Prazosin Hydrochloride

Product NDC
68788-7849
11-digit product format
687887849
Labeler code
68788
Product ID
68788-7849_6e4e7e3f-5240-4e61-aa8d-f2241e81a73e
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
Prazosin Hydrochloride
Dosage form
CAPSULE
Route
ORAL
Labeler
Preferred Pharmaceuticals Inc.
Application
ANDA210971
Marketing category
ANDA
Marketing start
2021-01-26
Substance
PRAZOSIN HYDROCHLORIDE
Active strength
5 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
A210971-001PRAZOSIN HYDROCHLORIDEPRAZOSIN HYDROCHLORIDEEQ 1MG BASECAPSULE / ORALAB2018-10-03
A210971-002PRAZOSIN HYDROCHLORIDEPRAZOSIN HYDROCHLORIDEEQ 2MG BASECAPSULE / ORALAB2018-10-03
A210971-003PRAZOSIN HYDROCHLORIDEPRAZOSIN HYDROCHLORIDEEQ 5MG BASECAPSULE / ORALAB2018-10-03

Therapeutic equivalence codes#

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

Application-product, TE code table
Application-productTE code
A210971-001AB
A210971-002AB
A210971-003AB

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 06:07:402026-07A210971-001PRAZOSIN HYDROCHLORIDEEQ 1MG BASECAPSULE / ORALAB2018-10-03caaa826d4ba7…
2026-08-18 06:07:402026-07A210971-002PRAZOSIN HYDROCHLORIDEEQ 2MG BASECAPSULE / ORALAB2018-10-03caaa826d4ba7…
2026-08-18 06:07:402026-07A210971-003PRAZOSIN HYDROCHLORIDEEQ 5MG BASECAPSULE / ORALAB2018-10-03caaa826d4ba7…
2026-02-19 14:30 UTC2026-02A210971-001PRAZOSIN HYDROCHLORIDEEQ 1MG BASECAPSULE / ORALAB2018-10-03011fe1cb6892…
2026-02-19 14:30 UTC2026-02A210971-002PRAZOSIN HYDROCHLORIDEEQ 2MG BASECAPSULE / ORALAB2018-10-03011fe1cb6892…
2026-02-19 14:30 UTC2026-02A210971-003PRAZOSIN HYDROCHLORIDEEQ 5MG BASECAPSULE / ORALAB2018-10-03011fe1cb6892…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A210971-001PRAZOSIN HYDROCHLORIDEEQ 1MG BASECAPSULE / ORALAB2018-10-0331067a03dcf5…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A210971-002PRAZOSIN HYDROCHLORIDEEQ 2MG BASECAPSULE / ORALAB2018-10-0331067a03dcf5…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A210971-003PRAZOSIN HYDROCHLORIDEEQ 5MG BASECAPSULE / ORALAB2018-10-0331067a03dcf5…
2025-08-23 18:47 UTC2025-08A210971-001PRAZOSIN HYDROCHLORIDEEQ 1MG BASECAPSULE / ORALAB2018-10-036a471c1ec25d…
2025-08-23 18:47 UTC2025-08A210971-002PRAZOSIN HYDROCHLORIDEEQ 2MG BASECAPSULE / ORALAB2018-10-036a471c1ec25d…
2025-08-23 18:47 UTC2025-08A210971-003PRAZOSIN HYDROCHLORIDEEQ 5MG BASECAPSULE / ORALAB2018-10-036a471c1ec25d…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03A210971-001PRAZOSIN HYDROCHLORIDEEQ 1MG BASECAPSULE / ORALAB2018-10-03fd3edfee7708…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03A210971-002PRAZOSIN HYDROCHLORIDEEQ 2MG BASECAPSULE / ORALAB2018-10-03fd3edfee7708…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03A210971-003PRAZOSIN HYDROCHLORIDEEQ 5MG BASECAPSULE / ORALAB2018-10-03fd3edfee7708…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02A210971-001PRAZOSIN HYDROCHLORIDEEQ 1MG BASECAPSULE / ORALAB2018-10-03b8a1b40f171c…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02A210971-002PRAZOSIN HYDROCHLORIDEEQ 2MG BASECAPSULE / ORALAB2018-10-03b8a1b40f171c…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02A210971-003PRAZOSIN HYDROCHLORIDEEQ 5MG BASECAPSULE / ORALAB2018-10-03b8a1b40f171c…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01A210971-001PRAZOSIN HYDROCHLORIDEEQ 1MG BASECAPSULE / ORALAB2018-10-0303ed91905a0d…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01A210971-002PRAZOSIN HYDROCHLORIDEEQ 2MG BASECAPSULE / ORALAB2018-10-0303ed91905a0d…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01A210971-003PRAZOSIN HYDROCHLORIDEEQ 5MG BASECAPSULE / ORALAB2018-10-0303ed91905a0d…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12A210971-001PRAZOSIN HYDROCHLORIDEEQ 1MG BASECAPSULE / ORALAB2018-10-032680178bc6a6…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12A210971-002PRAZOSIN HYDROCHLORIDEEQ 2MG BASECAPSULE / ORALAB2018-10-032680178bc6a6…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12A210971-003PRAZOSIN HYDROCHLORIDEEQ 5MG BASECAPSULE / ORALAB2018-10-032680178bc6a6…
2024-09-14 05:58 UTC · 2 captures of this ZIP2024-09A210971-001PRAZOSIN HYDROCHLORIDEEQ 1MG BASECAPSULE / ORALAB2018-10-035bbf6a4d5a75…
2024-09-14 05:58 UTC · 2 captures of this ZIP2024-09A210971-002PRAZOSIN HYDROCHLORIDEEQ 2MG BASECAPSULE / ORALAB2018-10-035bbf6a4d5a75…
2024-09-14 05:58 UTC · 2 captures of this ZIP2024-09A210971-003PRAZOSIN HYDROCHLORIDEEQ 5MG BASECAPSULE / ORALAB2018-10-035bbf6a4d5a75…
2024-11-08 22:44 UTC · 3 captures of this ZIP2024-11A210971-001PRAZOSIN HYDROCHLORIDEEQ 1MG BASECAPSULE / ORALAB2018-10-03d8e5a09893c0…
2024-11-08 22:44 UTC · 3 captures of this ZIP2024-11A210971-002PRAZOSIN HYDROCHLORIDEEQ 2MG BASECAPSULE / ORALAB2018-10-03d8e5a09893c0…
2024-11-08 22:44 UTC · 3 captures of this ZIP2024-11A210971-003PRAZOSIN HYDROCHLORIDEEQ 5MG BASECAPSULE / ORALAB2018-10-03d8e5a09893c0…
2024-10-29 15:01 UTC2024-10A210971-001PRAZOSIN HYDROCHLORIDEEQ 1MG BASECAPSULE / ORALAB2018-10-03d06236e962d9…
2024-10-29 15:01 UTC2024-10A210971-002PRAZOSIN HYDROCHLORIDEEQ 2MG BASECAPSULE / ORALAB2018-10-03d06236e962d9…
2024-10-29 15:01 UTC2024-10A210971-003PRAZOSIN HYDROCHLORIDEEQ 5MG BASECAPSULE / ORALAB2018-10-03d06236e962d9…
2024-08-13 05:28 UTC · 3 captures of this ZIP2024-08A210971-001PRAZOSIN HYDROCHLORIDEEQ 1MG BASECAPSULE / ORALAB2018-10-0379d66fd596c7…
2024-08-13 05:28 UTC · 3 captures of this ZIP2024-08A210971-002PRAZOSIN HYDROCHLORIDEEQ 2MG BASECAPSULE / ORALAB2018-10-0379d66fd596c7…
2024-08-13 05:28 UTC · 3 captures of this ZIP2024-08A210971-003PRAZOSIN HYDROCHLORIDEEQ 5MG BASECAPSULE / ORALAB2018-10-0379d66fd596c7…
2024-07-13 05:37 UTC · 2 captures of this ZIP2024-07A210971-001PRAZOSIN HYDROCHLORIDEEQ 1MG BASECAPSULE / ORALAB2018-10-03301d65b070ca…
2024-07-13 05:37 UTC · 2 captures of this ZIP2024-07A210971-002PRAZOSIN HYDROCHLORIDEEQ 2MG BASECAPSULE / ORALAB2018-10-03301d65b070ca…
2024-07-13 05:37 UTC · 2 captures of this ZIP2024-07A210971-003PRAZOSIN HYDROCHLORIDEEQ 5MG BASECAPSULE / ORALAB2018-10-03301d65b070ca…
2024-06-18 03:08 UTC · 5 captures of this ZIP2024-06A210971-001PRAZOSIN HYDROCHLORIDEEQ 1MG BASECAPSULE / ORALAB2018-10-031e350fbaab3a…

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 06:07:402026-07A210971-001AB1caaa826d4ba7…
2026-08-18 06:07:402026-07A210971-002AB1caaa826d4ba7…
2026-08-18 06:07:402026-07A210971-003AB1caaa826d4ba7…
2026-02-19 14:30 UTC2026-02A210971-001AB1011fe1cb6892…
2026-02-19 14:30 UTC2026-02A210971-002AB1011fe1cb6892…
2026-02-19 14:30 UTC2026-02A210971-003AB1011fe1cb6892…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A210971-001AB131067a03dcf5…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A210971-002AB131067a03dcf5…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A210971-003AB131067a03dcf5…
2025-08-23 18:47 UTC2025-08A210971-001AB16a471c1ec25d…
2025-08-23 18:47 UTC2025-08A210971-002AB16a471c1ec25d…
2025-08-23 18:47 UTC2025-08A210971-003AB16a471c1ec25d…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03A210971-001AB1fd3edfee7708…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03A210971-002AB1fd3edfee7708…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03A210971-003AB1fd3edfee7708…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02A210971-001AB1b8a1b40f171c…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02A210971-002AB1b8a1b40f171c…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02A210971-003AB1b8a1b40f171c…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01A210971-001AB103ed91905a0d…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01A210971-002AB103ed91905a0d…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01A210971-003AB103ed91905a0d…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12A210971-001AB12680178bc6a6…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12A210971-002AB12680178bc6a6…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12A210971-003AB12680178bc6a6…
2024-09-14 05:58 UTC · 2 captures of this ZIP2024-09A210971-001AB15bbf6a4d5a75…
2024-09-14 05:58 UTC · 2 captures of this ZIP2024-09A210971-002AB15bbf6a4d5a75…
2024-09-14 05:58 UTC · 2 captures of this ZIP2024-09A210971-003AB15bbf6a4d5a75…
2024-11-08 22:44 UTC · 3 captures of this ZIP2024-11A210971-001AB1d8e5a09893c0…
2024-11-08 22:44 UTC · 3 captures of this ZIP2024-11A210971-002AB1d8e5a09893c0…
2024-11-08 22:44 UTC · 3 captures of this ZIP2024-11A210971-003AB1d8e5a09893c0…
2024-10-29 15:01 UTC2024-10A210971-001AB1d06236e962d9…
2024-10-29 15:01 UTC2024-10A210971-002AB1d06236e962d9…
2024-10-29 15:01 UTC2024-10A210971-003AB1d06236e962d9…
2024-08-13 05:28 UTC · 3 captures of this ZIP2024-08A210971-001AB179d66fd596c7…
2024-08-13 05:28 UTC · 3 captures of this ZIP2024-08A210971-002AB179d66fd596c7…
2024-08-13 05:28 UTC · 3 captures of this ZIP2024-08A210971-003AB179d66fd596c7…
2024-07-13 05:37 UTC · 2 captures of this ZIP2024-07A210971-001AB1301d65b070ca…
2024-07-13 05:37 UTC · 2 captures of this ZIP2024-07A210971-002AB1301d65b070ca…
2024-07-13 05:37 UTC · 2 captures of this ZIP2024-07A210971-003AB1301d65b070ca…
2024-06-18 03:08 UTC · 5 captures of this ZIP2024-06A210971-001AB11e350fbaab3a…

Additional Listing Data#

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

Active Ingredients#

Ingredient, Strength table
IngredientStrength
PRAZOSIN HYDROCHLORIDE5 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
198141Internal RxNorm lookup

Harmonized SPL set identifiers#

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

Identifier, FDA.report destination table
IdentifierFDA.report destination
0e48b26e-afbe-4c61-93f4-f6548d05ea8cAvailable 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
68788-7849-1Prazosin Hydrochloride100 in 1 BOTTLECAPSULE1005
68788-7849-3Prazosin Hydrochloride30 in 1 BOTTLECAPSULE305
68788-7849-6Prazosin Hydrochloride60 in 1 BOTTLECAPSULE605
68788-7849-9Prazosin Hydrochloride90 in 1 BOTTLECAPSULE905

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
68788-7849-1EA - Each68788-784930941500-0f17-4262-bbd1-c652d830175412021-03-02
68788-7849-3EA - Each68788-7849447be522-0c6d-4c9b-9af5-3926228bf97012021-03-02
68788-7849-6EA - Each68788-78498d77834f-aa5d-4346-ba87-2f3da109a57b12021-03-02
68788-7849-9EA - Each68788-78492e653a73-21a3-4214-92a9-e7653a9adf6012021-03-02

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
68788-7849PRAZOSIN HYDROCHLORIDE CAPSULE [PREFERRED PHARMACEUTICALS INC.]4Current NDC, Legacy NDC, 4 package rows20240802_0e48b26e-afbe-4c61-93f4-f6548d05ea8c.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 · 16 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
Prazosin HydrochloridePRAZOSIN HYDROCHLORIDEREMEDYREPACK INC.4eaa58c1-a5c5-49b4-a8ac-89f12eb292222026-07-20Warnings, Adverse reactionsExact identifier
application applno (ANDA): 210971
application number: ANDA210971
Prazosin HydrochloridePRAZOSIN HYDROCHLORIDEANI Pharmaceuticals, Inc.35c7aa71-6171-4ba5-916c-384c28e5f5c12026-07-10Warnings, Adverse reactionsExact identifier
application applno (ANDA): 210971
application number: ANDA210971
Prazosin HydrochloridePRAZOSIN HYDROCHLORIDEBryant Ranch Prepack59602472-65d1-4ad8-8dad-a96a0f4cae0c2026-06-04Warnings, Adverse reactionsExact identifier
application applno (ANDA): 210971
application number: ANDA210971
Prazosin HydrochloridePRAZOSIN HYDROCHLORIDECoupler LLC5358bc3c-912c-bba4-e063-6394a90a44572026-06-03Warnings, Adverse reactionsExact identifier
application applno (ANDA): 210971
application number: ANDA210971
Prazosin HydrochloridePRAZOSIN HYDROCHLORIDENCS HealthCare of KY, LLC dba Vangard Labs511b4409-7273-4b74-ae55-47c97f0c3ea42026-05-19Warnings, Adverse reactionsExact identifier
application applno (ANDA): 210971
application number: ANDA210971
Prazosin HydrochloridePRAZOSIN HYDROCHLORIDECoupler LLC518c9848-bf84-9742-e063-6394a90aea2f2026-05-11Warnings, Adverse reactionsExact identifier
application applno (ANDA): 210971
application number: ANDA210971
Prazosin HydrochloridePRAZOSIN HYDROCHLORIDECoupler LLC5103a3cc-e88f-df52-e063-6294a90aec782026-05-04Warnings, Adverse reactionsExact identifier
application applno (ANDA): 210971
application number: ANDA210971
Prazosin HydrochloridePRAZOSIN HYDROCHLORIDECardinal Health 107, LLC6209ae19-7ea0-437d-8e5d-12e37917ed132026-02-26Warnings, Adverse reactionsExact identifier
application applno (ANDA): 210971
application number: ANDA210971
Prazosin HydrochloridePRAZOSIN HYDROCHLORIDEREMEDYREPACK INC.fd860756-9b2e-4bfd-9063-bc4d26366fe62026-02-16Warnings, Adverse reactionsExact identifier
application applno (ANDA): 210971
application number: ANDA210971
Prazosin HydrochloridePRAZOSIN HYDROCHLORIDEMajor Pharmaceuticals4f55f4db-dab3-4e50-9f71-5595fd3ccc122026-02-09Warnings, Adverse reactionsExact identifier
application applno (ANDA): 210971
application number: ANDA210971
Prazosin HydrochloridePRAZOSIN HYDROCHLORIDEAphena Pharma Solutions - Tennessee, LLC4870901f-5277-e6c0-e063-6394a90a1d3c2026-01-15Warnings, Adverse reactionsExact identifier
application applno (ANDA): 210971
application number: ANDA210971
Prazosin HydrochloridePRAZOSIN HYDROCHLORIDEMarlex Pharmaceuticals Inc1c28c337-6dbb-46bd-aa86-dbcd34e3f6e62025-11-21Warnings, Adverse reactionsExact identifier
application applno (ANDA): 210971
application number: ANDA210971
Prazosin HydrochloridePRAZOSIN HYDROCHLORIDEPreferred Pharmaceuticals Inc.0e48b26e-afbe-4c61-93f4-f6548d05ea8c2025-09-10Warnings, Adverse reactionsExact identifier
application applno (ANDA): 210971
application number: ANDA210971
ndc (product): 68788-7849
Prazosin HydrochloridePRAZOSIN HYDROCHLORIDEPreferred Pharmaceuticals Inc.c4449fa8-a637-4780-8e19-51cb54e1ee682025-09-10Warnings, Adverse reactionsExact identifier
application applno (ANDA): 210971
application number: ANDA210971
Prazosin HydrochloridePRAZOSIN HYDROCHLORIDEA-S Medication Solutions8a6fd4a0-4edd-41d5-a4dc-ce37bc1a67cc2023-12-09Warnings, Adverse reactionsExact identifier
application applno (ANDA): 210971
application number: ANDA210971
Prazosin HydrochloridePRAZOSIN HYDROCHLORIDEBryant Ranch Prepackbf6dbac4-a3d4-4689-8e74-072362328cd32023-10-31Warnings, Adverse reactionsExact identifier
application applno (ANDA): 210971
application number: ANDA210971

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
198141prazosin HCl 5 MG Oral CapsulePSN0e48b26e-afbe-4c61-93f4-f6548d05ea8c5
198141prazosin 5 MG Oral CapsuleSCD0e48b26e-afbe-4c61-93f4-f6548d05ea8c5
198141prazosin (as prazosin HCl) 5 MG Oral CapsuleSY0e48b26e-afbe-4c61-93f4-f6548d05ea8c5

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
68788-7849-168788784901100 CAPSULE in 1 BOTTLE (68788-7849-1) 100 capsule2021-01-260000-00-00NoNoCurrent
68788-7849-36878878490330 CAPSULE in 1 BOTTLE (68788-7849-3) 30 capsule2021-01-260000-00-00NoNoCurrent
68788-7849-66878878490660 CAPSULE in 1 BOTTLE (68788-7849-6) 60 capsule2021-01-260000-00-00NoNoCurrent
68788-7849-96878878490990 CAPSULE in 1 BOTTLE (68788-7849-9) 90 capsule2021-01-260000-00-00NoNoCurrent