Prazosin Hydrochloride
- Product NDC
- 43063-260
- 11-digit product format
- 430630260
- Labeler code
- 43063
- Product ID
- 43063-260_41acdd32-11a7-fe53-e063-6394a90a3623
- Type
- HUMAN PRESCRIPTION DRUG
- Nonproprietary name
- prazosin hydrochloride
- Dosage form
- CAPSULE
- Route
- ORAL
- Labeler
- PD-Rx Pharmaceuticals, Inc.
- Application
- ANDA072575
- Marketing category
- ANDA
- Marketing start
- 1989-02-28
- Substance
- PRAZOSIN HYDROCHLORIDE
- Active strength
- 2 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 |
|---|---|---|---|---|---|---|---|
| A072575-001 | PRAZOSIN HYDROCHLORIDE | PRAZOSIN HYDROCHLORIDE | EQ 5MG BASE | CAPSULE / ORAL | AB | 1989-05-16 | |
| A072575-002 | PRAZOSIN HYDROCHLORIDE | PRAZOSIN HYDROCHLORIDE | EQ 2MG BASE | CAPSULE / ORAL | AB | 1989-05-16 | |
| A072575-003 | PRAZOSIN HYDROCHLORIDE | PRAZOSIN HYDROCHLORIDE | EQ 1MG BASE | CAPSULE / ORAL | AB | 1989-05-16 |
Therapeutic equivalence codes#
| Application-product | TE code |
|---|---|
| A072575-001 | AB |
| A072575-002 | AB |
| A072575-003 | 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 |
|---|---|---|---|---|---|---|---|---|---|
| 2026-02-19 14:30 UTC | 2026-02 | A072575-001 | PRAZOSIN HYDROCHLORIDE | EQ 5MG BASE | CAPSULE / ORAL | AB | 1989-05-16 | 011fe1cb6892… | |
| 2026-02-19 14:30 UTC | 2026-02 | A072575-002 | PRAZOSIN HYDROCHLORIDE | EQ 2MG BASE | CAPSULE / ORAL | AB | 1989-05-16 | 011fe1cb6892… | |
| 2026-02-19 14:30 UTC | 2026-02 | A072575-003 | PRAZOSIN HYDROCHLORIDE | EQ 1MG BASE | CAPSULE / ORAL | AB | 1989-05-16 | 011fe1cb6892… | |
| 2025-12-14 10:44 UTC · 2 captures of this ZIP | 2025-12 | A072575-001 | PRAZOSIN HYDROCHLORIDE | EQ 5MG BASE | CAPSULE / ORAL | AB | 1989-05-16 | 31067a03dcf5… | |
| 2025-12-14 10:44 UTC · 2 captures of this ZIP | 2025-12 | A072575-002 | PRAZOSIN HYDROCHLORIDE | EQ 2MG BASE | CAPSULE / ORAL | AB | 1989-05-16 | 31067a03dcf5… | |
| 2025-12-14 10:44 UTC · 2 captures of this ZIP | 2025-12 | A072575-003 | PRAZOSIN HYDROCHLORIDE | EQ 1MG BASE | CAPSULE / ORAL | AB | 1989-05-16 | 31067a03dcf5… | |
| 2025-08-23 18:47 UTC | 2025-08 | A072575-001 | PRAZOSIN HYDROCHLORIDE | EQ 5MG BASE | CAPSULE / ORAL | AB | 1989-05-16 | 6a471c1ec25d… | |
| 2025-08-23 18:47 UTC | 2025-08 | A072575-002 | PRAZOSIN HYDROCHLORIDE | EQ 2MG BASE | CAPSULE / ORAL | AB | 1989-05-16 | 6a471c1ec25d… | |
| 2025-08-23 18:47 UTC | 2025-08 | A072575-003 | PRAZOSIN HYDROCHLORIDE | EQ 1MG BASE | CAPSULE / ORAL | AB | 1989-05-16 | 6a471c1ec25d… | |
| 2025-03-22 03:13 UTC · 3 captures of this ZIP | 2025-03 | A072575-001 | PRAZOSIN HYDROCHLORIDE | EQ 5MG BASE | CAPSULE / ORAL | AB | 1989-05-16 | fd3edfee7708… | |
| 2025-03-22 03:13 UTC · 3 captures of this ZIP | 2025-03 | A072575-002 | PRAZOSIN HYDROCHLORIDE | EQ 2MG BASE | CAPSULE / ORAL | AB | 1989-05-16 | fd3edfee7708… | |
| 2025-03-22 03:13 UTC · 3 captures of this ZIP | 2025-03 | A072575-003 | PRAZOSIN HYDROCHLORIDE | EQ 1MG BASE | CAPSULE / ORAL | AB | 1989-05-16 | fd3edfee7708… | |
| 2025-02-26 10:13 UTC · 3 captures of this ZIP | 2025-02 | A072575-001 | PRAZOSIN HYDROCHLORIDE | EQ 5MG BASE | CAPSULE / ORAL | AB | 1989-05-16 | b8a1b40f171c… | |
| 2025-02-26 10:13 UTC · 3 captures of this ZIP | 2025-02 | A072575-002 | PRAZOSIN HYDROCHLORIDE | EQ 2MG BASE | CAPSULE / ORAL | AB | 1989-05-16 | b8a1b40f171c… | |
| 2025-02-26 10:13 UTC · 3 captures of this ZIP | 2025-02 | A072575-003 | PRAZOSIN HYDROCHLORIDE | EQ 1MG BASE | CAPSULE / ORAL | AB | 1989-05-16 | b8a1b40f171c… | |
| 2025-01-19 17:59 UTC · 7 captures of this ZIP | 2025-01 | A072575-001 | PRAZOSIN HYDROCHLORIDE | EQ 5MG BASE | CAPSULE / ORAL | AB | 1989-05-16 | 03ed91905a0d… | |
| 2025-01-19 17:59 UTC · 7 captures of this ZIP | 2025-01 | A072575-002 | PRAZOSIN HYDROCHLORIDE | EQ 2MG BASE | CAPSULE / ORAL | AB | 1989-05-16 | 03ed91905a0d… | |
| 2025-01-19 17:59 UTC · 7 captures of this ZIP | 2025-01 | A072575-003 | PRAZOSIN HYDROCHLORIDE | EQ 1MG BASE | CAPSULE / ORAL | AB | 1989-05-16 | 03ed91905a0d… | |
| 2024-12-13 21:23 UTC · 2 captures of this ZIP | 2024-12 | A072575-001 | PRAZOSIN HYDROCHLORIDE | EQ 5MG BASE | CAPSULE / ORAL | AB | 1989-05-16 | 2680178bc6a6… | |
| 2024-12-13 21:23 UTC · 2 captures of this ZIP | 2024-12 | A072575-002 | PRAZOSIN HYDROCHLORIDE | EQ 2MG BASE | CAPSULE / ORAL | AB | 1989-05-16 | 2680178bc6a6… | |
| 2024-12-13 21:23 UTC · 2 captures of this ZIP | 2024-12 | A072575-003 | PRAZOSIN HYDROCHLORIDE | EQ 1MG BASE | CAPSULE / ORAL | AB | 1989-05-16 | 2680178bc6a6… | |
| 2024-09-14 05:58 UTC · 2 captures of this ZIP | 2024-09 | A072575-001 | PRAZOSIN HYDROCHLORIDE | EQ 5MG BASE | CAPSULE / ORAL | AB | 1989-05-16 | 5bbf6a4d5a75… | |
| 2024-09-14 05:58 UTC · 2 captures of this ZIP | 2024-09 | A072575-002 | PRAZOSIN HYDROCHLORIDE | EQ 2MG BASE | CAPSULE / ORAL | AB | 1989-05-16 | 5bbf6a4d5a75… | |
| 2024-09-14 05:58 UTC · 2 captures of this ZIP | 2024-09 | A072575-003 | PRAZOSIN HYDROCHLORIDE | EQ 1MG BASE | CAPSULE / ORAL | AB | 1989-05-16 | 5bbf6a4d5a75… | |
| 2024-11-08 22:44 UTC · 3 captures of this ZIP | 2024-11 | A072575-001 | PRAZOSIN HYDROCHLORIDE | EQ 5MG BASE | CAPSULE / ORAL | AB | 1989-05-16 | d8e5a09893c0… | |
| 2024-11-08 22:44 UTC · 3 captures of this ZIP | 2024-11 | A072575-002 | PRAZOSIN HYDROCHLORIDE | EQ 2MG BASE | CAPSULE / ORAL | AB | 1989-05-16 | d8e5a09893c0… | |
| 2024-11-08 22:44 UTC · 3 captures of this ZIP | 2024-11 | A072575-003 | PRAZOSIN HYDROCHLORIDE | EQ 1MG BASE | CAPSULE / ORAL | AB | 1989-05-16 | d8e5a09893c0… | |
| 2024-10-29 15:01 UTC | 2024-10 | A072575-001 | PRAZOSIN HYDROCHLORIDE | EQ 5MG BASE | CAPSULE / ORAL | AB | 1989-05-16 | d06236e962d9… | |
| 2024-10-29 15:01 UTC | 2024-10 | A072575-002 | PRAZOSIN HYDROCHLORIDE | EQ 2MG BASE | CAPSULE / ORAL | AB | 1989-05-16 | d06236e962d9… | |
| 2024-10-29 15:01 UTC | 2024-10 | A072575-003 | PRAZOSIN HYDROCHLORIDE | EQ 1MG BASE | CAPSULE / ORAL | AB | 1989-05-16 | d06236e962d9… | |
| 2024-08-13 05:28 UTC · 3 captures of this ZIP | 2024-08 | A072575-001 | PRAZOSIN HYDROCHLORIDE | EQ 5MG BASE | CAPSULE / ORAL | AB | 1989-05-16 | 79d66fd596c7… | |
| 2024-08-13 05:28 UTC · 3 captures of this ZIP | 2024-08 | A072575-002 | PRAZOSIN HYDROCHLORIDE | EQ 2MG BASE | CAPSULE / ORAL | AB | 1989-05-16 | 79d66fd596c7… | |
| 2024-08-13 05:28 UTC · 3 captures of this ZIP | 2024-08 | A072575-003 | PRAZOSIN HYDROCHLORIDE | EQ 1MG BASE | CAPSULE / ORAL | AB | 1989-05-16 | 79d66fd596c7… | |
| 2024-07-13 05:37 UTC · 2 captures of this ZIP | 2024-07 | A072575-001 | PRAZOSIN HYDROCHLORIDE | EQ 5MG BASE | CAPSULE / ORAL | AB | 1989-05-16 | 301d65b070ca… | |
| 2024-07-13 05:37 UTC · 2 captures of this ZIP | 2024-07 | A072575-002 | PRAZOSIN HYDROCHLORIDE | EQ 2MG BASE | CAPSULE / ORAL | AB | 1989-05-16 | 301d65b070ca… | |
| 2024-07-13 05:37 UTC · 2 captures of this ZIP | 2024-07 | A072575-003 | PRAZOSIN HYDROCHLORIDE | EQ 1MG BASE | CAPSULE / ORAL | AB | 1989-05-16 | 301d65b070ca… | |
| 2024-06-18 03:08 UTC · 5 captures of this ZIP | 2024-06 | A072575-001 | PRAZOSIN HYDROCHLORIDE | EQ 5MG BASE | CAPSULE / ORAL | AB | 1989-05-16 | 1e350fbaab3a… | |
| 2024-06-18 03:08 UTC · 5 captures of this ZIP | 2024-06 | A072575-002 | PRAZOSIN HYDROCHLORIDE | EQ 2MG BASE | CAPSULE / ORAL | AB | 1989-05-16 | 1e350fbaab3a… | |
| 2024-06-18 03:08 UTC · 5 captures of this ZIP | 2024-06 | A072575-003 | PRAZOSIN HYDROCHLORIDE | EQ 1MG BASE | CAPSULE / ORAL | AB | 1989-05-16 | 1e350fbaab3a… | |
| 2024-05-31 18:47 UTC | 2024-05 | A072575-001 | PRAZOSIN HYDROCHLORIDE | EQ 5MG BASE | CAPSULE / ORAL | AB | 1989-05-16 | 8072bd15b7f6… |
Observed Orange Book normalized TE history#
| Captured | Edition | Application-product | TE code | Order | Source SHA-256 |
|---|---|---|---|---|---|
| 2026-02-19 14:30 UTC | 2026-02 | A072575-001 | AB | 1 | 011fe1cb6892… |
| 2026-02-19 14:30 UTC | 2026-02 | A072575-002 | AB | 1 | 011fe1cb6892… |
| 2026-02-19 14:30 UTC | 2026-02 | A072575-003 | AB | 1 | 011fe1cb6892… |
| 2025-12-14 10:44 UTC · 2 captures of this ZIP | 2025-12 | A072575-001 | AB | 1 | 31067a03dcf5… |
| 2025-12-14 10:44 UTC · 2 captures of this ZIP | 2025-12 | A072575-002 | AB | 1 | 31067a03dcf5… |
| 2025-12-14 10:44 UTC · 2 captures of this ZIP | 2025-12 | A072575-003 | AB | 1 | 31067a03dcf5… |
| 2025-08-23 18:47 UTC | 2025-08 | A072575-001 | AB | 1 | 6a471c1ec25d… |
| 2025-08-23 18:47 UTC | 2025-08 | A072575-002 | AB | 1 | 6a471c1ec25d… |
| 2025-08-23 18:47 UTC | 2025-08 | A072575-003 | AB | 1 | 6a471c1ec25d… |
| 2025-03-22 03:13 UTC · 3 captures of this ZIP | 2025-03 | A072575-001 | AB | 1 | fd3edfee7708… |
| 2025-03-22 03:13 UTC · 3 captures of this ZIP | 2025-03 | A072575-002 | AB | 1 | fd3edfee7708… |
| 2025-03-22 03:13 UTC · 3 captures of this ZIP | 2025-03 | A072575-003 | AB | 1 | fd3edfee7708… |
| 2025-02-26 10:13 UTC · 3 captures of this ZIP | 2025-02 | A072575-001 | AB | 1 | b8a1b40f171c… |
| 2025-02-26 10:13 UTC · 3 captures of this ZIP | 2025-02 | A072575-002 | AB | 1 | b8a1b40f171c… |
| 2025-02-26 10:13 UTC · 3 captures of this ZIP | 2025-02 | A072575-003 | AB | 1 | b8a1b40f171c… |
| 2025-01-19 17:59 UTC · 7 captures of this ZIP | 2025-01 | A072575-001 | AB | 1 | 03ed91905a0d… |
| 2025-01-19 17:59 UTC · 7 captures of this ZIP | 2025-01 | A072575-002 | AB | 1 | 03ed91905a0d… |
| 2025-01-19 17:59 UTC · 7 captures of this ZIP | 2025-01 | A072575-003 | AB | 1 | 03ed91905a0d… |
| 2024-12-13 21:23 UTC · 2 captures of this ZIP | 2024-12 | A072575-001 | AB | 1 | 2680178bc6a6… |
| 2024-12-13 21:23 UTC · 2 captures of this ZIP | 2024-12 | A072575-002 | AB | 1 | 2680178bc6a6… |
| 2024-12-13 21:23 UTC · 2 captures of this ZIP | 2024-12 | A072575-003 | AB | 1 | 2680178bc6a6… |
| 2024-09-14 05:58 UTC · 2 captures of this ZIP | 2024-09 | A072575-001 | AB | 1 | 5bbf6a4d5a75… |
| 2024-09-14 05:58 UTC · 2 captures of this ZIP | 2024-09 | A072575-002 | AB | 1 | 5bbf6a4d5a75… |
| 2024-09-14 05:58 UTC · 2 captures of this ZIP | 2024-09 | A072575-003 | AB | 1 | 5bbf6a4d5a75… |
| 2024-11-08 22:44 UTC · 3 captures of this ZIP | 2024-11 | A072575-001 | AB | 1 | d8e5a09893c0… |
| 2024-11-08 22:44 UTC · 3 captures of this ZIP | 2024-11 | A072575-002 | AB | 1 | d8e5a09893c0… |
| 2024-11-08 22:44 UTC · 3 captures of this ZIP | 2024-11 | A072575-003 | AB | 1 | d8e5a09893c0… |
| 2024-10-29 15:01 UTC | 2024-10 | A072575-001 | AB | 1 | d06236e962d9… |
| 2024-10-29 15:01 UTC | 2024-10 | A072575-002 | AB | 1 | d06236e962d9… |
| 2024-10-29 15:01 UTC | 2024-10 | A072575-003 | AB | 1 | d06236e962d9… |
| 2024-08-13 05:28 UTC · 3 captures of this ZIP | 2024-08 | A072575-001 | AB | 1 | 79d66fd596c7… |
| 2024-08-13 05:28 UTC · 3 captures of this ZIP | 2024-08 | A072575-002 | AB | 1 | 79d66fd596c7… |
| 2024-08-13 05:28 UTC · 3 captures of this ZIP | 2024-08 | A072575-003 | AB | 1 | 79d66fd596c7… |
| 2024-07-13 05:37 UTC · 2 captures of this ZIP | 2024-07 | A072575-001 | AB | 1 | 301d65b070ca… |
| 2024-07-13 05:37 UTC · 2 captures of this ZIP | 2024-07 | A072575-002 | AB | 1 | 301d65b070ca… |
| 2024-07-13 05:37 UTC · 2 captures of this ZIP | 2024-07 | A072575-003 | AB | 1 | 301d65b070ca… |
| 2024-06-18 03:08 UTC · 5 captures of this ZIP | 2024-06 | A072575-001 | AB | 1 | 1e350fbaab3a… |
| 2024-06-18 03:08 UTC · 5 captures of this ZIP | 2024-06 | A072575-002 | AB | 1 | 1e350fbaab3a… |
| 2024-06-18 03:08 UTC · 5 captures of this ZIP | 2024-06 | A072575-003 | AB | 1 | 1e350fbaab3a… |
| 2024-05-31 18:47 UTC | 2024-05 | A072575-001 | AB | 1 | 8072bd15b7f6… |
Additional Listing Data#
- Finished product
- Yes
- Brand name base
- Prazosin Hydrochloride
- Listing expiration
- 2026-12-31
Active Ingredients#
| Ingredient | Strength |
|---|---|
| PRAZOSIN HYDROCHLORIDE | 2 mg/1 |
Harmonized UNII identifiers#
| Identifier | FDA.report destination |
|---|---|
| X0Z7454B90 | Internal UNII lookup |
Harmonized RxCUI identifiers#
| Identifier | FDA.report destination |
|---|---|
| 312594 | Internal RxNorm lookup |
Harmonized SPL set identifiers#
| Identifier | FDA.report destination |
|---|---|
| cd52f022-ca29-4f87-8684-da63e05b3c1f | 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 |
|---|---|---|---|---|---|---|
| 43063-260-30 | Prazosin Hydrochloride | 30 in 1 BOTTLE, PLASTIC | CAPSULE | 30 | 11 |
DailyMed Billing Units#
| Package NDC | Billing unit | Product NDC | DailyMed indexing SPL | SPL version | Effective |
|---|---|---|---|---|---|
| 43063-260-30 | EA - Each | 43063-260 | 59ae67e8-f1e3-4b89-b8df-c1a3be7f5a75 | 1 | 2012-07-24 |
DailyMed Socrata Ingredients#
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 | REMEDYREPACK INC. | 39e3fa5d-ea48-4b02-80f6-44591f5e013f | 2026-07-06 | Warnings, Adverse reactions | 072575 ANDA072575 |
| Prazosin Hydrochloride | PRAZOSIN HYDROCHLORIDE | Safecor Health LLC | 12cdde5b-173c-4f31-a326-3128d521930c | 2026-04-09 | Warnings, Adverse reactions | 072575 ANDA072575 |
| Prazosin Hydrochloride | PRAZOSIN HYDROCHLORIDE | PD-Rx Pharmaceuticals, Inc. | e5e129aa-2ee3-4c12-a327-5d5382cf2310 | 2025-10-21 | Warnings, Adverse reactions | 072575 ANDA072575 |
| Prazosin Hydrochloride | PRAZOSIN HYDROCHLORIDE | PD-Rx Pharmaceuticals, Inc. | 5d7dff44-84b1-4044-bc5a-c76ea11dd5a3 | 2025-10-21 | Warnings, Adverse reactions | 072575 ANDA072575 |
| Prazosin Hydrochloride | PRAZOSIN HYDROCHLORIDE | PD-Rx Pharmaceuticals, Inc. | cd52f022-ca29-4f87-8684-da63e05b3c1f | 2025-10-21 | Warnings, Adverse reactions | 072575 ANDA072575 43063-260 |
| Prazosin Hydrochloride | PRAZOSIN HYDROCHLORIDE | Mylan Institutional Inc. | e6a029b2-802f-4cc5-8795-20e177e8d779 | 2025-07-22 | Warnings, Adverse reactions | 072575 ANDA072575 |
| Prazosin Hydrochloride | PRAZOSIN HYDROCHLORIDE | Bryant Ranch Prepack | 1a92a503-cf5e-48ef-a6fd-79fe98fdd8a0 | 2023-04-03 | Warnings, Adverse reactions | 072575 ANDA072575 |
| Prazosin Hydrochloride | PRAZOSIN HYDROCHLORIDE | Mylan Pharmaceuticals Inc. | 1ce90aaf-d075-4617-9a47-e8d922096d23 | 2022-09-01 | Warnings, Adverse reactions | 072575 ANDA072575 |
DailyMed RxNorm Mappings#
| RxCUI | RxNorm string | TTY | DailyMed | SPL version |
|---|---|---|---|---|
| 312594 | prazosin HCl 2 MG Oral Capsule | PSN | cd52f022-ca29-4f87-8684-da63e05b3c1f | 11 |
| 312594 | prazosin 2 MG Oral Capsule | SCD | cd52f022-ca29-4f87-8684-da63e05b3c1f | 11 |
| 312594 | prazosin (as prazosin HCl) 2 MG Oral Capsule | SY | cd52f022-ca29-4f87-8684-da63e05b3c1f | 11 |
Packages#
| Package NDC | 11-digit format | Description | Units | Marketing start | Marketing end | Sample | Exclude flag | Status |
|---|---|---|---|---|---|---|---|---|
| 43063-260-30 | 43063026030 | 30 CAPSULE in 1 BOTTLE, PLASTIC (43063-260-30) | 30 capsule | 2010-06-23 | 0000-00-00 | No | No | Current |