Doxazosin
- Product NDC
- 0832-1359
- 11-digit product format
- 008321359
- Labeler code
- 0832
- Product ID
- 0832-1359_4367e154-1abf-01ad-e063-6394a90aca53
- Type
- HUMAN PRESCRIPTION DRUG
- Nonproprietary name
- Doxazosin Mesylate
- Dosage form
- TABLET
- Route
- ORAL
- Labeler
- Upsher-Smith laboratories, LLC
- Application
- ANDA209013
- Marketing category
- ANDA
- Marketing start
- 2018-04-17
- Marketing end
- 2027-08-31
- Substance
- DOXAZOSIN MESYLATE
- Active strength
- 8 mg/1
- Pharmacologic classes
- Adrenergic alpha-Antagonists [MoA], alpha-Adrenergic Blocker [EPC]
- NDC exclude flag
- No
- Current FDA listing
- Yes
Orange Book products#
| Application-product | Trade name | Ingredient | Strength | Dosage form / route | TE codes | RLD / RS | Approval date |
|---|---|---|---|---|---|---|---|
| A209013-001 | DOXAZOSIN MESYLATE | DOXAZOSIN MESYLATE | EQ 1MG BASE | TABLET / ORAL | AB | 2018-04-17 | |
| A209013-002 | DOXAZOSIN MESYLATE | DOXAZOSIN MESYLATE | EQ 2MG BASE | TABLET / ORAL | AB | 2018-04-17 | |
| A209013-003 | DOXAZOSIN MESYLATE | DOXAZOSIN MESYLATE | EQ 4MG BASE | TABLET / ORAL | AB | 2018-04-17 | |
| A209013-004 | DOXAZOSIN MESYLATE | DOXAZOSIN MESYLATE | EQ 8MG BASE | TABLET / ORAL | AB | 2018-04-17 |
Therapeutic equivalence codes#
| Application-product | TE code |
|---|---|
| A209013-001 | AB |
| A209013-002 | AB |
| A209013-003 | AB |
| A209013-004 | AB |
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 | Trade name | Strength | Dosage form / route | Product TE source text | RLD / RS | Approval date | Source SHA-256 |
|---|---|---|---|---|---|---|---|---|---|
| 2026-02-19 14:30 UTC | 2026-02 | A209013-001 | DOXAZOSIN MESYLATE | EQ 1MG BASE | TABLET / ORAL | AB | 2018-04-17 | 011fe1cb6892… | |
| 2026-02-19 14:30 UTC | 2026-02 | A209013-002 | DOXAZOSIN MESYLATE | EQ 2MG BASE | TABLET / ORAL | AB | 2018-04-17 | 011fe1cb6892… | |
| 2026-02-19 14:30 UTC | 2026-02 | A209013-003 | DOXAZOSIN MESYLATE | EQ 4MG BASE | TABLET / ORAL | AB | 2018-04-17 | 011fe1cb6892… | |
| 2026-02-19 14:30 UTC | 2026-02 | A209013-004 | DOXAZOSIN MESYLATE | EQ 8MG BASE | TABLET / ORAL | AB | 2018-04-17 | 011fe1cb6892… | |
| 2025-12-14 10:44 UTC · 2 captures of this ZIP | 2025-12 | A209013-001 | DOXAZOSIN MESYLATE | EQ 1MG BASE | TABLET / ORAL | AB | 2018-04-17 | 31067a03dcf5… | |
| 2025-12-14 10:44 UTC · 2 captures of this ZIP | 2025-12 | A209013-002 | DOXAZOSIN MESYLATE | EQ 2MG BASE | TABLET / ORAL | AB | 2018-04-17 | 31067a03dcf5… | |
| 2025-12-14 10:44 UTC · 2 captures of this ZIP | 2025-12 | A209013-003 | DOXAZOSIN MESYLATE | EQ 4MG BASE | TABLET / ORAL | AB | 2018-04-17 | 31067a03dcf5… | |
| 2025-12-14 10:44 UTC · 2 captures of this ZIP | 2025-12 | A209013-004 | DOXAZOSIN MESYLATE | EQ 8MG BASE | TABLET / ORAL | AB | 2018-04-17 | 31067a03dcf5… | |
| 2025-08-23 18:47 UTC | 2025-08 | A209013-001 | DOXAZOSIN MESYLATE | EQ 1MG BASE | TABLET / ORAL | AB | 2018-04-17 | 6a471c1ec25d… | |
| 2025-08-23 18:47 UTC | 2025-08 | A209013-002 | DOXAZOSIN MESYLATE | EQ 2MG BASE | TABLET / ORAL | AB | 2018-04-17 | 6a471c1ec25d… | |
| 2025-08-23 18:47 UTC | 2025-08 | A209013-003 | DOXAZOSIN MESYLATE | EQ 4MG BASE | TABLET / ORAL | AB | 2018-04-17 | 6a471c1ec25d… | |
| 2025-08-23 18:47 UTC | 2025-08 | A209013-004 | DOXAZOSIN MESYLATE | EQ 8MG BASE | TABLET / ORAL | AB | 2018-04-17 | 6a471c1ec25d… | |
| 2025-03-22 03:13 UTC · 3 captures of this ZIP | 2025-03 | A209013-001 | DOXAZOSIN MESYLATE | EQ 1MG BASE | TABLET / ORAL | AB | 2018-04-17 | fd3edfee7708… | |
| 2025-03-22 03:13 UTC · 3 captures of this ZIP | 2025-03 | A209013-002 | DOXAZOSIN MESYLATE | EQ 2MG BASE | TABLET / ORAL | AB | 2018-04-17 | fd3edfee7708… | |
| 2025-03-22 03:13 UTC · 3 captures of this ZIP | 2025-03 | A209013-003 | DOXAZOSIN MESYLATE | EQ 4MG BASE | TABLET / ORAL | AB | 2018-04-17 | fd3edfee7708… | |
| 2025-03-22 03:13 UTC · 3 captures of this ZIP | 2025-03 | A209013-004 | DOXAZOSIN MESYLATE | EQ 8MG BASE | TABLET / ORAL | AB | 2018-04-17 | fd3edfee7708… | |
| 2025-02-26 10:13 UTC · 3 captures of this ZIP | 2025-02 | A209013-001 | DOXAZOSIN MESYLATE | EQ 1MG BASE | TABLET / ORAL | AB | 2018-04-17 | b8a1b40f171c… | |
| 2025-02-26 10:13 UTC · 3 captures of this ZIP | 2025-02 | A209013-002 | DOXAZOSIN MESYLATE | EQ 2MG BASE | TABLET / ORAL | AB | 2018-04-17 | b8a1b40f171c… | |
| 2025-02-26 10:13 UTC · 3 captures of this ZIP | 2025-02 | A209013-003 | DOXAZOSIN MESYLATE | EQ 4MG BASE | TABLET / ORAL | AB | 2018-04-17 | b8a1b40f171c… | |
| 2025-02-26 10:13 UTC · 3 captures of this ZIP | 2025-02 | A209013-004 | DOXAZOSIN MESYLATE | EQ 8MG BASE | TABLET / ORAL | AB | 2018-04-17 | b8a1b40f171c… | |
| 2025-01-19 17:59 UTC · 7 captures of this ZIP | 2025-01 | A209013-001 | DOXAZOSIN MESYLATE | EQ 1MG BASE | TABLET / ORAL | AB | 2018-04-17 | 03ed91905a0d… | |
| 2025-01-19 17:59 UTC · 7 captures of this ZIP | 2025-01 | A209013-002 | DOXAZOSIN MESYLATE | EQ 2MG BASE | TABLET / ORAL | AB | 2018-04-17 | 03ed91905a0d… | |
| 2025-01-19 17:59 UTC · 7 captures of this ZIP | 2025-01 | A209013-003 | DOXAZOSIN MESYLATE | EQ 4MG BASE | TABLET / ORAL | AB | 2018-04-17 | 03ed91905a0d… | |
| 2025-01-19 17:59 UTC · 7 captures of this ZIP | 2025-01 | A209013-004 | DOXAZOSIN MESYLATE | EQ 8MG BASE | TABLET / ORAL | AB | 2018-04-17 | 03ed91905a0d… | |
| 2024-12-13 21:23 UTC · 2 captures of this ZIP | 2024-12 | A209013-001 | DOXAZOSIN MESYLATE | EQ 1MG BASE | TABLET / ORAL | AB | 2018-04-17 | 2680178bc6a6… | |
| 2024-12-13 21:23 UTC · 2 captures of this ZIP | 2024-12 | A209013-002 | DOXAZOSIN MESYLATE | EQ 2MG BASE | TABLET / ORAL | AB | 2018-04-17 | 2680178bc6a6… | |
| 2024-12-13 21:23 UTC · 2 captures of this ZIP | 2024-12 | A209013-003 | DOXAZOSIN MESYLATE | EQ 4MG BASE | TABLET / ORAL | AB | 2018-04-17 | 2680178bc6a6… | |
| 2024-12-13 21:23 UTC · 2 captures of this ZIP | 2024-12 | A209013-004 | DOXAZOSIN MESYLATE | EQ 8MG BASE | TABLET / ORAL | AB | 2018-04-17 | 2680178bc6a6… | |
| 2024-09-14 05:58 UTC · 2 captures of this ZIP | 2024-09 | A209013-001 | DOXAZOSIN MESYLATE | EQ 1MG BASE | TABLET / ORAL | AB | 2018-04-17 | 5bbf6a4d5a75… | |
| 2024-09-14 05:58 UTC · 2 captures of this ZIP | 2024-09 | A209013-002 | DOXAZOSIN MESYLATE | EQ 2MG BASE | TABLET / ORAL | AB | 2018-04-17 | 5bbf6a4d5a75… | |
| 2024-09-14 05:58 UTC · 2 captures of this ZIP | 2024-09 | A209013-003 | DOXAZOSIN MESYLATE | EQ 4MG BASE | TABLET / ORAL | AB | 2018-04-17 | 5bbf6a4d5a75… | |
| 2024-09-14 05:58 UTC · 2 captures of this ZIP | 2024-09 | A209013-004 | DOXAZOSIN MESYLATE | EQ 8MG BASE | TABLET / ORAL | AB | 2018-04-17 | 5bbf6a4d5a75… | |
| 2024-11-08 22:44 UTC · 3 captures of this ZIP | 2024-11 | A209013-001 | DOXAZOSIN MESYLATE | EQ 1MG BASE | TABLET / ORAL | AB | 2018-04-17 | d8e5a09893c0… | |
| 2024-11-08 22:44 UTC · 3 captures of this ZIP | 2024-11 | A209013-002 | DOXAZOSIN MESYLATE | EQ 2MG BASE | TABLET / ORAL | AB | 2018-04-17 | d8e5a09893c0… | |
| 2024-11-08 22:44 UTC · 3 captures of this ZIP | 2024-11 | A209013-003 | DOXAZOSIN MESYLATE | EQ 4MG BASE | TABLET / ORAL | AB | 2018-04-17 | d8e5a09893c0… | |
| 2024-11-08 22:44 UTC · 3 captures of this ZIP | 2024-11 | A209013-004 | DOXAZOSIN MESYLATE | EQ 8MG BASE | TABLET / ORAL | AB | 2018-04-17 | d8e5a09893c0… | |
| 2024-10-29 15:01 UTC | 2024-10 | A209013-001 | DOXAZOSIN MESYLATE | EQ 1MG BASE | TABLET / ORAL | AB | 2018-04-17 | d06236e962d9… | |
| 2024-10-29 15:01 UTC | 2024-10 | A209013-002 | DOXAZOSIN MESYLATE | EQ 2MG BASE | TABLET / ORAL | AB | 2018-04-17 | d06236e962d9… | |
| 2024-10-29 15:01 UTC | 2024-10 | A209013-003 | DOXAZOSIN MESYLATE | EQ 4MG BASE | TABLET / ORAL | AB | 2018-04-17 | d06236e962d9… | |
| 2024-10-29 15:01 UTC | 2024-10 | A209013-004 | DOXAZOSIN MESYLATE | EQ 8MG BASE | TABLET / ORAL | AB | 2018-04-17 | d06236e962d9… |
Observed Orange Book normalized TE history#
| Captured | Edition | Application-product | TE code | Order | Source SHA-256 |
|---|---|---|---|---|---|
| 2026-02-19 14:30 UTC | 2026-02 | A209013-001 | AB | 1 | 011fe1cb6892… |
| 2026-02-19 14:30 UTC | 2026-02 | A209013-002 | AB | 1 | 011fe1cb6892… |
| 2026-02-19 14:30 UTC | 2026-02 | A209013-003 | AB | 1 | 011fe1cb6892… |
| 2026-02-19 14:30 UTC | 2026-02 | A209013-004 | AB | 1 | 011fe1cb6892… |
| 2025-12-14 10:44 UTC · 2 captures of this ZIP | 2025-12 | A209013-001 | AB | 1 | 31067a03dcf5… |
| 2025-12-14 10:44 UTC · 2 captures of this ZIP | 2025-12 | A209013-002 | AB | 1 | 31067a03dcf5… |
| 2025-12-14 10:44 UTC · 2 captures of this ZIP | 2025-12 | A209013-003 | AB | 1 | 31067a03dcf5… |
| 2025-12-14 10:44 UTC · 2 captures of this ZIP | 2025-12 | A209013-004 | AB | 1 | 31067a03dcf5… |
| 2025-08-23 18:47 UTC | 2025-08 | A209013-001 | AB | 1 | 6a471c1ec25d… |
| 2025-08-23 18:47 UTC | 2025-08 | A209013-002 | AB | 1 | 6a471c1ec25d… |
| 2025-08-23 18:47 UTC | 2025-08 | A209013-003 | AB | 1 | 6a471c1ec25d… |
| 2025-08-23 18:47 UTC | 2025-08 | A209013-004 | AB | 1 | 6a471c1ec25d… |
| 2025-03-22 03:13 UTC · 3 captures of this ZIP | 2025-03 | A209013-001 | AB | 1 | fd3edfee7708… |
| 2025-03-22 03:13 UTC · 3 captures of this ZIP | 2025-03 | A209013-002 | AB | 1 | fd3edfee7708… |
| 2025-03-22 03:13 UTC · 3 captures of this ZIP | 2025-03 | A209013-003 | AB | 1 | fd3edfee7708… |
| 2025-03-22 03:13 UTC · 3 captures of this ZIP | 2025-03 | A209013-004 | AB | 1 | fd3edfee7708… |
| 2025-02-26 10:13 UTC · 3 captures of this ZIP | 2025-02 | A209013-001 | AB | 1 | b8a1b40f171c… |
| 2025-02-26 10:13 UTC · 3 captures of this ZIP | 2025-02 | A209013-002 | AB | 1 | b8a1b40f171c… |
| 2025-02-26 10:13 UTC · 3 captures of this ZIP | 2025-02 | A209013-003 | AB | 1 | b8a1b40f171c… |
| 2025-02-26 10:13 UTC · 3 captures of this ZIP | 2025-02 | A209013-004 | AB | 1 | b8a1b40f171c… |
| 2025-01-19 17:59 UTC · 7 captures of this ZIP | 2025-01 | A209013-001 | AB | 1 | 03ed91905a0d… |
| 2025-01-19 17:59 UTC · 7 captures of this ZIP | 2025-01 | A209013-002 | AB | 1 | 03ed91905a0d… |
| 2025-01-19 17:59 UTC · 7 captures of this ZIP | 2025-01 | A209013-003 | AB | 1 | 03ed91905a0d… |
| 2025-01-19 17:59 UTC · 7 captures of this ZIP | 2025-01 | A209013-004 | AB | 1 | 03ed91905a0d… |
| 2024-12-13 21:23 UTC · 2 captures of this ZIP | 2024-12 | A209013-001 | AB | 1 | 2680178bc6a6… |
| 2024-12-13 21:23 UTC · 2 captures of this ZIP | 2024-12 | A209013-002 | AB | 1 | 2680178bc6a6… |
| 2024-12-13 21:23 UTC · 2 captures of this ZIP | 2024-12 | A209013-003 | AB | 1 | 2680178bc6a6… |
| 2024-12-13 21:23 UTC · 2 captures of this ZIP | 2024-12 | A209013-004 | AB | 1 | 2680178bc6a6… |
| 2024-09-14 05:58 UTC · 2 captures of this ZIP | 2024-09 | A209013-001 | AB | 1 | 5bbf6a4d5a75… |
| 2024-09-14 05:58 UTC · 2 captures of this ZIP | 2024-09 | A209013-002 | AB | 1 | 5bbf6a4d5a75… |
| 2024-09-14 05:58 UTC · 2 captures of this ZIP | 2024-09 | A209013-003 | AB | 1 | 5bbf6a4d5a75… |
| 2024-09-14 05:58 UTC · 2 captures of this ZIP | 2024-09 | A209013-004 | AB | 1 | 5bbf6a4d5a75… |
| 2024-11-08 22:44 UTC · 3 captures of this ZIP | 2024-11 | A209013-001 | AB | 1 | d8e5a09893c0… |
| 2024-11-08 22:44 UTC · 3 captures of this ZIP | 2024-11 | A209013-002 | AB | 1 | d8e5a09893c0… |
| 2024-11-08 22:44 UTC · 3 captures of this ZIP | 2024-11 | A209013-003 | AB | 1 | d8e5a09893c0… |
| 2024-11-08 22:44 UTC · 3 captures of this ZIP | 2024-11 | A209013-004 | AB | 1 | d8e5a09893c0… |
| 2024-10-29 15:01 UTC | 2024-10 | A209013-001 | AB | 1 | d06236e962d9… |
| 2024-10-29 15:01 UTC | 2024-10 | A209013-002 | AB | 1 | d06236e962d9… |
| 2024-10-29 15:01 UTC | 2024-10 | A209013-003 | AB | 1 | d06236e962d9… |
| 2024-10-29 15:01 UTC | 2024-10 | A209013-004 | AB | 1 | d06236e962d9… |
Additional Listing Data#
- Finished product
- Yes
- Brand name base
- Doxazosin
Active Ingredients#
| Ingredient | Strength |
|---|---|
| DOXAZOSIN MESYLATE | 8 mg/1 |
Harmonized UNII identifiers#
| Identifier | FDA.report destination |
|---|---|
| 86P6PQK0MU | Internal UNII lookup |
Harmonized RxCUI identifiers#
Harmonized SPL set identifiers#
| Identifier | FDA.report destination |
|---|---|
| b5d1c604-ce3b-4973-845f-9db267a945cd | Available on FDA.report |
DailyMed Product Concepts#
| Product concept | Relation | Version | Effective |
|---|---|---|---|
| 07a517fc-5845-3816-0f81-0a121804ec9e | Product name | 6 | 20250107 |
| 171dd63c-7eea-ede4-c010-4c25ba0a1087 | Product name | 1 | 20140508 |
FDA-Initiated Inactive NDC Indexing#
DailyMed Package Descriptions#
| Package NDC | Product | Description | Form | Quantity | Strength | SPL version |
|---|---|---|---|---|---|---|
| 0832-1359-11 | Doxazosin | 100 in 1 BOTTLE | TABLET | 100 | 8 |
DailyMed Billing Units#
| Package NDC | Billing unit | Product NDC | DailyMed indexing SPL | SPL version | Effective |
|---|---|---|---|---|---|
| 0832-1359-11 | EA - Each | 0832-1359 | 68a9a7f5-fbfa-4eb4-a2d5-181458f7d1cb | 1 | 2018-07-03 |
DailyMed Dashboard NDC Coverage#
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.
| Brand | Generic | Manufacturer | SPL set ID | Effective date | Available safety fields | Join |
|---|---|---|---|---|---|---|
| Doxazosin | DOXAZOSIN MESYLATE | Bryant Ranch Prepack | 277c3278-4fe2-47ac-9115-15b417325ffd | 2026-04-13 | Warnings, Adverse reactions | 209013 ANDA209013 |
| Doxazosin | DOXAZOSIN MESYLATE | Northwind Health Company, LLC | f6c9856e-9154-f349-e053-6294a90a9f2c | 2026-01-19 | Warnings, Adverse reactions | 209013 ANDA209013 |
| Doxazosin | DOXAZOSIN MESYLATE | Upsher-Smith laboratories, LLC | b5d1c604-ce3b-4973-845f-9db267a945cd | 2025-11-12 | Warnings, Adverse reactions | 209013 ANDA209013 0832-1359 |
| Doxazosin | DOXAZOSIN MESYLATE | A-S Medication Solutions | b4c974ad-cbd6-4811-ab48-461e7ffa99f7 | 2025-09-17 | Warnings, Adverse reactions | 209013 ANDA209013 |
| Doxazosin | DOXAZOSIN MESYLATE | Aphena Pharma Solutions - Tennessee, LLC | 0d9df8e9-f823-4ff8-a5fe-0309dd132b04 | 2024-02-06 | Warnings, Adverse reactions | 209013 ANDA209013 |
| Doxazosin | DOXAZOSIN MESYLATE | Aphena Pharma Solutions - Tennessee, LLC | 6b74b18f-b89a-4109-a29e-c4fa65a3c5ee | 2020-12-10 | Warnings, Adverse reactions | 209013 ANDA209013 |
DailyMed RxNorm Mappings#
| RxCUI | RxNorm string | TTY | DailyMed | SPL version |
|---|---|---|---|---|
| 197625 | doxazosin mesylate 1 MG Oral Tablet | PSN | b5d1c604-ce3b-4973-845f-9db267a945cd | 8 |
| 197626 | doxazosin mesylate 2 MG Oral Tablet | PSN | b5d1c604-ce3b-4973-845f-9db267a945cd | 8 |
| 197627 | doxazosin mesylate 4 MG Oral Tablet | PSN | b5d1c604-ce3b-4973-845f-9db267a945cd | 8 |
| 197628 | doxazosin mesylate 8 MG Oral Tablet | PSN | b5d1c604-ce3b-4973-845f-9db267a945cd | 8 |
| 197625 | doxazosin 1 MG Oral Tablet | SCD | b5d1c604-ce3b-4973-845f-9db267a945cd | 8 |
| 197626 | doxazosin 2 MG Oral Tablet | SCD | b5d1c604-ce3b-4973-845f-9db267a945cd | 8 |
| 197627 | doxazosin 4 MG Oral Tablet | SCD | b5d1c604-ce3b-4973-845f-9db267a945cd | 8 |
| 197628 | doxazosin 8 MG Oral Tablet | SCD | b5d1c604-ce3b-4973-845f-9db267a945cd | 8 |
| 197625 | doxazosin (as doxazosin mesylate) 1 MG Oral Tablet | SY | b5d1c604-ce3b-4973-845f-9db267a945cd | 8 |
| 197626 | doxazosin (as doxazosin mesylate) 2 MG Oral Tablet | SY | b5d1c604-ce3b-4973-845f-9db267a945cd | 8 |
| 197627 | doxazosin (as doxazosin mesylate) 4 MG Oral Tablet | SY | b5d1c604-ce3b-4973-845f-9db267a945cd | 8 |
| 197628 | doxazosin (as doxazosin mesylate) 8 MG Oral Tablet | SY | b5d1c604-ce3b-4973-845f-9db267a945cd | 8 |
Packages#
| Package NDC | 11-digit format | Description | Units | Marketing start | Marketing end | Sample | Exclude flag | Status |
|---|---|---|---|---|---|---|---|---|
| 0832-1359-11 | 00832135911 | 100 TABLET in 1 BOTTLE (0832-1359-11) | 100 tablet | 2018-04-17 | 2027-01-31 | No | No | Current |