Cardura
- Product NDC
- 58151-076
- 11-digit product format
- 581510076
- Labeler code
- 58151
- Product ID
- 58151-076_438349cb-eae0-43b5-b045-d447b1c9a376
- Type
- HUMAN PRESCRIPTION DRUG
- Nonproprietary name
- doxazosin
- Dosage form
- TABLET
- Route
- ORAL
- Labeler
- Viatris Specialty LLC
- Application
- NDA019668
- Marketing category
- NDA
- Marketing start
- 2026-01-14
- 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
- 2027-12-31
- Current FDA listing
- Yes
Orange Book products#
| Application-product | Trade name | Ingredient | Strength | Dosage form / route | TE codes | RLD / RS | Approval date |
|---|---|---|---|---|---|---|---|
| N019668-001 | CARDURA | DOXAZOSIN MESYLATE | EQ 1MG BASE | TABLET / ORAL | AB | RLD, RS | 1990-11-02 |
| N019668-002 | CARDURA | DOXAZOSIN MESYLATE | EQ 2MG BASE | TABLET / ORAL | AB | RLD | 1990-11-02 |
| N019668-003 | CARDURA | DOXAZOSIN MESYLATE | EQ 4MG BASE | TABLET / ORAL | AB | RLD | 1990-11-02 |
| N019668-004 | CARDURA | DOXAZOSIN MESYLATE | EQ 8MG BASE | TABLET / ORAL | AB | RLD | 1990-11-02 |
Therapeutic equivalence codes#
| Application-product | TE code |
|---|---|
| N019668-001 | AB |
| N019668-002 | AB |
| N019668-003 | AB |
| N019668-004 | 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 | N019668-001 | CARDURA | EQ 1MG BASE | TABLET / ORAL | AB | RLD, RS | 1990-11-02 | 011fe1cb6892… |
| 2026-02-19 14:30 UTC | 2026-02 | N019668-002 | CARDURA | EQ 2MG BASE | TABLET / ORAL | AB | RLD | 1990-11-02 | 011fe1cb6892… |
| 2026-02-19 14:30 UTC | 2026-02 | N019668-003 | CARDURA | EQ 4MG BASE | TABLET / ORAL | AB | RLD | 1990-11-02 | 011fe1cb6892… |
| 2026-02-19 14:30 UTC | 2026-02 | N019668-004 | CARDURA | EQ 8MG BASE | TABLET / ORAL | AB | RLD | 1990-11-02 | 011fe1cb6892… |
| 2025-12-14 10:44 UTC · 2 captures of this ZIP | 2025-12 | N019668-001 | CARDURA | EQ 1MG BASE | TABLET / ORAL | AB | RLD, RS | 1990-11-02 | 31067a03dcf5… |
| 2025-12-14 10:44 UTC · 2 captures of this ZIP | 2025-12 | N019668-002 | CARDURA | EQ 2MG BASE | TABLET / ORAL | AB | RLD | 1990-11-02 | 31067a03dcf5… |
| 2025-12-14 10:44 UTC · 2 captures of this ZIP | 2025-12 | N019668-003 | CARDURA | EQ 4MG BASE | TABLET / ORAL | AB | RLD | 1990-11-02 | 31067a03dcf5… |
| 2025-12-14 10:44 UTC · 2 captures of this ZIP | 2025-12 | N019668-004 | CARDURA | EQ 8MG BASE | TABLET / ORAL | AB | RLD | 1990-11-02 | 31067a03dcf5… |
| 2025-08-23 18:47 UTC | 2025-08 | N019668-001 | CARDURA | EQ 1MG BASE | TABLET / ORAL | AB | RLD, RS | 1990-11-02 | 6a471c1ec25d… |
| 2025-08-23 18:47 UTC | 2025-08 | N019668-002 | CARDURA | EQ 2MG BASE | TABLET / ORAL | AB | RLD | 1990-11-02 | 6a471c1ec25d… |
| 2025-08-23 18:47 UTC | 2025-08 | N019668-003 | CARDURA | EQ 4MG BASE | TABLET / ORAL | AB | RLD | 1990-11-02 | 6a471c1ec25d… |
| 2025-08-23 18:47 UTC | 2025-08 | N019668-004 | CARDURA | EQ 8MG BASE | TABLET / ORAL | AB | RLD | 1990-11-02 | 6a471c1ec25d… |
| 2025-03-22 03:13 UTC · 3 captures of this ZIP | 2025-03 | N019668-001 | CARDURA | EQ 1MG BASE | TABLET / ORAL | AB | RLD, RS | 1990-11-02 | fd3edfee7708… |
| 2025-03-22 03:13 UTC · 3 captures of this ZIP | 2025-03 | N019668-002 | CARDURA | EQ 2MG BASE | TABLET / ORAL | AB | RLD | 1990-11-02 | fd3edfee7708… |
| 2025-03-22 03:13 UTC · 3 captures of this ZIP | 2025-03 | N019668-003 | CARDURA | EQ 4MG BASE | TABLET / ORAL | AB | RLD | 1990-11-02 | fd3edfee7708… |
| 2025-03-22 03:13 UTC · 3 captures of this ZIP | 2025-03 | N019668-004 | CARDURA | EQ 8MG BASE | TABLET / ORAL | AB | RLD | 1990-11-02 | fd3edfee7708… |
| 2025-02-26 10:13 UTC · 3 captures of this ZIP | 2025-02 | N019668-001 | CARDURA | EQ 1MG BASE | TABLET / ORAL | AB | RLD, RS | 1990-11-02 | b8a1b40f171c… |
| 2025-02-26 10:13 UTC · 3 captures of this ZIP | 2025-02 | N019668-002 | CARDURA | EQ 2MG BASE | TABLET / ORAL | AB | RLD | 1990-11-02 | b8a1b40f171c… |
| 2025-02-26 10:13 UTC · 3 captures of this ZIP | 2025-02 | N019668-003 | CARDURA | EQ 4MG BASE | TABLET / ORAL | AB | RLD | 1990-11-02 | b8a1b40f171c… |
| 2025-02-26 10:13 UTC · 3 captures of this ZIP | 2025-02 | N019668-004 | CARDURA | EQ 8MG BASE | TABLET / ORAL | AB | RLD | 1990-11-02 | b8a1b40f171c… |
| 2025-01-19 17:59 UTC · 7 captures of this ZIP | 2025-01 | N019668-001 | CARDURA | EQ 1MG BASE | TABLET / ORAL | AB | RLD, RS | 1990-11-02 | 03ed91905a0d… |
| 2025-01-19 17:59 UTC · 7 captures of this ZIP | 2025-01 | N019668-002 | CARDURA | EQ 2MG BASE | TABLET / ORAL | AB | RLD | 1990-11-02 | 03ed91905a0d… |
| 2025-01-19 17:59 UTC · 7 captures of this ZIP | 2025-01 | N019668-003 | CARDURA | EQ 4MG BASE | TABLET / ORAL | AB | RLD | 1990-11-02 | 03ed91905a0d… |
| 2025-01-19 17:59 UTC · 7 captures of this ZIP | 2025-01 | N019668-004 | CARDURA | EQ 8MG BASE | TABLET / ORAL | AB | RLD | 1990-11-02 | 03ed91905a0d… |
| 2024-12-13 21:23 UTC · 2 captures of this ZIP | 2024-12 | N019668-001 | CARDURA | EQ 1MG BASE | TABLET / ORAL | AB | RLD, RS | 1990-11-02 | 2680178bc6a6… |
| 2024-12-13 21:23 UTC · 2 captures of this ZIP | 2024-12 | N019668-002 | CARDURA | EQ 2MG BASE | TABLET / ORAL | AB | RLD | 1990-11-02 | 2680178bc6a6… |
| 2024-12-13 21:23 UTC · 2 captures of this ZIP | 2024-12 | N019668-003 | CARDURA | EQ 4MG BASE | TABLET / ORAL | AB | RLD | 1990-11-02 | 2680178bc6a6… |
| 2024-12-13 21:23 UTC · 2 captures of this ZIP | 2024-12 | N019668-004 | CARDURA | EQ 8MG BASE | TABLET / ORAL | AB | RLD | 1990-11-02 | 2680178bc6a6… |
| 2024-09-14 05:58 UTC · 2 captures of this ZIP | 2024-09 | N019668-001 | CARDURA | EQ 1MG BASE | TABLET / ORAL | AB | RLD, RS | 1990-11-02 | 5bbf6a4d5a75… |
| 2024-09-14 05:58 UTC · 2 captures of this ZIP | 2024-09 | N019668-002 | CARDURA | EQ 2MG BASE | TABLET / ORAL | AB | RLD | 1990-11-02 | 5bbf6a4d5a75… |
| 2024-09-14 05:58 UTC · 2 captures of this ZIP | 2024-09 | N019668-003 | CARDURA | EQ 4MG BASE | TABLET / ORAL | AB | RLD | 1990-11-02 | 5bbf6a4d5a75… |
| 2024-09-14 05:58 UTC · 2 captures of this ZIP | 2024-09 | N019668-004 | CARDURA | EQ 8MG BASE | TABLET / ORAL | AB | RLD | 1990-11-02 | 5bbf6a4d5a75… |
| 2024-11-08 22:44 UTC · 3 captures of this ZIP | 2024-11 | N019668-001 | CARDURA | EQ 1MG BASE | TABLET / ORAL | AB | RLD, RS | 1990-11-02 | d8e5a09893c0… |
| 2024-11-08 22:44 UTC · 3 captures of this ZIP | 2024-11 | N019668-002 | CARDURA | EQ 2MG BASE | TABLET / ORAL | AB | RLD | 1990-11-02 | d8e5a09893c0… |
| 2024-11-08 22:44 UTC · 3 captures of this ZIP | 2024-11 | N019668-003 | CARDURA | EQ 4MG BASE | TABLET / ORAL | AB | RLD | 1990-11-02 | d8e5a09893c0… |
| 2024-11-08 22:44 UTC · 3 captures of this ZIP | 2024-11 | N019668-004 | CARDURA | EQ 8MG BASE | TABLET / ORAL | AB | RLD | 1990-11-02 | d8e5a09893c0… |
| 2024-10-29 15:01 UTC | 2024-10 | N019668-001 | CARDURA | EQ 1MG BASE | TABLET / ORAL | AB | RLD, RS | 1990-11-02 | d06236e962d9… |
| 2024-10-29 15:01 UTC | 2024-10 | N019668-002 | CARDURA | EQ 2MG BASE | TABLET / ORAL | AB | RLD | 1990-11-02 | d06236e962d9… |
| 2024-10-29 15:01 UTC | 2024-10 | N019668-003 | CARDURA | EQ 4MG BASE | TABLET / ORAL | AB | RLD | 1990-11-02 | d06236e962d9… |
| 2024-10-29 15:01 UTC | 2024-10 | N019668-004 | CARDURA | EQ 8MG BASE | TABLET / ORAL | AB | RLD | 1990-11-02 | 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 | N019668-001 | AB | 1 | 011fe1cb6892… |
| 2026-02-19 14:30 UTC | 2026-02 | N019668-002 | AB | 1 | 011fe1cb6892… |
| 2026-02-19 14:30 UTC | 2026-02 | N019668-003 | AB | 1 | 011fe1cb6892… |
| 2026-02-19 14:30 UTC | 2026-02 | N019668-004 | AB | 1 | 011fe1cb6892… |
| 2025-12-14 10:44 UTC · 2 captures of this ZIP | 2025-12 | N019668-001 | AB | 1 | 31067a03dcf5… |
| 2025-12-14 10:44 UTC · 2 captures of this ZIP | 2025-12 | N019668-002 | AB | 1 | 31067a03dcf5… |
| 2025-12-14 10:44 UTC · 2 captures of this ZIP | 2025-12 | N019668-003 | AB | 1 | 31067a03dcf5… |
| 2025-12-14 10:44 UTC · 2 captures of this ZIP | 2025-12 | N019668-004 | AB | 1 | 31067a03dcf5… |
| 2025-08-23 18:47 UTC | 2025-08 | N019668-001 | AB | 1 | 6a471c1ec25d… |
| 2025-08-23 18:47 UTC | 2025-08 | N019668-002 | AB | 1 | 6a471c1ec25d… |
| 2025-08-23 18:47 UTC | 2025-08 | N019668-003 | AB | 1 | 6a471c1ec25d… |
| 2025-08-23 18:47 UTC | 2025-08 | N019668-004 | AB | 1 | 6a471c1ec25d… |
| 2025-03-22 03:13 UTC · 3 captures of this ZIP | 2025-03 | N019668-001 | AB | 1 | fd3edfee7708… |
| 2025-03-22 03:13 UTC · 3 captures of this ZIP | 2025-03 | N019668-002 | AB | 1 | fd3edfee7708… |
| 2025-03-22 03:13 UTC · 3 captures of this ZIP | 2025-03 | N019668-003 | AB | 1 | fd3edfee7708… |
| 2025-03-22 03:13 UTC · 3 captures of this ZIP | 2025-03 | N019668-004 | AB | 1 | fd3edfee7708… |
| 2025-02-26 10:13 UTC · 3 captures of this ZIP | 2025-02 | N019668-001 | AB | 1 | b8a1b40f171c… |
| 2025-02-26 10:13 UTC · 3 captures of this ZIP | 2025-02 | N019668-002 | AB | 1 | b8a1b40f171c… |
| 2025-02-26 10:13 UTC · 3 captures of this ZIP | 2025-02 | N019668-003 | AB | 1 | b8a1b40f171c… |
| 2025-02-26 10:13 UTC · 3 captures of this ZIP | 2025-02 | N019668-004 | AB | 1 | b8a1b40f171c… |
| 2025-01-19 17:59 UTC · 7 captures of this ZIP | 2025-01 | N019668-001 | AB | 1 | 03ed91905a0d… |
| 2025-01-19 17:59 UTC · 7 captures of this ZIP | 2025-01 | N019668-002 | AB | 1 | 03ed91905a0d… |
| 2025-01-19 17:59 UTC · 7 captures of this ZIP | 2025-01 | N019668-003 | AB | 1 | 03ed91905a0d… |
| 2025-01-19 17:59 UTC · 7 captures of this ZIP | 2025-01 | N019668-004 | AB | 1 | 03ed91905a0d… |
| 2024-12-13 21:23 UTC · 2 captures of this ZIP | 2024-12 | N019668-001 | AB | 1 | 2680178bc6a6… |
| 2024-12-13 21:23 UTC · 2 captures of this ZIP | 2024-12 | N019668-002 | AB | 1 | 2680178bc6a6… |
| 2024-12-13 21:23 UTC · 2 captures of this ZIP | 2024-12 | N019668-003 | AB | 1 | 2680178bc6a6… |
| 2024-12-13 21:23 UTC · 2 captures of this ZIP | 2024-12 | N019668-004 | AB | 1 | 2680178bc6a6… |
| 2024-09-14 05:58 UTC · 2 captures of this ZIP | 2024-09 | N019668-001 | AB | 1 | 5bbf6a4d5a75… |
| 2024-09-14 05:58 UTC · 2 captures of this ZIP | 2024-09 | N019668-002 | AB | 1 | 5bbf6a4d5a75… |
| 2024-09-14 05:58 UTC · 2 captures of this ZIP | 2024-09 | N019668-003 | AB | 1 | 5bbf6a4d5a75… |
| 2024-09-14 05:58 UTC · 2 captures of this ZIP | 2024-09 | N019668-004 | AB | 1 | 5bbf6a4d5a75… |
| 2024-11-08 22:44 UTC · 3 captures of this ZIP | 2024-11 | N019668-001 | AB | 1 | d8e5a09893c0… |
| 2024-11-08 22:44 UTC · 3 captures of this ZIP | 2024-11 | N019668-002 | AB | 1 | d8e5a09893c0… |
| 2024-11-08 22:44 UTC · 3 captures of this ZIP | 2024-11 | N019668-003 | AB | 1 | d8e5a09893c0… |
| 2024-11-08 22:44 UTC · 3 captures of this ZIP | 2024-11 | N019668-004 | AB | 1 | d8e5a09893c0… |
| 2024-10-29 15:01 UTC | 2024-10 | N019668-001 | AB | 1 | d06236e962d9… |
| 2024-10-29 15:01 UTC | 2024-10 | N019668-002 | AB | 1 | d06236e962d9… |
| 2024-10-29 15:01 UTC | 2024-10 | N019668-003 | AB | 1 | d06236e962d9… |
| 2024-10-29 15:01 UTC | 2024-10 | N019668-004 | AB | 1 | d06236e962d9… |
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.
| Brand | Generic | Manufacturer | SPL set ID | Effective date | Available safety fields | Join |
|---|---|---|---|---|---|---|
| Doxazosin mesylate | DOXAZOSIN MESYLATE | Aphena Pharma Solutions - Tennessee, LLC | 445dc831-1960-4b25-e063-6294a90a6efd | 2025-11-24 | Warnings, Adverse reactions | 019668 NDA019668 |
| Doxazosin | DOXAZOSIN | Aphena Pharma Solutions - Tennessee, LLC | 3ab222b7-74cc-5343-e063-6294a90a9616 | 2025-07-24 | Warnings, Adverse reactions | 019668 NDA019668 |
| Doxazosin mesylate | DOXAZOSIN MESYLATE | Mylan Pharmaceuticals Inc. | 2e524986-7903-416f-b2b8-d27295103e75 | 2024-03-11 | Warnings, Adverse reactions | 019668 NDA019668 |
| Cardura | DOXAZOSIN | Viatris Specialty LLC | 5e1f5e49-2da1-43ab-9795-228a8bcc5a82 | 2023-10-15 | Warnings, Adverse reactions | 019668 NDA019668 58151-076 |
| Doxazosin | DOXAZOSIN | Aphena Pharma Solutions - Tennessee, LLC | b364c7a8-72b5-4776-a500-400c37a72c9b | 2022-02-03 | Warnings, Adverse reactions | 019668 NDA019668 |
| Doxazosin | DOXAZOSIN | Mylan Pharmaceuticals Inc. | 6b887aa5-5edf-48c5-a480-dea8c35afa9d | 2022-01-20 | Warnings, Adverse reactions | 019668 NDA019668 |
| Cardura | DOXAZOSIN | ROERIG | eefc47bc-c10f-49bb-8ef7-5999f798ab39 | 2022-01-20 | Warnings, Adverse reactions | 019668 NDA019668 |
Additional Listing Data#
- Finished product
- Yes
- Brand name base
- Cardura
- Listing expiration
- 2027-12-31
Active Ingredients#
| Ingredient | Strength |
|---|---|
| DOXAZOSIN MESYLATE | 4 mg/1 |
Harmonized UNII identifiers#
| Identifier | FDA.report destination |
|---|---|
| 86P6PQK0MU | Internal UNII lookup |
Harmonized RxCUI identifiers#
Harmonized SPL set identifiers#
| Identifier | FDA.report destination |
|---|---|
| 5e1f5e49-2da1-43ab-9795-228a8bcc5a82 | 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 |
DailyMed Package Descriptions#
| Package NDC | Product | Description | Form | Quantity | Strength | SPL version |
|---|---|---|---|---|---|---|
| 58151-076-01 | Cardura | 100 in 1 BOTTLE | TABLET | 100 | 2 |
DailyMed Billing Units#
| Package NDC | Billing unit | Product NDC | DailyMed indexing SPL | SPL version | Effective |
|---|---|---|---|---|---|
| 58151-076-01 | EA - Each | 58151-076 | 6bf3c3eb-a97e-4867-b41b-deeef2696287 | 1 | 2026-02-05 |
DailyMed Dashboard NDC Coverage#
DailyMed RxNorm Mappings#
Packages#
| Package NDC | 11-digit format | Description | Units | Marketing start | Sample | Exclude flag | Status |
|---|---|---|---|---|---|---|---|
| 58151-076-01 | 58151007601 | 100 TABLET in 1 BOTTLE (58151-076-01) | 100 tablet | 2026-01-14 | No | No | Current |