TEZRULY

Product NDC: 70954-592
Requested package NDC: 70954-592-10
11-digit product format: 709540592
Labeler code: 70954
Product ID: 70954-592_0d2b0b80-5201-473a-9b43-f5c2127f6f7c
Type: HUMAN PRESCRIPTION DRUG
Nonproprietary name: Terazosin
Dosage form: SOLUTION
Route: ORAL
Labeler: ANI Pharmaceuticals, Inc.
Application: NDA218139
Marketing category: NDA
Marketing start: 2025-04-18
Substance: TERAZOSIN HYDROCHLORIDE
Active strength: 1 mg/mL
Pharmacologic classes: Adrenergic alpha-Antagonists [MoA], alpha-Adrenergic Blocker [EPC]
NDC exclude flag: No
Listing certified through: 2026-12-31
Current FDA listing: Yes

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 · 9 matching rows.

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

Captured / source date, Snapshot, Source SHA-256 table
Captured / source date	Snapshot	Source SHA-256
2025-04-01 02:39 UTC · source 2025-03-31	`2ef7874e63bc…`	`57b86245f4fa…`
2025-03-28 20:22 UTC · source 2025-03-28	`a1b67e2a42f9…`	`c4cf2c586c0d…`
2025-03-22 03:12 UTC · source 2025-03-21	`cfe11265f3b6…`	`090c488252e2…`
2025-03-10 12:48 UTC · source 2025-03-10	`cdf11ea48f46…`	`ba0047e9e063…`
2025-02-02 03:52 UTC · source 2025-01-31	`302b2466d912…`	`e7b80fea0513…`
2025-01-20 13:05 UTC · source 2025-01-20	`ed331223b511…`	`672a5bd82f5f…`
2025-01-11 03:41 UTC · source 2025-01-10	`0efc9e666f02…`	`f202fb6c5f17…`
2024-11-09 02:27 UTC · source 2024-11-08	`ad56d346431e…`	`cc804d4bbf1e…`
2024-10-04 04:10 UTC · source 2024-10-03	`367a005e9d99…`	`383a685ebd0f…`

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

Orange Book products#

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

Application-product, Trade name, Ingredient table
Application-product	Trade name	Ingredient	Strength	Dosage form / route	TE codes	RLD / RS	Approval date
N218139-001	TEZRULY	TERAZOSIN HYDROCHLORIDE	EQ 1MG BASE/ML	SOLUTION / ORAL		RLD	2024-07-29

Orange Book patents#

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

Application-product, Patent, Expiration table
Application-product	Patent	Expiration	Use code	Coverage / status	Submission date
N218139-001	11224572	2041-02-01	U-3990	Drug product	2024-09-24
N218139-001	11224572	2041-02-01	U-3991	Drug product	2024-09-24
N218139-001	12427108	2041-02-01	U-3990	Drug product	2025-10-03
N218139-001	12427108	2041-02-01	U-3991	Drug product	2025-10-03

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.

Captured, Edition, Application-product table
Captured	Edition	Application-product	Trade name	Strength	Dosage form / route	RLD / RS	Approval date	Source SHA-256
2026-02-19 14:30 UTC	2026-02	N218139-001	TEZRULY	EQ 1MG BASE/ML	SOLUTION / ORAL	RLD	2024-07-29	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	N218139-001	TEZRULY	EQ 1MG BASE/ML	SOLUTION / ORAL	RLD	2024-07-29	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	N218139-001	TEZRULY	EQ 1MG BASE/ML	SOLUTION / ORAL	RLD, RS	2024-07-29	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	N218139-001	TEZRULY	EQ 1MG BASE/ML	SOLUTION / ORAL	RLD, RS	2024-07-29	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	N218139-001	TEZRULY	EQ 1MG BASE/ML	SOLUTION / ORAL	RLD, RS	2024-07-29	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	N218139-001	TEZRULY	EQ 1MG BASE/ML	SOLUTION / ORAL	RLD, RS	2024-07-29	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	N218139-001	TEZRULY	EQ 1MG BASE/ML	SOLUTION / ORAL	RLD, RS	2024-07-29	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	N218139-001	TEZRULY	EQ 1MG BASE/ML	SOLUTION / ORAL	RLD	2024-07-29	`5bbf6a4d5a75…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	N218139-001	TEZRULY	EQ 1MG BASE/ML	SOLUTION / ORAL	RLD, RS	2024-07-29	`d8e5a09893c0…`
2024-10-29 15:01 UTC	2024-10	N218139-001	TEZRULY	EQ 1MG BASE/ML	SOLUTION / ORAL	RLD	2024-07-29	`d06236e962d9…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	N218139-001	TEZRULY	EQ 1MG BASE/ML	SOLUTION / ORAL	RLD, RS	2024-07-29	`79d66fd596c7…`
2026-07-26 02:55 UTC · 3 captures of this ZIP	2026-06	N218139-001	TEZRULY	EQ 1MG BASE/ML	SOLUTION / ORAL	RLD	2024-07-29	`a50c72e98297…`

Observed Orange Book patent history#

Captured, Edition, Application-product table
Captured	Edition	Application-product	Patent	Expiration	Use code	Coverage / status	Submission date	Source SHA-256
2026-02-19 14:30 UTC	2026-02	N218139-001	11224572	2041-02-01	U-3990	Drug product	2024-09-24	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	N218139-001	11224572	2041-02-01	U-3991	Drug product	2024-09-24	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	N218139-001	12427108	2041-02-01	U-3990	Drug product	2025-10-03	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	N218139-001	12427108	2041-02-01	U-3991	Drug product	2025-10-03	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	N218139-001	11224572	2041-02-01	U-3990	Drug product	2024-09-24	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	N218139-001	11224572	2041-02-01	U-3991	Drug product	2024-09-24	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	N218139-001	12427108	2041-02-01	U-3990	Drug product	2025-10-03	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	N218139-001	12427108	2041-02-01	U-3991	Drug product	2025-10-03	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	N218139-001	11224572	2042-01-18	U-3990	Drug product	2024-09-24	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	N218139-001	11224572	2042-01-18	U-3991	Drug product	2024-09-24	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	N218139-001	11224572	2042-01-18	U-3990	Drug product	2024-09-24	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	N218139-001	11224572	2042-01-18	U-3991	Drug product	2024-09-24	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	N218139-001	11224572	2042-01-18	U-3990	Drug product	2024-09-24	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	N218139-001	11224572	2042-01-18	U-3991	Drug product	2024-09-24	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	N218139-001	11224572	2042-01-18	U-3990	Drug product	2024-09-24	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	N218139-001	11224572	2042-01-18	U-3991	Drug product	2024-09-24	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	N218139-001	11224572	2042-01-18	U-3990	Drug product	2024-09-24	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	N218139-001	11224572	2042-01-18	U-3991	Drug product	2024-09-24	`2680178bc6a6…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	N218139-001	11224572	2042-01-18	U-3990	Drug product	2024-09-24	`d8e5a09893c0…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	N218139-001	11224572	2042-01-18	U-3991	Drug product	2024-09-24	`d8e5a09893c0…`
2024-10-29 15:01 UTC	2024-10	N218139-001	11224572	2042-01-18	U-3990	Drug product	2024-09-24	`d06236e962d9…`
2024-10-29 15:01 UTC	2024-10	N218139-001	11224572	2042-01-18	U-3991	Drug product	2024-09-24	`d06236e962d9…`
2026-07-26 02:55 UTC · 3 captures of this ZIP	2026-06	N218139-001	11224572	2041-02-01	U-3990	Drug product	2024-09-24	`a50c72e98297…`
2026-07-26 02:55 UTC · 3 captures of this ZIP	2026-06	N218139-001	11224572	2041-02-01	U-3991	Drug product	2024-09-24	`a50c72e98297…`
2026-07-26 02:55 UTC · 3 captures of this ZIP	2026-06	N218139-001	12427108	2041-02-01	U-3990	Drug product	2025-10-03	`a50c72e98297…`
2026-07-26 02:55 UTC · 3 captures of this ZIP	2026-06	N218139-001	12427108	2041-02-01	U-3991	Drug product	2025-10-03	`a50c72e98297…`

Additional Listing Data#

Finished product: Yes
Brand name base: TEZRULY
Listing expiration: 2026-12-31

Active Ingredients#

Ingredient, Strength table
Ingredient	Strength
TERAZOSIN HYDROCHLORIDE	1 mg/mL

Harmonized UNII identifiers#

UNII identifiers page 1 of 1 · 1 matching rows.

Identifier, FDA.report destination table
Identifier	FDA.report destination
D32S14F082	Internal UNII lookup

Harmonized RxCUI identifiers#

RxCUI identifiers page 1 of 1 · 2 matching rows.

Identifier, FDA.report destination table
Identifier	FDA.report destination
2689133	Internal RxNorm lookup
2689139	Internal RxNorm lookup

Harmonized SPL set identifiers#

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

Identifier, FDA.report destination table
Identifier	FDA.report destination
69582e0c-6569-490c-8c14-999f3750336f	Available on FDA.report

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

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDC	Product	Description	Form	Quantity	Strength	SPL version
70954-592-10	TEZRULY	150 mL in 1 BOTTLE	SOLUTION	150		3

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDC	Billing unit	Product NDC	DailyMed indexing SPL	SPL version	Effective
70954-592-10	ML - Milliliter	70954-592	77e99397-776d-4dc7-b8f1-762b9c9c34fb	1	2025-05-14

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDC	Dashboard title	SPL version	Validation	Dashboard ZIP
70954-592	TEZRULY (TERAZOSIN) SOLUTION [ANI PHARMACEUTICALS, INC.]	3	Current NDC, 1 package rows	20250419_69582e0c-6569-490c-8c14-999f3750336f.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 · 1 matching rows.

Brand, Generic, Manufacturer table
Brand	Generic	Manufacturer	SPL set ID	Effective date	Available safety fields	Join
TEZRULY	TERAZOSIN	ANI Pharmaceuticals, Inc.	69582e0c-6569-490c-8c14-999f3750336f	2025-04-18	Warnings, Adverse reactions	Exact identifier application applno (NDA): 218139 application number: NDA218139 ndc (package): 70954-592-10 ndc (product): 70954-592 ndc11 (package): 70954059210

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

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUI	RxNorm string	TTY	DailyMed	SPL version
2689133	terazosin 1 MG/mL Oral Solution	PSN	69582e0c-6569-490c-8c14-999f3750336f	3
2689139	TEZRULY 1 MG/mL Oral Solution	PSN	69582e0c-6569-490c-8c14-999f3750336f	3
2689139	terazosin 1 MG/ML Oral Solution [Tezruly]	SBD	69582e0c-6569-490c-8c14-999f3750336f	3
2689133	terazosin 1 MG/ML Oral Solution	SCD	69582e0c-6569-490c-8c14-999f3750336f	3
2689133	terazosin 1 MG (equivalent to terazosin hydrochloride 1.1 MG) per ML Oral Solution	SY	69582e0c-6569-490c-8c14-999f3750336f	3
2689139	Tezruly 1 MG (equivalent to terazosin hydrochloride 1.1 MG) per ML Oral Solution	SY	69582e0c-6569-490c-8c14-999f3750336f	3
2689139	Tezruly 1 MG/ML Oral Solution	SY	69582e0c-6569-490c-8c14-999f3750336f	3

Packages#

Package NDC, 11-digit format, Description table
Package NDC	11-digit format	Description	Units	Marketing start	Sample	Exclude flag	Status
70954-592-10	70954059210	150 mL in 1 BOTTLE (70954-592-10)	150 ml	2025-04-18	No	No	Current

Title, Manufacturer, Effective date table
Title	Manufacturer	Effective date	Type	Version
TEZRULY	ANI Pharmaceuticals, Inc. \| Novitium Pharma LLC	2025-04-18	Human Prescription Drug Label	3