Prazosin

Product NDC
0527-4180
11-digit product format
005274180
Labeler code
0527
Product ID
0527-4180_41beba09-90c1-42cc-bfba-ac8a84d09649
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
Prazosin
Dosage form
CAPSULE
Route
ORAL
Labeler
Lannett Company, Inc.
Application
ANDA214083
Marketing category
ANDA
Marketing start
2024-01-03
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

Source provenance: Browse the complete Orange Book source catalog · source snapshot 42.

Orange Book products#

Current product rows page 1 of 1 · 3 matching rows.

Application-product, Trade name, Ingredient table
Application-productTrade nameIngredientStrengthDosage form / routeTE codesRLD / RSApproval date
A214083-001PRAZOSIN HYDROCHLORIDEPRAZOSIN HYDROCHLORIDEEQ 1MG BASECAPSULE / ORAL2024-01-03
A214083-002PRAZOSIN HYDROCHLORIDEPRAZOSIN HYDROCHLORIDEEQ 2MG BASECAPSULE / ORAL2024-01-03
A214083-003PRAZOSIN HYDROCHLORIDEPRAZOSIN HYDROCHLORIDEEQ 5MG BASECAPSULE / ORAL2024-01-03

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 2 · 54 observed states.

Captured, Edition, Application-product table
CapturedEditionApplication-productTrade nameStrengthDosage form / routeProduct TE source textRLD / RSApproval dateSource SHA-256
2026-08-18 06:07:402026-07A214083-001PRAZOSIN HYDROCHLORIDEEQ 1MG BASECAPSULE / ORAL2024-01-03caaa826d4ba7…
2026-08-18 06:07:402026-07A214083-002PRAZOSIN HYDROCHLORIDEEQ 2MG BASECAPSULE / ORAL2024-01-03caaa826d4ba7…
2026-08-18 06:07:402026-07A214083-003PRAZOSIN HYDROCHLORIDEEQ 5MG BASECAPSULE / ORAL2024-01-03caaa826d4ba7…
2026-02-19 14:30 UTC2026-02A214083-001PRAZOSIN HYDROCHLORIDEEQ 1MG BASECAPSULE / ORAL2024-01-03011fe1cb6892…
2026-02-19 14:30 UTC2026-02A214083-002PRAZOSIN HYDROCHLORIDEEQ 2MG BASECAPSULE / ORAL2024-01-03011fe1cb6892…
2026-02-19 14:30 UTC2026-02A214083-003PRAZOSIN HYDROCHLORIDEEQ 5MG BASECAPSULE / ORAL2024-01-03011fe1cb6892…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A214083-001PRAZOSIN HYDROCHLORIDEEQ 1MG BASECAPSULE / ORAL2024-01-0331067a03dcf5…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A214083-002PRAZOSIN HYDROCHLORIDEEQ 2MG BASECAPSULE / ORAL2024-01-0331067a03dcf5…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A214083-003PRAZOSIN HYDROCHLORIDEEQ 5MG BASECAPSULE / ORAL2024-01-0331067a03dcf5…
2025-08-23 18:47 UTC2025-08A214083-001PRAZOSIN HYDROCHLORIDEEQ 1MG BASECAPSULE / ORAL2024-01-036a471c1ec25d…
2025-08-23 18:47 UTC2025-08A214083-002PRAZOSIN HYDROCHLORIDEEQ 2MG BASECAPSULE / ORAL2024-01-036a471c1ec25d…
2025-08-23 18:47 UTC2025-08A214083-003PRAZOSIN HYDROCHLORIDEEQ 5MG BASECAPSULE / ORAL2024-01-036a471c1ec25d…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03A214083-001PRAZOSIN HYDROCHLORIDEEQ 1MG BASECAPSULE / ORAL2024-01-03fd3edfee7708…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03A214083-002PRAZOSIN HYDROCHLORIDEEQ 2MG BASECAPSULE / ORAL2024-01-03fd3edfee7708…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03A214083-003PRAZOSIN HYDROCHLORIDEEQ 5MG BASECAPSULE / ORAL2024-01-03fd3edfee7708…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02A214083-001PRAZOSIN HYDROCHLORIDEEQ 1MG BASECAPSULE / ORAL2024-01-03b8a1b40f171c…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02A214083-002PRAZOSIN HYDROCHLORIDEEQ 2MG BASECAPSULE / ORAL2024-01-03b8a1b40f171c…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02A214083-003PRAZOSIN HYDROCHLORIDEEQ 5MG BASECAPSULE / ORAL2024-01-03b8a1b40f171c…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01A214083-001PRAZOSIN HYDROCHLORIDEEQ 1MG BASECAPSULE / ORAL2024-01-0303ed91905a0d…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01A214083-002PRAZOSIN HYDROCHLORIDEEQ 2MG BASECAPSULE / ORAL2024-01-0303ed91905a0d…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01A214083-003PRAZOSIN HYDROCHLORIDEEQ 5MG BASECAPSULE / ORAL2024-01-0303ed91905a0d…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12A214083-001PRAZOSIN HYDROCHLORIDEEQ 1MG BASECAPSULE / ORAL2024-01-032680178bc6a6…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12A214083-002PRAZOSIN HYDROCHLORIDEEQ 2MG BASECAPSULE / ORAL2024-01-032680178bc6a6…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12A214083-003PRAZOSIN HYDROCHLORIDEEQ 5MG BASECAPSULE / ORAL2024-01-032680178bc6a6…
2024-09-14 05:58 UTC · 2 captures of this ZIP2024-09A214083-001PRAZOSIN HYDROCHLORIDEEQ 1MG BASECAPSULE / ORAL2024-01-035bbf6a4d5a75…
2024-09-14 05:58 UTC · 2 captures of this ZIP2024-09A214083-002PRAZOSIN HYDROCHLORIDEEQ 2MG BASECAPSULE / ORAL2024-01-035bbf6a4d5a75…
2024-09-14 05:58 UTC · 2 captures of this ZIP2024-09A214083-003PRAZOSIN HYDROCHLORIDEEQ 5MG BASECAPSULE / ORAL2024-01-035bbf6a4d5a75…
2024-11-08 22:44 UTC · 3 captures of this ZIP2024-11A214083-001PRAZOSIN HYDROCHLORIDEEQ 1MG BASECAPSULE / ORAL2024-01-03d8e5a09893c0…
2024-11-08 22:44 UTC · 3 captures of this ZIP2024-11A214083-002PRAZOSIN HYDROCHLORIDEEQ 2MG BASECAPSULE / ORAL2024-01-03d8e5a09893c0…
2024-11-08 22:44 UTC · 3 captures of this ZIP2024-11A214083-003PRAZOSIN HYDROCHLORIDEEQ 5MG BASECAPSULE / ORAL2024-01-03d8e5a09893c0…
2024-10-29 15:01 UTC2024-10A214083-001PRAZOSIN HYDROCHLORIDEEQ 1MG BASECAPSULE / ORAL2024-01-03d06236e962d9…
2024-10-29 15:01 UTC2024-10A214083-002PRAZOSIN HYDROCHLORIDEEQ 2MG BASECAPSULE / ORAL2024-01-03d06236e962d9…
2024-10-29 15:01 UTC2024-10A214083-003PRAZOSIN HYDROCHLORIDEEQ 5MG BASECAPSULE / ORAL2024-01-03d06236e962d9…
2024-08-13 05:28 UTC · 3 captures of this ZIP2024-08A214083-001PRAZOSIN HYDROCHLORIDEEQ 1MG BASECAPSULE / ORAL2024-01-0379d66fd596c7…
2024-08-13 05:28 UTC · 3 captures of this ZIP2024-08A214083-002PRAZOSIN HYDROCHLORIDEEQ 2MG BASECAPSULE / ORAL2024-01-0379d66fd596c7…
2024-08-13 05:28 UTC · 3 captures of this ZIP2024-08A214083-003PRAZOSIN HYDROCHLORIDEEQ 5MG BASECAPSULE / ORAL2024-01-0379d66fd596c7…
2024-07-13 05:37 UTC · 2 captures of this ZIP2024-07A214083-001PRAZOSIN HYDROCHLORIDEEQ 1MG BASECAPSULE / ORALAB2024-01-03301d65b070ca…
2024-07-13 05:37 UTC · 2 captures of this ZIP2024-07A214083-002PRAZOSIN HYDROCHLORIDEEQ 2MG BASECAPSULE / ORALAB2024-01-03301d65b070ca…
2024-07-13 05:37 UTC · 2 captures of this ZIP2024-07A214083-003PRAZOSIN HYDROCHLORIDEEQ 5MG BASECAPSULE / ORALAB2024-01-03301d65b070ca…
2024-06-18 03:08 UTC · 5 captures of this ZIP2024-06A214083-001PRAZOSIN HYDROCHLORIDEEQ 1MG BASECAPSULE / ORALAB2024-01-031e350fbaab3a…

Observed Orange Book normalized TE history#

Captured, Edition, Application-product table
CapturedEditionApplication-productTE codeOrderSource SHA-256
2024-07-13 05:37 UTC · 2 captures of this ZIP2024-07A214083-001AB1301d65b070ca…
2024-07-13 05:37 UTC · 2 captures of this ZIP2024-07A214083-002AB1301d65b070ca…
2024-07-13 05:37 UTC · 2 captures of this ZIP2024-07A214083-003AB1301d65b070ca…
2024-06-18 03:08 UTC · 5 captures of this ZIP2024-06A214083-001AB11e350fbaab3a…
2024-06-18 03:08 UTC · 5 captures of this ZIP2024-06A214083-002AB11e350fbaab3a…
2024-06-18 03:08 UTC · 5 captures of this ZIP2024-06A214083-003AB11e350fbaab3a…
2024-05-31 18:47 UTC2024-05A214083-001AB18072bd15b7f6…
2024-05-31 18:47 UTC2024-05A214083-002AB18072bd15b7f6…
2024-05-31 18:47 UTC2024-05A214083-003AB18072bd15b7f6…
2024-03-16 18:09 UTC · 4 captures of this ZIP2024-03A214083-001AB16a51e52b5d6a…
2024-03-16 18:09 UTC · 4 captures of this ZIP2024-03A214083-002AB16a51e52b5d6a…
2024-03-16 18:09 UTC · 4 captures of this ZIP2024-03A214083-003AB16a51e52b5d6a…
2024-02-18 07:12 UTC2024-02A214083-001AB11c564ffb4f44…
2024-02-18 07:12 UTC2024-02A214083-002AB11c564ffb4f44…
2024-02-18 07:12 UTC2024-02A214083-003AB11c564ffb4f44…

Additional Listing Data#

Finished product
Yes
Brand name base
Prazosin
Listing expiration
2026-12-31

Active Ingredients#

Ingredient, Strength table
IngredientStrength
PRAZOSIN HYDROCHLORIDE1 mg/1

Harmonized UNII identifiers#

UNII identifiers page 1 of 1 · 1 matching rows.

Identifier, FDA.report destination table
IdentifierFDA.report destination
X0Z7454B90Internal UNII lookup

Harmonized RxCUI identifiers#

RxCUI identifiers page 1 of 1 · 3 matching rows.

Identifier, FDA.report destination table
IdentifierFDA.report destination
198141Internal RxNorm lookup
312593Internal RxNorm lookup
312594Internal RxNorm lookup

Harmonized SPL set identifiers#

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

Identifier, FDA.report destination table
IdentifierFDA.report destination
94021822-60cb-4da6-b809-f565e1d6452dAvailable on FDA.report

DailyMed Product Concepts#

Product concept, Relation, Version table
Product conceptRelationVersionEffective
d5a3de99-75de-4527-38ae-07b1328b93cbProduct name520250331

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
0527-4180-37Prazosin100 in 1 BOTTLECAPSULE1008
0527-4180-43Prazosin1000 in 1 BOTTLECAPSULE10008

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
0527-4180PRAZOSIN CAPSULE [LANNETT COMPANY, INC.]8Current NDC, 2 package rows20250316_94021822-60cb-4da6-b809-f565e1d6452d.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 · 1 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
PrazosinPRAZOSINLannett Company, Inc.94021822-60cb-4da6-b809-f565e1d6452d2023-09-15Warnings, Adverse reactionsExact identifier
application applno (ANDA): 214083
application number: ANDA214083
ndc (product): 0527-4180

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
312593prazosin HCl 1 MG Oral CapsulePSN94021822-60cb-4da6-b809-f565e1d6452d8
312594prazosin HCl 2 MG Oral CapsulePSN94021822-60cb-4da6-b809-f565e1d6452d8
198141prazosin HCl 5 MG Oral CapsulePSN94021822-60cb-4da6-b809-f565e1d6452d8
312593prazosin 1 MG Oral CapsuleSCD94021822-60cb-4da6-b809-f565e1d6452d8
312594prazosin 2 MG Oral CapsuleSCD94021822-60cb-4da6-b809-f565e1d6452d8
198141prazosin 5 MG Oral CapsuleSCD94021822-60cb-4da6-b809-f565e1d6452d8
312593prazosin (as prazosin HCl) 1 MG Oral CapsuleSY94021822-60cb-4da6-b809-f565e1d6452d8
312594prazosin (as prazosin HCl) 2 MG Oral CapsuleSY94021822-60cb-4da6-b809-f565e1d6452d8
198141prazosin (as prazosin HCl) 5 MG Oral CapsuleSY94021822-60cb-4da6-b809-f565e1d6452d8

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startSampleExclude flagStatus
0527-4180-3700527418037100 CAPSULE in 1 BOTTLE (0527-4180-37) 100 capsule2024-01-03NoNoCurrent
0527-4180-43005274180431000 CAPSULE in 1 BOTTLE (0527-4180-43) 1000 capsule2024-01-03NoNoCurrent