Terazosin

Product NDC
55700-750
Requested package NDC
55700-750-90
11-digit product format
557000750
Labeler code
55700
Product ID
55700-750_f5b5de5f-c7b6-479b-8e7c-8cdcfee11505
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
Terazosin Hydrochloride
Dosage form
CAPSULE
Route
ORAL
Labeler
Quality Care Products, LLC
Application
ANDA075317
Marketing category
ANDA
Marketing start
2019-04-26
Marketing end
0000-00-00
Substance
TERAZOSIN HYDROCHLORIDE
Active strength
1 mg/1
Pharmacologic classes
Adrenergic alpha-Antagonists [MoA], alpha-Adrenergic Blocker [EPC]
NDC exclude flag
No
Listing certified through
2023-12-31
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 · 1 matching rows.

Dataset, Scope, Product NDC table
DatasetScopeProduct NDCPackage NDCCodeStatusReporting periodSource date
excluded packagepackage55700-75055700-750-90DDiscontinued 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 · 2 matching rows.

View current auxiliary records. · View the auxiliary file history.

Captured / source date, Dataset, Scope table
Captured / source dateDatasetScopeProduct NDCPackage NDCCodeStatusReporting periodArchiveSnapshotSource SHA-256
2025-12-14 17:58 UTC · source 2025-12-05excluded packagepackage55700-75055700-750-90DDiscontinued by firmexcluded / ndc_excluded.zipd630ba8d3edf…732f749b63fb…
2025-08-27 00:01 UTC · source 2025-08-26excluded packagepackage55700-75055700-750-90DDiscontinued by firmexcluded / ndc_excluded.zipf5e01cc5f278…a2eaf40c39c3…

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 Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
55700-750-90EA - Each55700-7501ccd1215-457e-4c28-ab28-315608a6cf7212019-06-19

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

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
55700-750-905570007509090 CAPSULE in 1 BOTTLE (55700-750-90) 90 capsule2019-04-260000-00-00NoNoCurrent