Terazosin

Product NDC
70518-0074
11-digit product format
705180074
Labeler code
70518
Product ID
70518-0074_522c0862-82ce-90ce-e063-6394a90a48b5
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
Terazosin Hydrochloride
Dosage form
CAPSULE
Route
ORAL
Labeler
REMEDYREPACK INC.
Application
ANDA075317
Marketing category
ANDA
Marketing start
2016-12-21
Substance
TERAZOSIN HYDROCHLORIDE
Active strength
2 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

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 · 1 matching rows.

Dataset, Scope, Product NDC table
DatasetScopeProduct NDCPackage NDCCodeStatusReporting periodSource date
excluded packagepackage70518-007470518-0074-0DDiscontinued by firm2026-08-10

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 1 · 24 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 packagepackage70518-0074-0d630ba8d3edf…732f749b63fb…
2025-08-27 00:01 UTC · source 2025-08-26excluded packagepackage70518-0074-0f5e01cc5f278…a2eaf40c39c3…
2025-04-01 02:39 UTC · source 2025-03-31excluded packagepackage70518-0074-02ef7874e63bc…57b86245f4fa…
2025-03-28 20:22 UTC · source 2025-03-28excluded packagepackage70518-0074-0a1b67e2a42f9…c4cf2c586c0d…
2025-03-22 03:12 UTC · source 2025-03-21excluded packagepackage70518-0074-0cfe11265f3b6…090c488252e2…
2025-03-10 12:48 UTC · source 2025-03-10excluded packagepackage70518-0074-0cdf11ea48f46…ba0047e9e063…
2025-02-02 03:52 UTC · source 2025-01-31excluded productproduct302b2466d912…e7b80fea0513…
2025-02-02 03:52 UTC · source 2025-01-31excluded packagepackage70518-0074-1302b2466d912…e7b80fea0513…
2025-02-02 03:52 UTC · source 2025-01-31excluded packagepackage70518-0074-0302b2466d912…e7b80fea0513…
2025-01-20 13:05 UTC · source 2025-01-20excluded productproducted331223b511…672a5bd82f5f…
2025-01-20 13:05 UTC · source 2025-01-20excluded packagepackage70518-0074-1ed331223b511…672a5bd82f5f…
2025-01-20 13:05 UTC · source 2025-01-20excluded packagepackage70518-0074-0ed331223b511…672a5bd82f5f…
2025-01-11 03:41 UTC · source 2025-01-10excluded productproduct0efc9e666f02…f202fb6c5f17…
2025-01-11 03:41 UTC · source 2025-01-10excluded packagepackage70518-0074-10efc9e666f02…f202fb6c5f17…
2025-01-11 03:41 UTC · source 2025-01-10excluded packagepackage70518-0074-00efc9e666f02…f202fb6c5f17…
2024-11-09 02:27 UTC · source 2024-11-08excluded productproductad56d346431e…cc804d4bbf1e…
2024-11-09 02:27 UTC · source 2024-11-08excluded packagepackage70518-0074-1ad56d346431e…cc804d4bbf1e…
2024-11-09 02:27 UTC · source 2024-11-08excluded packagepackage70518-0074-0ad56d346431e…cc804d4bbf1e…
2024-10-04 04:10 UTC · source 2024-10-03excluded productproduct367a005e9d99…383a685ebd0f…
2024-10-04 04:10 UTC · source 2024-10-03excluded packagepackage70518-0074-1367a005e9d99…383a685ebd0f…
2024-10-04 04:10 UTC · source 2024-10-03excluded packagepackage70518-0074-0367a005e9d99…383a685ebd0f…
2024-07-10 04:00 UTC · source 2024-07-09excluded productproduct557ba5c1ecfa…9c80585c8c6e…
2024-07-10 04:00 UTC · source 2024-07-09excluded packagepackage70518-0074-1557ba5c1ecfa…9c80585c8c6e…
2024-07-10 04:00 UTC · source 2024-07-09excluded packagepackage70518-0074-0557ba5c1ecfa…9c80585c8c6e…

Source provenance: Browse the complete Orange Book source catalog · source snapshot 1.

Orange Book products#

Current product rows page 1 of 1 · 4 matching rows.

Application-product, Trade name, Ingredient table
Application-productTrade nameIngredientStrengthDosage form / routeTE codesRLD / RSApproval date
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 HYDROCHLORIDE2 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 · 1 matching rows.

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

Harmonized SPL set identifiers#

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

Identifier, FDA.report destination table
IdentifierFDA.report destination
a3a5901a-6395-4030-a27b-1fb17cd97315Available 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

FDA-Initiated Inactive NDC Indexing#

Effective, Related label table
EffectiveRelated label
2020-04-16TERAZOSIN CAPSULES, USP
2020-04-16TERAZOSIN CAPSULES, USP
2020-04-16TERAZOSIN CAPSULES, USP
2020-01-31TERAZOSIN CAPSULES, USP
2020-01-31TERAZOSIN CAPSULES, USP
2020-01-31TERAZOSIN CAPSULES, USP

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
70518-0074-0Terazosin30 in 1 BLISTER PACKCAPSULE3015
70518-0074-1Terazosin30 in 1 BLISTER PACKCAPSULE3015

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
70518-0074TERAZOSIN (TERAZOSIN HYDROCHLORIDE) CAPSULE [REMEDYREPACK INC.]10Current NDC, Legacy NDC, 2 package rows20250529_a3a5901a-6395-4030-a27b-1fb17cd97315.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
ndc (product): 70518-0074
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 CapsulePSNa3a5901a-6395-4030-a27b-1fb17cd9731515
313217terazosin 2 MG Oral CapsuleSCDa3a5901a-6395-4030-a27b-1fb17cd9731515
313217terazosin (as terazosin HCl) 2 MG Oral CapsuleSYa3a5901a-6395-4030-a27b-1fb17cd9731515

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
70518-0074-07051800740030 CAPSULE in 1 BLISTER PACK (70518-0074-0) 30 capsule2016-12-210000-00-00NoNoCurrent
70518-0074-17051800740130 CAPSULE in 1 BLISTER PACK (70518-0074-1) 30 capsule2021-03-240000-00-00NoNoCurrent