Doxazosin mesylate

Product NDC
62135-052
11-digit product format
621350052
Labeler code
62135
Product ID
62135-052_fdb507a5-0211-0689-e053-6394a90a860a
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
Doxazosin mesylate
Dosage form
TABLET
Route
ORAL
Labeler
Chartwell RX, LLC
Application
ANDA075646
Marketing category
ANDA
Marketing start
2000-10-18
Substance
DOXAZOSIN MESYLATE
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 1.

Orange Book products#

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

Application-product, Trade name, Ingredient table
Application-productTrade nameIngredientStrengthDosage form / routeTE codesRLD / RSApproval date
A075646-001DOXAZOSIN MESYLATEDOXAZOSIN MESYLATEEQ 1MG BASETABLET / ORAL2000-10-18
A075646-002DOXAZOSIN MESYLATEDOXAZOSIN MESYLATEEQ 2MG BASETABLET / ORAL2000-10-18
A075646-003DOXAZOSIN MESYLATEDOXAZOSIN MESYLATEEQ 4MG BASETABLET / ORAL2000-10-18
A075646-004DOXAZOSIN MESYLATEDOXAZOSIN MESYLATEEQ 8MG BASETABLET / ORAL2000-10-18

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 · 164 observed states.

Captured, Edition, Application-product table
CapturedEditionApplication-productTrade nameStrengthDosage form / routeProduct TE source textRLD / RSApproval dateSource SHA-256
2026-02-19 14:30 UTC2026-02A075646-001DOXAZOSIN MESYLATEEQ 1MG BASETABLET / ORAL2000-10-18011fe1cb6892…
2026-02-19 14:30 UTC2026-02A075646-002DOXAZOSIN MESYLATEEQ 2MG BASETABLET / ORAL2000-10-18011fe1cb6892…
2026-02-19 14:30 UTC2026-02A075646-003DOXAZOSIN MESYLATEEQ 4MG BASETABLET / ORAL2000-10-18011fe1cb6892…
2026-02-19 14:30 UTC2026-02A075646-004DOXAZOSIN MESYLATEEQ 8MG BASETABLET / ORAL2000-10-18011fe1cb6892…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A075646-001DOXAZOSIN MESYLATEEQ 1MG BASETABLET / ORAL2000-10-1831067a03dcf5…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A075646-002DOXAZOSIN MESYLATEEQ 2MG BASETABLET / ORAL2000-10-1831067a03dcf5…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A075646-003DOXAZOSIN MESYLATEEQ 4MG BASETABLET / ORAL2000-10-1831067a03dcf5…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A075646-004DOXAZOSIN MESYLATEEQ 8MG BASETABLET / ORAL2000-10-1831067a03dcf5…
2025-08-23 18:47 UTC2025-08A075646-001DOXAZOSIN MESYLATEEQ 1MG BASETABLET / ORAL2000-10-186a471c1ec25d…
2025-08-23 18:47 UTC2025-08A075646-002DOXAZOSIN MESYLATEEQ 2MG BASETABLET / ORAL2000-10-186a471c1ec25d…
2025-08-23 18:47 UTC2025-08A075646-003DOXAZOSIN MESYLATEEQ 4MG BASETABLET / ORAL2000-10-186a471c1ec25d…
2025-08-23 18:47 UTC2025-08A075646-004DOXAZOSIN MESYLATEEQ 8MG BASETABLET / ORAL2000-10-186a471c1ec25d…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03A075646-001DOXAZOSIN MESYLATEEQ 1MG BASETABLET / ORAL2000-10-18fd3edfee7708…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03A075646-002DOXAZOSIN MESYLATEEQ 2MG BASETABLET / ORAL2000-10-18fd3edfee7708…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03A075646-003DOXAZOSIN MESYLATEEQ 4MG BASETABLET / ORAL2000-10-18fd3edfee7708…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03A075646-004DOXAZOSIN MESYLATEEQ 8MG BASETABLET / ORAL2000-10-18fd3edfee7708…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02A075646-001DOXAZOSIN MESYLATEEQ 1MG BASETABLET / ORAL2000-10-18b8a1b40f171c…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02A075646-002DOXAZOSIN MESYLATEEQ 2MG BASETABLET / ORAL2000-10-18b8a1b40f171c…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02A075646-003DOXAZOSIN MESYLATEEQ 4MG BASETABLET / ORAL2000-10-18b8a1b40f171c…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02A075646-004DOXAZOSIN MESYLATEEQ 8MG BASETABLET / ORAL2000-10-18b8a1b40f171c…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01A075646-001DOXAZOSIN MESYLATEEQ 1MG BASETABLET / ORAL2000-10-1803ed91905a0d…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01A075646-002DOXAZOSIN MESYLATEEQ 2MG BASETABLET / ORAL2000-10-1803ed91905a0d…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01A075646-003DOXAZOSIN MESYLATEEQ 4MG BASETABLET / ORAL2000-10-1803ed91905a0d…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01A075646-004DOXAZOSIN MESYLATEEQ 8MG BASETABLET / ORAL2000-10-1803ed91905a0d…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12A075646-001DOXAZOSIN MESYLATEEQ 1MG BASETABLET / ORAL2000-10-182680178bc6a6…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12A075646-002DOXAZOSIN MESYLATEEQ 2MG BASETABLET / ORAL2000-10-182680178bc6a6…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12A075646-003DOXAZOSIN MESYLATEEQ 4MG BASETABLET / ORAL2000-10-182680178bc6a6…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12A075646-004DOXAZOSIN MESYLATEEQ 8MG BASETABLET / ORAL2000-10-182680178bc6a6…
2024-09-14 05:58 UTC · 2 captures of this ZIP2024-09A075646-001DOXAZOSIN MESYLATEEQ 1MG BASETABLET / ORAL2000-10-185bbf6a4d5a75…
2024-09-14 05:58 UTC · 2 captures of this ZIP2024-09A075646-002DOXAZOSIN MESYLATEEQ 2MG BASETABLET / ORAL2000-10-185bbf6a4d5a75…
2024-09-14 05:58 UTC · 2 captures of this ZIP2024-09A075646-003DOXAZOSIN MESYLATEEQ 4MG BASETABLET / ORAL2000-10-185bbf6a4d5a75…
2024-09-14 05:58 UTC · 2 captures of this ZIP2024-09A075646-004DOXAZOSIN MESYLATEEQ 8MG BASETABLET / ORAL2000-10-185bbf6a4d5a75…
2024-11-08 22:44 UTC · 3 captures of this ZIP2024-11A075646-001DOXAZOSIN MESYLATEEQ 1MG BASETABLET / ORAL2000-10-18d8e5a09893c0…
2024-11-08 22:44 UTC · 3 captures of this ZIP2024-11A075646-002DOXAZOSIN MESYLATEEQ 2MG BASETABLET / ORAL2000-10-18d8e5a09893c0…
2024-11-08 22:44 UTC · 3 captures of this ZIP2024-11A075646-003DOXAZOSIN MESYLATEEQ 4MG BASETABLET / ORAL2000-10-18d8e5a09893c0…
2024-11-08 22:44 UTC · 3 captures of this ZIP2024-11A075646-004DOXAZOSIN MESYLATEEQ 8MG BASETABLET / ORAL2000-10-18d8e5a09893c0…
2024-10-29 15:01 UTC2024-10A075646-001DOXAZOSIN MESYLATEEQ 1MG BASETABLET / ORAL2000-10-18d06236e962d9…
2024-10-29 15:01 UTC2024-10A075646-002DOXAZOSIN MESYLATEEQ 2MG BASETABLET / ORAL2000-10-18d06236e962d9…
2024-10-29 15:01 UTC2024-10A075646-003DOXAZOSIN MESYLATEEQ 4MG BASETABLET / ORAL2000-10-18d06236e962d9…
2024-10-29 15:01 UTC2024-10A075646-004DOXAZOSIN MESYLATEEQ 8MG BASETABLET / ORAL2000-10-18d06236e962d9…

Additional Listing Data#

Finished product
Yes
Brand name base
Doxazosin mesylate
Listing expiration
2026-12-31

Active Ingredients#

Ingredient, Strength table
IngredientStrength
DOXAZOSIN MESYLATE2 mg/1

Harmonized UNII identifiers#

UNII identifiers page 1 of 1 · 1 matching rows.

Identifier, FDA.report destination table
IdentifierFDA.report destination
86P6PQK0MUInternal UNII lookup

Harmonized RxCUI identifiers#

RxCUI identifiers page 1 of 1 · 4 matching rows.

Identifier, FDA.report destination table
IdentifierFDA.report destination
197625Internal RxNorm lookup
197626Internal RxNorm lookup
197627Internal RxNorm lookup
197628Internal RxNorm lookup

Harmonized SPL set identifiers#

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

Identifier, FDA.report destination table
IdentifierFDA.report destination
a7f589b0-eebb-48cb-912f-a4bd956e4dcbAvailable on FDA.report

DailyMed Product Concepts#

Product concept, Relation, Version table
Product conceptRelationVersionEffective
07a517fc-5845-3816-0f81-0a121804ec9eProduct name620250107
171dd63c-7eea-ede4-c010-4c25ba0a1087Product name120140508

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
62135-052-90Doxazosin mesylate90 in 1 BOTTLETABLET901

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
62135-052-90EA - Each62135-05259923121-6903-4e5f-b90c-6bbd6c1e3dcb12023-07-06

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
62135-052DOXAZOSIN MESYLATE TABLET [CHARTWELL RX, LLC]1Current NDC, 1 package rows20230620_a7f589b0-eebb-48cb-912f-a4bd956e4dcb.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
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
Doxazosin mesylateDOXAZOSIN MESYLATEChartwell RX, LLCa7f589b0-eebb-48cb-912f-a4bd956e4dcb2023-06-09Warnings, Adverse reactionsExact identifier
application applno (ANDA): 075646
application number: ANDA075646
ndc (product): 62135-052

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
197625doxazosin mesylate 1 MG Oral TabletPSNa7f589b0-eebb-48cb-912f-a4bd956e4dcb1
197626doxazosin mesylate 2 MG Oral TabletPSNa7f589b0-eebb-48cb-912f-a4bd956e4dcb1
197627doxazosin mesylate 4 MG Oral TabletPSNa7f589b0-eebb-48cb-912f-a4bd956e4dcb1
197628doxazosin mesylate 8 MG Oral TabletPSNa7f589b0-eebb-48cb-912f-a4bd956e4dcb1
197625doxazosin 1 MG Oral TabletSCDa7f589b0-eebb-48cb-912f-a4bd956e4dcb1
197626doxazosin 2 MG Oral TabletSCDa7f589b0-eebb-48cb-912f-a4bd956e4dcb1
197627doxazosin 4 MG Oral TabletSCDa7f589b0-eebb-48cb-912f-a4bd956e4dcb1
197628doxazosin 8 MG Oral TabletSCDa7f589b0-eebb-48cb-912f-a4bd956e4dcb1
197625doxazosin (as doxazosin mesylate) 1 MG Oral TabletSYa7f589b0-eebb-48cb-912f-a4bd956e4dcb1
197626doxazosin (as doxazosin mesylate) 2 MG Oral TabletSYa7f589b0-eebb-48cb-912f-a4bd956e4dcb1
197627doxazosin (as doxazosin mesylate) 4 MG Oral TabletSYa7f589b0-eebb-48cb-912f-a4bd956e4dcb1
197628doxazosin (as doxazosin mesylate) 8 MG Oral TabletSYa7f589b0-eebb-48cb-912f-a4bd956e4dcb1

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startSampleExclude flagStatus
62135-052-906213500529090 TABLET in 1 BOTTLE (62135-052-90) 90 tablet2023-06-06NoNoCurrent