Prazosin Hydrochloride

Product NDC
70518-3271
11-digit product format
705183271
Labeler code
70518
Product ID
70518-3271_4edfc77d-dec5-611b-e063-6294a90a47f8
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
prazosin hydrochloride
Dosage form
CAPSULE
Route
ORAL
Labeler
REMEDYREPACK INC.
Application
NDA017442
Marketing category
NDA AUTHORIZED GENERIC
Marketing start
2021-11-17
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
2027-12-31
Current FDA listing
Yes

NDC auxiliary status#

These records are reproduced from FDA’s unfinished, excluded, and compounder listings. They describe what appeared in the source files; a missing record does not establish a regulatory status. View all current auxiliary records, including entries without an NDC. · View the auxiliary file history.

Current NDC status page 1 of 1 · 1 matching rows.

Dataset, Scope, Product NDC table
DatasetScopeProduct NDCPackage NDCCodeStatusReporting periodSource date
excluded packagepackage70518-327170518-3271-2DDiscontinued by firm2026-08-17

Observed NDC auxiliary status history#

This history shows the information present in each captured FDA auxiliary file. It is not a continuous regulatory timeline, and a missing record does not establish a status.

Historic NDC status page 1 of 1 · 2 matching rows.

View current auxiliary records. · View the auxiliary file history.

Captured / source date, Dataset, Scope table
Captured / source dateDatasetScopeProduct NDCPackage NDCCodeStatusReporting periodArchiveSnapshotSource SHA-256
2025-12-14 17:58 UTC · source 2025-12-05excluded packagepackage70518-327170518-3271-2DDiscontinued by firmexcluded / ndc_excluded.zipd630ba8d3edf…732f749b63fb…
2025-08-27 00:01 UTC · source 2025-08-26excluded packagepackage70518-327170518-3271-2DDiscontinued by firmexcluded / ndc_excluded.zipf5e01cc5f278…a2eaf40c39c3…

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
N017442-001MINIPRESSPRAZOSIN HYDROCHLORIDEEQ 5MG BASECAPSULE / ORALABRLD, Approved before 1982
N017442-002MINIPRESSPRAZOSIN HYDROCHLORIDEEQ 1MG BASECAPSULE / ORALABRLD, Approved before 1982
N017442-003MINIPRESSPRAZOSIN HYDROCHLORIDEEQ 2MG BASECAPSULE / ORALABRLD, RS, Approved before 1982

Therapeutic equivalence codes#

Current TE-code rows page 1 of 1 · 3 matching rows.

Application-product, TE code table
Application-productTE code
N017442-001AB
N017442-002AB
N017442-003AB

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 4 · 126 observed states.

Captured, Edition, Application-product table
CapturedEditionApplication-productTrade nameStrengthDosage form / routeProduct TE source textRLD / RSApproval dateSource SHA-256
2026-08-18 06:07:402026-07N017442-001MINIPRESSEQ 5MG BASECAPSULE / ORALABRLD, Approved before 1982caaa826d4ba7…
2026-08-18 06:07:402026-07N017442-002MINIPRESSEQ 1MG BASECAPSULE / ORALABRLD, Approved before 1982caaa826d4ba7…
2026-08-18 06:07:402026-07N017442-003MINIPRESSEQ 2MG BASECAPSULE / ORALABRLD, RS, Approved before 1982caaa826d4ba7…
2026-02-19 14:30 UTC2026-02N017442-001MINIPRESSEQ 5MG BASECAPSULE / ORALABRLD, Approved before 1982011fe1cb6892…
2026-02-19 14:30 UTC2026-02N017442-002MINIPRESSEQ 1MG BASECAPSULE / ORALABRLD, Approved before 1982011fe1cb6892…
2026-02-19 14:30 UTC2026-02N017442-003MINIPRESSEQ 2MG BASECAPSULE / ORALABRLD, RS, Approved before 1982011fe1cb6892…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12N017442-001MINIPRESSEQ 5MG BASECAPSULE / ORALABRLD, Approved before 198231067a03dcf5…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12N017442-002MINIPRESSEQ 1MG BASECAPSULE / ORALABRLD, Approved before 198231067a03dcf5…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12N017442-003MINIPRESSEQ 2MG BASECAPSULE / ORALABRLD, RS, Approved before 198231067a03dcf5…
2025-08-23 18:47 UTC2025-08N017442-001MINIPRESSEQ 5MG BASECAPSULE / ORALABRLD, Approved before 19826a471c1ec25d…
2025-08-23 18:47 UTC2025-08N017442-002MINIPRESSEQ 1MG BASECAPSULE / ORALABRLD, Approved before 19826a471c1ec25d…
2025-08-23 18:47 UTC2025-08N017442-003MINIPRESSEQ 2MG BASECAPSULE / ORALABRLD, RS, Approved before 19826a471c1ec25d…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03N017442-001MINIPRESSEQ 5MG BASECAPSULE / ORALABRLD, Approved before 1982fd3edfee7708…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03N017442-002MINIPRESSEQ 1MG BASECAPSULE / ORALABRLD, Approved before 1982fd3edfee7708…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03N017442-003MINIPRESSEQ 2MG BASECAPSULE / ORALABRLD, RS, Approved before 1982fd3edfee7708…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02N017442-001MINIPRESSEQ 5MG BASECAPSULE / ORALABRLD, Approved before 1982b8a1b40f171c…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02N017442-002MINIPRESSEQ 1MG BASECAPSULE / ORALABRLD, Approved before 1982b8a1b40f171c…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02N017442-003MINIPRESSEQ 2MG BASECAPSULE / ORALABRLD, RS, Approved before 1982b8a1b40f171c…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01N017442-001MINIPRESSEQ 5MG BASECAPSULE / ORALABRLD, Approved before 198203ed91905a0d…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01N017442-002MINIPRESSEQ 1MG BASECAPSULE / ORALABRLD, Approved before 198203ed91905a0d…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01N017442-003MINIPRESSEQ 2MG BASECAPSULE / ORALABRLD, RS, Approved before 198203ed91905a0d…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12N017442-001MINIPRESSEQ 5MG BASECAPSULE / ORALABRLD, Approved before 19822680178bc6a6…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12N017442-002MINIPRESSEQ 1MG BASECAPSULE / ORALABRLD, Approved before 19822680178bc6a6…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12N017442-003MINIPRESSEQ 2MG BASECAPSULE / ORALABRLD, RS, Approved before 19822680178bc6a6…
2024-09-14 05:58 UTC · 2 captures of this ZIP2024-09N017442-001MINIPRESSEQ 5MG BASECAPSULE / ORALABRLD, Approved before 19825bbf6a4d5a75…
2024-09-14 05:58 UTC · 2 captures of this ZIP2024-09N017442-002MINIPRESSEQ 1MG BASECAPSULE / ORALABRLD, Approved before 19825bbf6a4d5a75…
2024-09-14 05:58 UTC · 2 captures of this ZIP2024-09N017442-003MINIPRESSEQ 2MG BASECAPSULE / ORALABRLD, RS, Approved before 19825bbf6a4d5a75…
2024-11-08 22:44 UTC · 3 captures of this ZIP2024-11N017442-001MINIPRESSEQ 5MG BASECAPSULE / ORALABRLD, Approved before 1982d8e5a09893c0…
2024-11-08 22:44 UTC · 3 captures of this ZIP2024-11N017442-002MINIPRESSEQ 1MG BASECAPSULE / ORALABRLD, Approved before 1982d8e5a09893c0…
2024-11-08 22:44 UTC · 3 captures of this ZIP2024-11N017442-003MINIPRESSEQ 2MG BASECAPSULE / ORALABRLD, RS, Approved before 1982d8e5a09893c0…
2024-10-29 15:01 UTC2024-10N017442-001MINIPRESSEQ 5MG BASECAPSULE / ORALABRLD, Approved before 1982d06236e962d9…
2024-10-29 15:01 UTC2024-10N017442-002MINIPRESSEQ 1MG BASECAPSULE / ORALABRLD, Approved before 1982d06236e962d9…
2024-10-29 15:01 UTC2024-10N017442-003MINIPRESSEQ 2MG BASECAPSULE / ORALABRLD, RS, Approved before 1982d06236e962d9…
2024-08-13 05:28 UTC · 3 captures of this ZIP2024-08N017442-001MINIPRESSEQ 5MG BASECAPSULE / ORALABRLD, Approved before 198279d66fd596c7…
2024-08-13 05:28 UTC · 3 captures of this ZIP2024-08N017442-002MINIPRESSEQ 1MG BASECAPSULE / ORALABRLD, Approved before 198279d66fd596c7…
2024-08-13 05:28 UTC · 3 captures of this ZIP2024-08N017442-003MINIPRESSEQ 2MG BASECAPSULE / ORALABRLD, RS, Approved before 198279d66fd596c7…
2024-07-13 05:37 UTC · 2 captures of this ZIP2024-07N017442-001MINIPRESSEQ 5MG BASECAPSULE / ORALABRLD, Approved before 1982301d65b070ca…
2024-07-13 05:37 UTC · 2 captures of this ZIP2024-07N017442-002MINIPRESSEQ 1MG BASECAPSULE / ORALABRLD, Approved before 1982301d65b070ca…
2024-07-13 05:37 UTC · 2 captures of this ZIP2024-07N017442-003MINIPRESSEQ 2MG BASECAPSULE / ORALABRLD, RS, Approved before 1982301d65b070ca…
2024-06-18 03:08 UTC · 5 captures of this ZIP2024-06N017442-001MINIPRESSEQ 5MG BASECAPSULE / ORALABRLD, Approved before 19821e350fbaab3a…

Observed Orange Book normalized TE history#

Normalized TE history page 1 of 4 · 126 observed states.

Captured, Edition, Application-product table
CapturedEditionApplication-productTE codeOrderSource SHA-256
2026-08-18 06:07:402026-07N017442-001AB1caaa826d4ba7…
2026-08-18 06:07:402026-07N017442-002AB1caaa826d4ba7…
2026-08-18 06:07:402026-07N017442-003AB1caaa826d4ba7…
2026-02-19 14:30 UTC2026-02N017442-001AB1011fe1cb6892…
2026-02-19 14:30 UTC2026-02N017442-002AB1011fe1cb6892…
2026-02-19 14:30 UTC2026-02N017442-003AB1011fe1cb6892…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12N017442-001AB131067a03dcf5…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12N017442-002AB131067a03dcf5…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12N017442-003AB131067a03dcf5…
2025-08-23 18:47 UTC2025-08N017442-001AB16a471c1ec25d…
2025-08-23 18:47 UTC2025-08N017442-002AB16a471c1ec25d…
2025-08-23 18:47 UTC2025-08N017442-003AB16a471c1ec25d…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03N017442-001AB1fd3edfee7708…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03N017442-002AB1fd3edfee7708…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03N017442-003AB1fd3edfee7708…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02N017442-001AB1b8a1b40f171c…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02N017442-002AB1b8a1b40f171c…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02N017442-003AB1b8a1b40f171c…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01N017442-001AB103ed91905a0d…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01N017442-002AB103ed91905a0d…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01N017442-003AB103ed91905a0d…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12N017442-001AB12680178bc6a6…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12N017442-002AB12680178bc6a6…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12N017442-003AB12680178bc6a6…
2024-09-14 05:58 UTC · 2 captures of this ZIP2024-09N017442-001AB15bbf6a4d5a75…
2024-09-14 05:58 UTC · 2 captures of this ZIP2024-09N017442-002AB15bbf6a4d5a75…
2024-09-14 05:58 UTC · 2 captures of this ZIP2024-09N017442-003AB15bbf6a4d5a75…
2024-11-08 22:44 UTC · 3 captures of this ZIP2024-11N017442-001AB1d8e5a09893c0…
2024-11-08 22:44 UTC · 3 captures of this ZIP2024-11N017442-002AB1d8e5a09893c0…
2024-11-08 22:44 UTC · 3 captures of this ZIP2024-11N017442-003AB1d8e5a09893c0…
2024-10-29 15:01 UTC2024-10N017442-001AB1d06236e962d9…
2024-10-29 15:01 UTC2024-10N017442-002AB1d06236e962d9…
2024-10-29 15:01 UTC2024-10N017442-003AB1d06236e962d9…
2024-08-13 05:28 UTC · 3 captures of this ZIP2024-08N017442-001AB179d66fd596c7…
2024-08-13 05:28 UTC · 3 captures of this ZIP2024-08N017442-002AB179d66fd596c7…
2024-08-13 05:28 UTC · 3 captures of this ZIP2024-08N017442-003AB179d66fd596c7…
2024-07-13 05:37 UTC · 2 captures of this ZIP2024-07N017442-001AB1301d65b070ca…
2024-07-13 05:37 UTC · 2 captures of this ZIP2024-07N017442-002AB1301d65b070ca…
2024-07-13 05:37 UTC · 2 captures of this ZIP2024-07N017442-003AB1301d65b070ca…
2024-06-18 03:08 UTC · 5 captures of this ZIP2024-06N017442-001AB11e350fbaab3a…

Additional Listing Data#

Finished product
Yes
Brand name base
Prazosin Hydrochloride
Listing expiration
2027-12-31

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 · 1 matching rows.

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

Harmonized SPL set identifiers#

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

Identifier, FDA.report destination table
IdentifierFDA.report destination
2f86fc8e-71c1-4749-b67e-86d86cf1d984Available on FDA.report

DailyMed Product Concepts#

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

FDA-Initiated Inactive NDC Indexing#

Effective, Related label table
EffectiveRelated label
2023-03-23Prazosin Hydrochloride Capsules
2023-03-23Prazosin Hydrochloride Capsules
2023-01-30Prazosin Hydrochloride Capsules
2023-01-30Prazosin Hydrochloride Capsules

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
70518-3271-0Prazosin Hydrochloride30 in 1 BOXCAPSULE307
70518-3271-1Prazosin Hydrochloride1 in 1 POUCHCAPSULE17
70518-3271-2Prazosin Hydrochloride30 in 1 BLISTER PACKCAPSULE307

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
70518-3271PRAZOSIN HYDROCHLORIDE CAPSULE [REMEDYREPACK INC.]5Current NDC, Legacy NDC, 3 package rows20240316_2f86fc8e-71c1-4749-b67e-86d86cf1d984.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 · 2 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
Prazosin HydrochloridePRAZOSIN HYDROCHLORIDEREMEDYREPACK INC.2f86fc8e-71c1-4749-b67e-86d86cf1d9842026-08-05Warnings, Adverse reactionsExact identifier
application applno (NDA): 017442
application number: NDA017442
ndc (product): 70518-3271
Prazosin HydrochloridePRAZOSIN HYDROCHLORIDEPrasco Laboratoriescbe89216-7dea-43d7-b12e-44ccfb69af3d2026-03-06Warnings, Adverse reactionsExact identifier
application applno (NDA): 017442
application number: NDA017442

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
312593prazosin HCl 1 MG Oral CapsulePSN2f86fc8e-71c1-4749-b67e-86d86cf1d9847
312593prazosin 1 MG Oral CapsuleSCD2f86fc8e-71c1-4749-b67e-86d86cf1d9847
312593prazosin (as prazosin HCl) 1 MG Oral CapsuleSY2f86fc8e-71c1-4749-b67e-86d86cf1d9847

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
70518-3271-07051832710030 POUCH in 1 BOX (70518-3271-0) / 1 CAPSULE in 1 POUCH (70518-3271-1) 30 pouch2021-11-170000-00-00NoNoCurrent
70518-3271-1705183271011 in 1 POUCHHistorical
70518-3271-27051832710230 in 1 BLISTER PACKHistorical