FDA.reportPublic FDA data

Prazosin Hydrochloride

Product NDC
0904-7020
11-digit product format
009047020
Labeler code
0904
Product ID
0904-7020_693144cc-ea54-4a3d-9938-9b4051a64f0b
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
Prazosin Hydrochloride
Dosage form
CAPSULE
Route
ORAL
Labeler
Major Pharmaceuticals
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
0904-7020-61Prazosin Hydrochloride1 in 1 BLISTER PACKCAPSULE16
0904-7020-61Prazosin Hydrochloride100 in 1 CARTONCAPSULE1006

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
0904-7020-61EA - Each0904-702042419c4c-8f72-414b-89fc-fe2a9a0b38a312020-07-13

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
0904-7020PRAZOSIN HYDROCHLORIDE CAPSULE [MAJOR PHARMACEUTICALS]4Current NDC, Legacy NDC, 2 package rows20241009_4f55f4db-dab3-4e50-9f71-5595fd3ccc12.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
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 CapsulePSN6209ae19-7ea0-437d-8e5d-12e37917ed135
312593prazosin 1 MG Oral CapsuleSCD6209ae19-7ea0-437d-8e5d-12e37917ed135
312593prazosin (as prazosin HCl) 1 MG Oral CapsuleSY6209ae19-7ea0-437d-8e5d-12e37917ed135

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
0904-7020-6100904702061100 BLISTER PACK in 1 CARTON (0904-7020-61) / 1 CAPSULE in 1 BLISTER PACK100 blister pack2018-10-030000-00-00NoNoCurrent