FDA.reportPublic FDA data

Doxazosin

Product NDC
68382-783
11-digit product format
683820783
Labeler code
68382
Product ID
68382-783_92ead971-9de8-4240-b2c7-fc2e9abac7dd
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
Doxazosin
Dosage form
TABLET
Route
ORAL
Labeler
Zydus Pharmaceuticals USA Inc.
Application
ANDA208719
Marketing category
ANDA
Marketing start
2017-08-31
Substance
DOXAZOSIN MESYLATE
Active strength
1 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
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
ndc (product): 68382-783

Additional Listing Data#

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

Active Ingredients#

Ingredient, Strength table
IngredientStrength
DOXAZOSIN MESYLATE1 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
e4758bf9-b9d4-4268-beb8-0d7e06890895Available 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
68382-783-01Doxazosin100 in 1 BOTTLETABLET1004
68382-783-06Doxazosin30 in 1 BOTTLETABLET304
68382-783-10Doxazosin1000 in 1 BOTTLETABLET10004
68382-783-30Doxazosin10 in 1 BLISTER PACKTABLET104
68382-783-77Doxazosin10 in 1 CARTONTABLET104

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
68382-783-01EA - Each68382-783c206724c-df31-490b-9d3a-d9e02c83b03f12018-03-08
68382-783-10EA - Each68382-783c25b3680-a036-4c46-a5d5-c733f5c6998712018-03-08

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
68382-783DOXAZOSIN TABLET [ZYDUS PHARMACEUTICALS USA INC.]4Current NDC, Legacy NDC, 5 package rows20230921_e4758bf9-b9d4-4268-beb8-0d7e06890895.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
197625doxazosin mesylate 1 MG Oral TabletPSNe4758bf9-b9d4-4268-beb8-0d7e068908954
197626doxazosin mesylate 2 MG Oral TabletPSNe4758bf9-b9d4-4268-beb8-0d7e068908954
197627doxazosin mesylate 4 MG Oral TabletPSNe4758bf9-b9d4-4268-beb8-0d7e068908954
197628doxazosin mesylate 8 MG Oral TabletPSNe4758bf9-b9d4-4268-beb8-0d7e068908954
197625doxazosin 1 MG Oral TabletSCDe4758bf9-b9d4-4268-beb8-0d7e068908954
197626doxazosin 2 MG Oral TabletSCDe4758bf9-b9d4-4268-beb8-0d7e068908954
197627doxazosin 4 MG Oral TabletSCDe4758bf9-b9d4-4268-beb8-0d7e068908954
197628doxazosin 8 MG Oral TabletSCDe4758bf9-b9d4-4268-beb8-0d7e068908954
197625doxazosin (as doxazosin mesylate) 1 MG Oral TabletSYe4758bf9-b9d4-4268-beb8-0d7e068908954
197626doxazosin (as doxazosin mesylate) 2 MG Oral TabletSYe4758bf9-b9d4-4268-beb8-0d7e068908954
197627doxazosin (as doxazosin mesylate) 4 MG Oral TabletSYe4758bf9-b9d4-4268-beb8-0d7e068908954
197628doxazosin (as doxazosin mesylate) 8 MG Oral TabletSYe4758bf9-b9d4-4268-beb8-0d7e068908954
197625doxazosin mesylate 1 MG Oral TabletPSNad7a234d-c1c2-44a1-830e-f97e202cbeab3
197625doxazosin 1 MG Oral TabletSCDad7a234d-c1c2-44a1-830e-f97e202cbeab3
197625doxazosin (as doxazosin mesylate) 1 MG Oral TabletSYad7a234d-c1c2-44a1-830e-f97e202cbeab3

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
68382-783-0168382078301100 TABLET in 1 BOTTLE (68382-783-01) 100 tablet2017-08-310000-00-00NoNoCurrent
68382-783-066838207830630 TABLET in 1 BOTTLE (68382-783-06) 30 tablet2017-08-310000-00-00NoNoCurrent
68382-783-10683820783101000 TABLET in 1 BOTTLE (68382-783-10) 1000 tablet2017-08-310000-00-00NoNoCurrent
68382-783-306838207833010 in 1 BLISTER PACKHistorical
68382-783-776838207837710 BLISTER PACK in 1 CARTON (68382-783-77) / 10 TABLET in 1 BLISTER PACK (68382-783-30) 10 blister pack2017-08-310000-00-00NoNoCurrent