FDA.reportPublic FDA data

Prazosin Hydrochloride

Product NDC
87441-067
Requested package NDC
87441-067-01
11-digit product format
874410067
Labeler code
87441
Product ID
87441-067_558ea679-fa0b-9e85-e063-6394a90a7bb8
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
Prazosin Hydrochloride
Dosage form
CAPSULE
Route
ORAL
Labeler
Unit Dose Solutions, Inc.
Application
ANDA213052
Marketing category
ANDA
Marketing start
2026-07-01
Substance
PRAZOSIN HYDROCHLORIDE
Active strength
1 mg/1
Pharmacologic classes
Adrenergic alpha-Antagonists [MoA]; alpha-Adrenergic Blocker [EPC]
Listing certified through
2027-12-31
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
A213052-001PRAZOSIN HYDROCHLORIDEPRAZOSIN HYDROCHLORIDEEQ 1MG BASECAPSULE / ORALAB2023-03-31
A213052-002PRAZOSIN HYDROCHLORIDEPRAZOSIN HYDROCHLORIDEEQ 2MG BASECAPSULE / ORALAB2023-03-31
A213052-003PRAZOSIN HYDROCHLORIDEPRAZOSIN HYDROCHLORIDEEQ 5MG BASECAPSULE / ORALAB2023-03-31

Therapeutic equivalence codes#

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

Application-product, TE code table
Application-productTE code
A213052-001AB
A213052-002AB
A213052-003AB

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.

Captured, Edition, Application-product table
CapturedEditionApplication-productTrade nameStrengthDosage form / routeProduct TE source textRLD / RSApproval dateSource SHA-256
2026-08-01 22:54:322026-06A213052-001PRAZOSIN HYDROCHLORIDEEQ 1MG BASECAPSULE / ORALAB2023-03-31a50c72e98297…
2026-08-01 22:54:322026-06A213052-002PRAZOSIN HYDROCHLORIDEEQ 2MG BASECAPSULE / ORALAB2023-03-31a50c72e98297…
2026-08-01 22:54:322026-06A213052-003PRAZOSIN HYDROCHLORIDEEQ 5MG BASECAPSULE / ORALAB2023-03-31a50c72e98297…

Observed Orange Book normalized TE history#

Captured, Edition, Application-product table
CapturedEditionApplication-productTE codeOrderSource SHA-256
2026-08-01 22:54:322026-06A213052-001AB1a50c72e98297…
2026-08-01 22:54:322026-06A213052-002AB1a50c72e98297…
2026-08-01 22:54:322026-06A213052-003AB1a50c72e98297…

openFDA label cross-check#

Cross-check layer: openFDA label JSON enriches search and identifies hydration gaps. The DailyMed Structured Product Label remains the canonical label presentation on FDA.report. Every label matching the complete exact-identifier union is deduplicated and paginated below.

Matched openFDA labels page 1 of 1 · 6 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
Prazosin HydrochloridePRAZOSIN HYDROCHLORIDEUnit Dose Solutions, Inc.558ea3fc-0bfc-32a0-e063-6294a90ae1062026-07-01Warnings, Adverse reactionsExact identifier
application applno (ANDA): 213052
application number: ANDA213052
ndc (package): 87441-067-01
ndc (product): 87441-067
ndc11 (package): 87441006701
Prazosin HydrochloridePRAZOSIN HYDROCHLORIDEUnit Dose Solutions, Inc.559082c2-4130-a2bc-e063-6294a90ab7812026-07-01Warnings, Adverse reactionsExact identifier
application applno (ANDA): 213052
application number: ANDA213052
Prazosin HydrochloridePRAZOSIN HYDROCHLORIDECoupler LLC52ce82b0-3cb5-b5b2-e063-6394a90a9f122026-05-27Warnings, Adverse reactionsExact identifier
application applno (ANDA): 213052
application number: ANDA213052
Prazosin HydrochloridePRAZOSIN HYDROCHLORIDEAphena Pharma Solutions - Tennessee, LLC4870ed0b-abde-5ae5-e063-6394a90ad0ba2026-01-15Warnings, Adverse reactionsExact identifier
application applno (ANDA): 213052
application number: ANDA213052
Prazosin HydrochloridePRAZOSIN HYDROCHLORIDEREMEDYREPACK INC.2aa62e0a-442d-41af-a2d8-0b8f88d233192025-10-01Warnings, Adverse reactionsExact identifier
application applno (ANDA): 213052
application number: ANDA213052
Prazosin HydrochloridePRAZOSIN HYDROCHLORIDEAurobindo Pharma Limited08114092-fa12-4f58-b08e-03cadf9f726b2023-04-04Warnings, Adverse reactionsExact identifier
application applno (ANDA): 213052
application number: ANDA213052

Additional Listing Data#

Finished product
Yes
Brand name base
Prazosin Hydrochloride
Listing expiration
2027-12-31

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 · 1 matching rows.

Identifier, FDA.report destination table
IdentifierFDA.report destination
312593Internal RxNorm lookup

Harmonized SPL set identifiers#

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

Identifier, FDA.report destination table
IdentifierFDA.report destination
558ea3fc-0bfc-32a0-e063-6294a90ae106Available on FDA.report

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startSampleStatus
87441-067-018744100670130 CAPSULE in 1 BLISTER PACK (87441-067-01)30 capsule2026-07-010Current