Home NDC 70518-4263 Prazosin hydrochloride
Product NDC 70518-4263
11-digit product format 705184263
Labeler code 70518
Product ID 70518-4263_4009c02d-01f9-3a17-e063-6294a90aece1
Type HUMAN PRESCRIPTION DRUG
Nonproprietary name Prazosin hydrochloride
Dosage form CAPSULE
Route ORAL
Labeler REMEDYREPACK INC.
Application ANDA213406
Marketing category ANDA
Marketing start 2025-01-23
Substance PRAZOSIN HYDROCHLORIDE
Active strength 2 mg/1
Pharmacologic classes Adrenergic alpha-Antagonists [MoA], alpha-Adrenergic Blocker [EPC]
NDC exclude flag No
Listing certified through 2026-12-31
Current FDA listing Yes Source provenance: Browse the complete Orange Book source catalog · source snapshot 42 .
Orange Book products# Current product rows page 1 of 1 · 3 matching rows.
Application-product, Trade name, Ingredient table Application-product Trade name Ingredient Strength Dosage form / route TE codes RLD / RS Approval date A213406-001 PRAZOSIN HYDROCHLORIDE PRAZOSIN HYDROCHLORIDE EQ 1MG BASE CAPSULE / ORAL AB 2022-10-21 A213406-002 PRAZOSIN HYDROCHLORIDE PRAZOSIN HYDROCHLORIDE EQ 2MG BASE CAPSULE / ORAL AB 2022-10-21 A213406-003 PRAZOSIN HYDROCHLORIDE PRAZOSIN HYDROCHLORIDE EQ 5MG BASE CAPSULE / ORAL AB 2022-10-21
Therapeutic equivalence codes# Current TE-code rows page 1 of 1 · 3 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 2 · 78 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 2026-08-18 06:07:40 2026-07 A213406-001 PRAZOSIN HYDROCHLORIDE EQ 1MG BASE CAPSULE / ORAL AB 2022-10-21 caaa826d4ba7…2026-08-18 06:07:40 2026-07 A213406-002 PRAZOSIN HYDROCHLORIDE EQ 2MG BASE CAPSULE / ORAL AB 2022-10-21 caaa826d4ba7…2026-08-18 06:07:40 2026-07 A213406-003 PRAZOSIN HYDROCHLORIDE EQ 5MG BASE CAPSULE / ORAL AB 2022-10-21 caaa826d4ba7…2026-02-19 14:30 UTC 2026-02 A213406-001 PRAZOSIN HYDROCHLORIDE EQ 1MG BASE CAPSULE / ORAL AB 2022-10-21 011fe1cb6892…2026-02-19 14:30 UTC 2026-02 A213406-002 PRAZOSIN HYDROCHLORIDE EQ 2MG BASE CAPSULE / ORAL AB 2022-10-21 011fe1cb6892…2026-02-19 14:30 UTC 2026-02 A213406-003 PRAZOSIN HYDROCHLORIDE EQ 5MG BASE CAPSULE / ORAL AB 2022-10-21 011fe1cb6892…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 A213406-001 PRAZOSIN HYDROCHLORIDE EQ 1MG BASE CAPSULE / ORAL AB 2022-10-21 31067a03dcf5…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 A213406-002 PRAZOSIN HYDROCHLORIDE EQ 2MG BASE CAPSULE / ORAL AB 2022-10-21 31067a03dcf5…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 A213406-003 PRAZOSIN HYDROCHLORIDE EQ 5MG BASE CAPSULE / ORAL AB 2022-10-21 31067a03dcf5…2025-08-23 18:47 UTC 2025-08 A213406-001 PRAZOSIN HYDROCHLORIDE EQ 1MG BASE CAPSULE / ORAL AB 2022-10-21 6a471c1ec25d…2025-08-23 18:47 UTC 2025-08 A213406-002 PRAZOSIN HYDROCHLORIDE EQ 2MG BASE CAPSULE / ORAL AB 2022-10-21 6a471c1ec25d…2025-08-23 18:47 UTC 2025-08 A213406-003 PRAZOSIN HYDROCHLORIDE EQ 5MG BASE CAPSULE / ORAL AB 2022-10-21 6a471c1ec25d…2025-03-22 03:13 UTC · 3 captures of this ZIP 2025-03 A213406-001 PRAZOSIN HYDROCHLORIDE EQ 1MG BASE CAPSULE / ORAL AB 2022-10-21 fd3edfee7708…2025-03-22 03:13 UTC · 3 captures of this ZIP 2025-03 A213406-002 PRAZOSIN HYDROCHLORIDE EQ 2MG BASE CAPSULE / ORAL AB 2022-10-21 fd3edfee7708…2025-03-22 03:13 UTC · 3 captures of this ZIP 2025-03 A213406-003 PRAZOSIN HYDROCHLORIDE EQ 5MG BASE CAPSULE / ORAL AB 2022-10-21 fd3edfee7708…2025-02-26 10:13 UTC · 3 captures of this ZIP 2025-02 A213406-001 PRAZOSIN HYDROCHLORIDE EQ 1MG BASE CAPSULE / ORAL AB 2022-10-21 b8a1b40f171c…2025-02-26 10:13 UTC · 3 captures of this ZIP 2025-02 A213406-002 PRAZOSIN HYDROCHLORIDE EQ 2MG BASE CAPSULE / ORAL AB 2022-10-21 b8a1b40f171c…2025-02-26 10:13 UTC · 3 captures of this ZIP 2025-02 A213406-003 PRAZOSIN HYDROCHLORIDE EQ 5MG BASE CAPSULE / ORAL AB 2022-10-21 b8a1b40f171c…2025-01-19 17:59 UTC · 7 captures of this ZIP 2025-01 A213406-001 PRAZOSIN HYDROCHLORIDE EQ 1MG BASE CAPSULE / ORAL AB 2022-10-21 03ed91905a0d…2025-01-19 17:59 UTC · 7 captures of this ZIP 2025-01 A213406-002 PRAZOSIN HYDROCHLORIDE EQ 2MG BASE CAPSULE / ORAL AB 2022-10-21 03ed91905a0d…2025-01-19 17:59 UTC · 7 captures of this ZIP 2025-01 A213406-003 PRAZOSIN HYDROCHLORIDE EQ 5MG BASE CAPSULE / ORAL AB 2022-10-21 03ed91905a0d…2024-12-13 21:23 UTC · 2 captures of this ZIP 2024-12 A213406-001 PRAZOSIN HYDROCHLORIDE EQ 1MG BASE CAPSULE / ORAL AB 2022-10-21 2680178bc6a6…2024-12-13 21:23 UTC · 2 captures of this ZIP 2024-12 A213406-002 PRAZOSIN HYDROCHLORIDE EQ 2MG BASE CAPSULE / ORAL AB 2022-10-21 2680178bc6a6…2024-12-13 21:23 UTC · 2 captures of this ZIP 2024-12 A213406-003 PRAZOSIN HYDROCHLORIDE EQ 5MG BASE CAPSULE / ORAL AB 2022-10-21 2680178bc6a6…2024-09-14 05:58 UTC · 2 captures of this ZIP 2024-09 A213406-001 PRAZOSIN HYDROCHLORIDE EQ 1MG BASE CAPSULE / ORAL AB 2022-10-21 5bbf6a4d5a75…2024-09-14 05:58 UTC · 2 captures of this ZIP 2024-09 A213406-002 PRAZOSIN HYDROCHLORIDE EQ 2MG BASE CAPSULE / ORAL AB 2022-10-21 5bbf6a4d5a75…2024-09-14 05:58 UTC · 2 captures of this ZIP 2024-09 A213406-003 PRAZOSIN HYDROCHLORIDE EQ 5MG BASE CAPSULE / ORAL AB 2022-10-21 5bbf6a4d5a75…2024-11-08 22:44 UTC · 3 captures of this ZIP 2024-11 A213406-001 PRAZOSIN HYDROCHLORIDE EQ 1MG BASE CAPSULE / ORAL AB 2022-10-21 d8e5a09893c0…2024-11-08 22:44 UTC · 3 captures of this ZIP 2024-11 A213406-002 PRAZOSIN HYDROCHLORIDE EQ 2MG BASE CAPSULE / ORAL AB 2022-10-21 d8e5a09893c0…2024-11-08 22:44 UTC · 3 captures of this ZIP 2024-11 A213406-003 PRAZOSIN HYDROCHLORIDE EQ 5MG BASE CAPSULE / ORAL AB 2022-10-21 d8e5a09893c0…2024-10-29 15:01 UTC 2024-10 A213406-001 PRAZOSIN HYDROCHLORIDE EQ 1MG BASE CAPSULE / ORAL AB 2022-10-21 d06236e962d9…2024-10-29 15:01 UTC 2024-10 A213406-002 PRAZOSIN HYDROCHLORIDE EQ 2MG BASE CAPSULE / ORAL AB 2022-10-21 d06236e962d9…2024-10-29 15:01 UTC 2024-10 A213406-003 PRAZOSIN HYDROCHLORIDE EQ 5MG BASE CAPSULE / ORAL AB 2022-10-21 d06236e962d9…2024-08-13 05:28 UTC · 3 captures of this ZIP 2024-08 A213406-001 PRAZOSIN HYDROCHLORIDE EQ 1MG BASE CAPSULE / ORAL AB 2022-10-21 79d66fd596c7…2024-08-13 05:28 UTC · 3 captures of this ZIP 2024-08 A213406-002 PRAZOSIN HYDROCHLORIDE EQ 2MG BASE CAPSULE / ORAL AB 2022-10-21 79d66fd596c7…2024-08-13 05:28 UTC · 3 captures of this ZIP 2024-08 A213406-003 PRAZOSIN HYDROCHLORIDE EQ 5MG BASE CAPSULE / ORAL AB 2022-10-21 79d66fd596c7…2024-07-13 05:37 UTC · 2 captures of this ZIP 2024-07 A213406-001 PRAZOSIN HYDROCHLORIDE EQ 1MG BASE CAPSULE / ORAL AB 2022-10-21 301d65b070ca…2024-07-13 05:37 UTC · 2 captures of this ZIP 2024-07 A213406-002 PRAZOSIN HYDROCHLORIDE EQ 2MG BASE CAPSULE / ORAL AB 2022-10-21 301d65b070ca…2024-07-13 05:37 UTC · 2 captures of this ZIP 2024-07 A213406-003 PRAZOSIN HYDROCHLORIDE EQ 5MG BASE CAPSULE / ORAL AB 2022-10-21 301d65b070ca…2024-06-18 03:08 UTC · 5 captures of this ZIP 2024-06 A213406-001 PRAZOSIN HYDROCHLORIDE EQ 1MG BASE CAPSULE / ORAL AB 2022-10-21 1e350fbaab3a…
Observed Orange Book normalized TE history# Normalized TE history page 1 of 2 · 78 observed states.
Additional Listing Data#
Finished product Yes
Brand name base Prazosin hydrochloride
Listing expiration 2026-12-31 Active Ingredients# Ingredient, Strength table Ingredient Strength PRAZOSIN HYDROCHLORIDE 2 mg/1
Harmonized UNII identifiers# UNII identifiers page 1 of 1 · 1 matching rows.
Identifier, FDA.report destination table Identifier FDA.report destination X0Z7454B90 Internal UNII lookup
Harmonized RxCUI identifiers# RxCUI identifiers page 1 of 1 · 1 matching rows.
Identifier, FDA.report destination table Identifier FDA.report destination 312594 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 70518-4263-0 Prazosin hydrochloride 30 in 1 BLISTER PACK CAPSULE 30 2
DailyMed Dashboard NDC Coverage# NDC, Dashboard title, SPL version table NDC Dashboard title SPL version Validation Dashboard ZIP 70518-4263 PRAZOSIN HYDROCHLORIDE CAPSULE [REMEDYREPACK INC.] 1 Current NDC, 1 package rows 20250125_b55790fa-2413-4243-83ec-0391b2effe11.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 · 3 matching rows.
DailyMed RxNorm Mappings# Packages# Package NDC, 11-digit format, Description table Package NDC 11-digit format Description Units Marketing start Sample Exclude flag Status 70518-4263-0 70518426300 30 CAPSULE in 1 BLISTER PACK (70518-4263-0) 30 capsule 2025-01-23 No No Current