Prazosin Hydrochloride

Product NDC
70010-084
11-digit product format
700100084
Labeler code
70010
Product ID
70010-084_253979ce-5078-deec-e063-6294a90a5c52
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
Prazosin Hydrochloride
Dosage form
CAPSULE
Route
ORAL
Labeler
Granules Pharmaceuticals Inc.
Application
ANDA214608
Marketing category
ANDA
Marketing start
2022-01-03
Substance
PRAZOSIN HYDROCHLORIDE
Active strength
1 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
A214608-001PRAZOSIN HYDROCHLORIDEPRAZOSIN HYDROCHLORIDEEQ 1MG BASECAPSULE / ORALAB2021-12-23
A214608-002PRAZOSIN HYDROCHLORIDEPRAZOSIN HYDROCHLORIDEEQ 2MG BASECAPSULE / ORALAB2021-12-23
A214608-003PRAZOSIN HYDROCHLORIDEPRAZOSIN HYDROCHLORIDEEQ 5MG BASECAPSULE / ORALAB2021-12-23

Therapeutic equivalence codes#

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

Application-product, TE code table
Application-productTE code
A214608-001AB
A214608-002AB
A214608-003AB

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 3 · 96 observed states.

Captured, Edition, Application-product table
CapturedEditionApplication-productTrade nameStrengthDosage form / routeProduct TE source textRLD / RSApproval dateSource SHA-256
2026-02-19 14:30 UTC2026-02A214608-001PRAZOSIN HYDROCHLORIDEEQ 1MG BASECAPSULE / ORALAB2021-12-23011fe1cb6892…
2026-02-19 14:30 UTC2026-02A214608-002PRAZOSIN HYDROCHLORIDEEQ 2MG BASECAPSULE / ORALAB2021-12-23011fe1cb6892…
2026-02-19 14:30 UTC2026-02A214608-003PRAZOSIN HYDROCHLORIDEEQ 5MG BASECAPSULE / ORALAB2021-12-23011fe1cb6892…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A214608-001PRAZOSIN HYDROCHLORIDEEQ 1MG BASECAPSULE / ORALAB2021-12-2331067a03dcf5…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A214608-002PRAZOSIN HYDROCHLORIDEEQ 2MG BASECAPSULE / ORALAB2021-12-2331067a03dcf5…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A214608-003PRAZOSIN HYDROCHLORIDEEQ 5MG BASECAPSULE / ORALAB2021-12-2331067a03dcf5…
2025-08-23 18:47 UTC2025-08A214608-001PRAZOSIN HYDROCHLORIDEEQ 1MG BASECAPSULE / ORALAB2021-12-236a471c1ec25d…
2025-08-23 18:47 UTC2025-08A214608-002PRAZOSIN HYDROCHLORIDEEQ 2MG BASECAPSULE / ORALAB2021-12-236a471c1ec25d…
2025-08-23 18:47 UTC2025-08A214608-003PRAZOSIN HYDROCHLORIDEEQ 5MG BASECAPSULE / ORALAB2021-12-236a471c1ec25d…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03A214608-001PRAZOSIN HYDROCHLORIDEEQ 1MG BASECAPSULE / ORALAB2021-12-23fd3edfee7708…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03A214608-002PRAZOSIN HYDROCHLORIDEEQ 2MG BASECAPSULE / ORALAB2021-12-23fd3edfee7708…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03A214608-003PRAZOSIN HYDROCHLORIDEEQ 5MG BASECAPSULE / ORALAB2021-12-23fd3edfee7708…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02A214608-001PRAZOSIN HYDROCHLORIDEEQ 1MG BASECAPSULE / ORALAB2021-12-23b8a1b40f171c…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02A214608-002PRAZOSIN HYDROCHLORIDEEQ 2MG BASECAPSULE / ORALAB2021-12-23b8a1b40f171c…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02A214608-003PRAZOSIN HYDROCHLORIDEEQ 5MG BASECAPSULE / ORALAB2021-12-23b8a1b40f171c…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01A214608-001PRAZOSIN HYDROCHLORIDEEQ 1MG BASECAPSULE / ORALAB2021-12-2303ed91905a0d…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01A214608-002PRAZOSIN HYDROCHLORIDEEQ 2MG BASECAPSULE / ORALAB2021-12-2303ed91905a0d…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01A214608-003PRAZOSIN HYDROCHLORIDEEQ 5MG BASECAPSULE / ORALAB2021-12-2303ed91905a0d…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12A214608-001PRAZOSIN HYDROCHLORIDEEQ 1MG BASECAPSULE / ORALAB2021-12-232680178bc6a6…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12A214608-002PRAZOSIN HYDROCHLORIDEEQ 2MG BASECAPSULE / ORALAB2021-12-232680178bc6a6…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12A214608-003PRAZOSIN HYDROCHLORIDEEQ 5MG BASECAPSULE / ORALAB2021-12-232680178bc6a6…
2024-09-14 05:58 UTC · 2 captures of this ZIP2024-09A214608-001PRAZOSIN HYDROCHLORIDEEQ 1MG BASECAPSULE / ORALAB2021-12-235bbf6a4d5a75…
2024-09-14 05:58 UTC · 2 captures of this ZIP2024-09A214608-002PRAZOSIN HYDROCHLORIDEEQ 2MG BASECAPSULE / ORALAB2021-12-235bbf6a4d5a75…
2024-09-14 05:58 UTC · 2 captures of this ZIP2024-09A214608-003PRAZOSIN HYDROCHLORIDEEQ 5MG BASECAPSULE / ORALAB2021-12-235bbf6a4d5a75…
2024-11-08 22:44 UTC · 3 captures of this ZIP2024-11A214608-001PRAZOSIN HYDROCHLORIDEEQ 1MG BASECAPSULE / ORALAB2021-12-23d8e5a09893c0…
2024-11-08 22:44 UTC · 3 captures of this ZIP2024-11A214608-002PRAZOSIN HYDROCHLORIDEEQ 2MG BASECAPSULE / ORALAB2021-12-23d8e5a09893c0…
2024-11-08 22:44 UTC · 3 captures of this ZIP2024-11A214608-003PRAZOSIN HYDROCHLORIDEEQ 5MG BASECAPSULE / ORALAB2021-12-23d8e5a09893c0…
2024-10-29 15:01 UTC2024-10A214608-001PRAZOSIN HYDROCHLORIDEEQ 1MG BASECAPSULE / ORALAB2021-12-23d06236e962d9…
2024-10-29 15:01 UTC2024-10A214608-002PRAZOSIN HYDROCHLORIDEEQ 2MG BASECAPSULE / ORALAB2021-12-23d06236e962d9…
2024-10-29 15:01 UTC2024-10A214608-003PRAZOSIN HYDROCHLORIDEEQ 5MG BASECAPSULE / ORALAB2021-12-23d06236e962d9…
2024-08-13 05:28 UTC · 3 captures of this ZIP2024-08A214608-001PRAZOSIN HYDROCHLORIDEEQ 1MG BASECAPSULE / ORALAB2021-12-2379d66fd596c7…
2024-08-13 05:28 UTC · 3 captures of this ZIP2024-08A214608-002PRAZOSIN HYDROCHLORIDEEQ 2MG BASECAPSULE / ORALAB2021-12-2379d66fd596c7…
2024-08-13 05:28 UTC · 3 captures of this ZIP2024-08A214608-003PRAZOSIN HYDROCHLORIDEEQ 5MG BASECAPSULE / ORALAB2021-12-2379d66fd596c7…
2024-07-13 05:37 UTC · 2 captures of this ZIP2024-07A214608-001PRAZOSIN HYDROCHLORIDEEQ 1MG BASECAPSULE / ORALAB2021-12-23301d65b070ca…
2024-07-13 05:37 UTC · 2 captures of this ZIP2024-07A214608-002PRAZOSIN HYDROCHLORIDEEQ 2MG BASECAPSULE / ORALAB2021-12-23301d65b070ca…
2024-07-13 05:37 UTC · 2 captures of this ZIP2024-07A214608-003PRAZOSIN HYDROCHLORIDEEQ 5MG BASECAPSULE / ORALAB2021-12-23301d65b070ca…
2024-06-18 03:08 UTC · 5 captures of this ZIP2024-06A214608-001PRAZOSIN HYDROCHLORIDEEQ 1MG BASECAPSULE / ORALAB2021-12-231e350fbaab3a…
2024-06-18 03:08 UTC · 5 captures of this ZIP2024-06A214608-002PRAZOSIN HYDROCHLORIDEEQ 2MG BASECAPSULE / ORALAB2021-12-231e350fbaab3a…
2024-06-18 03:08 UTC · 5 captures of this ZIP2024-06A214608-003PRAZOSIN HYDROCHLORIDEEQ 5MG BASECAPSULE / ORALAB2021-12-231e350fbaab3a…
2024-05-31 18:47 UTC2024-05A214608-001PRAZOSIN HYDROCHLORIDEEQ 1MG BASECAPSULE / ORALAB2021-12-238072bd15b7f6…

Observed Orange Book normalized TE history#

Normalized TE history page 1 of 3 · 96 observed states.

Captured, Edition, Application-product table
CapturedEditionApplication-productTE codeOrderSource SHA-256
2026-02-19 14:30 UTC2026-02A214608-001AB1011fe1cb6892…
2026-02-19 14:30 UTC2026-02A214608-002AB1011fe1cb6892…
2026-02-19 14:30 UTC2026-02A214608-003AB1011fe1cb6892…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A214608-001AB131067a03dcf5…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A214608-002AB131067a03dcf5…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A214608-003AB131067a03dcf5…
2025-08-23 18:47 UTC2025-08A214608-001AB16a471c1ec25d…
2025-08-23 18:47 UTC2025-08A214608-002AB16a471c1ec25d…
2025-08-23 18:47 UTC2025-08A214608-003AB16a471c1ec25d…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03A214608-001AB1fd3edfee7708…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03A214608-002AB1fd3edfee7708…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03A214608-003AB1fd3edfee7708…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02A214608-001AB1b8a1b40f171c…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02A214608-002AB1b8a1b40f171c…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02A214608-003AB1b8a1b40f171c…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01A214608-001AB103ed91905a0d…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01A214608-002AB103ed91905a0d…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01A214608-003AB103ed91905a0d…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12A214608-001AB12680178bc6a6…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12A214608-002AB12680178bc6a6…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12A214608-003AB12680178bc6a6…
2024-09-14 05:58 UTC · 2 captures of this ZIP2024-09A214608-001AB15bbf6a4d5a75…
2024-09-14 05:58 UTC · 2 captures of this ZIP2024-09A214608-002AB15bbf6a4d5a75…
2024-09-14 05:58 UTC · 2 captures of this ZIP2024-09A214608-003AB15bbf6a4d5a75…
2024-11-08 22:44 UTC · 3 captures of this ZIP2024-11A214608-001AB1d8e5a09893c0…
2024-11-08 22:44 UTC · 3 captures of this ZIP2024-11A214608-002AB1d8e5a09893c0…
2024-11-08 22:44 UTC · 3 captures of this ZIP2024-11A214608-003AB1d8e5a09893c0…
2024-10-29 15:01 UTC2024-10A214608-001AB1d06236e962d9…
2024-10-29 15:01 UTC2024-10A214608-002AB1d06236e962d9…
2024-10-29 15:01 UTC2024-10A214608-003AB1d06236e962d9…
2024-08-13 05:28 UTC · 3 captures of this ZIP2024-08A214608-001AB179d66fd596c7…
2024-08-13 05:28 UTC · 3 captures of this ZIP2024-08A214608-002AB179d66fd596c7…
2024-08-13 05:28 UTC · 3 captures of this ZIP2024-08A214608-003AB179d66fd596c7…
2024-07-13 05:37 UTC · 2 captures of this ZIP2024-07A214608-001AB1301d65b070ca…
2024-07-13 05:37 UTC · 2 captures of this ZIP2024-07A214608-002AB1301d65b070ca…
2024-07-13 05:37 UTC · 2 captures of this ZIP2024-07A214608-003AB1301d65b070ca…
2024-06-18 03:08 UTC · 5 captures of this ZIP2024-06A214608-001AB11e350fbaab3a…
2024-06-18 03:08 UTC · 5 captures of this ZIP2024-06A214608-002AB11e350fbaab3a…
2024-06-18 03:08 UTC · 5 captures of this ZIP2024-06A214608-003AB11e350fbaab3a…
2024-05-31 18:47 UTC2024-05A214608-001AB18072bd15b7f6…

Additional Listing Data#

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

Active Ingredients#

Ingredient, Strength table
IngredientStrength
PRAZOSIN HYDROCHLORIDE1 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
d01b8927-a422-43b3-89de-088506fdee3cAvailable 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
70010-084-01Prazosin Hydrochloride100 in 1 BOTTLECAPSULE1004
70010-084-10Prazosin Hydrochloride1000 in 1 BOTTLECAPSULE10004

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
70010-084-01EA - Each70010-084fb79bd22-4981-4d79-b7c0-0f43e57c21eb12022-02-07

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
70010-084PRAZOSIN HYDROCHLORIDE CAPSULE [GRANULES PHARMACEUTICALS INC.]4Current NDC, Legacy NDC, 2 package rows20241027_d01b8927-a422-43b3-89de-088506fdee3c.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 · 4 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
Prazosin HydrochloridePRAZOSIN HYDROCHLORIDEGranules Pharmaceuticals Inc.d01b8927-a422-43b3-89de-088506fdee3c2024-10-25Warnings, Adverse reactionsExact identifier
application applno (ANDA): 214608
application number: ANDA214608
ndc (product): 70010-084
Prazosin HydrochloridePRAZOSIN HYDROCHLORIDEAphena Pharma Solutions - Tennessee, LLC18680157-a123-1072-e063-6394a90ad5ef2024-05-14Warnings, Adverse reactionsExact identifier
application applno (ANDA): 214608
application number: ANDA214608
Prazosin HydrochloridePRAZOSIN HYDROCHLORIDEAphena Pharma Solutions - Tennessee, LLCd33bb132-1b5f-44a2-bc42-e9201cb6566a2023-03-20Warnings, Adverse reactionsExact identifier
application applno (ANDA): 214608
application number: ANDA214608
Prazosin HydrochloridePRAZOSIN HYDROCHLORIDEExelan Pharmaceuticalscdde7b22-6b29-4cac-8bd6-f613dab6eef12023-01-26Warnings, Adverse reactionsExact identifier
application applno (ANDA): 214608
application number: ANDA214608

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
312593prazosin HCl 1 MG Oral CapsulePSNd01b8927-a422-43b3-89de-088506fdee3c4
312594prazosin HCl 2 MG Oral CapsulePSNd01b8927-a422-43b3-89de-088506fdee3c4
198141prazosin HCl 5 MG Oral CapsulePSNd01b8927-a422-43b3-89de-088506fdee3c4
312593prazosin 1 MG Oral CapsuleSCDd01b8927-a422-43b3-89de-088506fdee3c4
312594prazosin 2 MG Oral CapsuleSCDd01b8927-a422-43b3-89de-088506fdee3c4
198141prazosin 5 MG Oral CapsuleSCDd01b8927-a422-43b3-89de-088506fdee3c4
312593prazosin (as prazosin HCl) 1 MG Oral CapsuleSYd01b8927-a422-43b3-89de-088506fdee3c4
312594prazosin (as prazosin HCl) 2 MG Oral CapsuleSYd01b8927-a422-43b3-89de-088506fdee3c4
198141prazosin (as prazosin HCl) 5 MG Oral CapsuleSYd01b8927-a422-43b3-89de-088506fdee3c4

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
70010-084-0170010008401100 CAPSULE in 1 BOTTLE (70010-084-01) 100 capsule2022-01-030000-00-00NoNoCurrent
70010-084-10700100084101000 CAPSULE in 1 BOTTLE (70010-084-10) 1000 capsule2022-01-030000-00-00NoNoCurrent