Home NDC 16571-167 Doxazosin
Product NDC 16571-167
11-digit product format 165710167
Labeler code 16571
Product ID 16571-167_c7ae6273-26c7-4116-a42a-5c82e1b59849
Type HUMAN PRESCRIPTION DRUG
Nonproprietary name Doxazosin
Dosage form TABLET
Route ORAL
Labeler Rising Pharma Holdings, Inc.
Application ANDA212727
Marketing category ANDA
Marketing start 2024-05-20
Substance DOXAZOSIN MESYLATE
Active strength 4 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 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 RLD / RS Approval date A212727-001 DOXAZOSIN MESYLATE DOXAZOSIN MESYLATE EQ 1MG BASE TABLET / ORAL AB 2022-03-15 A212727-002 DOXAZOSIN MESYLATE DOXAZOSIN MESYLATE EQ 2MG BASE TABLET / ORAL AB 2022-03-15 A212727-003 DOXAZOSIN MESYLATE DOXAZOSIN MESYLATE EQ 4MG BASE TABLET / ORAL AB 2022-03-15 A212727-004 DOXAZOSIN MESYLATE DOXAZOSIN MESYLATE EQ 8MG BASE TABLET / ORAL AB 2022-03-15
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 3 · 84 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 2024-10-29 15:01 UTC 2024-10 A212727-001 DOXAZOSIN MESYLATE EQ 1MG BASE TABLET / ORAL AB 2022-03-15 d06236e962d9…2024-10-29 15:01 UTC 2024-10 A212727-002 DOXAZOSIN MESYLATE EQ 2MG BASE TABLET / ORAL AB 2022-03-15 d06236e962d9…2024-10-29 15:01 UTC 2024-10 A212727-003 DOXAZOSIN MESYLATE EQ 4MG BASE TABLET / ORAL AB 2022-03-15 d06236e962d9…2024-10-29 15:01 UTC 2024-10 A212727-004 DOXAZOSIN MESYLATE EQ 8MG BASE TABLET / ORAL AB 2022-03-15 d06236e962d9…2024-08-13 05:28 UTC · 3 captures of this ZIP 2024-08 A212727-001 DOXAZOSIN MESYLATE EQ 1MG BASE TABLET / ORAL AB 2022-03-15 79d66fd596c7…2024-08-13 05:28 UTC · 3 captures of this ZIP 2024-08 A212727-002 DOXAZOSIN MESYLATE EQ 2MG BASE TABLET / ORAL AB 2022-03-15 79d66fd596c7…2024-08-13 05:28 UTC · 3 captures of this ZIP 2024-08 A212727-003 DOXAZOSIN MESYLATE EQ 4MG BASE TABLET / ORAL AB 2022-03-15 79d66fd596c7…2024-08-13 05:28 UTC · 3 captures of this ZIP 2024-08 A212727-004 DOXAZOSIN MESYLATE EQ 8MG BASE TABLET / ORAL AB 2022-03-15 79d66fd596c7…2024-07-13 05:37 UTC · 2 captures of this ZIP 2024-07 A212727-001 DOXAZOSIN MESYLATE EQ 1MG BASE TABLET / ORAL AB 2022-03-15 301d65b070ca…2024-07-13 05:37 UTC · 2 captures of this ZIP 2024-07 A212727-002 DOXAZOSIN MESYLATE EQ 2MG BASE TABLET / ORAL AB 2022-03-15 301d65b070ca…2024-07-13 05:37 UTC · 2 captures of this ZIP 2024-07 A212727-003 DOXAZOSIN MESYLATE EQ 4MG BASE TABLET / ORAL AB 2022-03-15 301d65b070ca…2024-07-13 05:37 UTC · 2 captures of this ZIP 2024-07 A212727-004 DOXAZOSIN MESYLATE EQ 8MG BASE TABLET / ORAL AB 2022-03-15 301d65b070ca…2024-06-18 03:08 UTC · 5 captures of this ZIP 2024-06 A212727-001 DOXAZOSIN MESYLATE EQ 1MG BASE TABLET / ORAL AB 2022-03-15 1e350fbaab3a…2024-06-18 03:08 UTC · 5 captures of this ZIP 2024-06 A212727-002 DOXAZOSIN MESYLATE EQ 2MG BASE TABLET / ORAL AB 2022-03-15 1e350fbaab3a…2024-06-18 03:08 UTC · 5 captures of this ZIP 2024-06 A212727-003 DOXAZOSIN MESYLATE EQ 4MG BASE TABLET / ORAL AB 2022-03-15 1e350fbaab3a…2024-06-18 03:08 UTC · 5 captures of this ZIP 2024-06 A212727-004 DOXAZOSIN MESYLATE EQ 8MG BASE TABLET / ORAL AB 2022-03-15 1e350fbaab3a…2024-05-31 18:47 UTC 2024-05 A212727-001 DOXAZOSIN MESYLATE EQ 1MG BASE TABLET / ORAL AB 2022-03-15 8072bd15b7f6…2024-05-31 18:47 UTC 2024-05 A212727-002 DOXAZOSIN MESYLATE EQ 2MG BASE TABLET / ORAL AB 2022-03-15 8072bd15b7f6…2024-05-31 18:47 UTC 2024-05 A212727-003 DOXAZOSIN MESYLATE EQ 4MG BASE TABLET / ORAL AB 2022-03-15 8072bd15b7f6…2024-05-31 18:47 UTC 2024-05 A212727-004 DOXAZOSIN MESYLATE EQ 8MG BASE TABLET / ORAL AB 2022-03-15 8072bd15b7f6…2022-06-29 02:47 UTC · 2 captures of this ZIP 2022-06 A212727-001 DOXAZOSIN MESYLATE EQ 1MG BASE TABLET / ORAL AB 2022-03-15 5c6f7cd8ea54…2022-06-29 02:47 UTC · 2 captures of this ZIP 2022-06 A212727-002 DOXAZOSIN MESYLATE EQ 2MG BASE TABLET / ORAL AB 2022-03-15 5c6f7cd8ea54…2022-06-29 02:47 UTC · 2 captures of this ZIP 2022-06 A212727-003 DOXAZOSIN MESYLATE EQ 4MG BASE TABLET / ORAL AB 2022-03-15 5c6f7cd8ea54…2022-06-29 02:47 UTC · 2 captures of this ZIP 2022-06 A212727-004 DOXAZOSIN MESYLATE EQ 8MG BASE TABLET / ORAL AB 2022-03-15 5c6f7cd8ea54…2022-04-08 23:34 UTC 2022-04 A212727-001 DOXAZOSIN MESYLATE EQ 1MG BASE TABLET / ORAL AB 2022-03-15 5d02ea3f76ae…2022-04-08 23:34 UTC 2022-04 A212727-002 DOXAZOSIN MESYLATE EQ 2MG BASE TABLET / ORAL AB 2022-03-15 5d02ea3f76ae…2022-04-08 23:34 UTC 2022-04 A212727-003 DOXAZOSIN MESYLATE EQ 4MG BASE TABLET / ORAL AB 2022-03-15 5d02ea3f76ae…2022-04-08 23:34 UTC 2022-04 A212727-004 DOXAZOSIN MESYLATE EQ 8MG BASE TABLET / ORAL AB 2022-03-15 5d02ea3f76ae…2024-03-16 18:09 UTC · 4 captures of this ZIP 2024-03 A212727-001 DOXAZOSIN MESYLATE EQ 1MG BASE TABLET / ORAL AB 2022-03-15 6a51e52b5d6a…2024-03-16 18:09 UTC · 4 captures of this ZIP 2024-03 A212727-002 DOXAZOSIN MESYLATE EQ 2MG BASE TABLET / ORAL AB 2022-03-15 6a51e52b5d6a…2024-03-16 18:09 UTC · 4 captures of this ZIP 2024-03 A212727-003 DOXAZOSIN MESYLATE EQ 4MG BASE TABLET / ORAL AB 2022-03-15 6a51e52b5d6a…2024-03-16 18:09 UTC · 4 captures of this ZIP 2024-03 A212727-004 DOXAZOSIN MESYLATE EQ 8MG BASE TABLET / ORAL AB 2022-03-15 6a51e52b5d6a…2024-02-18 07:12 UTC 2024-02 A212727-001 DOXAZOSIN MESYLATE EQ 1MG BASE TABLET / ORAL AB 2022-03-15 1c564ffb4f44…2024-02-18 07:12 UTC 2024-02 A212727-002 DOXAZOSIN MESYLATE EQ 2MG BASE TABLET / ORAL AB 2022-03-15 1c564ffb4f44…2024-02-18 07:12 UTC 2024-02 A212727-003 DOXAZOSIN MESYLATE EQ 4MG BASE TABLET / ORAL AB 2022-03-15 1c564ffb4f44…2024-02-18 07:12 UTC 2024-02 A212727-004 DOXAZOSIN MESYLATE EQ 8MG BASE TABLET / ORAL AB 2022-03-15 1c564ffb4f44…2023-12-20 04:57 UTC 2023-12 A212727-001 DOXAZOSIN MESYLATE EQ 1MG BASE TABLET / ORAL AB 2022-03-15 ea1830bbd6c7…2023-12-20 04:57 UTC 2023-12 A212727-002 DOXAZOSIN MESYLATE EQ 2MG BASE TABLET / ORAL AB 2022-03-15 ea1830bbd6c7…2023-12-20 04:57 UTC 2023-12 A212727-003 DOXAZOSIN MESYLATE EQ 4MG BASE TABLET / ORAL AB 2022-03-15 ea1830bbd6c7…2023-12-20 04:57 UTC 2023-12 A212727-004 DOXAZOSIN MESYLATE EQ 8MG BASE TABLET / ORAL AB 2022-03-15 ea1830bbd6c7…
Observed Orange Book normalized TE history# Normalized TE history page 1 of 3 · 84 observed states.
openFDA label cross-check# Cross-check layer: openFDA label JSON enriches search and identifies hydration gaps. The DailyMed Structured Product Label remains the canonical label presentation on FDA.report. Every label matching the complete exact-identifier union is deduplicated and paginated below.
Matched openFDA labels page 1 of 1 · 1 matching rows.
Additional Listing Data#
Finished product Yes
Brand name base Doxazosin
Listing expiration 2026-12-31 Active Ingredients# Ingredient, Strength table Ingredient Strength DOXAZOSIN MESYLATE 4 mg/1
Harmonized UNII identifiers# UNII identifiers page 1 of 1 · 1 matching rows.
Identifier, FDA.report destination table Identifier FDA.report destination 86P6PQK0MU Internal UNII lookup
Harmonized RxCUI identifiers# RxCUI identifiers page 1 of 1 · 4 matching rows.
Identifier, FDA.report destination table Identifier FDA.report destination 197625 Internal RxNorm lookup 197626 Internal RxNorm lookup 197627 Internal RxNorm lookup 197628 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 16571-167-01 Doxazosin 100 in 1 BOTTLE TABLET 100 2
DailyMed Dashboard NDC Coverage# NDC, Dashboard title, SPL version table NDC Dashboard title SPL version Validation Dashboard ZIP 16571-167 DOXAZOSIN TABLET [RISING PHARMA HOLDINGS, INC.] 2 Current NDC, 1 package rows 20240620_508b908e-8d80-422e-8ec0-2081185f4c95.zip
DailyMed RxNorm Mappings# Packages# Package NDC, 11-digit format, Description table Package NDC 11-digit format Description Units Marketing start Sample Exclude flag Status 16571-167-01 16571016701 100 TABLET in 1 BOTTLE (16571-167-01) 100 tablet 2024-05-20 No No Current