Doxazosin

Product NDC
68071-4892
Requested package NDC
68071-4892-9
11-digit product format
680714892
Labeler code
68071
Product ID
68071-4892_297e74b0-5b39-7420-e063-6294a90aa73d
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
Doxazosin
Dosage form
TABLET
Route
ORAL
Labeler
NuCare Pharmaceuticals,Inc.
Application
ANDA208719
Marketing category
ANDA
Marketing start
2017-08-31
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

Observed NDC auxiliary status history#

This history shows the information present in each captured FDA auxiliary file. It is not a continuous regulatory timeline, and a missing record does not establish a status.

Historic NDC status page 1 of 1 · 6 matching rows.

View current auxiliary records. · View the auxiliary file history.

Captured / source date, Dataset, Scope table
Captured / source dateDatasetScopeProduct NDCPackage NDCCodeStatusReporting periodArchiveSnapshotSource SHA-256
2024-11-09 02:27 UTC · source 2024-11-08excluded packagepackage68071-489268071-4892-9DDiscontinued by firmexcluded / ndc_excluded.zipad56d346431e…cc804d4bbf1e…
2024-10-04 04:10 UTC · source 2024-10-03excluded packagepackage68071-489268071-4892-9DDiscontinued by firmexcluded / ndc_excluded.zip367a005e9d99…383a685ebd0f…
2024-07-10 04:00 UTC · source 2024-07-09excluded packagepackage68071-489268071-4892-9DDiscontinued by firmexcluded / ndc_excluded.zip557ba5c1ecfa…9c80585c8c6e…
2024-05-28 21:12 UTC · source 2024-05-28excluded packagepackage68071-489268071-4892-9IInactivated by FDAexcluded / ndc_excluded.zip8af77b9d5b6f…d9bbb34c5368…
2024-05-15 03:39 UTC · source 2024-05-14excluded packagepackage68071-489268071-4892-9IInactivated by FDAexcluded / ndc_excluded.zip834df4deac94…adcc014656a3…
2024-03-11 06:39 UTC · source 2024-03-08excluded packagepackage68071-489268071-4892-9IInactivated by FDAexcluded / ndc_excluded.zip1332a3947898…d4bfe170f9cd…

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 MESYLATE4 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
197627Internal RxNorm lookup

Harmonized SPL set identifiers#

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

Identifier, FDA.report destination table
IdentifierFDA.report destination
88efdfb0-710f-768a-e053-2995a90aede4Available 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

FDA-Initiated Inactive NDC Indexing#

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
68071-4892-3Doxazosin30 in 1 BOTTLETABLET305
68071-4892-9Doxazosin90 in 1 BOTTLETABLET905

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
68071-4892DOXAZOSIN TABLET [NUCARE PHARMACEUTICALS,INC.]5Current NDC, Legacy NDC, 2 package rows20241220_88efdfb0-710f-768a-e053-2995a90aede4.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
ndc (package): 68071-4892-9
ndc (product): 68071-4892
ndc11 (package): 68071489209
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

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
197627doxazosin mesylate 4 MG Oral TabletPSN88efdfb0-710f-768a-e053-2995a90aede45
197627doxazosin 4 MG Oral TabletSCD88efdfb0-710f-768a-e053-2995a90aede45
197627doxazosin (as doxazosin mesylate) 4 MG Oral TabletSY88efdfb0-710f-768a-e053-2995a90aede45

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
68071-4892-96807148920990 TABLET in 1 BOTTLE (68071-4892-9) 90 tablet2019-05-150000-00-00NoNoCurrent