Prazosin Hydrochloride

Product NDC
63629-6873
Requested package NDC
63629-6873-4
11-digit product format
636296873
Labeler code
63629
Product ID
63629-6873_f4862d3e-f96f-422e-9da6-34c4fd4e0826
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
Prazosin Hydrochloride
Dosage form
CAPSULE
Route
ORAL
Labeler
Bryant Ranch Prepack
Application
ANDA071745
Marketing category
ANDA
Marketing start
2007-02-22
Marketing end
0000-00-00
Substance
PRAZOSIN HYDROCHLORIDE
Active strength
2 mg/1
Pharmacologic classes
alpha-Adrenergic Blocker [EPC],Adrenergic alpha-Antagonists [MoA]
NDC exclude flag
No
Listing certified through
2021-12-31
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 packagepackage63629-687363629-6873-4DDiscontinued 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 · 12 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…

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…

FDA-Initiated Inactive NDC Indexing#

DailyMed Socrata Ingredients#

Ingredient, Type, UNII table
IngredientTypeUNIIDailyMed labelSPL versionUploaded
PRAZOSIN HYDROCHLORIDEACTIVE INGREDIENTX0Z7454B90PRAZOSIN HYDROCHLORIDE CAPSULE [BRYANT RANCH PREPACK]1002
PRAZOSINACTIVE MOIETYXM03YJ541DPRAZOSIN HYDROCHLORIDE CAPSULE [BRYANT RANCH PREPACK]1002
ANHYDROUS LACTOSEINACTIVE INGREDIENT3SY5LH9PMKPRAZOSIN HYDROCHLORIDE CAPSULE [BRYANT RANCH PREPACK]1002
D&C YELLOW NO. 10INACTIVE INGREDIENT35SW5USQ3GPRAZOSIN HYDROCHLORIDE CAPSULE [BRYANT RANCH PREPACK]1002
MAGNESIUM STEARATEINACTIVE INGREDIENT70097M6I30PRAZOSIN HYDROCHLORIDE CAPSULE [BRYANT RANCH PREPACK]1002
STARCH, CORNINACTIVE INGREDIENTO8232NY3SJPRAZOSIN HYDROCHLORIDE CAPSULE [BRYANT RANCH PREPACK]1002
TITANIUM DIOXIDEINACTIVE INGREDIENT15FIX9V2JPPRAZOSIN HYDROCHLORIDE CAPSULE [BRYANT RANCH PREPACK]1002

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
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

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
63629-6873-46362968730490 CAPSULE in 1 BOTTLE (63629-6873-4) 90 capsule2015-12-240000-00-00NoNoCurrent