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.

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 UTC2026-02A208719-001DOXAZOSIN MESYLATEEQ 1MG BASETABLET / ORALAB2017-07-07011fe1cb6892…
2026-02-19 14:30 UTC2026-02A208719-002DOXAZOSIN MESYLATEEQ 2MG BASETABLET / ORALAB2017-07-07011fe1cb6892…
2026-02-19 14:30 UTC2026-02A208719-003DOXAZOSIN MESYLATEEQ 4MG BASETABLET / ORALAB2017-07-07011fe1cb6892…
2026-02-19 14:30 UTC2026-02A208719-004DOXAZOSIN MESYLATEEQ 8MG BASETABLET / ORALAB2017-07-07011fe1cb6892…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A208719-001DOXAZOSIN MESYLATEEQ 1MG BASETABLET / ORALAB2017-07-0731067a03dcf5…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A208719-002DOXAZOSIN MESYLATEEQ 2MG BASETABLET / ORALAB2017-07-0731067a03dcf5…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A208719-003DOXAZOSIN MESYLATEEQ 4MG BASETABLET / ORALAB2017-07-0731067a03dcf5…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A208719-004DOXAZOSIN MESYLATEEQ 8MG BASETABLET / ORALAB2017-07-0731067a03dcf5…
2025-08-23 18:47 UTC2025-08A208719-001DOXAZOSIN MESYLATEEQ 1MG BASETABLET / ORALAB2017-07-076a471c1ec25d…
2025-08-23 18:47 UTC2025-08A208719-002DOXAZOSIN MESYLATEEQ 2MG BASETABLET / ORALAB2017-07-076a471c1ec25d…
2025-08-23 18:47 UTC2025-08A208719-003DOXAZOSIN MESYLATEEQ 4MG BASETABLET / ORALAB2017-07-076a471c1ec25d…
2025-08-23 18:47 UTC2025-08A208719-004DOXAZOSIN MESYLATEEQ 8MG BASETABLET / ORALAB2017-07-076a471c1ec25d…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03A208719-001DOXAZOSIN MESYLATEEQ 1MG BASETABLET / ORALAB2017-07-07fd3edfee7708…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03A208719-002DOXAZOSIN MESYLATEEQ 2MG BASETABLET / ORALAB2017-07-07fd3edfee7708…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03A208719-003DOXAZOSIN MESYLATEEQ 4MG BASETABLET / ORALAB2017-07-07fd3edfee7708…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03A208719-004DOXAZOSIN MESYLATEEQ 8MG BASETABLET / ORALAB2017-07-07fd3edfee7708…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02A208719-001DOXAZOSIN MESYLATEEQ 1MG BASETABLET / ORALAB2017-07-07b8a1b40f171c…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02A208719-002DOXAZOSIN MESYLATEEQ 2MG BASETABLET / ORALAB2017-07-07b8a1b40f171c…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02A208719-003DOXAZOSIN MESYLATEEQ 4MG BASETABLET / ORALAB2017-07-07b8a1b40f171c…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02A208719-004DOXAZOSIN MESYLATEEQ 8MG BASETABLET / ORALAB2017-07-07b8a1b40f171c…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01A208719-001DOXAZOSIN MESYLATEEQ 1MG BASETABLET / ORALAB2017-07-0703ed91905a0d…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01A208719-002DOXAZOSIN MESYLATEEQ 2MG BASETABLET / ORALAB2017-07-0703ed91905a0d…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01A208719-003DOXAZOSIN MESYLATEEQ 4MG BASETABLET / ORALAB2017-07-0703ed91905a0d…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01A208719-004DOXAZOSIN MESYLATEEQ 8MG BASETABLET / ORALAB2017-07-0703ed91905a0d…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12A208719-001DOXAZOSIN MESYLATEEQ 1MG BASETABLET / ORALAB2017-07-072680178bc6a6…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12A208719-002DOXAZOSIN MESYLATEEQ 2MG BASETABLET / ORALAB2017-07-072680178bc6a6…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12A208719-003DOXAZOSIN MESYLATEEQ 4MG BASETABLET / ORALAB2017-07-072680178bc6a6…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12A208719-004DOXAZOSIN MESYLATEEQ 8MG BASETABLET / ORALAB2017-07-072680178bc6a6…
2024-09-14 05:58 UTC · 2 captures of this ZIP2024-09A208719-001DOXAZOSIN MESYLATEEQ 1MG BASETABLET / ORALAB2017-07-075bbf6a4d5a75…
2024-09-14 05:58 UTC · 2 captures of this ZIP2024-09A208719-002DOXAZOSIN MESYLATEEQ 2MG BASETABLET / ORALAB2017-07-075bbf6a4d5a75…
2024-09-14 05:58 UTC · 2 captures of this ZIP2024-09A208719-003DOXAZOSIN MESYLATEEQ 4MG BASETABLET / ORALAB2017-07-075bbf6a4d5a75…
2024-09-14 05:58 UTC · 2 captures of this ZIP2024-09A208719-004DOXAZOSIN MESYLATEEQ 8MG BASETABLET / ORALAB2017-07-075bbf6a4d5a75…
2024-11-08 22:44 UTC · 3 captures of this ZIP2024-11A208719-001DOXAZOSIN MESYLATEEQ 1MG BASETABLET / ORALAB2017-07-07d8e5a09893c0…
2024-11-08 22:44 UTC · 3 captures of this ZIP2024-11A208719-002DOXAZOSIN MESYLATEEQ 2MG BASETABLET / ORALAB2017-07-07d8e5a09893c0…
2024-11-08 22:44 UTC · 3 captures of this ZIP2024-11A208719-003DOXAZOSIN MESYLATEEQ 4MG BASETABLET / ORALAB2017-07-07d8e5a09893c0…
2024-11-08 22:44 UTC · 3 captures of this ZIP2024-11A208719-004DOXAZOSIN MESYLATEEQ 8MG BASETABLET / ORALAB2017-07-07d8e5a09893c0…
2024-10-29 15:01 UTC2024-10A208719-001DOXAZOSIN MESYLATEEQ 1MG BASETABLET / ORALAB2017-07-07d06236e962d9…
2024-10-29 15:01 UTC2024-10A208719-002DOXAZOSIN MESYLATEEQ 2MG BASETABLET / ORALAB2017-07-07d06236e962d9…
2024-10-29 15:01 UTC2024-10A208719-003DOXAZOSIN MESYLATEEQ 4MG BASETABLET / ORALAB2017-07-07d06236e962d9…
2024-10-29 15:01 UTC2024-10A208719-004DOXAZOSIN MESYLATEEQ 8MG BASETABLET / ORALAB2017-07-07d06236e962d9…

Observed Orange Book normalized TE history#

Normalized TE history page 1 of 5 · 164 observed states.

Captured, Edition, Application-product table
CapturedEditionApplication-productTE codeOrderSource SHA-256
2026-02-19 14:30 UTC2026-02A208719-001AB1011fe1cb6892…
2026-02-19 14:30 UTC2026-02A208719-002AB1011fe1cb6892…
2026-02-19 14:30 UTC2026-02A208719-003AB1011fe1cb6892…
2026-02-19 14:30 UTC2026-02A208719-004AB1011fe1cb6892…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A208719-001AB131067a03dcf5…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A208719-002AB131067a03dcf5…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A208719-003AB131067a03dcf5…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A208719-004AB131067a03dcf5…
2025-08-23 18:47 UTC2025-08A208719-001AB16a471c1ec25d…
2025-08-23 18:47 UTC2025-08A208719-002AB16a471c1ec25d…
2025-08-23 18:47 UTC2025-08A208719-003AB16a471c1ec25d…
2025-08-23 18:47 UTC2025-08A208719-004AB16a471c1ec25d…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03A208719-001AB1fd3edfee7708…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03A208719-002AB1fd3edfee7708…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03A208719-003AB1fd3edfee7708…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03A208719-004AB1fd3edfee7708…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02A208719-001AB1b8a1b40f171c…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02A208719-002AB1b8a1b40f171c…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02A208719-003AB1b8a1b40f171c…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02A208719-004AB1b8a1b40f171c…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01A208719-001AB103ed91905a0d…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01A208719-002AB103ed91905a0d…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01A208719-003AB103ed91905a0d…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01A208719-004AB103ed91905a0d…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12A208719-001AB12680178bc6a6…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12A208719-002AB12680178bc6a6…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12A208719-003AB12680178bc6a6…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12A208719-004AB12680178bc6a6…
2024-09-14 05:58 UTC · 2 captures of this ZIP2024-09A208719-001AB15bbf6a4d5a75…
2024-09-14 05:58 UTC · 2 captures of this ZIP2024-09A208719-002AB15bbf6a4d5a75…
2024-09-14 05:58 UTC · 2 captures of this ZIP2024-09A208719-003AB15bbf6a4d5a75…
2024-09-14 05:58 UTC · 2 captures of this ZIP2024-09A208719-004AB15bbf6a4d5a75…
2024-11-08 22:44 UTC · 3 captures of this ZIP2024-11A208719-001AB1d8e5a09893c0…
2024-11-08 22:44 UTC · 3 captures of this ZIP2024-11A208719-002AB1d8e5a09893c0…
2024-11-08 22:44 UTC · 3 captures of this ZIP2024-11A208719-003AB1d8e5a09893c0…
2024-11-08 22:44 UTC · 3 captures of this ZIP2024-11A208719-004AB1d8e5a09893c0…
2024-10-29 15:01 UTC2024-10A208719-001AB1d06236e962d9…
2024-10-29 15:01 UTC2024-10A208719-002AB1d06236e962d9…
2024-10-29 15:01 UTC2024-10A208719-003AB1d06236e962d9…
2024-10-29 15:01 UTC2024-10A208719-004AB1d06236e962d9…

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

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 · 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

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