prazosin hydrochloride

Product NDC
76420-525
Requested package NDC
76420-525-20
11-digit product format
764200525
Labeler code
76420
Product ID
76420-525_412ebee3-8ea7-9e7a-e063-6394a90aa63a
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
prazosin hydrochloride
Dosage form
CAPSULE
Route
ORAL
Labeler
ASCLEMED USA INC.
Application
ANDA215697
Marketing category
ANDA
Marketing start
2023-01-03
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 1.

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
A215697-001PRAZOSIN HYDROCHLORIDEPRAZOSIN HYDROCHLORIDEEQ 1MG BASECAPSULE / ORALAB2022-12-30
A215697-002PRAZOSIN HYDROCHLORIDEPRAZOSIN HYDROCHLORIDEEQ 2MG BASECAPSULE / ORALAB2022-12-30
A215697-003PRAZOSIN HYDROCHLORIDEPRAZOSIN HYDROCHLORIDEEQ 5MG BASECAPSULE / ORALAB2022-12-30

Therapeutic equivalence codes#

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

Application-product, TE code table
Application-productTE code
A215697-001AB
A215697-002AB
A215697-003AB

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 2 · 72 observed states.

Captured, Edition, Application-product table
CapturedEditionApplication-productTrade nameStrengthDosage form / routeProduct TE source textRLD / RSApproval dateSource SHA-256
2026-02-19 14:30 UTC2026-02A215697-001PRAZOSIN HYDROCHLORIDEEQ 1MG BASECAPSULE / ORALAB2022-12-30011fe1cb6892…
2026-02-19 14:30 UTC2026-02A215697-002PRAZOSIN HYDROCHLORIDEEQ 2MG BASECAPSULE / ORALAB2022-12-30011fe1cb6892…
2026-02-19 14:30 UTC2026-02A215697-003PRAZOSIN HYDROCHLORIDEEQ 5MG BASECAPSULE / ORALAB2022-12-30011fe1cb6892…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A215697-001PRAZOSIN HYDROCHLORIDEEQ 1MG BASECAPSULE / ORALAB2022-12-3031067a03dcf5…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A215697-002PRAZOSIN HYDROCHLORIDEEQ 2MG BASECAPSULE / ORALAB2022-12-3031067a03dcf5…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A215697-003PRAZOSIN HYDROCHLORIDEEQ 5MG BASECAPSULE / ORALAB2022-12-3031067a03dcf5…
2025-08-23 18:47 UTC2025-08A215697-001PRAZOSIN HYDROCHLORIDEEQ 1MG BASECAPSULE / ORALAB2022-12-306a471c1ec25d…
2025-08-23 18:47 UTC2025-08A215697-002PRAZOSIN HYDROCHLORIDEEQ 2MG BASECAPSULE / ORALAB2022-12-306a471c1ec25d…
2025-08-23 18:47 UTC2025-08A215697-003PRAZOSIN HYDROCHLORIDEEQ 5MG BASECAPSULE / ORALAB2022-12-306a471c1ec25d…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03A215697-001PRAZOSIN HYDROCHLORIDEEQ 1MG BASECAPSULE / ORALAB2022-12-30fd3edfee7708…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03A215697-002PRAZOSIN HYDROCHLORIDEEQ 2MG BASECAPSULE / ORALAB2022-12-30fd3edfee7708…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03A215697-003PRAZOSIN HYDROCHLORIDEEQ 5MG BASECAPSULE / ORALAB2022-12-30fd3edfee7708…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02A215697-001PRAZOSIN HYDROCHLORIDEEQ 1MG BASECAPSULE / ORALAB2022-12-30b8a1b40f171c…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02A215697-002PRAZOSIN HYDROCHLORIDEEQ 2MG BASECAPSULE / ORALAB2022-12-30b8a1b40f171c…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02A215697-003PRAZOSIN HYDROCHLORIDEEQ 5MG BASECAPSULE / ORALAB2022-12-30b8a1b40f171c…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01A215697-001PRAZOSIN HYDROCHLORIDEEQ 1MG BASECAPSULE / ORALAB2022-12-3003ed91905a0d…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01A215697-002PRAZOSIN HYDROCHLORIDEEQ 2MG BASECAPSULE / ORALAB2022-12-3003ed91905a0d…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01A215697-003PRAZOSIN HYDROCHLORIDEEQ 5MG BASECAPSULE / ORALAB2022-12-3003ed91905a0d…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12A215697-001PRAZOSIN HYDROCHLORIDEEQ 1MG BASECAPSULE / ORALAB2022-12-302680178bc6a6…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12A215697-002PRAZOSIN HYDROCHLORIDEEQ 2MG BASECAPSULE / ORALAB2022-12-302680178bc6a6…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12A215697-003PRAZOSIN HYDROCHLORIDEEQ 5MG BASECAPSULE / ORALAB2022-12-302680178bc6a6…
2024-09-14 05:58 UTC · 2 captures of this ZIP2024-09A215697-001PRAZOSIN HYDROCHLORIDEEQ 1MG BASECAPSULE / ORALAB2022-12-305bbf6a4d5a75…
2024-09-14 05:58 UTC · 2 captures of this ZIP2024-09A215697-002PRAZOSIN HYDROCHLORIDEEQ 2MG BASECAPSULE / ORALAB2022-12-305bbf6a4d5a75…
2024-09-14 05:58 UTC · 2 captures of this ZIP2024-09A215697-003PRAZOSIN HYDROCHLORIDEEQ 5MG BASECAPSULE / ORALAB2022-12-305bbf6a4d5a75…
2024-11-08 22:44 UTC · 3 captures of this ZIP2024-11A215697-001PRAZOSIN HYDROCHLORIDEEQ 1MG BASECAPSULE / ORALAB2022-12-30d8e5a09893c0…
2024-11-08 22:44 UTC · 3 captures of this ZIP2024-11A215697-002PRAZOSIN HYDROCHLORIDEEQ 2MG BASECAPSULE / ORALAB2022-12-30d8e5a09893c0…
2024-11-08 22:44 UTC · 3 captures of this ZIP2024-11A215697-003PRAZOSIN HYDROCHLORIDEEQ 5MG BASECAPSULE / ORALAB2022-12-30d8e5a09893c0…
2024-10-29 15:01 UTC2024-10A215697-001PRAZOSIN HYDROCHLORIDEEQ 1MG BASECAPSULE / ORALAB2022-12-30d06236e962d9…
2024-10-29 15:01 UTC2024-10A215697-002PRAZOSIN HYDROCHLORIDEEQ 2MG BASECAPSULE / ORALAB2022-12-30d06236e962d9…
2024-10-29 15:01 UTC2024-10A215697-003PRAZOSIN HYDROCHLORIDEEQ 5MG BASECAPSULE / ORALAB2022-12-30d06236e962d9…
2024-08-13 05:28 UTC · 3 captures of this ZIP2024-08A215697-001PRAZOSIN HYDROCHLORIDEEQ 1MG BASECAPSULE / ORALAB2022-12-3079d66fd596c7…
2024-08-13 05:28 UTC · 3 captures of this ZIP2024-08A215697-002PRAZOSIN HYDROCHLORIDEEQ 2MG BASECAPSULE / ORALAB2022-12-3079d66fd596c7…
2024-08-13 05:28 UTC · 3 captures of this ZIP2024-08A215697-003PRAZOSIN HYDROCHLORIDEEQ 5MG BASECAPSULE / ORALAB2022-12-3079d66fd596c7…
2024-07-13 05:37 UTC · 2 captures of this ZIP2024-07A215697-001PRAZOSIN HYDROCHLORIDEEQ 1MG BASECAPSULE / ORALAB2022-12-30301d65b070ca…
2024-07-13 05:37 UTC · 2 captures of this ZIP2024-07A215697-002PRAZOSIN HYDROCHLORIDEEQ 2MG BASECAPSULE / ORALAB2022-12-30301d65b070ca…
2024-07-13 05:37 UTC · 2 captures of this ZIP2024-07A215697-003PRAZOSIN HYDROCHLORIDEEQ 5MG BASECAPSULE / ORALAB2022-12-30301d65b070ca…
2024-06-18 03:08 UTC · 5 captures of this ZIP2024-06A215697-001PRAZOSIN HYDROCHLORIDEEQ 1MG BASECAPSULE / ORALAB2022-12-301e350fbaab3a…
2024-06-18 03:08 UTC · 5 captures of this ZIP2024-06A215697-002PRAZOSIN HYDROCHLORIDEEQ 2MG BASECAPSULE / ORALAB2022-12-301e350fbaab3a…
2024-06-18 03:08 UTC · 5 captures of this ZIP2024-06A215697-003PRAZOSIN HYDROCHLORIDEEQ 5MG BASECAPSULE / ORALAB2022-12-301e350fbaab3a…
2024-05-31 18:47 UTC2024-05A215697-001PRAZOSIN HYDROCHLORIDEEQ 1MG BASECAPSULE / ORALAB2022-12-308072bd15b7f6…

Observed Orange Book normalized TE history#

Normalized TE history page 1 of 2 · 72 observed states.

Captured, Edition, Application-product table
CapturedEditionApplication-productTE codeOrderSource SHA-256
2026-02-19 14:30 UTC2026-02A215697-001AB1011fe1cb6892…
2026-02-19 14:30 UTC2026-02A215697-002AB1011fe1cb6892…
2026-02-19 14:30 UTC2026-02A215697-003AB1011fe1cb6892…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A215697-001AB131067a03dcf5…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A215697-002AB131067a03dcf5…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A215697-003AB131067a03dcf5…
2025-08-23 18:47 UTC2025-08A215697-001AB16a471c1ec25d…
2025-08-23 18:47 UTC2025-08A215697-002AB16a471c1ec25d…
2025-08-23 18:47 UTC2025-08A215697-003AB16a471c1ec25d…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03A215697-001AB1fd3edfee7708…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03A215697-002AB1fd3edfee7708…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03A215697-003AB1fd3edfee7708…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02A215697-001AB1b8a1b40f171c…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02A215697-002AB1b8a1b40f171c…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02A215697-003AB1b8a1b40f171c…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01A215697-001AB103ed91905a0d…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01A215697-002AB103ed91905a0d…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01A215697-003AB103ed91905a0d…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12A215697-001AB12680178bc6a6…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12A215697-002AB12680178bc6a6…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12A215697-003AB12680178bc6a6…
2024-09-14 05:58 UTC · 2 captures of this ZIP2024-09A215697-001AB15bbf6a4d5a75…
2024-09-14 05:58 UTC · 2 captures of this ZIP2024-09A215697-002AB15bbf6a4d5a75…
2024-09-14 05:58 UTC · 2 captures of this ZIP2024-09A215697-003AB15bbf6a4d5a75…
2024-11-08 22:44 UTC · 3 captures of this ZIP2024-11A215697-001AB1d8e5a09893c0…
2024-11-08 22:44 UTC · 3 captures of this ZIP2024-11A215697-002AB1d8e5a09893c0…
2024-11-08 22:44 UTC · 3 captures of this ZIP2024-11A215697-003AB1d8e5a09893c0…
2024-10-29 15:01 UTC2024-10A215697-001AB1d06236e962d9…
2024-10-29 15:01 UTC2024-10A215697-002AB1d06236e962d9…
2024-10-29 15:01 UTC2024-10A215697-003AB1d06236e962d9…
2024-08-13 05:28 UTC · 3 captures of this ZIP2024-08A215697-001AB179d66fd596c7…
2024-08-13 05:28 UTC · 3 captures of this ZIP2024-08A215697-002AB179d66fd596c7…
2024-08-13 05:28 UTC · 3 captures of this ZIP2024-08A215697-003AB179d66fd596c7…
2024-07-13 05:37 UTC · 2 captures of this ZIP2024-07A215697-001AB1301d65b070ca…
2024-07-13 05:37 UTC · 2 captures of this ZIP2024-07A215697-002AB1301d65b070ca…
2024-07-13 05:37 UTC · 2 captures of this ZIP2024-07A215697-003AB1301d65b070ca…
2024-06-18 03:08 UTC · 5 captures of this ZIP2024-06A215697-001AB11e350fbaab3a…
2024-06-18 03:08 UTC · 5 captures of this ZIP2024-06A215697-002AB11e350fbaab3a…
2024-06-18 03:08 UTC · 5 captures of this ZIP2024-06A215697-003AB11e350fbaab3a…
2024-05-31 18:47 UTC2024-05A215697-001AB18072bd15b7f6…

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 · 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
b66d105b-be78-4e54-9c01-b38e36ad74deAvailable 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
76420-525-01prazosin hydrochloride100 in 1 BOTTLECAPSULE1001
76420-525-10prazosin hydrochloride10 in 1 BOTTLECAPSULE101
76420-525-20prazosin hydrochloride20 in 1 BOTTLECAPSULE201
76420-525-30prazosin hydrochloride30 in 1 BOTTLECAPSULE301
76420-525-60prazosin hydrochloride60 in 1 BOTTLECAPSULE601
76420-525-90prazosin hydrochloride90 in 1 BOTTLECAPSULE901

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 · 18 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
prazosin hydrochloridePRAZOSIN HYDROCHLORIDEREMEDYREPACK INC.8606d9b8-4529-4689-8c93-7114c84c2e542026-04-27Warnings, Adverse reactionsExact identifier
application applno (ANDA): 215697
application number: ANDA215697
prazosin hydrochloridePRAZOSIN HYDROCHLORIDEREMEDYREPACK INC.95aa9ffb-66bb-4049-a241-0e1166b4c2642026-04-15Warnings, Adverse reactionsExact identifier
application applno (ANDA): 215697
application number: ANDA215697
prazosin hydrochloridePRAZOSIN HYDROCHLORIDEASCLEMED USA INC.b66d105b-be78-4e54-9c01-b38e36ad74de2025-10-15Warnings, Adverse reactionsExact identifier
application applno (ANDA): 215697
application number: ANDA215697
ndc (package): 76420-525-20
ndc (product): 76420-525
ndc11 (package): 76420052520
prazosin hydrochloridePRAZOSIN HYDROCHLORIDEREMEDYREPACK INC.e4852fc2-b763-40e2-b8bb-a3f6da5c72fe2025-10-01Warnings, Adverse reactionsExact identifier
application applno (ANDA): 215697
application number: ANDA215697
prazosin hydrochloridePRAZOSIN HYDROCHLORIDEPreferred Pharmaceuticals Inc.e5bd5728-ea7c-4f16-832b-8d58fe14b9942025-09-10Warnings, Adverse reactionsExact identifier
application applno (ANDA): 215697
application number: ANDA215697
prazosin hydrochloridePRAZOSIN HYDROCHLORIDEBryant Ranch Prepackfa00e99e-f050-4544-a11b-d20c9710761e2025-07-03Warnings, Adverse reactionsExact identifier
application applno (ANDA): 215697
application number: ANDA215697
prazosin hydrochloridePRAZOSIN HYDROCHLORIDEST. MARY'S MEDICAL PARK PHARMACY35a996a5-abba-838d-e063-6294a90a72a42025-05-21Warnings, Adverse reactionsExact identifier
application applno (ANDA): 215697
application number: ANDA215697
prazosin hydrochloridePRAZOSIN HYDROCHLORIDEST. MARY'S MEDICAL PARK PHARMACY35a9c70d-b611-cf9d-e063-6294a90a23f72025-05-21Warnings, Adverse reactionsExact identifier
application applno (ANDA): 215697
application number: ANDA215697
prazosin hydrochloridePRAZOSIN HYDROCHLORIDECoupler, LLC30b70064-79e1-b8a9-e063-6394a90a69cb2025-03-19Warnings, Adverse reactionsExact identifier
application applno (ANDA): 215697
application number: ANDA215697
Prazosin HCLPRAZOSIN HCLDirect_Rxfb6db16d-3768-631b-e053-6294a90a1cee2025-01-22Warnings, Adverse reactionsExact identifier
application applno (ANDA): 215697
application number: ANDA215697
prazosin hydrochloridePRAZOSIN HYDROCHLORIDENuCare Pharmaceuticals,Inc.f8fd7e1d-471d-f4ae-e053-6294a90a8b412024-12-13Warnings, Adverse reactionsExact identifier
application applno (ANDA): 215697
application number: ANDA215697
Prazosin HCLPRAZOSIN HCLDirect_Rxf6c9eef9-c016-9020-e053-6294a90a1cd82024-09-13Warnings, Adverse reactionsExact identifier
application applno (ANDA): 215697
application number: ANDA215697
Prazosin HCLPRAZOSIN HCLDirect_Rx13018fa7-5e30-ed92-e063-6394a90a44272024-03-06Warnings, Adverse reactionsExact identifier
application applno (ANDA): 215697
application number: ANDA215697
prazosin hydrochloridePRAZOSIN HYDROCHLORIDEProficient Rx LP2a928735-179f-4637-8c4e-3b5e01d45bf22024-03-01Warnings, Adverse reactionsExact identifier
application applno (ANDA): 215697
application number: ANDA215697
prazosin hydrochloridePRAZOSIN HYDROCHLORIDEBryant Ranch Prepack61e5108a-70eb-4d48-a742-defb2e918b632024-02-21Warnings, Adverse reactionsExact identifier
application applno (ANDA): 215697
application number: ANDA215697
prazosin hydrochloridePRAZOSIN HYDROCHLORIDEBryant Ranch Prepackf475c5e7-94df-40c8-b35f-ce6f866ed1b92023-12-21Warnings, Adverse reactionsExact identifier
application applno (ANDA): 215697
application number: ANDA215697
prazosin hydrochloridePRAZOSIN HYDROCHLORIDEProficient Rx LPb8a9cbee-c526-4d1e-ad2f-cf7fbb7849362023-10-01Warnings, Adverse reactionsExact identifier
application applno (ANDA): 215697
application number: ANDA215697
prazosin hydrochloridePRAZOSIN HYDROCHLORIDELifestar Pharma LLC73bbc360-5bfb-4139-a63e-0cb6e4ea83132023-03-17Warnings, Adverse reactionsExact identifier
application applno (ANDA): 215697
application number: ANDA215697

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
312593prazosin HCl 1 MG Oral CapsulePSNb66d105b-be78-4e54-9c01-b38e36ad74de1
312594prazosin HCl 2 MG Oral CapsulePSNb66d105b-be78-4e54-9c01-b38e36ad74de1
198141prazosin HCl 5 MG Oral CapsulePSNb66d105b-be78-4e54-9c01-b38e36ad74de1
312593prazosin 1 MG Oral CapsuleSCDb66d105b-be78-4e54-9c01-b38e36ad74de1
312594prazosin 2 MG Oral CapsuleSCDb66d105b-be78-4e54-9c01-b38e36ad74de1
198141prazosin 5 MG Oral CapsuleSCDb66d105b-be78-4e54-9c01-b38e36ad74de1
312593prazosin (as prazosin HCl) 1 MG Oral CapsuleSYb66d105b-be78-4e54-9c01-b38e36ad74de1
312594prazosin (as prazosin HCl) 2 MG Oral CapsuleSYb66d105b-be78-4e54-9c01-b38e36ad74de1
198141prazosin (as prazosin HCl) 5 MG Oral CapsuleSYb66d105b-be78-4e54-9c01-b38e36ad74de1

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startSampleExclude flagStatus
76420-525-207642005252020 CAPSULE in 1 BOTTLE (76420-525-20) 20 capsule2025-10-15NoNoCurrent