FDA.reportPublic FDA data

prazosin hydrochloride

Product NDC
82804-021
11-digit product format
828040021
Labeler code
82804
Product ID
82804-021_b8a9cbee-c526-4d1e-ad2f-cf7fbb784936
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
prazosin hydrochloride
Dosage form
CAPSULE
Route
ORAL
Labeler
Proficient Rx LP
Application
ANDA215697
Marketing category
ANDA
Marketing start
2023-01-03
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
2026-12-31
Current FDA listing
Yes

Additional Listing Data#

Finished product
Yes
Brand name base
prazosin hydrochloride
Listing expiration
2026-12-31

Active Ingredients#

Ingredient, Strength table
IngredientStrength
PRAZOSIN HYDROCHLORIDE2 mg/1

Harmonized Identifiers#

Field, Values table
FieldValues
UniiX0Z7454B90
Rxcui312594

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
82804-021-30prazosin hydrochloride30 in 1 BOTTLECAPSULE301
82804-021-60prazosin hydrochloride60 in 1 BOTTLECAPSULE601
82804-021-90prazosin hydrochloride90 in 1 BOTTLECAPSULE901

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
82804-021-30EA - Each82804-021f0e47368-3a0d-46e0-b9f2-37e81c962dd912025-05-14

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
82804-021PRAZOSIN HYDROCHLORIDE CAPSULE [PROFICIENT RX LP]1Current NDC, 3 package rows20231012_b8a9cbee-c526-4d1e-ad2f-cf7fbb784936.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
312594prazosin HCl 2 MG Oral CapsulePSNb8a9cbee-c526-4d1e-ad2f-cf7fbb7849361
312594prazosin 2 MG Oral CapsuleSCDb8a9cbee-c526-4d1e-ad2f-cf7fbb7849361
312594prazosin (as prazosin HCl) 2 MG Oral CapsuleSYb8a9cbee-c526-4d1e-ad2f-cf7fbb7849361

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startSampleExclude flagStatus
82804-021-308280400213030 CAPSULE in 1 BOTTLE (82804-021-30) 30 capsule2023-10-11NoNoCurrent
82804-021-608280400216060 CAPSULE in 1 BOTTLE (82804-021-60) 60 capsule2023-10-11NoNoCurrent
82804-021-908280400219090 CAPSULE in 1 BOTTLE (82804-021-90) 90 capsule2023-10-11NoNoCurrent