Home NDC 46708-692 PRAZOSIN HYDROCHLORIDE
Product NDC 46708-692
11-digit product format 467080692
Labeler code 46708
Product ID 46708-692_fea187a3-ee8b-4463-8485-3b1de1504609
Type HUMAN PRESCRIPTION DRUG
Nonproprietary name PRAZOSIN HYDROCHLORIDE
Dosage form CAPSULE
Route ORAL
Labeler Alembic Pharmaceuticals Limited
Application ANDA217268
Marketing category ANDA
Marketing start 2023-03-09
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 A217268-001 PRAZOSIN HYDROCHLORIDE PRAZOSIN HYDROCHLORIDE EQ 1MG BASE CAPSULE / ORAL AB 2023-03-06 A217268-002 PRAZOSIN HYDROCHLORIDE PRAZOSIN HYDROCHLORIDE EQ 2MG BASE CAPSULE / ORAL AB 2023-03-06 A217268-003 PRAZOSIN HYDROCHLORIDE PRAZOSIN HYDROCHLORIDE EQ 5MG BASE CAPSULE / ORAL AB 2023-03-06
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 · 72 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 A217268-001 PRAZOSIN HYDROCHLORIDE EQ 1MG BASE CAPSULE / ORAL AB 2023-03-06 caaa826d4ba7…2026-08-18 06:07:40 2026-07 A217268-002 PRAZOSIN HYDROCHLORIDE EQ 2MG BASE CAPSULE / ORAL AB 2023-03-06 caaa826d4ba7…2026-08-18 06:07:40 2026-07 A217268-003 PRAZOSIN HYDROCHLORIDE EQ 5MG BASE CAPSULE / ORAL AB 2023-03-06 caaa826d4ba7…2026-02-19 14:30 UTC 2026-02 A217268-001 PRAZOSIN HYDROCHLORIDE EQ 1MG BASE CAPSULE / ORAL AB 2023-03-06 011fe1cb6892…2026-02-19 14:30 UTC 2026-02 A217268-002 PRAZOSIN HYDROCHLORIDE EQ 2MG BASE CAPSULE / ORAL AB 2023-03-06 011fe1cb6892…2026-02-19 14:30 UTC 2026-02 A217268-003 PRAZOSIN HYDROCHLORIDE EQ 5MG BASE CAPSULE / ORAL AB 2023-03-06 011fe1cb6892…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 A217268-001 PRAZOSIN HYDROCHLORIDE EQ 1MG BASE CAPSULE / ORAL AB 2023-03-06 31067a03dcf5…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 A217268-002 PRAZOSIN HYDROCHLORIDE EQ 2MG BASE CAPSULE / ORAL AB 2023-03-06 31067a03dcf5…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 A217268-003 PRAZOSIN HYDROCHLORIDE EQ 5MG BASE CAPSULE / ORAL AB 2023-03-06 31067a03dcf5…2025-08-23 18:47 UTC 2025-08 A217268-001 PRAZOSIN HYDROCHLORIDE EQ 1MG BASE CAPSULE / ORAL AB 2023-03-06 6a471c1ec25d…2025-08-23 18:47 UTC 2025-08 A217268-002 PRAZOSIN HYDROCHLORIDE EQ 2MG BASE CAPSULE / ORAL AB 2023-03-06 6a471c1ec25d…2025-08-23 18:47 UTC 2025-08 A217268-003 PRAZOSIN HYDROCHLORIDE EQ 5MG BASE CAPSULE / ORAL AB 2023-03-06 6a471c1ec25d…2025-03-22 03:13 UTC · 3 captures of this ZIP 2025-03 A217268-001 PRAZOSIN HYDROCHLORIDE EQ 1MG BASE CAPSULE / ORAL AB 2023-03-06 fd3edfee7708…2025-03-22 03:13 UTC · 3 captures of this ZIP 2025-03 A217268-002 PRAZOSIN HYDROCHLORIDE EQ 2MG BASE CAPSULE / ORAL AB 2023-03-06 fd3edfee7708…2025-03-22 03:13 UTC · 3 captures of this ZIP 2025-03 A217268-003 PRAZOSIN HYDROCHLORIDE EQ 5MG BASE CAPSULE / ORAL AB 2023-03-06 fd3edfee7708…2025-02-26 10:13 UTC · 3 captures of this ZIP 2025-02 A217268-001 PRAZOSIN HYDROCHLORIDE EQ 1MG BASE CAPSULE / ORAL AB 2023-03-06 b8a1b40f171c…2025-02-26 10:13 UTC · 3 captures of this ZIP 2025-02 A217268-002 PRAZOSIN HYDROCHLORIDE EQ 2MG BASE CAPSULE / ORAL AB 2023-03-06 b8a1b40f171c…2025-02-26 10:13 UTC · 3 captures of this ZIP 2025-02 A217268-003 PRAZOSIN HYDROCHLORIDE EQ 5MG BASE CAPSULE / ORAL AB 2023-03-06 b8a1b40f171c…2025-01-19 17:59 UTC · 7 captures of this ZIP 2025-01 A217268-001 PRAZOSIN HYDROCHLORIDE EQ 1MG BASE CAPSULE / ORAL AB 2023-03-06 03ed91905a0d…2025-01-19 17:59 UTC · 7 captures of this ZIP 2025-01 A217268-002 PRAZOSIN HYDROCHLORIDE EQ 2MG BASE CAPSULE / ORAL AB 2023-03-06 03ed91905a0d…2025-01-19 17:59 UTC · 7 captures of this ZIP 2025-01 A217268-003 PRAZOSIN HYDROCHLORIDE EQ 5MG BASE CAPSULE / ORAL AB 2023-03-06 03ed91905a0d…2024-12-13 21:23 UTC · 2 captures of this ZIP 2024-12 A217268-001 PRAZOSIN HYDROCHLORIDE EQ 1MG BASE CAPSULE / ORAL AB 2023-03-06 2680178bc6a6…2024-12-13 21:23 UTC · 2 captures of this ZIP 2024-12 A217268-002 PRAZOSIN HYDROCHLORIDE EQ 2MG BASE CAPSULE / ORAL AB 2023-03-06 2680178bc6a6…2024-12-13 21:23 UTC · 2 captures of this ZIP 2024-12 A217268-003 PRAZOSIN HYDROCHLORIDE EQ 5MG BASE CAPSULE / ORAL AB 2023-03-06 2680178bc6a6…2024-09-14 05:58 UTC · 2 captures of this ZIP 2024-09 A217268-001 PRAZOSIN HYDROCHLORIDE EQ 1MG BASE CAPSULE / ORAL AB 2023-03-06 5bbf6a4d5a75…2024-09-14 05:58 UTC · 2 captures of this ZIP 2024-09 A217268-002 PRAZOSIN HYDROCHLORIDE EQ 2MG BASE CAPSULE / ORAL AB 2023-03-06 5bbf6a4d5a75…2024-09-14 05:58 UTC · 2 captures of this ZIP 2024-09 A217268-003 PRAZOSIN HYDROCHLORIDE EQ 5MG BASE CAPSULE / ORAL AB 2023-03-06 5bbf6a4d5a75…2024-11-08 22:44 UTC · 3 captures of this ZIP 2024-11 A217268-001 PRAZOSIN HYDROCHLORIDE EQ 1MG BASE CAPSULE / ORAL AB 2023-03-06 d8e5a09893c0…2024-11-08 22:44 UTC · 3 captures of this ZIP 2024-11 A217268-002 PRAZOSIN HYDROCHLORIDE EQ 2MG BASE CAPSULE / ORAL AB 2023-03-06 d8e5a09893c0…2024-11-08 22:44 UTC · 3 captures of this ZIP 2024-11 A217268-003 PRAZOSIN HYDROCHLORIDE EQ 5MG BASE CAPSULE / ORAL AB 2023-03-06 d8e5a09893c0…2024-10-29 15:01 UTC 2024-10 A217268-001 PRAZOSIN HYDROCHLORIDE EQ 1MG BASE CAPSULE / ORAL AB 2023-03-06 d06236e962d9…2024-10-29 15:01 UTC 2024-10 A217268-002 PRAZOSIN HYDROCHLORIDE EQ 2MG BASE CAPSULE / ORAL AB 2023-03-06 d06236e962d9…2024-10-29 15:01 UTC 2024-10 A217268-003 PRAZOSIN HYDROCHLORIDE EQ 5MG BASE CAPSULE / ORAL AB 2023-03-06 d06236e962d9…2024-08-13 05:28 UTC · 3 captures of this ZIP 2024-08 A217268-001 PRAZOSIN HYDROCHLORIDE EQ 1MG BASE CAPSULE / ORAL AB 2023-03-06 79d66fd596c7…2024-08-13 05:28 UTC · 3 captures of this ZIP 2024-08 A217268-002 PRAZOSIN HYDROCHLORIDE EQ 2MG BASE CAPSULE / ORAL AB 2023-03-06 79d66fd596c7…2024-08-13 05:28 UTC · 3 captures of this ZIP 2024-08 A217268-003 PRAZOSIN HYDROCHLORIDE EQ 5MG BASE CAPSULE / ORAL AB 2023-03-06 79d66fd596c7…2024-07-13 05:37 UTC · 2 captures of this ZIP 2024-07 A217268-001 PRAZOSIN HYDROCHLORIDE EQ 1MG BASE CAPSULE / ORAL AB 2023-03-06 301d65b070ca…2024-07-13 05:37 UTC · 2 captures of this ZIP 2024-07 A217268-002 PRAZOSIN HYDROCHLORIDE EQ 2MG BASE CAPSULE / ORAL AB 2023-03-06 301d65b070ca…2024-07-13 05:37 UTC · 2 captures of this ZIP 2024-07 A217268-003 PRAZOSIN HYDROCHLORIDE EQ 5MG BASE CAPSULE / ORAL AB 2023-03-06 301d65b070ca…2024-06-18 03:08 UTC · 5 captures of this ZIP 2024-06 A217268-001 PRAZOSIN HYDROCHLORIDE EQ 1MG BASE CAPSULE / ORAL AB 2023-03-06 1e350fbaab3a…
Observed Orange Book normalized TE history# Normalized TE history page 1 of 2 · 72 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 · 3 matching rows.
Identifier, FDA.report destination table Identifier FDA.report destination 198141 Internal RxNorm lookup 312593 Internal RxNorm lookup 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 46708-692-31 PRAZOSIN HYDROCHLORIDE 100 in 1 BOTTLE CAPSULE 100 1 46708-692-61 PRAZOSIN HYDROCHLORIDE 250 in 1 BOTTLE CAPSULE 250 1 46708-692-91 PRAZOSIN HYDROCHLORIDE 1000 in 1 BOTTLE CAPSULE 1000 1
DailyMed Dashboard NDC Coverage# NDC, Dashboard title, SPL version table NDC Dashboard title SPL version Validation Dashboard ZIP 46708-692 PRAZOSIN HYDROCHLORIDE CAPSULE [ALEMBIC PHARMACEUTICALS LIMITED] 1 Current NDC, 3 package rows 20230315_fea187a3-ee8b-4463-8485-3b1de1504609.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 · 2 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 46708-692-31 46708069231 100 CAPSULE in 1 BOTTLE (46708-692-31) 100 capsule 2023-03-09 No No Current 46708-692-61 46708069261 250 CAPSULE in 1 BOTTLE (46708-692-61) 250 capsule 2023-03-09 No No Current 46708-692-91 46708069291 1000 CAPSULE in 1 BOTTLE (46708-692-91) 1000 capsule 2023-03-09 No No Current