Terazosin Hydrochloride

Product NDC
21695-813
11-digit product format
216950813
Labeler code
21695
Product ID
21695-813_a00604ff-041d-4ad4-a3bb-d0911bf0727e
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
Terazosin Hydrochloride
Dosage form
CAPSULE
Route
ORAL
Labeler
Rebel Distributors Corp
Application
ANDA075317
Marketing category
ANDA
Marketing start
2009-07-01
Marketing end
0000-00-00
Substance
TERAZOSIN HYDROCHLORIDE
Active strength
5 mg/1
Pharmacologic classes
Adrenergic alpha-Antagonists [MoA],alpha-Adrenergic Blocker [EPC]
NDC exclude flag
E
Listing certified through
2017-12-31
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 productproduct21695-813IInactivated by FDA2026-08-10
excluded packagepackage21695-81321695-813-30IInactivated by FDA2026-08-10
excluded packagepackage21695-81321695-813-90IInactivated by FDA2026-08-10

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 2 · 66 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 packagepackage21695-813-30d630ba8d3edf…732f749b63fb…
2025-12-14 17:58 UTC · source 2025-12-05excluded packagepackage21695-813-90d630ba8d3edf…732f749b63fb…
2025-08-27 00:01 UTC · source 2025-08-26excluded productproductf5e01cc5f278…a2eaf40c39c3…
2025-08-27 00:01 UTC · source 2025-08-26excluded packagepackage21695-813-30f5e01cc5f278…a2eaf40c39c3…
2025-08-27 00:01 UTC · source 2025-08-26excluded packagepackage21695-813-90f5e01cc5f278…a2eaf40c39c3…
2025-04-01 02:39 UTC · source 2025-03-31excluded productproduct2ef7874e63bc…57b86245f4fa…
2025-04-01 02:39 UTC · source 2025-03-31excluded packagepackage21695-813-302ef7874e63bc…57b86245f4fa…
2025-04-01 02:39 UTC · source 2025-03-31excluded packagepackage21695-813-902ef7874e63bc…57b86245f4fa…
2025-03-28 20:22 UTC · source 2025-03-28excluded productproducta1b67e2a42f9…c4cf2c586c0d…
2025-03-28 20:22 UTC · source 2025-03-28excluded packagepackage21695-813-30a1b67e2a42f9…c4cf2c586c0d…
2025-03-28 20:22 UTC · source 2025-03-28excluded packagepackage21695-813-90a1b67e2a42f9…c4cf2c586c0d…
2025-03-22 03:12 UTC · source 2025-03-21excluded productproductcfe11265f3b6…090c488252e2…
2025-03-22 03:12 UTC · source 2025-03-21excluded packagepackage21695-813-30cfe11265f3b6…090c488252e2…
2025-03-22 03:12 UTC · source 2025-03-21excluded packagepackage21695-813-90cfe11265f3b6…090c488252e2…
2025-03-10 12:48 UTC · source 2025-03-10excluded productproductcdf11ea48f46…ba0047e9e063…
2025-03-10 12:48 UTC · source 2025-03-10excluded packagepackage21695-813-30cdf11ea48f46…ba0047e9e063…
2025-03-10 12:48 UTC · source 2025-03-10excluded packagepackage21695-813-90cdf11ea48f46…ba0047e9e063…
2025-02-02 03:52 UTC · source 2025-01-31excluded productproduct302b2466d912…e7b80fea0513…
2025-02-02 03:52 UTC · source 2025-01-31excluded packagepackage21695-813-30302b2466d912…e7b80fea0513…
2025-02-02 03:52 UTC · source 2025-01-31excluded packagepackage21695-813-90302b2466d912…e7b80fea0513…
2025-01-20 13:05 UTC · source 2025-01-20excluded productproducted331223b511…672a5bd82f5f…
2025-01-20 13:05 UTC · source 2025-01-20excluded packagepackage21695-813-30ed331223b511…672a5bd82f5f…
2025-01-20 13:05 UTC · source 2025-01-20excluded packagepackage21695-813-90ed331223b511…672a5bd82f5f…
2025-01-11 03:41 UTC · source 2025-01-10excluded productproduct0efc9e666f02…f202fb6c5f17…
2025-01-11 03:41 UTC · source 2025-01-10excluded packagepackage21695-813-300efc9e666f02…f202fb6c5f17…
2025-01-11 03:41 UTC · source 2025-01-10excluded packagepackage21695-813-900efc9e666f02…f202fb6c5f17…
2024-11-09 02:27 UTC · source 2024-11-08excluded productproductad56d346431e…cc804d4bbf1e…
2024-11-09 02:27 UTC · source 2024-11-08excluded packagepackage21695-813-30ad56d346431e…cc804d4bbf1e…
2024-11-09 02:27 UTC · source 2024-11-08excluded packagepackage21695-813-90ad56d346431e…cc804d4bbf1e…
2024-10-04 04:10 UTC · source 2024-10-03excluded productproduct367a005e9d99…383a685ebd0f…
2024-10-04 04:10 UTC · source 2024-10-03excluded packagepackage21695-813-30367a005e9d99…383a685ebd0f…
2024-10-04 04:10 UTC · source 2024-10-03excluded packagepackage21695-813-90367a005e9d99…383a685ebd0f…
2024-07-10 04:00 UTC · source 2024-07-09excluded productproduct557ba5c1ecfa…9c80585c8c6e…
2024-07-10 04:00 UTC · source 2024-07-09excluded packagepackage21695-813-30557ba5c1ecfa…9c80585c8c6e…
2024-07-10 04:00 UTC · source 2024-07-09excluded packagepackage21695-813-90557ba5c1ecfa…9c80585c8c6e…
2024-05-28 21:12 UTC · source 2024-05-28excluded productproduct8af77b9d5b6f…d9bbb34c5368…
2024-05-28 21:12 UTC · source 2024-05-28excluded packagepackage21695-813-308af77b9d5b6f…d9bbb34c5368…
2024-05-28 21:12 UTC · source 2024-05-28excluded packagepackage21695-813-908af77b9d5b6f…d9bbb34c5368…
2024-05-15 03:39 UTC · source 2024-05-14excluded productproduct834df4deac94…adcc014656a3…
2024-05-15 03:39 UTC · source 2024-05-14excluded packagepackage21695-813-30834df4deac94…adcc014656a3…
2024-05-15 03:39 UTC · source 2024-05-14excluded packagepackage21695-813-90834df4deac94…adcc014656a3…
2024-03-11 06:39 UTC · source 2024-03-08excluded productproduct1332a3947898…d4bfe170f9cd…
2024-03-11 06:39 UTC · source 2024-03-08excluded packagepackage21695-813-301332a3947898…d4bfe170f9cd…
2024-03-11 06:39 UTC · source 2024-03-08excluded packagepackage21695-813-901332a3947898…d4bfe170f9cd…
2022-08-30 03:57 UTC · source 2022-08-29excluded productproductfb8cb913e6d1…eb8c232b6be0…
2022-08-30 03:57 UTC · source 2022-08-29excluded packagepackage21695-813-30fb8cb913e6d1…eb8c232b6be0…
2022-08-30 03:57 UTC · source 2022-08-29excluded packagepackage21695-813-90fb8cb913e6d1…eb8c232b6be0…
2022-04-09 23:13 UTC · source 2022-04-08excluded productproduct86f5da6cb304…a595104c45d7…
2022-04-09 23:13 UTC · source 2022-04-08excluded packagepackage21695-813-3086f5da6cb304…a595104c45d7…
2022-04-09 23:13 UTC · source 2022-04-08excluded packagepackage21695-813-9086f5da6cb304…a595104c45d7…
2022-04-04 05:40 UTC · source 2022-04-01excluded productproductbd6a592717d7…303034d00443…
2022-04-04 05:40 UTC · source 2022-04-01excluded packagepackage21695-813-30bd6a592717d7…303034d00443…
2022-04-04 05:40 UTC · source 2022-04-01excluded packagepackage21695-813-90bd6a592717d7…303034d00443…
2021-12-27 23:28 UTC · source 2021-12-27excluded productproduct8dfbde2a14a4…c9ff85d89658…
2021-12-27 23:28 UTC · source 2021-12-27excluded packagepackage21695-813-308dfbde2a14a4…c9ff85d89658…
2021-12-27 23:28 UTC · source 2021-12-27excluded packagepackage21695-813-908dfbde2a14a4…c9ff85d89658…
2020-12-18 03:04 UTC · source 2020-12-17excluded productproducte2bbac7714bc…27bdfed8d636…
2020-12-18 03:04 UTC · source 2020-12-17excluded packagepackage21695-813-30e2bbac7714bc…27bdfed8d636…
2020-12-18 03:04 UTC · source 2020-12-17excluded packagepackage21695-813-90e2bbac7714bc…27bdfed8d636…

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…

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
21695-813-302019-09-24C16284748780-1934fe258-499b-48b1-e053-8cdaa90a720aTERAZOSIN HYDROCHLORIDE CAPSULES
21695-813-902019-09-24C16284748780-1934fe258-499b-48b1-e053-8cdaa90a720aTERAZOSIN HYDROCHLORIDE CAPSULES

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
21695-813-30Terazosin Hydrochloride30 in 1 BOTTLECAPSULE301
21695-813-90Terazosin Hydrochloride90 in 1 BOTTLECAPSULE901

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
21695-813-30EA - Each21695-81329f592b6-9470-42cb-be3e-88edf3a04ad412012-07-24
21695-813-90EA - Each21695-81356479d3e-8656-47b0-bcd5-d06aa3737de812012-07-24

DailyMed Socrata Ingredients#

Ingredient, Type, UNII table
IngredientTypeUNIIDailyMed labelSPL versionUploaded
TERAZOSIN HYDROCHLORIDEACTIVE INGREDIENTD32S14F082TERAZOSIN HYDROCHLORIDE CAPSULE [REBEL DISTRIBUTORS CORP]1
TERAZOSINACTIVE MOIETY8L5014XET7TERAZOSIN HYDROCHLORIDE CAPSULE [REBEL DISTRIBUTORS CORP]1
CELLULOSE, MICROCRYSTALLINEINACTIVE INGREDIENTOP1R32D61UTERAZOSIN HYDROCHLORIDE CAPSULE [REBEL DISTRIBUTORS CORP]1
COLLOIDAL SILICON DIOXIDEINACTIVE INGREDIENTETJ7Z6XBU4TERAZOSIN HYDROCHLORIDE CAPSULE [REBEL DISTRIBUTORS CORP]1
CROSPOVIDONEINACTIVE INGREDIENT68401960MKTERAZOSIN HYDROCHLORIDE CAPSULE [REBEL DISTRIBUTORS CORP]1
D&C RED NO. 28INACTIVE INGREDIENT767IP0Y5NHTERAZOSIN HYDROCHLORIDE CAPSULE [REBEL DISTRIBUTORS CORP]1
D&C YELLOW NO. 10INACTIVE INGREDIENT35SW5USQ3GTERAZOSIN HYDROCHLORIDE CAPSULE [REBEL DISTRIBUTORS CORP]1
FD&C BLUE NO. 1INACTIVE INGREDIENTH3R47K3TBDTERAZOSIN HYDROCHLORIDE CAPSULE [REBEL DISTRIBUTORS CORP]1
FD&C BLUE NO. 2INACTIVE INGREDIENTL06K8R7DQKTERAZOSIN HYDROCHLORIDE CAPSULE [REBEL DISTRIBUTORS CORP]1
FD&C RED NO. 40INACTIVE INGREDIENTWZB9127XOATERAZOSIN HYDROCHLORIDE CAPSULE [REBEL DISTRIBUTORS CORP]1
FERROSOFERRIC OXIDEINACTIVE INGREDIENTXM0M87F357TERAZOSIN HYDROCHLORIDE CAPSULE [REBEL DISTRIBUTORS CORP]1
GELATININACTIVE INGREDIENT2G86QN327LTERAZOSIN HYDROCHLORIDE CAPSULE [REBEL DISTRIBUTORS CORP]1
LACTOSE MONOHYDRATEINACTIVE INGREDIENTEWQ57Q8I5XTERAZOSIN HYDROCHLORIDE CAPSULE [REBEL DISTRIBUTORS CORP]1
MAGNESIUM STEARATEINACTIVE INGREDIENT70097M6I30TERAZOSIN HYDROCHLORIDE CAPSULE [REBEL DISTRIBUTORS CORP]1
PROPYLENE GLYCOLINACTIVE INGREDIENT6DC9Q167V3TERAZOSIN HYDROCHLORIDE CAPSULE [REBEL DISTRIBUTORS CORP]1
SHELLACINACTIVE INGREDIENT46N107B71OTERAZOSIN HYDROCHLORIDE CAPSULE [REBEL DISTRIBUTORS CORP]1
SILICON DIOXIDEINACTIVE INGREDIENTETJ7Z6XBU4TERAZOSIN HYDROCHLORIDE CAPSULE [REBEL DISTRIBUTORS CORP]1
SODIUM LAURYL SULFATEINACTIVE INGREDIENT368GB5141JTERAZOSIN HYDROCHLORIDE CAPSULE [REBEL DISTRIBUTORS CORP]1
TITANIUM DIOXIDEINACTIVE INGREDIENT15FIX9V2JPTERAZOSIN HYDROCHLORIDE CAPSULE [REBEL DISTRIBUTORS CORP]1

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
21695-813TERAZOSIN HYDROCHLORIDE CAPSULE [REBEL DISTRIBUTORS CORP]1Legacy NDC, 2 package rows20110121_a00604ff-041d-4ad4-a3bb-d0911bf0727e.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
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
313217terazosin HCl 2 MG Oral CapsulePSNa00604ff-041d-4ad4-a3bb-d0911bf0727e1
313219terazosin HCl 5 MG Oral CapsulePSNa00604ff-041d-4ad4-a3bb-d0911bf0727e1
313217terazosin 2 MG Oral CapsuleSCDa00604ff-041d-4ad4-a3bb-d0911bf0727e1
313219terazosin 5 MG Oral CapsuleSCDa00604ff-041d-4ad4-a3bb-d0911bf0727e1
313217terazosin (as terazosin HCl) 2 MG Oral CapsuleSYa00604ff-041d-4ad4-a3bb-d0911bf0727e1
313219terazosin (as terazosin hydrochloride) 5 MG Oral CapsuleSYa00604ff-041d-4ad4-a3bb-d0911bf0727e1

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionStatus
21695-813-302169508133030 in 1 BOTTLEHistorical
21695-813-902169508139090 in 1 BOTTLEHistorical