FDA.reportPublic FDA data

Prazosin Hydrochloride

Product NDC
70954-020
11-digit product format
709540020
Labeler code
70954
Product ID
70954-020_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
2 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 HYDROCHLORIDE2 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
70954-020-10Prazosin Hydrochloride100 in 1 BOTTLECAPSULE1007
70954-020-20Prazosin Hydrochloride1000 in 1 BOTTLECAPSULE10007
70954-020-30Prazosin Hydrochloride1 in 1 BLISTER PACKCAPSULE17
70954-020-40Prazosin Hydrochloride100 in 1 CARTONCAPSULE1007

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
70954-020-10EA - Each70954-02028a042b2-65a2-4af5-ad63-cf0970b92f7212018-11-06
70954-020-20EA - Each70954-02009e56513-94f9-4c59-9e47-72888902b1a312018-11-06

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
70954-020PRAZOSIN HYDROCHLORIDE CAPSULE [NOVITIUM PHARMA LLC]5Current NDC, Legacy NDC, 4 package rows20210908_35c7aa71-6171-4ba5-916c-384c28e5f5c1.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
312594prazosin HCl 2 MG Oral CapsulePSN4eaa58c1-a5c5-49b4-a8ac-89f12eb2922213
312594prazosin 2 MG Oral CapsuleSCD4eaa58c1-a5c5-49b4-a8ac-89f12eb2922213
312594prazosin (as prazosin HCl) 2 MG Oral CapsuleSY4eaa58c1-a5c5-49b4-a8ac-89f12eb2922213
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 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 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
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
312594prazosin HCl 2 MG Oral CapsulePSN59602472-65d1-4ad8-8dad-a96a0f4cae0c4
312594prazosin 2 MG Oral CapsuleSCD59602472-65d1-4ad8-8dad-a96a0f4cae0c4
312594prazosin (as prazosin HCl) 2 MG Oral CapsuleSY59602472-65d1-4ad8-8dad-a96a0f4cae0c4
312593prazosin HCl 1 MG Oral CapsulePSN511b4409-7273-4b74-ae55-47c97f0c3ea42
312594prazosin HCl 2 MG Oral CapsulePSNc4449fa8-a637-4780-8e19-51cb54e1ee682
312594prazosin HCl 2 MG Oral CapsulePSN511b4409-7273-4b74-ae55-47c97f0c3ea42
312593prazosin 1 MG Oral CapsuleSCD511b4409-7273-4b74-ae55-47c97f0c3ea42
312594prazosin 2 MG Oral CapsuleSCDc4449fa8-a637-4780-8e19-51cb54e1ee682
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
312594prazosin (as prazosin HCl) 2 MG Oral CapsuleSYc4449fa8-a637-4780-8e19-51cb54e1ee682
312594prazosin HCl 2 MG Oral CapsulePSN518c9848-bf84-9742-e063-6394a90aea2f1
312594prazosin HCl 2 MG Oral CapsulePSN4870901f-5277-e6c0-e063-6394a90a1d3c1
312594prazosin 2 MG Oral CapsuleSCD518c9848-bf84-9742-e063-6394a90aea2f1
312594prazosin 2 MG Oral CapsuleSCD4870901f-5277-e6c0-e063-6394a90a1d3c1
312594prazosin (as prazosin HCl) 2 MG Oral CapsuleSY518c9848-bf84-9742-e063-6394a90aea2f1
312594prazosin (as prazosin HCl) 2 MG Oral CapsuleSY4870901f-5277-e6c0-e063-6394a90a1d3c1

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
70954-020-1070954002010100 CAPSULE in 1 BOTTLE (70954-020-10) 100 capsule2018-10-030000-00-00NoNoCurrent
70954-020-20709540020201000 CAPSULE in 1 BOTTLE (70954-020-20) 1000 capsule2018-10-030000-00-00NoNoCurrent
70954-020-30709540020301 in 1 BLISTER PACKHistorical
70954-020-4070954002040100 BLISTER PACK in 1 CARTON (70954-020-40) / 1 CAPSULE in 1 BLISTER PACK (70954-020-30) 100 blister pack2021-04-130000-00-00NoNoCurrent