Prazosin Hydrochloride
- Product NDC
- 59651-271
- 11-digit product format
- 596510271
- Labeler code
- 59651
- Product ID
- 59651-271_08114092-fa12-4f58-b08e-03cadf9f726b
- Type
- HUMAN PRESCRIPTION DRUG
- Nonproprietary name
- Prazosin Hydrochloride
- Dosage form
- CAPSULE
- Route
- ORAL
- Labeler
- Aurobindo Pharma Limited
- Application
- ANDA213052
- Marketing category
- ANDA
- Marketing start
- 2023-03-31
- Substance
- PRAZOSIN HYDROCHLORIDE
- 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
Orange Book products#
| Application-product | Trade name | Ingredient | Strength | Dosage form / route | TE codes | RLD / RS | Approval date |
|---|---|---|---|---|---|---|---|
| A213052-001 | PRAZOSIN HYDROCHLORIDE | PRAZOSIN HYDROCHLORIDE | EQ 1MG BASE | CAPSULE / ORAL | AB | 2023-03-31 | |
| A213052-002 | PRAZOSIN HYDROCHLORIDE | PRAZOSIN HYDROCHLORIDE | EQ 2MG BASE | CAPSULE / ORAL | AB | 2023-03-31 | |
| A213052-003 | PRAZOSIN HYDROCHLORIDE | PRAZOSIN HYDROCHLORIDE | EQ 5MG BASE | CAPSULE / ORAL | AB | 2023-03-31 |
Therapeutic equivalence codes#
| Application-product | TE code |
|---|---|
| A213052-001 | AB |
| A213052-002 | AB |
| A213052-003 | 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 |
|---|---|---|---|---|---|---|---|---|---|
| 2026-08-18 06:07:40 | 2026-07 | A213052-001 | PRAZOSIN HYDROCHLORIDE | EQ 1MG BASE | CAPSULE / ORAL | AB | 2023-03-31 | caaa826d4ba7… | |
| 2026-08-18 06:07:40 | 2026-07 | A213052-002 | PRAZOSIN HYDROCHLORIDE | EQ 2MG BASE | CAPSULE / ORAL | AB | 2023-03-31 | caaa826d4ba7… | |
| 2026-08-18 06:07:40 | 2026-07 | A213052-003 | PRAZOSIN HYDROCHLORIDE | EQ 5MG BASE | CAPSULE / ORAL | AB | 2023-03-31 | caaa826d4ba7… | |
| 2026-02-19 14:30 UTC | 2026-02 | A213052-001 | PRAZOSIN HYDROCHLORIDE | EQ 1MG BASE | CAPSULE / ORAL | AB | 2023-03-31 | 011fe1cb6892… | |
| 2026-02-19 14:30 UTC | 2026-02 | A213052-002 | PRAZOSIN HYDROCHLORIDE | EQ 2MG BASE | CAPSULE / ORAL | AB | 2023-03-31 | 011fe1cb6892… | |
| 2026-02-19 14:30 UTC | 2026-02 | A213052-003 | PRAZOSIN HYDROCHLORIDE | EQ 5MG BASE | CAPSULE / ORAL | AB | 2023-03-31 | 011fe1cb6892… | |
| 2025-12-14 10:44 UTC · 2 captures of this ZIP | 2025-12 | A213052-001 | PRAZOSIN HYDROCHLORIDE | EQ 1MG BASE | CAPSULE / ORAL | AB | 2023-03-31 | 31067a03dcf5… | |
| 2025-12-14 10:44 UTC · 2 captures of this ZIP | 2025-12 | A213052-002 | PRAZOSIN HYDROCHLORIDE | EQ 2MG BASE | CAPSULE / ORAL | AB | 2023-03-31 | 31067a03dcf5… | |
| 2025-12-14 10:44 UTC · 2 captures of this ZIP | 2025-12 | A213052-003 | PRAZOSIN HYDROCHLORIDE | EQ 5MG BASE | CAPSULE / ORAL | AB | 2023-03-31 | 31067a03dcf5… | |
| 2025-08-23 18:47 UTC | 2025-08 | A213052-001 | PRAZOSIN HYDROCHLORIDE | EQ 1MG BASE | CAPSULE / ORAL | AB | 2023-03-31 | 6a471c1ec25d… | |
| 2025-08-23 18:47 UTC | 2025-08 | A213052-002 | PRAZOSIN HYDROCHLORIDE | EQ 2MG BASE | CAPSULE / ORAL | AB | 2023-03-31 | 6a471c1ec25d… | |
| 2025-08-23 18:47 UTC | 2025-08 | A213052-003 | PRAZOSIN HYDROCHLORIDE | EQ 5MG BASE | CAPSULE / ORAL | AB | 2023-03-31 | 6a471c1ec25d… | |
| 2025-03-22 03:13 UTC · 3 captures of this ZIP | 2025-03 | A213052-001 | PRAZOSIN HYDROCHLORIDE | EQ 1MG BASE | CAPSULE / ORAL | AB | 2023-03-31 | fd3edfee7708… | |
| 2025-03-22 03:13 UTC · 3 captures of this ZIP | 2025-03 | A213052-002 | PRAZOSIN HYDROCHLORIDE | EQ 2MG BASE | CAPSULE / ORAL | AB | 2023-03-31 | fd3edfee7708… | |
| 2025-03-22 03:13 UTC · 3 captures of this ZIP | 2025-03 | A213052-003 | PRAZOSIN HYDROCHLORIDE | EQ 5MG BASE | CAPSULE / ORAL | AB | 2023-03-31 | fd3edfee7708… | |
| 2025-02-26 10:13 UTC · 3 captures of this ZIP | 2025-02 | A213052-001 | PRAZOSIN HYDROCHLORIDE | EQ 1MG BASE | CAPSULE / ORAL | AB | 2023-03-31 | b8a1b40f171c… | |
| 2025-02-26 10:13 UTC · 3 captures of this ZIP | 2025-02 | A213052-002 | PRAZOSIN HYDROCHLORIDE | EQ 2MG BASE | CAPSULE / ORAL | AB | 2023-03-31 | b8a1b40f171c… | |
| 2025-02-26 10:13 UTC · 3 captures of this ZIP | 2025-02 | A213052-003 | PRAZOSIN HYDROCHLORIDE | EQ 5MG BASE | CAPSULE / ORAL | AB | 2023-03-31 | b8a1b40f171c… | |
| 2025-01-19 17:59 UTC · 7 captures of this ZIP | 2025-01 | A213052-001 | PRAZOSIN HYDROCHLORIDE | EQ 1MG BASE | CAPSULE / ORAL | AB | 2023-03-31 | 03ed91905a0d… | |
| 2025-01-19 17:59 UTC · 7 captures of this ZIP | 2025-01 | A213052-002 | PRAZOSIN HYDROCHLORIDE | EQ 2MG BASE | CAPSULE / ORAL | AB | 2023-03-31 | 03ed91905a0d… | |
| 2025-01-19 17:59 UTC · 7 captures of this ZIP | 2025-01 | A213052-003 | PRAZOSIN HYDROCHLORIDE | EQ 5MG BASE | CAPSULE / ORAL | AB | 2023-03-31 | 03ed91905a0d… | |
| 2024-12-13 21:23 UTC · 2 captures of this ZIP | 2024-12 | A213052-001 | PRAZOSIN HYDROCHLORIDE | EQ 1MG BASE | CAPSULE / ORAL | AB | 2023-03-31 | 2680178bc6a6… | |
| 2024-12-13 21:23 UTC · 2 captures of this ZIP | 2024-12 | A213052-002 | PRAZOSIN HYDROCHLORIDE | EQ 2MG BASE | CAPSULE / ORAL | AB | 2023-03-31 | 2680178bc6a6… | |
| 2024-12-13 21:23 UTC · 2 captures of this ZIP | 2024-12 | A213052-003 | PRAZOSIN HYDROCHLORIDE | EQ 5MG BASE | CAPSULE / ORAL | AB | 2023-03-31 | 2680178bc6a6… | |
| 2024-09-14 05:58 UTC · 2 captures of this ZIP | 2024-09 | A213052-001 | PRAZOSIN HYDROCHLORIDE | EQ 1MG BASE | CAPSULE / ORAL | AB | 2023-03-31 | 5bbf6a4d5a75… | |
| 2024-09-14 05:58 UTC · 2 captures of this ZIP | 2024-09 | A213052-002 | PRAZOSIN HYDROCHLORIDE | EQ 2MG BASE | CAPSULE / ORAL | AB | 2023-03-31 | 5bbf6a4d5a75… | |
| 2024-09-14 05:58 UTC · 2 captures of this ZIP | 2024-09 | A213052-003 | PRAZOSIN HYDROCHLORIDE | EQ 5MG BASE | CAPSULE / ORAL | AB | 2023-03-31 | 5bbf6a4d5a75… | |
| 2024-11-08 22:44 UTC · 3 captures of this ZIP | 2024-11 | A213052-001 | PRAZOSIN HYDROCHLORIDE | EQ 1MG BASE | CAPSULE / ORAL | AB | 2023-03-31 | d8e5a09893c0… | |
| 2024-11-08 22:44 UTC · 3 captures of this ZIP | 2024-11 | A213052-002 | PRAZOSIN HYDROCHLORIDE | EQ 2MG BASE | CAPSULE / ORAL | AB | 2023-03-31 | d8e5a09893c0… | |
| 2024-11-08 22:44 UTC · 3 captures of this ZIP | 2024-11 | A213052-003 | PRAZOSIN HYDROCHLORIDE | EQ 5MG BASE | CAPSULE / ORAL | AB | 2023-03-31 | d8e5a09893c0… | |
| 2024-10-29 15:01 UTC | 2024-10 | A213052-001 | PRAZOSIN HYDROCHLORIDE | EQ 1MG BASE | CAPSULE / ORAL | AB | 2023-03-31 | d06236e962d9… | |
| 2024-10-29 15:01 UTC | 2024-10 | A213052-002 | PRAZOSIN HYDROCHLORIDE | EQ 2MG BASE | CAPSULE / ORAL | AB | 2023-03-31 | d06236e962d9… | |
| 2024-10-29 15:01 UTC | 2024-10 | A213052-003 | PRAZOSIN HYDROCHLORIDE | EQ 5MG BASE | CAPSULE / ORAL | AB | 2023-03-31 | d06236e962d9… | |
| 2024-08-13 05:28 UTC · 3 captures of this ZIP | 2024-08 | A213052-001 | PRAZOSIN HYDROCHLORIDE | EQ 1MG BASE | CAPSULE / ORAL | AB | 2023-03-31 | 79d66fd596c7… | |
| 2024-08-13 05:28 UTC · 3 captures of this ZIP | 2024-08 | A213052-002 | PRAZOSIN HYDROCHLORIDE | EQ 2MG BASE | CAPSULE / ORAL | AB | 2023-03-31 | 79d66fd596c7… | |
| 2024-08-13 05:28 UTC · 3 captures of this ZIP | 2024-08 | A213052-003 | PRAZOSIN HYDROCHLORIDE | EQ 5MG BASE | CAPSULE / ORAL | AB | 2023-03-31 | 79d66fd596c7… | |
| 2024-07-13 05:37 UTC · 2 captures of this ZIP | 2024-07 | A213052-001 | PRAZOSIN HYDROCHLORIDE | EQ 1MG BASE | CAPSULE / ORAL | AB | 2023-03-31 | 301d65b070ca… | |
| 2024-07-13 05:37 UTC · 2 captures of this ZIP | 2024-07 | A213052-002 | PRAZOSIN HYDROCHLORIDE | EQ 2MG BASE | CAPSULE / ORAL | AB | 2023-03-31 | 301d65b070ca… | |
| 2024-07-13 05:37 UTC · 2 captures of this ZIP | 2024-07 | A213052-003 | PRAZOSIN HYDROCHLORIDE | EQ 5MG BASE | CAPSULE / ORAL | AB | 2023-03-31 | 301d65b070ca… | |
| 2024-06-18 03:08 UTC · 5 captures of this ZIP | 2024-06 | A213052-001 | PRAZOSIN HYDROCHLORIDE | EQ 1MG BASE | CAPSULE / ORAL | AB | 2023-03-31 | 1e350fbaab3a… |
Observed Orange Book normalized TE history#
| Captured | Edition | Application-product | TE code | Order | Source SHA-256 |
|---|---|---|---|---|---|
| 2026-08-18 06:07:40 | 2026-07 | A213052-001 | AB | 1 | caaa826d4ba7… |
| 2026-08-18 06:07:40 | 2026-07 | A213052-002 | AB | 1 | caaa826d4ba7… |
| 2026-08-18 06:07:40 | 2026-07 | A213052-003 | AB | 1 | caaa826d4ba7… |
| 2026-02-19 14:30 UTC | 2026-02 | A213052-001 | AB | 1 | 011fe1cb6892… |
| 2026-02-19 14:30 UTC | 2026-02 | A213052-002 | AB | 1 | 011fe1cb6892… |
| 2026-02-19 14:30 UTC | 2026-02 | A213052-003 | AB | 1 | 011fe1cb6892… |
| 2025-12-14 10:44 UTC · 2 captures of this ZIP | 2025-12 | A213052-001 | AB | 1 | 31067a03dcf5… |
| 2025-12-14 10:44 UTC · 2 captures of this ZIP | 2025-12 | A213052-002 | AB | 1 | 31067a03dcf5… |
| 2025-12-14 10:44 UTC · 2 captures of this ZIP | 2025-12 | A213052-003 | AB | 1 | 31067a03dcf5… |
| 2025-08-23 18:47 UTC | 2025-08 | A213052-001 | AB | 1 | 6a471c1ec25d… |
| 2025-08-23 18:47 UTC | 2025-08 | A213052-002 | AB | 1 | 6a471c1ec25d… |
| 2025-08-23 18:47 UTC | 2025-08 | A213052-003 | AB | 1 | 6a471c1ec25d… |
| 2025-03-22 03:13 UTC · 3 captures of this ZIP | 2025-03 | A213052-001 | AB | 1 | fd3edfee7708… |
| 2025-03-22 03:13 UTC · 3 captures of this ZIP | 2025-03 | A213052-002 | AB | 1 | fd3edfee7708… |
| 2025-03-22 03:13 UTC · 3 captures of this ZIP | 2025-03 | A213052-003 | AB | 1 | fd3edfee7708… |
| 2025-02-26 10:13 UTC · 3 captures of this ZIP | 2025-02 | A213052-001 | AB | 1 | b8a1b40f171c… |
| 2025-02-26 10:13 UTC · 3 captures of this ZIP | 2025-02 | A213052-002 | AB | 1 | b8a1b40f171c… |
| 2025-02-26 10:13 UTC · 3 captures of this ZIP | 2025-02 | A213052-003 | AB | 1 | b8a1b40f171c… |
| 2025-01-19 17:59 UTC · 7 captures of this ZIP | 2025-01 | A213052-001 | AB | 1 | 03ed91905a0d… |
| 2025-01-19 17:59 UTC · 7 captures of this ZIP | 2025-01 | A213052-002 | AB | 1 | 03ed91905a0d… |
| 2025-01-19 17:59 UTC · 7 captures of this ZIP | 2025-01 | A213052-003 | AB | 1 | 03ed91905a0d… |
| 2024-12-13 21:23 UTC · 2 captures of this ZIP | 2024-12 | A213052-001 | AB | 1 | 2680178bc6a6… |
| 2024-12-13 21:23 UTC · 2 captures of this ZIP | 2024-12 | A213052-002 | AB | 1 | 2680178bc6a6… |
| 2024-12-13 21:23 UTC · 2 captures of this ZIP | 2024-12 | A213052-003 | AB | 1 | 2680178bc6a6… |
| 2024-09-14 05:58 UTC · 2 captures of this ZIP | 2024-09 | A213052-001 | AB | 1 | 5bbf6a4d5a75… |
| 2024-09-14 05:58 UTC · 2 captures of this ZIP | 2024-09 | A213052-002 | AB | 1 | 5bbf6a4d5a75… |
| 2024-09-14 05:58 UTC · 2 captures of this ZIP | 2024-09 | A213052-003 | AB | 1 | 5bbf6a4d5a75… |
| 2024-11-08 22:44 UTC · 3 captures of this ZIP | 2024-11 | A213052-001 | AB | 1 | d8e5a09893c0… |
| 2024-11-08 22:44 UTC · 3 captures of this ZIP | 2024-11 | A213052-002 | AB | 1 | d8e5a09893c0… |
| 2024-11-08 22:44 UTC · 3 captures of this ZIP | 2024-11 | A213052-003 | AB | 1 | d8e5a09893c0… |
| 2024-10-29 15:01 UTC | 2024-10 | A213052-001 | AB | 1 | d06236e962d9… |
| 2024-10-29 15:01 UTC | 2024-10 | A213052-002 | AB | 1 | d06236e962d9… |
| 2024-10-29 15:01 UTC | 2024-10 | A213052-003 | AB | 1 | d06236e962d9… |
| 2024-08-13 05:28 UTC · 3 captures of this ZIP | 2024-08 | A213052-001 | AB | 1 | 79d66fd596c7… |
| 2024-08-13 05:28 UTC · 3 captures of this ZIP | 2024-08 | A213052-002 | AB | 1 | 79d66fd596c7… |
| 2024-08-13 05:28 UTC · 3 captures of this ZIP | 2024-08 | A213052-003 | AB | 1 | 79d66fd596c7… |
| 2024-07-13 05:37 UTC · 2 captures of this ZIP | 2024-07 | A213052-001 | AB | 1 | 301d65b070ca… |
| 2024-07-13 05:37 UTC · 2 captures of this ZIP | 2024-07 | A213052-002 | AB | 1 | 301d65b070ca… |
| 2024-07-13 05:37 UTC · 2 captures of this ZIP | 2024-07 | A213052-003 | AB | 1 | 301d65b070ca… |
| 2024-06-18 03:08 UTC · 5 captures of this ZIP | 2024-06 | A213052-001 | AB | 1 | 1e350fbaab3a… |
Additional Listing Data#
- Finished product
- Yes
- Brand name base
- Prazosin Hydrochloride
- Listing expiration
- 2026-12-31
Active Ingredients#
| Ingredient | Strength |
|---|---|
| PRAZOSIN HYDROCHLORIDE | 1 mg/1 |
Harmonized UNII identifiers#
| Identifier | FDA.report destination |
|---|---|
| X0Z7454B90 | Internal UNII lookup |
Harmonized RxCUI identifiers#
Harmonized SPL set identifiers#
| Identifier | FDA.report destination |
|---|---|
| 08114092-fa12-4f58-b08e-03cadf9f726b | Available on FDA.report |
DailyMed Product Concepts#
| Product concept | Relation | Version | Effective |
|---|---|---|---|
| d5a3de99-75de-4527-38ae-07b1328b93cb | Product name | 5 | 20250331 |
DailyMed Package Descriptions#
| Package NDC | Product | Description | Form | Quantity | Strength | SPL version |
|---|---|---|---|---|---|---|
| 59651-271-01 | Prazosin Hydrochloride | 100 in 1 BOTTLE | CAPSULE | 100 | 1 | |
| 59651-271-99 | Prazosin Hydrochloride | 1000 in 1 BOTTLE | CAPSULE | 1000 | 1 |
DailyMed Billing Units#
| Package NDC | Billing unit | Product NDC | DailyMed indexing SPL | SPL version | Effective |
|---|---|---|---|---|---|
| 59651-271-01 | EA - Each | 59651-271 | 0a562f41-c92b-46da-84ca-a96d4ae6cc72 | 1 | 2024-02-14 |
| 59651-271-99 | EA - Each | 59651-271 | 7c2fc4bb-2ef1-4cd5-b20b-0deb34252efd | 1 | 2024-02-14 |
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 |
|---|---|---|---|---|---|---|
| Prazosin Hydrochloride | PRAZOSIN HYDROCHLORIDE | Unit Dose Solutions, Inc. | 558ea3fc-0bfc-32a0-e063-6294a90ae106 | 2026-07-01 | Warnings, Adverse reactions | 213052 ANDA213052 |
| Prazosin Hydrochloride | PRAZOSIN HYDROCHLORIDE | Unit Dose Solutions, Inc. | 559082c2-4130-a2bc-e063-6294a90ab781 | 2026-07-01 | Warnings, Adverse reactions | 213052 ANDA213052 |
| Prazosin Hydrochloride | PRAZOSIN HYDROCHLORIDE | Coupler LLC | 52ce82b0-3cb5-b5b2-e063-6394a90a9f12 | 2026-05-27 | Warnings, Adverse reactions | 213052 ANDA213052 |
| Prazosin Hydrochloride | PRAZOSIN HYDROCHLORIDE | Aphena Pharma Solutions - Tennessee, LLC | 4870ed0b-abde-5ae5-e063-6394a90ad0ba | 2026-01-15 | Warnings, Adverse reactions | 213052 ANDA213052 |
| Prazosin Hydrochloride | PRAZOSIN HYDROCHLORIDE | REMEDYREPACK INC. | 2aa62e0a-442d-41af-a2d8-0b8f88d23319 | 2025-10-01 | Warnings, Adverse reactions | 213052 ANDA213052 |
| Prazosin Hydrochloride | PRAZOSIN HYDROCHLORIDE | Aurobindo Pharma Limited | 08114092-fa12-4f58-b08e-03cadf9f726b | 2023-04-04 | Warnings, Adverse reactions | 213052 ANDA213052 59651-271 |
DailyMed RxNorm Mappings#
| RxCUI | RxNorm string | TTY | DailyMed | SPL version |
|---|---|---|---|---|
| 312593 | prazosin HCl 1 MG Oral Capsule | PSN | 08114092-fa12-4f58-b08e-03cadf9f726b | 1 |
| 312593 | prazosin HCl 1 MG Oral Capsule | PSN | 2aa62e0a-442d-41af-a2d8-0b8f88d23319 | 1 |
| 312594 | prazosin HCl 2 MG Oral Capsule | PSN | 08114092-fa12-4f58-b08e-03cadf9f726b | 1 |
| 198141 | prazosin HCl 5 MG Oral Capsule | PSN | 08114092-fa12-4f58-b08e-03cadf9f726b | 1 |
| 312593 | prazosin 1 MG Oral Capsule | SCD | 08114092-fa12-4f58-b08e-03cadf9f726b | 1 |
| 312593 | prazosin 1 MG Oral Capsule | SCD | 2aa62e0a-442d-41af-a2d8-0b8f88d23319 | 1 |
| 312594 | prazosin 2 MG Oral Capsule | SCD | 08114092-fa12-4f58-b08e-03cadf9f726b | 1 |
| 198141 | prazosin 5 MG Oral Capsule | SCD | 08114092-fa12-4f58-b08e-03cadf9f726b | 1 |
| 312593 | prazosin (as prazosin HCl) 1 MG Oral Capsule | SY | 08114092-fa12-4f58-b08e-03cadf9f726b | 1 |
| 312593 | prazosin (as prazosin HCl) 1 MG Oral Capsule | SY | 2aa62e0a-442d-41af-a2d8-0b8f88d23319 | 1 |
| 312594 | prazosin (as prazosin HCl) 2 MG Oral Capsule | SY | 08114092-fa12-4f58-b08e-03cadf9f726b | 1 |
| 198141 | prazosin (as prazosin HCl) 5 MG Oral Capsule | SY | 08114092-fa12-4f58-b08e-03cadf9f726b | 1 |
Packages#
| Package NDC | 11-digit format | Description | Units | Marketing start | Sample | Exclude flag | Status |
|---|---|---|---|---|---|---|---|
| 59651-271-01 | 59651027101 | 100 CAPSULE in 1 BOTTLE (59651-271-01) | 100 capsule | 2023-03-31 | No | No | Current |
| 59651-271-99 | 59651027199 | 1000 CAPSULE in 1 BOTTLE (59651-271-99) | 1000 capsule | 2023-03-31 | No | No | Current |