terazosin

Product NDC: 70518-3272
Requested package NDC: 70518-3272-0
11-digit product format: 705183272
Labeler code: 70518
Product ID: 70518-3272_d3c3cee7-e65a-16bc-e053-2a95a90ab12a
Type: HUMAN PRESCRIPTION DRUG
Nonproprietary name: terazosin
Dosage form: CAPSULE
Route: ORAL
Labeler: REMEDYREPACK INC.
Application: ANDA075614
Marketing category: ANDA
Marketing start: 2021-11-18
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: No
Listing certified through: 2022-12-31
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
Dataset	Scope	Product NDC	Package NDC	Code	Status	Reporting period	Source date
excluded package	package	70518-3272	70518-3272-0	D	Discontinued by firm		2026-08-11

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 · 1 matching rows.

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

Captured / source date, Dataset, Scope table
Captured / source date	Dataset	Scope	Product NDC	Package NDC	Code	Status	Reporting period	Archive	Snapshot	Source SHA-256
2025-12-14 17:58 UTC · source 2025-12-05	excluded package	package	70518-3272	70518-3272-0	D	Discontinued by firm		excluded / ndc_excluded.zip	`d630ba8d3edf…`	`732f749b63fb…`

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-product	Trade name	Ingredient	Strength	Dosage form / route	TE codes	Approval date
A075614-001	TERAZOSIN HYDROCHLORIDE	TERAZOSIN HYDROCHLORIDE	EQ 2MG BASE	CAPSULE / ORAL	AB	2001-01-30
A075614-002	TERAZOSIN HYDROCHLORIDE	TERAZOSIN HYDROCHLORIDE	EQ 1MG BASE	CAPSULE / ORAL	AB	2001-01-30
A075614-003	TERAZOSIN HYDROCHLORIDE	TERAZOSIN HYDROCHLORIDE	EQ 5MG BASE	CAPSULE / ORAL	AB	2001-01-30
A075614-004	TERAZOSIN HYDROCHLORIDE	TERAZOSIN HYDROCHLORIDE	EQ 10MG BASE	CAPSULE / ORAL	AB	2001-01-30

Therapeutic equivalence codes#

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

Application-product, TE code table
Application-product	TE code
A075614-001	AB
A075614-002	AB
A075614-003	AB
A075614-004	AB

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
Captured	Edition	Application-product	Trade name	Strength	Dosage form / route	Product TE source text	Approval date	Source SHA-256
2026-02-19 14:30 UTC	2026-02	A075614-001	TERAZOSIN HYDROCHLORIDE	EQ 2MG BASE	CAPSULE / ORAL	AB	2001-01-30	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A075614-002	TERAZOSIN HYDROCHLORIDE	EQ 1MG BASE	CAPSULE / ORAL	AB	2001-01-30	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A075614-003	TERAZOSIN HYDROCHLORIDE	EQ 5MG BASE	CAPSULE / ORAL	AB	2001-01-30	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A075614-004	TERAZOSIN HYDROCHLORIDE	EQ 10MG BASE	CAPSULE / ORAL	AB	2001-01-30	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A075614-001	TERAZOSIN HYDROCHLORIDE	EQ 2MG BASE	CAPSULE / ORAL	AB	2001-01-30	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A075614-002	TERAZOSIN HYDROCHLORIDE	EQ 1MG BASE	CAPSULE / ORAL	AB	2001-01-30	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A075614-003	TERAZOSIN HYDROCHLORIDE	EQ 5MG BASE	CAPSULE / ORAL	AB	2001-01-30	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A075614-004	TERAZOSIN HYDROCHLORIDE	EQ 10MG BASE	CAPSULE / ORAL	AB	2001-01-30	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	A075614-001	TERAZOSIN HYDROCHLORIDE	EQ 2MG BASE	CAPSULE / ORAL	AB	2001-01-30	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A075614-002	TERAZOSIN HYDROCHLORIDE	EQ 1MG BASE	CAPSULE / ORAL	AB	2001-01-30	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A075614-003	TERAZOSIN HYDROCHLORIDE	EQ 5MG BASE	CAPSULE / ORAL	AB	2001-01-30	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A075614-004	TERAZOSIN HYDROCHLORIDE	EQ 10MG BASE	CAPSULE / ORAL	AB	2001-01-30	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A075614-001	TERAZOSIN HYDROCHLORIDE	EQ 2MG BASE	CAPSULE / ORAL	AB	2001-01-30	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A075614-002	TERAZOSIN HYDROCHLORIDE	EQ 1MG BASE	CAPSULE / ORAL	AB	2001-01-30	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A075614-003	TERAZOSIN HYDROCHLORIDE	EQ 5MG BASE	CAPSULE / ORAL	AB	2001-01-30	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A075614-004	TERAZOSIN HYDROCHLORIDE	EQ 10MG BASE	CAPSULE / ORAL	AB	2001-01-30	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A075614-001	TERAZOSIN HYDROCHLORIDE	EQ 2MG BASE	CAPSULE / ORAL	AB	2001-01-30	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A075614-002	TERAZOSIN HYDROCHLORIDE	EQ 1MG BASE	CAPSULE / ORAL	AB	2001-01-30	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A075614-003	TERAZOSIN HYDROCHLORIDE	EQ 5MG BASE	CAPSULE / ORAL	AB	2001-01-30	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A075614-004	TERAZOSIN HYDROCHLORIDE	EQ 10MG BASE	CAPSULE / ORAL	AB	2001-01-30	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A075614-001	TERAZOSIN HYDROCHLORIDE	EQ 2MG BASE	CAPSULE / ORAL	AB	2001-01-30	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A075614-002	TERAZOSIN HYDROCHLORIDE	EQ 1MG BASE	CAPSULE / ORAL	AB	2001-01-30	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A075614-003	TERAZOSIN HYDROCHLORIDE	EQ 5MG BASE	CAPSULE / ORAL	AB	2001-01-30	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A075614-004	TERAZOSIN HYDROCHLORIDE	EQ 10MG BASE	CAPSULE / ORAL	AB	2001-01-30	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A075614-001	TERAZOSIN HYDROCHLORIDE	EQ 2MG BASE	CAPSULE / ORAL	AB	2001-01-30	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A075614-002	TERAZOSIN HYDROCHLORIDE	EQ 1MG BASE	CAPSULE / ORAL	AB	2001-01-30	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A075614-003	TERAZOSIN HYDROCHLORIDE	EQ 5MG BASE	CAPSULE / ORAL	AB	2001-01-30	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A075614-004	TERAZOSIN HYDROCHLORIDE	EQ 10MG BASE	CAPSULE / ORAL	AB	2001-01-30	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A075614-001	TERAZOSIN HYDROCHLORIDE	EQ 2MG BASE	CAPSULE / ORAL	AB	2001-01-30	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A075614-002	TERAZOSIN HYDROCHLORIDE	EQ 1MG BASE	CAPSULE / ORAL	AB	2001-01-30	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A075614-003	TERAZOSIN HYDROCHLORIDE	EQ 5MG BASE	CAPSULE / ORAL	AB	2001-01-30	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A075614-004	TERAZOSIN HYDROCHLORIDE	EQ 10MG BASE	CAPSULE / ORAL	AB	2001-01-30	`5bbf6a4d5a75…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A075614-001	TERAZOSIN HYDROCHLORIDE	EQ 2MG BASE	CAPSULE / ORAL	AB	2001-01-30	`d8e5a09893c0…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A075614-002	TERAZOSIN HYDROCHLORIDE	EQ 1MG BASE	CAPSULE / ORAL	AB	2001-01-30	`d8e5a09893c0…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A075614-003	TERAZOSIN HYDROCHLORIDE	EQ 5MG BASE	CAPSULE / ORAL	AB	2001-01-30	`d8e5a09893c0…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A075614-004	TERAZOSIN HYDROCHLORIDE	EQ 10MG BASE	CAPSULE / ORAL	AB	2001-01-30	`d8e5a09893c0…`
2024-10-29 15:01 UTC	2024-10	A075614-001	TERAZOSIN HYDROCHLORIDE	EQ 2MG BASE	CAPSULE / ORAL	AB	2001-01-30	`d06236e962d9…`
2024-10-29 15:01 UTC	2024-10	A075614-002	TERAZOSIN HYDROCHLORIDE	EQ 1MG BASE	CAPSULE / ORAL	AB	2001-01-30	`d06236e962d9…`
2024-10-29 15:01 UTC	2024-10	A075614-003	TERAZOSIN HYDROCHLORIDE	EQ 5MG BASE	CAPSULE / ORAL	AB	2001-01-30	`d06236e962d9…`
2024-10-29 15:01 UTC	2024-10	A075614-004	TERAZOSIN HYDROCHLORIDE	EQ 10MG BASE	CAPSULE / ORAL	AB	2001-01-30	`d06236e962d9…`

Observed Orange Book normalized TE history#

Normalized TE history page 1 of 4 · 148 observed states.

Captured, Edition, Application-product table
Captured	Edition	Application-product	TE code	Order	Source SHA-256
2026-02-19 14:30 UTC	2026-02	A075614-001	AB	1	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A075614-002	AB	1	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A075614-003	AB	1	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A075614-004	AB	1	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A075614-001	AB	1	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A075614-002	AB	1	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A075614-003	AB	1	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A075614-004	AB	1	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	A075614-001	AB	1	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A075614-002	AB	1	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A075614-003	AB	1	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A075614-004	AB	1	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A075614-001	AB	1	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A075614-002	AB	1	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A075614-003	AB	1	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A075614-004	AB	1	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A075614-001	AB	1	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A075614-002	AB	1	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A075614-003	AB	1	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A075614-004	AB	1	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A075614-001	AB	1	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A075614-002	AB	1	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A075614-003	AB	1	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A075614-004	AB	1	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A075614-001	AB	1	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A075614-002	AB	1	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A075614-003	AB	1	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A075614-004	AB	1	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A075614-001	AB	1	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A075614-002	AB	1	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A075614-003	AB	1	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A075614-004	AB	1	`5bbf6a4d5a75…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A075614-001	AB	1	`d8e5a09893c0…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A075614-002	AB	1	`d8e5a09893c0…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A075614-003	AB	1	`d8e5a09893c0…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A075614-004	AB	1	`d8e5a09893c0…`
2024-10-29 15:01 UTC	2024-10	A075614-001	AB	1	`d06236e962d9…`
2024-10-29 15:01 UTC	2024-10	A075614-002	AB	1	`d06236e962d9…`
2024-10-29 15:01 UTC	2024-10	A075614-003	AB	1	`d06236e962d9…`
2024-10-29 15:01 UTC	2024-10	A075614-004	AB	1	`d06236e962d9…`

DailyMed Product Concepts#

Product concept, Relation, Version table
Product concept	Relation	Version	Effective
975cd6e7-95ee-60f8-7c38-135ffbb09240	Product name	2	20260223
1bc6d1ac-ef0f-4fc6-8704-c443f03b274a	Product name	1	20250311
8adc9826-3fee-6091-f1ee-af9fd6f9caf8	Product name	1	20140508

FDA-Initiated Inactive NDC Indexing#

NDC, Effective, Action table
NDC	Effective	Action	Document	Indexing SPL	Related label
70518-3272-0	2023-03-23	C162847	48780-1	f386c64a-1bd6-0266-e053-dadaa90a7c1a	Terazosin Capsules, USP
70518-3272-0	2023-01-30	C162847	48780-1	f386c64a-1bd6-0266-e053-dadaa90a7c1a	Terazosin Capsules, USP

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDC	Dashboard title	SPL version	Validation	Dashboard ZIP
70518-3272	TERAZOSIN CAPSULE [REMEDYREPACK INC.]	3	Legacy NDC	20240316_64251bda-afa8-4d0e-93dd-36753dd5f112.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 · 8 matching rows.

Brand, Generic, Manufacturer table
Brand	Generic	Manufacturer	SPL set ID	Effective date	Available safety fields	Join
terazosin	TERAZOSIN	Aphena Pharma Solutions - Tennessee, LLC	57125b47-2156-181c-e063-6394a90ad763	2026-07-20	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 075614 application number: ANDA075614
terazosin	TERAZOSIN	REMEDYREPACK INC.	77e01f71-f6d8-4bbe-b13e-352c7af6b1ef	2026-05-20	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 075614 application number: ANDA075614
terazosin	TERAZOSIN	A-S Medication Solutions	916cf0fa-8e39-4b4d-b564-a16aa8511ff6	2026-01-09	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 075614 application number: ANDA075614
terazosin	TERAZOSIN	Northwind Health Company, LLC	ff0efbc2-d7aa-9783-e053-6394a90a384f	2026-01-01	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 075614 application number: ANDA075614
Terazosin	TERAZOSIN	Chartwell RX, LLC	da4ca0f8-6888-447e-9948-d37196c5a19a	2025-12-11	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 075614 application number: ANDA075614
terazosin	TERAZOSIN	Preferred Pharmaceuticals Inc.	a78f74ce-1c53-41ea-878e-13674db10a67	2025-09-30	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 075614 application number: ANDA075614
terazosin	TERAZOSIN	Bryant Ranch Prepack	2cdbb03d-0ac9-477b-88f6-5d9492277048	2023-11-27	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 075614 application number: ANDA075614
terazosin	TERAZOSIN	Heritage Pharmaceuticals Inc. d/b/a Avet Pharmaceuticals Inc.	1dabd4d6-3023-460a-8577-08b3690e7c93	2021-08-18	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 075614 application number: ANDA075614

UNII, Preferred term, Registry number table
UNII	Preferred term	Registry number	Matched term
D32S14F082	TERAZOSIN HYDROCHLORIDE	70024-40-7	TERAZOSIN HYDROCHLORIDE
8L5014XET7	TERAZOSIN	63590-64-7	terazosin

Packages#

Package NDC, 11-digit format, Description table
Package NDC	11-digit format	Description	Units	Marketing start	Marketing end	Sample	Exclude flag	Status
70518-3272-0	70518327200	30 CAPSULE in 1 BLISTER PACK (70518-3272-0)	30 capsule	2021-11-18	0000-00-00	No	No	Current