…383a685ebd0f…
2024-07-10 04:00 UTC · source 2024-07-09excluded productproductIInactivated by FDA557ba5c1ecfa…9c80585c8c6e…
2024-07-10 04:00 UTC · source 2024-07-09excluded packagepackage50090-0659-1IInactivated by FDA557ba5c1ecfa…9c80585c8c6e…
2024-07-10 04:00 UTC · source 2024-07-09excluded packagepackage50090-0659-0DDiscontinued by firm557ba5c1ecfa…9c80585c8c6e…
2024-05-28 21:12 UTC · source 2024-05-28excluded productproductIInactivated by FDA8af77b9d5b6f…d9bbb34c5368…
2024-05-28 21:12 UTC · source 2024-05-28excluded packagepackage50090-0659-1IInactivated by FDA8af77b9d5b6f…d9bbb34c5368…
2024-05-15 03:39 UTC · source 2024-05-14excluded productproductIInactivated by FDA834df4deac94…adcc014656a3…
2024-05-15 03:39 UTC · source 2024-05-14excluded packagepackage50090-0659-1IInactivated by FDA834df4deac94…adcc014656a3…
2024-03-11 06:39 UTC · source 2024-03-08excluded productproductIInactivated by FDA1332a3947898…d4bfe170f9cd…
2024-03-11 06:39 UTC · source 2024-03-08excluded packagepackage50090-0659-1IInactivated by FDA1332a3947898…d4bfe170f9cd…

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

FDA-Initiated Inactive NDC Indexing#

NDC, Effective, Action table
NDCEffectiveActionDocumentIndexing SPLRelated label
50090-0659-02023-01-30C16284748780-1f386c64a-31b5-0266-e053-dadaa90a7c1aTerazosin Capsules, USP
50090-0659-12023-01-30C16284748780-1f386c64a-31b5-0266-e053-dadaa90a7c1aTerazosin Capsules, USP

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
50090-0659-0Terazosin Hydrochloride30 in 1 BOTTLECAPSULE3023
50090-0659-1Terazosin Hydrochloride90 in 1 BOTTLECAPSULE9023

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
50090-0659-1EA - Each50090-0659e61203ee-150a-4eca-9e03-3c9cda5b321a12018-12-13

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
50090-0659TERAZOSIN HYDROCHLORIDE CAPSULE [A-S MEDICATION SOLUTIONS]23Legacy NDC, 2 package rows20200220_40369190-10a4-4af5-a5f2-ed38562b443c.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 · 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

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
50090-0659-05009006590030 in 1 BOTTLEHistorical
50090-0659-15009006590190 CAPSULE in 1 BOTTLE (50090-0659-1) 90 capsule2014-11-280000-00-00NoNoCurrent