FDA.reportPublic FDA data

Doxazosin

Product NDC
70518-3965
11-digit product format
705183965
Labeler code
70518
Product ID
70518-3965_3bb3e30f-210c-291c-e063-6294a90a280b
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
Doxazosin
Dosage form
TABLET
Route
ORAL
Labeler
REMEDYREPACK INC.
Application
ANDA208719
Marketing category
ANDA
Marketing start
2023-12-17
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
A208719-001DOXAZOSIN MESYLATEDOXAZOSIN MESYLATEEQ 1MG BASETABLET / ORALAB2017-07-07
A208719-002DOXAZOSIN MESYLATEDOXAZOSIN MESYLATEEQ 2MG BASETABLET / ORALAB2017-07-07
A208719-003DOXAZOSIN MESYLATEDOXAZOSIN MESYLATEEQ 4MG BASETABLET / ORALAB2017-07-07
A208719-004DOXAZOSIN MESYLATEDOXAZOSIN MESYLATEEQ 8MG BASETABLET / ORALAB2017-07-07

Therapeutic equivalence codes#

Current TE-code rows page 1 of 1 · 4 matching rows.

Application-product, TE code table
Application-productTE code
A208719-001AB
A208719-002AB
A208719-003AB
A208719-004AB

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.

Captured, Edition, Application-product table
CapturedEditionApplication-productTrade nameStrengthDosage form / routeProduct TE source textRLD / RSApproval dateSource SHA-256
2026-08-01 22:54:322026-06A208719-001DOXAZOSIN MESYLATEEQ 1MG BASETABLET / ORALAB2017-07-07a50c72e98297…
2026-08-01 22:54:322026-06A208719-002DOXAZOSIN MESYLATEEQ 2MG BASETABLET / ORALAB2017-07-07a50c72e98297…
2026-08-01 22:54:322026-06A208719-003DOXAZOSIN MESYLATEEQ 4MG BASETABLET / ORALAB2017-07-07a50c72e98297…
2026-08-01 22:54:322026-06A208719-004DOXAZOSIN MESYLATEEQ 8MG BASETABLET / ORALAB2017-07-07a50c72e98297…

Observed Orange Book normalized TE history#

Captured, Edition, Application-product table
CapturedEditionApplication-productTE codeOrderSource SHA-256
2026-08-01 22:54:322026-06A208719-001AB1a50c72e98297…
2026-08-01 22:54:322026-06A208719-002AB1a50c72e98297…
2026-08-01 22:54:322026-06A208719-003AB1a50c72e98297…
2026-08-01 22:54:322026-06A208719-004AB1a50c72e98297…

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 · 8 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
DoxazosinDOXAZOSINREMEDYREPACK INC.ec06f008-37a1-4757-a3ee-0b4720912bc42026-06-11Warnings, Adverse reactionsExact identifier
application applno (ANDA): 208719
application number: ANDA208719
ndc (product): 70518-3965
DoxazosinDOXAZOSINNuCare Pharmaceuticals, Inc.30b709d6-c438-c721-e063-6294a90abd612025-03-19Warnings, Adverse reactionsExact identifier
application applno (ANDA): 208719
application number: ANDA208719
DoxazosinDOXAZOSINNuCare Pharmaceuticals,Inc.88efdfb0-710f-768a-e053-2995a90aede42024-12-17Warnings, Adverse reactionsExact identifier
application applno (ANDA): 208719
application number: ANDA208719
DoxazosinDOXAZOSINZydus Lifesciences Limitedac889877-133c-4448-af5a-d77b3cbfe8782024-11-28Exact identifier
application applno (ANDA): 208719
application number: ANDA208719
DoxazosinDOXAZOSINA-S Medication Solutions46b01b1d-c48a-4c36-bf3c-bba98066166c2024-06-10Warnings, Adverse reactionsExact identifier
application applno (ANDA): 208719
application number: ANDA208719
DoxazosinDOXAZOSINAphena Pharma Solutions - Tennessee, LLC187bc51b-7a3a-5910-e063-6294a90aa8882024-05-15Warnings, Adverse reactionsExact identifier
application applno (ANDA): 208719
application number: ANDA208719
DoxazosinDOXAZOSINBryant Ranch Prepack6fbb9ca2-e8ca-45c7-a178-b4c8dd7a9a1f2024-04-29Warnings, Adverse reactionsExact identifier
application applno (ANDA): 208719
application number: ANDA208719
DoxazosinDOXAZOSINZydus Pharmaceuticals USA Inc.e4758bf9-b9d4-4268-beb8-0d7e068908952023-09-16Warnings, Adverse reactionsExact identifier
application applno (ANDA): 208719
application number: ANDA208719

Additional Listing Data#

Finished product
Yes
Brand name base
Doxazosin
Listing expiration
2027-12-31

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 · 1 matching rows.

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

Harmonized SPL set identifiers#

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

Identifier, FDA.report destination table
IdentifierFDA.report destination
ec06f008-37a1-4757-a3ee-0b4720912bc4Available 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
70518-3965-0Doxazosin30 in 1 BLISTER PACKTABLET304
70518-3965-1Doxazosin90 in 1 BOTTLE, PLASTICTABLET904

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
70518-3965DOXAZOSIN TABLET [REMEDYREPACK INC.]3Current NDC, 2 package rows20240503_ec06f008-37a1-4757-a3ee-0b4720912bc4.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
197626doxazosin mesylate 2 MG Oral TabletPSNec06f008-37a1-4757-a3ee-0b4720912bc44
197626doxazosin 2 MG Oral TabletSCDec06f008-37a1-4757-a3ee-0b4720912bc44
197626doxazosin (as doxazosin mesylate) 2 MG Oral TabletSYec06f008-37a1-4757-a3ee-0b4720912bc44

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startSampleExclude flagStatus
70518-3965-07051839650030 TABLET in 1 BLISTER PACK (70518-3965-0) 30 tablet2023-12-17NoNoCurrent
70518-3965-17051839650190 TABLET in 1 BOTTLE, PLASTIC (70518-3965-1) 90 tablet2024-05-01NoNoCurrent