FDA.reportPublic FDA data

Prazosin Hydrochloride

Product NDC
70954-019
11-digit product format
709540019
Labeler code
70954
Product ID
70954-019_48c81ece-bd52-4a98-a286-3fa5d594d854
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
Prazosin Hydrochloride
Dosage form
CAPSULE
Route
ORAL
Labeler
ANI Pharmaceuticals, Inc.
Application
ANDA210971
Marketing category
ANDA
Marketing start
2018-10-03
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
2027-12-31
Current FDA listing
Yes

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 Identifiers#

Field, Values table
FieldValues
UniiX0Z7454B90
Rxcui198141, 312593, 312594

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
70954-019-10Prazosin Hydrochloride100 in 1 BOTTLECAPSULE1007
70954-019-20Prazosin Hydrochloride1000 in 1 BOTTLECAPSULE10007
70954-019-30Prazosin Hydrochloride1 in 1 BLISTER PACKCAPSULE17
70954-019-40Prazosin Hydrochloride100 in 1 CARTONCAPSULE1007
70954-019-50Prazosin Hydrochloride90 in 1 BOTTLECAPSULE907

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
70954-019-10EA - Each70954-019f12b9124-bc30-4ddf-8f9c-c07f77db930712018-11-06
70954-019-20EA - Each70954-019f0a10bbe-9d94-4dcd-badf-c3ae3a856efa12018-11-06
70954-019-50EA - Each70954-019629549b0-3eaf-418a-b170-1209fef9789612021-11-09

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
70954-019PRAZOSIN HYDROCHLORIDE CAPSULE [NOVITIUM PHARMA LLC]5Current NDC, Legacy NDC, 5 package rows20210908_35c7aa71-6171-4ba5-916c-384c28e5f5c1.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
312593prazosin HCl 1 MG Oral CapsulePSNbf6dbac4-a3d4-4689-8e74-072362328cd3101
312593prazosin 1 MG Oral CapsuleSCDbf6dbac4-a3d4-4689-8e74-072362328cd3101
312593prazosin (as prazosin HCl) 1 MG Oral CapsuleSYbf6dbac4-a3d4-4689-8e74-072362328cd3101
312593prazosin HCl 1 MG Oral CapsulePSN35c7aa71-6171-4ba5-916c-384c28e5f5c17
312594prazosin HCl 2 MG Oral CapsulePSN35c7aa71-6171-4ba5-916c-384c28e5f5c17
198141prazosin HCl 5 MG Oral CapsulePSN35c7aa71-6171-4ba5-916c-384c28e5f5c17
312593prazosin 1 MG Oral CapsuleSCD35c7aa71-6171-4ba5-916c-384c28e5f5c17
312594prazosin 2 MG Oral CapsuleSCD35c7aa71-6171-4ba5-916c-384c28e5f5c17
198141prazosin 5 MG Oral CapsuleSCD35c7aa71-6171-4ba5-916c-384c28e5f5c17
312593prazosin (as prazosin HCl) 1 MG Oral CapsuleSY35c7aa71-6171-4ba5-916c-384c28e5f5c17
312594prazosin (as prazosin HCl) 2 MG Oral CapsuleSY35c7aa71-6171-4ba5-916c-384c28e5f5c17
198141prazosin (as prazosin HCl) 5 MG Oral CapsuleSY35c7aa71-6171-4ba5-916c-384c28e5f5c17
312593prazosin HCl 1 MG Oral CapsulePSN8a6fd4a0-4edd-41d5-a4dc-ce37bc1a67cc6
312593prazosin HCl 1 MG Oral CapsulePSN4f55f4db-dab3-4e50-9f71-5595fd3ccc126
312594prazosin HCl 2 MG Oral CapsulePSN4f55f4db-dab3-4e50-9f71-5595fd3ccc126
198141prazosin HCl 5 MG Oral CapsulePSN4f55f4db-dab3-4e50-9f71-5595fd3ccc126
312593prazosin 1 MG Oral CapsuleSCD8a6fd4a0-4edd-41d5-a4dc-ce37bc1a67cc6
312593prazosin 1 MG Oral CapsuleSCD4f55f4db-dab3-4e50-9f71-5595fd3ccc126
312594prazosin 2 MG Oral CapsuleSCD4f55f4db-dab3-4e50-9f71-5595fd3ccc126
198141prazosin 5 MG Oral CapsuleSCD4f55f4db-dab3-4e50-9f71-5595fd3ccc126
312593prazosin (as prazosin HCl) 1 MG Oral CapsuleSY4f55f4db-dab3-4e50-9f71-5595fd3ccc126
312593prazosin (as prazosin HCl) 1 MG Oral CapsuleSY8a6fd4a0-4edd-41d5-a4dc-ce37bc1a67cc6
312594prazosin (as prazosin HCl) 2 MG Oral CapsuleSY4f55f4db-dab3-4e50-9f71-5595fd3ccc126
198141prazosin (as prazosin HCl) 5 MG Oral CapsuleSY4f55f4db-dab3-4e50-9f71-5595fd3ccc126
312593prazosin HCl 1 MG Oral CapsulePSN1c28c337-6dbb-46bd-aa86-dbcd34e3f6e65
312594prazosin HCl 2 MG Oral CapsulePSN1c28c337-6dbb-46bd-aa86-dbcd34e3f6e65
198141prazosin HCl 5 MG Oral CapsulePSN1c28c337-6dbb-46bd-aa86-dbcd34e3f6e65
312593prazosin 1 MG Oral CapsuleSCD1c28c337-6dbb-46bd-aa86-dbcd34e3f6e65
312594prazosin 2 MG Oral CapsuleSCD1c28c337-6dbb-46bd-aa86-dbcd34e3f6e65
198141prazosin 5 MG Oral CapsuleSCD1c28c337-6dbb-46bd-aa86-dbcd34e3f6e65
312593prazosin (as prazosin HCl) 1 MG Oral CapsuleSY1c28c337-6dbb-46bd-aa86-dbcd34e3f6e65
312594prazosin (as prazosin HCl) 2 MG Oral CapsuleSY1c28c337-6dbb-46bd-aa86-dbcd34e3f6e65
198141prazosin (as prazosin HCl) 5 MG Oral CapsuleSY1c28c337-6dbb-46bd-aa86-dbcd34e3f6e65
312593prazosin HCl 1 MG Oral CapsulePSNfd860756-9b2e-4bfd-9063-bc4d26366fe63
312593prazosin 1 MG Oral CapsuleSCDfd860756-9b2e-4bfd-9063-bc4d26366fe63
312593prazosin (as prazosin HCl) 1 MG Oral CapsuleSYfd860756-9b2e-4bfd-9063-bc4d26366fe63
312593prazosin HCl 1 MG Oral CapsulePSN511b4409-7273-4b74-ae55-47c97f0c3ea42
312594prazosin HCl 2 MG Oral CapsulePSN511b4409-7273-4b74-ae55-47c97f0c3ea42
312593prazosin 1 MG Oral CapsuleSCD511b4409-7273-4b74-ae55-47c97f0c3ea42
312594prazosin 2 MG Oral CapsuleSCD511b4409-7273-4b74-ae55-47c97f0c3ea42
312593prazosin (as prazosin HCl) 1 MG Oral CapsuleSY511b4409-7273-4b74-ae55-47c97f0c3ea42
312594prazosin (as prazosin HCl) 2 MG Oral CapsuleSY511b4409-7273-4b74-ae55-47c97f0c3ea42
312593prazosin HCl 1 MG Oral CapsulePSN5103a3cc-e88f-df52-e063-6294a90aec781
312593prazosin HCl 1 MG Oral CapsulePSNb8e957e8-816c-4fcb-ba35-f20b9421ae591
312593prazosin HCl 1 MG Oral CapsulePSNdf7434aa-d4c2-63a1-e053-2a95a90a27511
312593prazosin 1 MG Oral CapsuleSCDb8e957e8-816c-4fcb-ba35-f20b9421ae591
312593prazosin 1 MG Oral CapsuleSCD5103a3cc-e88f-df52-e063-6294a90aec781
312593prazosin 1 MG Oral CapsuleSCDdf7434aa-d4c2-63a1-e053-2a95a90a27511
312593prazosin (as prazosin HCl) 1 MG Oral CapsuleSYb8e957e8-816c-4fcb-ba35-f20b9421ae591
312593prazosin (as prazosin HCl) 1 MG Oral CapsuleSY5103a3cc-e88f-df52-e063-6294a90aec781
312593prazosin (as prazosin HCl) 1 MG Oral CapsuleSYdf7434aa-d4c2-63a1-e053-2a95a90a27511

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
70954-019-1070954001910100 CAPSULE in 1 BOTTLE (70954-019-10) 100 capsule2018-10-030000-00-00NoNoCurrent
70954-019-20709540019201000 CAPSULE in 1 BOTTLE (70954-019-20) 1000 capsule2018-10-030000-00-00NoNoCurrent
70954-019-30709540019301 in 1 BLISTER PACKHistorical
70954-019-4070954001940100 BLISTER PACK in 1 CARTON (70954-019-40) / 1 CAPSULE in 1 BLISTER PACK (70954-019-30) 100 blister pack2021-04-130000-00-00NoNoCurrent
70954-019-507095400195090 CAPSULE in 1 BOTTLE (70954-019-50) 90 capsule2021-09-070000-00-00NoNoCurrent