FDA.reportPublic FDA data

Prazosin Hydrochloride

Product NDC
70010-085
11-digit product format
700100085
Labeler code
70010
Product ID
70010-085_253979ce-5078-deec-e063-6294a90a5c52
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
Prazosin Hydrochloride
Dosage form
CAPSULE
Route
ORAL
Labeler
Granules Pharmaceuticals Inc.
Application
ANDA214608
Marketing category
ANDA
Marketing start
2022-01-03
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
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
70010-085-01Prazosin Hydrochloride100 in 1 BOTTLECAPSULE1004
70010-085-10Prazosin Hydrochloride1000 in 1 BOTTLECAPSULE10004

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
70010-085-01EA - Each70010-08547293aa7-826f-4dc7-b49e-bc1a69415bd312022-02-07

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
70010-085PRAZOSIN HYDROCHLORIDE CAPSULE [GRANULES PHARMACEUTICALS INC.]4Current NDC, Legacy NDC, 2 package rows20241027_d01b8927-a422-43b3-89de-088506fdee3c.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
312593prazosin HCl 1 MG Oral CapsulePSNd01b8927-a422-43b3-89de-088506fdee3c4
312594prazosin HCl 2 MG Oral CapsulePSNd01b8927-a422-43b3-89de-088506fdee3c4
198141prazosin HCl 5 MG Oral CapsulePSNd01b8927-a422-43b3-89de-088506fdee3c4
312593prazosin 1 MG Oral CapsuleSCDd01b8927-a422-43b3-89de-088506fdee3c4
312594prazosin 2 MG Oral CapsuleSCDd01b8927-a422-43b3-89de-088506fdee3c4
198141prazosin 5 MG Oral CapsuleSCDd01b8927-a422-43b3-89de-088506fdee3c4
312593prazosin (as prazosin HCl) 1 MG Oral CapsuleSYd01b8927-a422-43b3-89de-088506fdee3c4
312594prazosin (as prazosin HCl) 2 MG Oral CapsuleSYd01b8927-a422-43b3-89de-088506fdee3c4
198141prazosin (as prazosin HCl) 5 MG Oral CapsuleSYd01b8927-a422-43b3-89de-088506fdee3c4

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
70010-085-0170010008501100 CAPSULE in 1 BOTTLE (70010-085-01) 100 capsule2022-01-030000-00-00NoNoCurrent
70010-085-10700100085101000 CAPSULE in 1 BOTTLE (70010-085-10) 1000 capsule2022-01-030000-00-00NoNoCurrent