Home NDC 70518-0342 Terazosin
Product NDC 70518-0342
11-digit product format 705180342
Labeler code 70518
Product ID 70518-0342_522d3d90-4456-513c-e063-6394a90a1046
Type HUMAN PRESCRIPTION DRUG
Nonproprietary name Terazosin Hydrochloride
Dosage form CAPSULE
Route ORAL
Labeler REMEDYREPACK INC.
Application ANDA075317
Marketing category ANDA
Marketing start 2017-03-20
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 2027-12-31
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 · 12 matching rows.
View current auxiliary records. · View the auxiliary file history.
Captured / source date, Dataset, Scope table Captured / source date Dataset Scope Package NDC Snapshot Source SHA-256 2025-02-02 03:52 UTC · source 2025-01-31 excluded product product 302b2466d912…e7b80fea0513…2025-02-02 03:52 UTC · source 2025-01-31 excluded package package 70518-0342-0 302b2466d912…e7b80fea0513…2025-01-20 13:05 UTC · source 2025-01-20 excluded product product ed331223b511…672a5bd82f5f…2025-01-20 13:05 UTC · source 2025-01-20 excluded package package 70518-0342-0 ed331223b511…672a5bd82f5f…2025-01-11 03:41 UTC · source 2025-01-10 excluded product product 0efc9e666f02…f202fb6c5f17…2025-01-11 03:41 UTC · source 2025-01-10 excluded package package 70518-0342-0 0efc9e666f02…f202fb6c5f17…2024-11-09 02:27 UTC · source 2024-11-08 excluded product product ad56d346431e…cc804d4bbf1e…2024-11-09 02:27 UTC · source 2024-11-08 excluded package package 70518-0342-0 ad56d346431e…cc804d4bbf1e…2024-10-04 04:10 UTC · source 2024-10-03 excluded product product 367a005e9d99…383a685ebd0f…2024-10-04 04:10 UTC · source 2024-10-03 excluded package package 70518-0342-0 367a005e9d99…383a685ebd0f…2024-07-10 04:00 UTC · source 2024-07-09 excluded product product 557ba5c1ecfa…9c80585c8c6e…2024-07-10 04:00 UTC · source 2024-07-09 excluded package package 70518-0342-0 557ba5c1ecfa…9c80585c8c6e…
Source provenance: Browse the complete Orange Book source catalog · source snapshot 43 .
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 RLD / RS Approval date A075317-001 TERAZOSIN HYDROCHLORIDE TERAZOSIN HYDROCHLORIDE EQ 1MG BASE CAPSULE / ORAL AB RS 2004-12-20 A075317-002 TERAZOSIN HYDROCHLORIDE TERAZOSIN HYDROCHLORIDE EQ 2MG BASE CAPSULE / ORAL AB 2004-12-20 A075317-003 TERAZOSIN HYDROCHLORIDE TERAZOSIN HYDROCHLORIDE EQ 5MG BASE CAPSULE / ORAL AB 2004-12-20 A075317-004 TERAZOSIN HYDROCHLORIDE TERAZOSIN HYDROCHLORIDE EQ 10MG BASE CAPSULE / ORAL AB 2004-12-20
Therapeutic equivalence codes# Current TE-code rows page 1 of 1 · 4 matching rows.
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 · 172 observed states.
Captured, Edition, Application-product table Captured Edition Application-product Trade name Strength Dosage form / route Product TE source text RLD / RS Approval date Source SHA-256 2026-09-14 22:38:34 2026-08 A075317-001 TERAZOSIN HYDROCHLORIDE EQ 1MG BASE CAPSULE / ORAL AB RS 2004-12-20 84e616aacf4f…2026-09-14 22:38:34 2026-08 A075317-002 TERAZOSIN HYDROCHLORIDE EQ 2MG BASE CAPSULE / ORAL AB 2004-12-20 84e616aacf4f…2026-09-14 22:38:34 2026-08 A075317-003 TERAZOSIN HYDROCHLORIDE EQ 5MG BASE CAPSULE / ORAL AB 2004-12-20 84e616aacf4f…2026-09-14 22:38:34 2026-08 A075317-004 TERAZOSIN HYDROCHLORIDE EQ 10MG BASE CAPSULE / ORAL AB 2004-12-20 84e616aacf4f…2026-08-18 06:07:40 2026-07 A075317-001 TERAZOSIN HYDROCHLORIDE EQ 1MG BASE CAPSULE / ORAL AB RS 2004-12-20 caaa826d4ba7…2026-08-18 06:07:40 2026-07 A075317-002 TERAZOSIN HYDROCHLORIDE EQ 2MG BASE CAPSULE / ORAL AB 2004-12-20 caaa826d4ba7…2026-08-18 06:07:40 2026-07 A075317-003 TERAZOSIN HYDROCHLORIDE EQ 5MG BASE CAPSULE / ORAL AB 2004-12-20 caaa826d4ba7…2026-08-18 06:07:40 2026-07 A075317-004 TERAZOSIN HYDROCHLORIDE EQ 10MG BASE CAPSULE / ORAL AB 2004-12-20 caaa826d4ba7…2026-02-19 14:30 UTC 2026-02 A075317-001 TERAZOSIN HYDROCHLORIDE EQ 1MG BASE CAPSULE / ORAL AB RS 2004-12-20 011fe1cb6892…2026-02-19 14:30 UTC 2026-02 A075317-002 TERAZOSIN HYDROCHLORIDE EQ 2MG BASE CAPSULE / ORAL AB 2004-12-20 011fe1cb6892…2026-02-19 14:30 UTC 2026-02 A075317-003 TERAZOSIN HYDROCHLORIDE EQ 5MG BASE CAPSULE / ORAL AB 2004-12-20 011fe1cb6892…2026-02-19 14:30 UTC 2026-02 A075317-004 TERAZOSIN HYDROCHLORIDE EQ 10MG BASE CAPSULE / ORAL AB 2004-12-20 011fe1cb6892…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 A075317-001 TERAZOSIN HYDROCHLORIDE EQ 1MG BASE CAPSULE / ORAL AB RS 2004-12-20 31067a03dcf5…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 A075317-002 TERAZOSIN HYDROCHLORIDE EQ 2MG BASE CAPSULE / ORAL AB 2004-12-20 31067a03dcf5…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 A075317-003 TERAZOSIN HYDROCHLORIDE EQ 5MG BASE CAPSULE / ORAL AB 2004-12-20 31067a03dcf5…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 A075317-004 TERAZOSIN HYDROCHLORIDE EQ 10MG BASE CAPSULE / ORAL AB 2004-12-20 31067a03dcf5…2025-08-23 18:47 UTC 2025-08 A075317-001 TERAZOSIN HYDROCHLORIDE EQ 1MG BASE CAPSULE / ORAL AB RS 2004-12-20 6a471c1ec25d…2025-08-23 18:47 UTC 2025-08 A075317-002 TERAZOSIN HYDROCHLORIDE EQ 2MG BASE CAPSULE / ORAL AB 2004-12-20 6a471c1ec25d…2025-08-23 18:47 UTC 2025-08 A075317-003 TERAZOSIN HYDROCHLORIDE EQ 5MG BASE CAPSULE / ORAL AB 2004-12-20 6a471c1ec25d…2025-08-23 18:47 UTC 2025-08 A075317-004 TERAZOSIN HYDROCHLORIDE EQ 10MG BASE CAPSULE / ORAL AB 2004-12-20 6a471c1ec25d…2025-03-22 03:13 UTC · 3 captures of this ZIP 2025-03 A075317-001 TERAZOSIN HYDROCHLORIDE EQ 1MG BASE CAPSULE / ORAL AB RS 2004-12-20 fd3edfee7708…2025-03-22 03:13 UTC · 3 captures of this ZIP 2025-03 A075317-002 TERAZOSIN HYDROCHLORIDE EQ 2MG BASE CAPSULE / ORAL AB 2004-12-20 fd3edfee7708…2025-03-22 03:13 UTC · 3 captures of this ZIP 2025-03 A075317-003 TERAZOSIN HYDROCHLORIDE EQ 5MG BASE CAPSULE / ORAL AB 2004-12-20 fd3edfee7708…2025-03-22 03:13 UTC · 3 captures of this ZIP 2025-03 A075317-004 TERAZOSIN HYDROCHLORIDE EQ 10MG BASE CAPSULE / ORAL AB 2004-12-20 fd3edfee7708…2025-02-26 10:13 UTC · 3 captures of this ZIP 2025-02 A075317-001 TERAZOSIN HYDROCHLORIDE EQ 1MG BASE CAPSULE / ORAL AB RS 2004-12-20 b8a1b40f171c…2025-02-26 10:13 UTC · 3 captures of this ZIP 2025-02 A075317-002 TERAZOSIN HYDROCHLORIDE EQ 2MG BASE CAPSULE / ORAL AB 2004-12-20 b8a1b40f171c…2025-02-26 10:13 UTC · 3 captures of this ZIP 2025-02 A075317-003 TERAZOSIN HYDROCHLORIDE EQ 5MG BASE CAPSULE / ORAL AB 2004-12-20 b8a1b40f171c…2025-02-26 10:13 UTC · 3 captures of this ZIP 2025-02 A075317-004 TERAZOSIN HYDROCHLORIDE EQ 10MG BASE CAPSULE / ORAL AB 2004-12-20 b8a1b40f171c…2025-01-19 17:59 UTC · 7 captures of this ZIP 2025-01 A075317-001 TERAZOSIN HYDROCHLORIDE EQ 1MG BASE CAPSULE / ORAL AB RS 2004-12-20 03ed91905a0d…2025-01-19 17:59 UTC · 7 captures of this ZIP 2025-01 A075317-002 TERAZOSIN HYDROCHLORIDE EQ 2MG BASE CAPSULE / ORAL AB 2004-12-20 03ed91905a0d…2025-01-19 17:59 UTC · 7 captures of this ZIP 2025-01 A075317-003 TERAZOSIN HYDROCHLORIDE EQ 5MG BASE CAPSULE / ORAL AB 2004-12-20 03ed91905a0d…2025-01-19 17:59 UTC · 7 captures of this ZIP 2025-01 A075317-004 TERAZOSIN HYDROCHLORIDE EQ 10MG BASE CAPSULE / ORAL AB 2004-12-20 03ed91905a0d…2024-12-13 21:23 UTC · 2 captures of this ZIP 2024-12 A075317-001 TERAZOSIN HYDROCHLORIDE EQ 1MG BASE CAPSULE / ORAL AB RS 2004-12-20 2680178bc6a6…2024-12-13 21:23 UTC · 2 captures of this ZIP 2024-12 A075317-002 TERAZOSIN HYDROCHLORIDE EQ 2MG BASE CAPSULE / ORAL AB 2004-12-20 2680178bc6a6…2024-12-13 21:23 UTC · 2 captures of this ZIP 2024-12 A075317-003 TERAZOSIN HYDROCHLORIDE EQ 5MG BASE CAPSULE / ORAL AB 2004-12-20 2680178bc6a6…2024-12-13 21:23 UTC · 2 captures of this ZIP 2024-12 A075317-004 TERAZOSIN HYDROCHLORIDE EQ 10MG BASE CAPSULE / ORAL AB 2004-12-20 2680178bc6a6…2024-09-14 05:58 UTC · 2 captures of this ZIP 2024-09 A075317-001 TERAZOSIN HYDROCHLORIDE EQ 1MG BASE CAPSULE / ORAL AB RS 2004-12-20 5bbf6a4d5a75…2024-09-14 05:58 UTC · 2 captures of this ZIP 2024-09 A075317-002 TERAZOSIN HYDROCHLORIDE EQ 2MG BASE CAPSULE / ORAL AB 2004-12-20 5bbf6a4d5a75…2024-09-14 05:58 UTC · 2 captures of this ZIP 2024-09 A075317-003 TERAZOSIN HYDROCHLORIDE EQ 5MG BASE CAPSULE / ORAL AB 2004-12-20 5bbf6a4d5a75…2024-09-14 05:58 UTC · 2 captures of this ZIP 2024-09 A075317-004 TERAZOSIN HYDROCHLORIDE EQ 10MG BASE CAPSULE / ORAL AB 2004-12-20 5bbf6a4d5a75…
Observed Orange Book normalized TE history# Normalized TE history page 1 of 5 · 172 observed states.
Reported adverse events (FAERS/openFDA)# Adverse event summaries are temporarily unavailable. Other product information remains available.
Additional Listing Data#
Finished product Yes
Brand name base Terazosin
Listing expiration 2027-12-31 Active Ingredients# Ingredient, Strength table Ingredient Strength TERAZOSIN HYDROCHLORIDE 1 mg/1
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 · 1 matching rows.
Identifier, FDA.report destination table Identifier FDA.report destination 313215 Internal RxNorm lookup
Harmonized SPL set identifiers# SPL set identifiers page 1 of 1 · 1 matching rows.
DailyMed Product Concepts# DailyMed Package Descriptions# Package NDC, Product, Description table Package NDC Product Description Form Quantity Strength SPL version 70518-0342-0 Terazosin 30 in 1 BLISTER PACK CAPSULE 30 14
DailyMed Dashboard NDC Coverage# NDC, Dashboard title, SPL version table NDC Dashboard title SPL version Validation Dashboard ZIP 70518-0342 TERAZOSIN (TERAZOSIN HYDROCHLORIDE) CAPSULE [REMEDYREPACK INC.] 9 Current NDC, Legacy NDC, 1 package rows 20250426_242589f0-0c79-4ea1-b900-10bccfec2b82.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 2 of 2 · 24 matching rows.
DailyMed RxNorm Mappings# Packages# Package NDC, 11-digit format, Description table Package NDC 11-digit format Description Units Marketing start Marketing end Sample Exclude flag Status 70518-0342-0 70518034200 30 CAPSULE in 1 BLISTER PACK (70518-0342-0) 30 capsule 2017-03-20 0000-00-00 No No Current