Prazosin Hydrochloride

Product NDC
68084-997
11-digit product format
680840997
Labeler code
68084
Product ID
68084-997_2b32cc04-a4d4-2cdd-e063-6394a90a2c85
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
Prazosin Hydrochloride
Dosage form
CAPSULE
Route
ORAL
Labeler
American Health Packaging
Application
ANDA071745
Marketing category
ANDA
Marketing start
2018-05-11
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

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
A071745-001PRAZOSIN HYDROCHLORIDEPRAZOSIN HYDROCHLORIDEEQ 5MG BASECAPSULE / ORALAB1988-09-12
A071745-002PRAZOSIN HYDROCHLORIDEPRAZOSIN HYDROCHLORIDEEQ 1MG BASECAPSULE / ORALAB1988-09-12
A071745-003PRAZOSIN HYDROCHLORIDEPRAZOSIN HYDROCHLORIDEEQ 2MG BASECAPSULE / ORALAB1988-09-12

Therapeutic equivalence codes#

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

Application-product, TE code table
Application-productTE code
A071745-001AB
A071745-002AB
A071745-003AB

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 06:07:402026-07A071745-001PRAZOSIN HYDROCHLORIDEEQ 5MG BASECAPSULE / ORALAB1988-09-12caaa826d4ba7…
2026-08-18 06:07:402026-07A071745-002PRAZOSIN HYDROCHLORIDEEQ 1MG BASECAPSULE / ORALAB1988-09-12caaa826d4ba7…
2026-08-18 06:07:402026-07A071745-003PRAZOSIN HYDROCHLORIDEEQ 2MG BASECAPSULE / ORALAB1988-09-12caaa826d4ba7…
2026-02-19 14:30 UTC2026-02A071745-001PRAZOSIN HYDROCHLORIDEEQ 5MG BASECAPSULE / ORALAB1988-09-12011fe1cb6892…
2026-02-19 14:30 UTC2026-02A071745-002PRAZOSIN HYDROCHLORIDEEQ 1MG BASECAPSULE / ORALAB1988-09-12011fe1cb6892…
2026-02-19 14:30 UTC2026-02A071745-003PRAZOSIN HYDROCHLORIDEEQ 2MG BASECAPSULE / ORALAB1988-09-12011fe1cb6892…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A071745-001PRAZOSIN HYDROCHLORIDEEQ 5MG BASECAPSULE / ORALAB1988-09-1231067a03dcf5…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A071745-002PRAZOSIN HYDROCHLORIDEEQ 1MG BASECAPSULE / ORALAB1988-09-1231067a03dcf5…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A071745-003PRAZOSIN HYDROCHLORIDEEQ 2MG BASECAPSULE / ORALAB1988-09-1231067a03dcf5…
2025-08-23 18:47 UTC2025-08A071745-001PRAZOSIN HYDROCHLORIDEEQ 5MG BASECAPSULE / ORALAB1988-09-126a471c1ec25d…
2025-08-23 18:47 UTC2025-08A071745-002PRAZOSIN HYDROCHLORIDEEQ 1MG BASECAPSULE / ORALAB1988-09-126a471c1ec25d…
2025-08-23 18:47 UTC2025-08A071745-003PRAZOSIN HYDROCHLORIDEEQ 2MG BASECAPSULE / ORALAB1988-09-126a471c1ec25d…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03A071745-001PRAZOSIN HYDROCHLORIDEEQ 5MG BASECAPSULE / ORALAB1988-09-12fd3edfee7708…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03A071745-002PRAZOSIN HYDROCHLORIDEEQ 1MG BASECAPSULE / ORALAB1988-09-12fd3edfee7708…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03A071745-003PRAZOSIN HYDROCHLORIDEEQ 2MG BASECAPSULE / ORALAB1988-09-12fd3edfee7708…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02A071745-001PRAZOSIN HYDROCHLORIDEEQ 5MG BASECAPSULE / ORALAB1988-09-12b8a1b40f171c…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02A071745-002PRAZOSIN HYDROCHLORIDEEQ 1MG BASECAPSULE / ORALAB1988-09-12b8a1b40f171c…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02A071745-003PRAZOSIN HYDROCHLORIDEEQ 2MG BASECAPSULE / ORALAB1988-09-12b8a1b40f171c…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01A071745-001PRAZOSIN HYDROCHLORIDEEQ 5MG BASECAPSULE / ORALAB1988-09-1203ed91905a0d…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01A071745-002PRAZOSIN HYDROCHLORIDEEQ 1MG BASECAPSULE / ORALAB1988-09-1203ed91905a0d…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01A071745-003PRAZOSIN HYDROCHLORIDEEQ 2MG BASECAPSULE / ORALAB1988-09-1203ed91905a0d…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12A071745-001PRAZOSIN HYDROCHLORIDEEQ 5MG BASECAPSULE / ORALAB1988-09-122680178bc6a6…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12A071745-002PRAZOSIN HYDROCHLORIDEEQ 1MG BASECAPSULE / ORALAB1988-09-122680178bc6a6…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12A071745-003PRAZOSIN HYDROCHLORIDEEQ 2MG BASECAPSULE / ORALAB1988-09-122680178bc6a6…
2024-09-14 05:58 UTC · 2 captures of this ZIP2024-09A071745-001PRAZOSIN HYDROCHLORIDEEQ 5MG BASECAPSULE / ORALAB1988-09-125bbf6a4d5a75…
2024-09-14 05:58 UTC · 2 captures of this ZIP2024-09A071745-002PRAZOSIN HYDROCHLORIDEEQ 1MG BASECAPSULE / ORALAB1988-09-125bbf6a4d5a75…
2024-09-14 05:58 UTC · 2 captures of this ZIP2024-09A071745-003PRAZOSIN HYDROCHLORIDEEQ 2MG BASECAPSULE / ORALAB1988-09-125bbf6a4d5a75…
2024-11-08 22:44 UTC · 3 captures of this ZIP2024-11A071745-001PRAZOSIN HYDROCHLORIDEEQ 5MG BASECAPSULE / ORALAB1988-09-12d8e5a09893c0…
2024-11-08 22:44 UTC · 3 captures of this ZIP2024-11A071745-002PRAZOSIN HYDROCHLORIDEEQ 1MG BASECAPSULE / ORALAB1988-09-12d8e5a09893c0…
2024-11-08 22:44 UTC · 3 captures of this ZIP2024-11A071745-003PRAZOSIN HYDROCHLORIDEEQ 2MG BASECAPSULE / ORALAB1988-09-12d8e5a09893c0…
2024-10-29 15:01 UTC2024-10A071745-001PRAZOSIN HYDROCHLORIDEEQ 5MG BASECAPSULE / ORALAB1988-09-12d06236e962d9…
2024-10-29 15:01 UTC2024-10A071745-002PRAZOSIN HYDROCHLORIDEEQ 1MG BASECAPSULE / ORALAB1988-09-12d06236e962d9…
2024-10-29 15:01 UTC2024-10A071745-003PRAZOSIN HYDROCHLORIDEEQ 2MG BASECAPSULE / ORALAB1988-09-12d06236e962d9…
2024-08-13 05:28 UTC · 3 captures of this ZIP2024-08A071745-001PRAZOSIN HYDROCHLORIDEEQ 5MG BASECAPSULE / ORALAB1988-09-1279d66fd596c7…
2024-08-13 05:28 UTC · 3 captures of this ZIP2024-08A071745-002PRAZOSIN HYDROCHLORIDEEQ 1MG BASECAPSULE / ORALAB1988-09-1279d66fd596c7…
2024-08-13 05:28 UTC · 3 captures of this ZIP2024-08A071745-003PRAZOSIN HYDROCHLORIDEEQ 2MG BASECAPSULE / ORALAB1988-09-1279d66fd596c7…
2024-07-13 05:37 UTC · 2 captures of this ZIP2024-07A071745-001PRAZOSIN HYDROCHLORIDEEQ 5MG BASECAPSULE / ORALAB1988-09-12301d65b070ca…
2024-07-13 05:37 UTC · 2 captures of this ZIP2024-07A071745-002PRAZOSIN HYDROCHLORIDEEQ 1MG BASECAPSULE / ORALAB1988-09-12301d65b070ca…
2024-07-13 05:37 UTC · 2 captures of this ZIP2024-07A071745-003PRAZOSIN HYDROCHLORIDEEQ 2MG BASECAPSULE / ORALAB1988-09-12301d65b070ca…
2024-06-18 03:08 UTC · 5 captures of this ZIP2024-06A071745-001PRAZOSIN HYDROCHLORIDEEQ 5MG BASECAPSULE / ORALAB1988-09-121e350fbaab3a…

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 06:07:402026-07A071745-001AB1caaa826d4ba7…
2026-08-18 06:07:402026-07A071745-002AB1caaa826d4ba7…
2026-08-18 06:07:402026-07A071745-003AB1caaa826d4ba7…
2026-02-19 14:30 UTC2026-02A071745-001AB1011fe1cb6892…
2026-02-19 14:30 UTC2026-02A071745-002AB1011fe1cb6892…
2026-02-19 14:30 UTC2026-02A071745-003AB1011fe1cb6892…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A071745-001AB131067a03dcf5…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A071745-002AB131067a03dcf5…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A071745-003AB131067a03dcf5…
2025-08-23 18:47 UTC2025-08A071745-001AB16a471c1ec25d…
2025-08-23 18:47 UTC2025-08A071745-002AB16a471c1ec25d…
2025-08-23 18:47 UTC2025-08A071745-003AB16a471c1ec25d…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03A071745-001AB1fd3edfee7708…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03A071745-002AB1fd3edfee7708…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03A071745-003AB1fd3edfee7708…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02A071745-001AB1b8a1b40f171c…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02A071745-002AB1b8a1b40f171c…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02A071745-003AB1b8a1b40f171c…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01A071745-001AB103ed91905a0d…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01A071745-002AB103ed91905a0d…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01A071745-003AB103ed91905a0d…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12A071745-001AB12680178bc6a6…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12A071745-002AB12680178bc6a6…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12A071745-003AB12680178bc6a6…
2024-09-14 05:58 UTC · 2 captures of this ZIP2024-09A071745-001AB15bbf6a4d5a75…
2024-09-14 05:58 UTC · 2 captures of this ZIP2024-09A071745-002AB15bbf6a4d5a75…
2024-09-14 05:58 UTC · 2 captures of this ZIP2024-09A071745-003AB15bbf6a4d5a75…
2024-11-08 22:44 UTC · 3 captures of this ZIP2024-11A071745-001AB1d8e5a09893c0…
2024-11-08 22:44 UTC · 3 captures of this ZIP2024-11A071745-002AB1d8e5a09893c0…
2024-11-08 22:44 UTC · 3 captures of this ZIP2024-11A071745-003AB1d8e5a09893c0…
2024-10-29 15:01 UTC2024-10A071745-001AB1d06236e962d9…
2024-10-29 15:01 UTC2024-10A071745-002AB1d06236e962d9…
2024-10-29 15:01 UTC2024-10A071745-003AB1d06236e962d9…
2024-08-13 05:28 UTC · 3 captures of this ZIP2024-08A071745-001AB179d66fd596c7…
2024-08-13 05:28 UTC · 3 captures of this ZIP2024-08A071745-002AB179d66fd596c7…
2024-08-13 05:28 UTC · 3 captures of this ZIP2024-08A071745-003AB179d66fd596c7…
2024-07-13 05:37 UTC · 2 captures of this ZIP2024-07A071745-001AB1301d65b070ca…
2024-07-13 05:37 UTC · 2 captures of this ZIP2024-07A071745-002AB1301d65b070ca…
2024-07-13 05:37 UTC · 2 captures of this ZIP2024-07A071745-003AB1301d65b070ca…
2024-06-18 03:08 UTC · 5 captures of this ZIP2024-06A071745-001AB11e350fbaab3a…

Additional Listing Data#

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

Active Ingredients#

Ingredient, Strength table
IngredientStrength
PRAZOSIN HYDROCHLORIDE2 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 · 2 matching rows.

Identifier, FDA.report destination table
IdentifierFDA.report destination
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
2b9f51fb-da48-4c81-b6b7-eb74b9cbaaf4Available 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
68084-997-01Prazosin Hydrochloride100 in 1 BOX, UNIT-DOSECAPSULE10011
68084-997-11Prazosin Hydrochloride1 in 1 BLISTER PACKCAPSULE111

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
68084-997-01EA - Each68084-99775bceb58-753b-4e10-b977-deb806dbafcb12018-06-11
68084-997-11EA - Each68084-99743d6ec5b-4c5f-4dda-8c15-c92b952739d812018-06-11

DailyMed Socrata Ingredients#

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
68084-997PRAZOSIN HYDROCHLORIDE CAPSULE [AMERICAN HEALTH PACKAGING]11Current NDC, Legacy NDC, 2 package rows20250110_2b9f51fb-da48-4c81-b6b7-eb74b9cbaaf4.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 · 9 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
Prazosin HydrochloridePRAZOSIN HYDROCHLORIDEREMEDYREPACK INC.a3045d80-33f4-4aab-8dce-42fbbf9d3ef72026-07-07Warnings, Adverse reactionsExact identifier
application applno (ANDA): 071745
application number: ANDA071745
Prazosin HydrochloridePRAZOSIN HYDROCHLORIDECardinal Health 107, LLC879df2f9-d238-4cde-bbf8-82aef20fde3b2025-10-24Warnings, Adverse reactionsExact identifier
application applno (ANDA): 071745
application number: ANDA071745
Prazosin HydrochloridePRAZOSIN HYDROCHLORIDEPreferred Pharmaceuticals Inc.c8202658-422f-41db-bdee-7bb95b972b322025-09-10Warnings, Adverse reactionsExact identifier
application applno (ANDA): 071745
application number: ANDA071745
Prazosin HydrochloridePRAZOSIN HYDROCHLORIDEAmerican Health Packaging2b9f51fb-da48-4c81-b6b7-eb74b9cbaaf42025-01-08Warnings, Adverse reactionsExact identifier
application applno (ANDA): 071745
application number: ANDA071745
ndc (product): 68084-997
Prazosin HydrochloridePRAZOSIN HYDROCHLORIDEAmerican Health Packaginga2b84746-f780-4e21-adc9-62d09c9363cf2025-01-08Warnings, Adverse reactionsExact identifier
application applno (ANDA): 071745
application number: ANDA071745
Prazosin HydrochloridePRAZOSIN HYDROCHLORIDEBryant Ranch Prepackd58fd197-ca7a-481b-bf3c-0babb80db0232024-01-11Warnings, Adverse reactionsExact identifier
application applno (ANDA): 071745
application number: ANDA071745
Prazosin HydrochloridePRAZOSIN HYDROCHLORIDEBryant Ranch Prepackce926a30-d417-4fc1-8aa3-71405f09ec5e2024-01-11Warnings, Adverse reactionsExact identifier
application applno (ANDA): 071745
application number: ANDA071745
Prazosin HydrochloridePRAZOSIN HYDROCHLORIDEProficient Rx LPd7a9f9c3-fbb7-421e-ab65-fdd805a3197f2023-10-01Warnings, Adverse reactionsExact identifier
application applno (ANDA): 071745
application number: ANDA071745
Prazosin HydrochloridePRAZOSIN HYDROCHLORIDETeva Pharmaceuticals USA, Inc.7293cef3-ef9e-40dc-9995-875ef047f6932018-10-25Warnings, Adverse reactionsExact identifier
application applno (ANDA): 071745
application number: ANDA071745

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
312593prazosin HCl 1 MG Oral CapsulePSN2b9f51fb-da48-4c81-b6b7-eb74b9cbaaf411
312594prazosin HCl 2 MG Oral CapsulePSN2b9f51fb-da48-4c81-b6b7-eb74b9cbaaf411
312593prazosin 1 MG Oral CapsuleSCD2b9f51fb-da48-4c81-b6b7-eb74b9cbaaf411
312594prazosin 2 MG Oral CapsuleSCD2b9f51fb-da48-4c81-b6b7-eb74b9cbaaf411
312593prazosin (as prazosin HCl) 1 MG Oral CapsuleSY2b9f51fb-da48-4c81-b6b7-eb74b9cbaaf411
312594prazosin (as prazosin HCl) 2 MG Oral CapsuleSY2b9f51fb-da48-4c81-b6b7-eb74b9cbaaf411

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
68084-997-0168084099701100 BLISTER PACK in 1 BOX, UNIT-DOSE (68084-997-01) / 1 CAPSULE in 1 BLISTER PACK (68084-997-11) 100 blister pack2018-05-110000-00-00NoNoCurrent
68084-997-11680840997111 in 1 BLISTER PACKHistorical