Prazosin Hydrochloride

Product NDC
67046-209
Requested package NDC
67046-209-07
11-digit product format
670460209
Labeler code
67046
Product ID
67046-209_59b56b39-55f8-eb74-e053-2991aa0ae46a
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
prazosin hydrochloride
Dosage form
CAPSULE
Route
ORAL
Labeler
Contract Pharmacy Services-PA
Application
ANDA072575
Marketing category
ANDA
Marketing start
2017-09-21
Marketing end
0000-00-00
Substance
PRAZOSIN HYDROCHLORIDE
Active strength
1 mg/1
Pharmacologic classes
alpha-Adrenergic Blocker [EPC],Adrenergic alpha-Antagonists [MoA]
NDC exclude flag
No
Listing certified through
2020-12-31
Current FDA listing
Historical FDA.report record

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 packagepackage67046-20967046-209-07IInactivated by FDA2026-08-11

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 · 18 matching rows.

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

Captured / source date, Snapshot, Source SHA-256 table
Captured / source dateSnapshotSource SHA-256
2025-12-14 17:58 UTC · source 2025-12-05d630ba8d3edf…732f749b63fb…
2025-08-27 00:01 UTC · source 2025-08-26f5e01cc5f278…a2eaf40c39c3…
2025-04-01 02:39 UTC · source 2025-03-312ef7874e63bc…57b86245f4fa…
2025-03-28 20:22 UTC · source 2025-03-28a1b67e2a42f9…c4cf2c586c0d…
2025-03-22 03:12 UTC · source 2025-03-21cfe11265f3b6…090c488252e2…
2025-03-10 12:48 UTC · source 2025-03-10cdf11ea48f46…ba0047e9e063…
2025-02-02 03:52 UTC · source 2025-01-31302b2466d912…e7b80fea0513…
2025-01-20 13:05 UTC · source 2025-01-20ed331223b511…672a5bd82f5f…
2025-01-11 03:41 UTC · source 2025-01-100efc9e666f02…f202fb6c5f17…
2024-11-09 02:27 UTC · source 2024-11-08ad56d346431e…cc804d4bbf1e…
2024-10-04 04:10 UTC · source 2024-10-03367a005e9d99…383a685ebd0f…
2024-07-10 04:00 UTC · source 2024-07-09557ba5c1ecfa…9c80585c8c6e…
2024-05-28 21:12 UTC · source 2024-05-288af77b9d5b6f…d9bbb34c5368…
2024-05-15 03:39 UTC · source 2024-05-14834df4deac94…adcc014656a3…
2024-03-11 06:39 UTC · source 2024-03-081332a3947898…d4bfe170f9cd…
2022-08-30 03:57 UTC · source 2022-08-29fb8cb913e6d1…eb8c232b6be0…
2022-04-09 23:13 UTC · source 2022-04-0886f5da6cb304…a595104c45d7…
2022-04-04 05:40 UTC · source 2022-04-01bd6a592717d7…303034d00443…

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
A072575-001PRAZOSIN HYDROCHLORIDEPRAZOSIN HYDROCHLORIDEEQ 5MG BASECAPSULE / ORALAB1989-05-16
A072575-002PRAZOSIN HYDROCHLORIDEPRAZOSIN HYDROCHLORIDEEQ 2MG BASECAPSULE / ORALAB1989-05-16
A072575-003PRAZOSIN HYDROCHLORIDEPRAZOSIN HYDROCHLORIDEEQ 1MG BASECAPSULE / ORALAB1989-05-16

Therapeutic equivalence codes#

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

Application-product, TE code table
Application-productTE code
A072575-001AB
A072575-002AB
A072575-003AB

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 · 123 observed states.

Captured, Edition, Application-product table
CapturedEditionApplication-productTrade nameStrengthDosage form / routeProduct TE source textRLD / RSApproval dateSource SHA-256
2026-02-19 14:30 UTC2026-02A072575-001PRAZOSIN HYDROCHLORIDEEQ 5MG BASECAPSULE / ORALAB1989-05-16011fe1cb6892…
2026-02-19 14:30 UTC2026-02A072575-002PRAZOSIN HYDROCHLORIDEEQ 2MG BASECAPSULE / ORALAB1989-05-16011fe1cb6892…
2026-02-19 14:30 UTC2026-02A072575-003PRAZOSIN HYDROCHLORIDEEQ 1MG BASECAPSULE / ORALAB1989-05-16011fe1cb6892…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A072575-001PRAZOSIN HYDROCHLORIDEEQ 5MG BASECAPSULE / ORALAB1989-05-1631067a03dcf5…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A072575-002PRAZOSIN HYDROCHLORIDEEQ 2MG BASECAPSULE / ORALAB1989-05-1631067a03dcf5…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A072575-003PRAZOSIN HYDROCHLORIDEEQ 1MG BASECAPSULE / ORALAB1989-05-1631067a03dcf5…
2025-08-23 18:47 UTC2025-08A072575-001PRAZOSIN HYDROCHLORIDEEQ 5MG BASECAPSULE / ORALAB1989-05-166a471c1ec25d…
2025-08-23 18:47 UTC2025-08A072575-002PRAZOSIN HYDROCHLORIDEEQ 2MG BASECAPSULE / ORALAB1989-05-166a471c1ec25d…
2025-08-23 18:47 UTC2025-08A072575-003PRAZOSIN HYDROCHLORIDEEQ 1MG BASECAPSULE / ORALAB1989-05-166a471c1ec25d…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03A072575-001PRAZOSIN HYDROCHLORIDEEQ 5MG BASECAPSULE / ORALAB1989-05-16fd3edfee7708…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03A072575-002PRAZOSIN HYDROCHLORIDEEQ 2MG BASECAPSULE / ORALAB1989-05-16fd3edfee7708…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03A072575-003PRAZOSIN HYDROCHLORIDEEQ 1MG BASECAPSULE / ORALAB1989-05-16fd3edfee7708…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02A072575-001PRAZOSIN HYDROCHLORIDEEQ 5MG BASECAPSULE / ORALAB1989-05-16b8a1b40f171c…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02A072575-002PRAZOSIN HYDROCHLORIDEEQ 2MG BASECAPSULE / ORALAB1989-05-16b8a1b40f171c…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02A072575-003PRAZOSIN HYDROCHLORIDEEQ 1MG BASECAPSULE / ORALAB1989-05-16b8a1b40f171c…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01A072575-001PRAZOSIN HYDROCHLORIDEEQ 5MG BASECAPSULE / ORALAB1989-05-1603ed91905a0d…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01A072575-002PRAZOSIN HYDROCHLORIDEEQ 2MG BASECAPSULE / ORALAB1989-05-1603ed91905a0d…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01A072575-003PRAZOSIN HYDROCHLORIDEEQ 1MG BASECAPSULE / ORALAB1989-05-1603ed91905a0d…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12A072575-001PRAZOSIN HYDROCHLORIDEEQ 5MG BASECAPSULE / ORALAB1989-05-162680178bc6a6…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12A072575-002PRAZOSIN HYDROCHLORIDEEQ 2MG BASECAPSULE / ORALAB1989-05-162680178bc6a6…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12A072575-003PRAZOSIN HYDROCHLORIDEEQ 1MG BASECAPSULE / ORALAB1989-05-162680178bc6a6…
2024-09-14 05:58 UTC · 2 captures of this ZIP2024-09A072575-001PRAZOSIN HYDROCHLORIDEEQ 5MG BASECAPSULE / ORALAB1989-05-165bbf6a4d5a75…
2024-09-14 05:58 UTC · 2 captures of this ZIP2024-09A072575-002PRAZOSIN HYDROCHLORIDEEQ 2MG BASECAPSULE / ORALAB1989-05-165bbf6a4d5a75…
2024-09-14 05:58 UTC · 2 captures of this ZIP2024-09A072575-003PRAZOSIN HYDROCHLORIDEEQ 1MG BASECAPSULE / ORALAB1989-05-165bbf6a4d5a75…
2024-11-08 22:44 UTC · 3 captures of this ZIP2024-11A072575-001PRAZOSIN HYDROCHLORIDEEQ 5MG BASECAPSULE / ORALAB1989-05-16d8e5a09893c0…
2024-11-08 22:44 UTC · 3 captures of this ZIP2024-11A072575-002PRAZOSIN HYDROCHLORIDEEQ 2MG BASECAPSULE / ORALAB1989-05-16d8e5a09893c0…
2024-11-08 22:44 UTC · 3 captures of this ZIP2024-11A072575-003PRAZOSIN HYDROCHLORIDEEQ 1MG BASECAPSULE / ORALAB1989-05-16d8e5a09893c0…
2024-10-29 15:01 UTC2024-10A072575-001PRAZOSIN HYDROCHLORIDEEQ 5MG BASECAPSULE / ORALAB1989-05-16d06236e962d9…
2024-10-29 15:01 UTC2024-10A072575-002PRAZOSIN HYDROCHLORIDEEQ 2MG BASECAPSULE / ORALAB1989-05-16d06236e962d9…
2024-10-29 15:01 UTC2024-10A072575-003PRAZOSIN HYDROCHLORIDEEQ 1MG BASECAPSULE / ORALAB1989-05-16d06236e962d9…
2024-08-13 05:28 UTC · 3 captures of this ZIP2024-08A072575-001PRAZOSIN HYDROCHLORIDEEQ 5MG BASECAPSULE / ORALAB1989-05-1679d66fd596c7…
2024-08-13 05:28 UTC · 3 captures of this ZIP2024-08A072575-002PRAZOSIN HYDROCHLORIDEEQ 2MG BASECAPSULE / ORALAB1989-05-1679d66fd596c7…
2024-08-13 05:28 UTC · 3 captures of this ZIP2024-08A072575-003PRAZOSIN HYDROCHLORIDEEQ 1MG BASECAPSULE / ORALAB1989-05-1679d66fd596c7…
2024-07-13 05:37 UTC · 2 captures of this ZIP2024-07A072575-001PRAZOSIN HYDROCHLORIDEEQ 5MG BASECAPSULE / ORALAB1989-05-16301d65b070ca…
2024-07-13 05:37 UTC · 2 captures of this ZIP2024-07A072575-002PRAZOSIN HYDROCHLORIDEEQ 2MG BASECAPSULE / ORALAB1989-05-16301d65b070ca…
2024-07-13 05:37 UTC · 2 captures of this ZIP2024-07A072575-003PRAZOSIN HYDROCHLORIDEEQ 1MG BASECAPSULE / ORALAB1989-05-16301d65b070ca…
2024-06-18 03:08 UTC · 5 captures of this ZIP2024-06A072575-001PRAZOSIN HYDROCHLORIDEEQ 5MG BASECAPSULE / ORALAB1989-05-161e350fbaab3a…
2024-06-18 03:08 UTC · 5 captures of this ZIP2024-06A072575-002PRAZOSIN HYDROCHLORIDEEQ 2MG BASECAPSULE / ORALAB1989-05-161e350fbaab3a…
2024-06-18 03:08 UTC · 5 captures of this ZIP2024-06A072575-003PRAZOSIN HYDROCHLORIDEEQ 1MG BASECAPSULE / ORALAB1989-05-161e350fbaab3a…
2024-05-31 18:47 UTC2024-05A072575-001PRAZOSIN HYDROCHLORIDEEQ 5MG BASECAPSULE / ORALAB1989-05-168072bd15b7f6…

Observed Orange Book normalized TE history#

Normalized TE history page 1 of 4 · 123 observed states.

Captured, Edition, Application-product table
CapturedEditionApplication-productTE codeOrderSource SHA-256
2026-02-19 14:30 UTC2026-02A072575-001AB1011fe1cb6892…
2026-02-19 14:30 UTC2026-02A072575-002AB1011fe1cb6892…
2026-02-19 14:30 UTC2026-02A072575-003AB1011fe1cb6892…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A072575-001AB131067a03dcf5…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A072575-002AB131067a03dcf5…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A072575-003AB131067a03dcf5…
2025-08-23 18:47 UTC2025-08A072575-001AB16a471c1ec25d…
2025-08-23 18:47 UTC2025-08A072575-002AB16a471c1ec25d…
2025-08-23 18:47 UTC2025-08A072575-003AB16a471c1ec25d…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03A072575-001AB1fd3edfee7708…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03A072575-002AB1fd3edfee7708…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03A072575-003AB1fd3edfee7708…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02A072575-001AB1b8a1b40f171c…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02A072575-002AB1b8a1b40f171c…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02A072575-003AB1b8a1b40f171c…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01A072575-001AB103ed91905a0d…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01A072575-002AB103ed91905a0d…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01A072575-003AB103ed91905a0d…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12A072575-001AB12680178bc6a6…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12A072575-002AB12680178bc6a6…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12A072575-003AB12680178bc6a6…
2024-09-14 05:58 UTC · 2 captures of this ZIP2024-09A072575-001AB15bbf6a4d5a75…
2024-09-14 05:58 UTC · 2 captures of this ZIP2024-09A072575-002AB15bbf6a4d5a75…
2024-09-14 05:58 UTC · 2 captures of this ZIP2024-09A072575-003AB15bbf6a4d5a75…
2024-11-08 22:44 UTC · 3 captures of this ZIP2024-11A072575-001AB1d8e5a09893c0…
2024-11-08 22:44 UTC · 3 captures of this ZIP2024-11A072575-002AB1d8e5a09893c0…
2024-11-08 22:44 UTC · 3 captures of this ZIP2024-11A072575-003AB1d8e5a09893c0…
2024-10-29 15:01 UTC2024-10A072575-001AB1d06236e962d9…
2024-10-29 15:01 UTC2024-10A072575-002AB1d06236e962d9…
2024-10-29 15:01 UTC2024-10A072575-003AB1d06236e962d9…
2024-08-13 05:28 UTC · 3 captures of this ZIP2024-08A072575-001AB179d66fd596c7…
2024-08-13 05:28 UTC · 3 captures of this ZIP2024-08A072575-002AB179d66fd596c7…
2024-08-13 05:28 UTC · 3 captures of this ZIP2024-08A072575-003AB179d66fd596c7…
2024-07-13 05:37 UTC · 2 captures of this ZIP2024-07A072575-001AB1301d65b070ca…
2024-07-13 05:37 UTC · 2 captures of this ZIP2024-07A072575-002AB1301d65b070ca…
2024-07-13 05:37 UTC · 2 captures of this ZIP2024-07A072575-003AB1301d65b070ca…
2024-06-18 03:08 UTC · 5 captures of this ZIP2024-06A072575-001AB11e350fbaab3a…
2024-06-18 03:08 UTC · 5 captures of this ZIP2024-06A072575-002AB11e350fbaab3a…
2024-06-18 03:08 UTC · 5 captures of this ZIP2024-06A072575-003AB11e350fbaab3a…
2024-05-31 18:47 UTC2024-05A072575-001AB18072bd15b7f6…

DailyMed Product Concepts#

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

FDA-Initiated Inactive NDC Indexing#

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
67046-209-07Prazosin Hydrochloride7 in 1 BLISTER PACKCAPSULE71
67046-209-14Prazosin Hydrochloride14 in 1 BLISTER PACKCAPSULE141
67046-209-15Prazosin Hydrochloride15 in 1 BLISTER PACKCAPSULE151
67046-209-20Prazosin Hydrochloride20 in 1 BLISTER PACKCAPSULE201
67046-209-21Prazosin Hydrochloride21 in 1 BLISTER PACKCAPSULE211
67046-209-28Prazosin Hydrochloride28 in 1 BLISTER PACKCAPSULE281
67046-209-30Prazosin Hydrochloride30 in 1 BLISTER PACKCAPSULE301
67046-209-60Prazosin Hydrochloride60 in 1 BLISTER PACKCAPSULE601

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
67046-209PRAZOSIN HYDROCHLORIDE CAPSULE [CONTRACT PHARMACY SERVICES-PA]1Legacy NDC, 8 package rows20170921_59b56b39-55f7-eb74-e053-2991aa0ae46a.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 · 8 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
Prazosin HydrochloridePRAZOSIN HYDROCHLORIDEREMEDYREPACK INC.39e3fa5d-ea48-4b02-80f6-44591f5e013f2026-07-06Warnings, Adverse reactionsExact identifier
application applno (ANDA): 072575
application number: ANDA072575
Prazosin HydrochloridePRAZOSIN HYDROCHLORIDESafecor Health LLC12cdde5b-173c-4f31-a326-3128d521930c2026-04-09Warnings, Adverse reactionsExact identifier
application applno (ANDA): 072575
application number: ANDA072575
Prazosin HydrochloridePRAZOSIN HYDROCHLORIDEPD-Rx Pharmaceuticals, Inc.e5e129aa-2ee3-4c12-a327-5d5382cf23102025-10-21Warnings, Adverse reactionsExact identifier
application applno (ANDA): 072575
application number: ANDA072575
Prazosin HydrochloridePRAZOSIN HYDROCHLORIDEPD-Rx Pharmaceuticals, Inc.5d7dff44-84b1-4044-bc5a-c76ea11dd5a32025-10-21Warnings, Adverse reactionsExact identifier
application applno (ANDA): 072575
application number: ANDA072575
Prazosin HydrochloridePRAZOSIN HYDROCHLORIDEPD-Rx Pharmaceuticals, Inc.cd52f022-ca29-4f87-8684-da63e05b3c1f2025-10-21Warnings, Adverse reactionsExact identifier
application applno (ANDA): 072575
application number: ANDA072575
Prazosin HydrochloridePRAZOSIN HYDROCHLORIDEMylan Institutional Inc.e6a029b2-802f-4cc5-8795-20e177e8d7792025-07-22Warnings, Adverse reactionsExact identifier
application applno (ANDA): 072575
application number: ANDA072575
Prazosin HydrochloridePRAZOSIN HYDROCHLORIDEBryant Ranch Prepack1a92a503-cf5e-48ef-a6fd-79fe98fdd8a02023-04-03Warnings, Adverse reactionsExact identifier
application applno (ANDA): 072575
application number: ANDA072575
Prazosin HydrochloridePRAZOSIN HYDROCHLORIDEMylan Pharmaceuticals Inc.1ce90aaf-d075-4617-9a47-e8d922096d232022-09-01Warnings, Adverse reactionsExact identifier
application applno (ANDA): 072575
application number: ANDA072575

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
312593prazosin HCl 1 MG Oral CapsulePSN59b56b39-55f7-eb74-e053-2991aa0ae46a1
312594prazosin HCl 2 MG Oral CapsulePSN59b56b39-55f7-eb74-e053-2991aa0ae46a1
312593prazosin 1 MG Oral CapsuleSCD59b56b39-55f7-eb74-e053-2991aa0ae46a1
312594prazosin 2 MG Oral CapsuleSCD59b56b39-55f7-eb74-e053-2991aa0ae46a1
312593prazosin (as prazosin HCl) 1 MG Oral CapsuleSY59b56b39-55f7-eb74-e053-2991aa0ae46a1
312594prazosin (as prazosin HCl) 2 MG Oral CapsuleSY59b56b39-55f7-eb74-e053-2991aa0ae46a1

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
67046-209-07670460209077 CAPSULE in 1 BLISTER PACK (67046-209-07) 7 capsule2017-09-210000-00-00NoNoCurrent