Prazosin Hydrochloride

Product NDC
43353-868
11-digit product format
433530868
Labeler code
43353
Product ID
43353-868_b1e524e2-cf67-4344-9a06-3e82920af608
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
prazosin hydrochloride
Dosage form
CAPSULE
Route
ORAL
Labeler
Aphena Pharma Solutions - Tennessee, LLC
Application
ANDA072575
Marketing category
ANDA
Marketing start
2013-05-17
Marketing end
0000-00-00
Substance
PRAZOSIN HYDROCHLORIDE
Active strength
2 mg/1
Pharmacologic classes
alpha-Adrenergic Blocker [EPC],Adrenergic alpha-Antagonists [MoA]
NDC exclude flag
No
Listing certified through
2019-12-31
Current FDA listing
Historical FDA.report record

DailyMed Product Concepts#

Product concept, Relation, Version table
Product conceptRelationVersionEffective
d5a3de99-75de-4527-38ae-07b1328b93cbProduct name520250331

FDA-Initiated Inactive NDC Indexing#

NDC, Effective, Action table
NDCEffectiveActionDocumentIndexing SPLRelated label
43353-868-602020-01-31C16284748780-19d75b9d0-ff79-f424-e053-dadaa90a57ce4db5fdc0-f5a2-49f0-8129-bad6e7c2f998
43353-868-802020-01-31C16284748780-19d75b9d0-ff79-f424-e053-dadaa90a57ce4db5fdc0-f5a2-49f0-8129-bad6e7c2f998

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
43353-868-60Prazosin Hydrochloride90 in 1 BOTTLE, PLASTICCAPSULE901
43353-868-80Prazosin Hydrochloride180 in 1 BOTTLE, PLASTICCAPSULE1801

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
43353-868-60EA - Each43353-8688b9c1c1f-c23d-46a2-a240-3183c11a395912014-07-02
43353-868-80EA - Each43353-868fb3a66c9-3575-4d52-8a8b-4b4764a720dc12014-07-02

DailyMed Socrata Ingredients#

Ingredient, Type, UNII table
IngredientTypeUNIIDailyMed labelSPL versionUploaded
PRAZOSIN HYDROCHLORIDEACTIVE INGREDIENTX0Z7454B90PRAZOSIN HYDROCHLORIDE CAPSULE [APHENA PHARMA SOLUTIONS - TENNESSEE, LLC]1
PRAZOSINACTIVE MOIETYXM03YJ541DPRAZOSIN HYDROCHLORIDE CAPSULE [APHENA PHARMA SOLUTIONS - TENNESSEE, LLC]1
AMMONIAINACTIVE INGREDIENT5138Q19F1XPRAZOSIN HYDROCHLORIDE CAPSULE [APHENA PHARMA SOLUTIONS - TENNESSEE, LLC]1
CELLULOSE, MICROCRYSTALLINEINACTIVE INGREDIENTOP1R32D61UPRAZOSIN HYDROCHLORIDE CAPSULE [APHENA PHARMA SOLUTIONS - TENNESSEE, LLC]1
D&C RED NO. 28INACTIVE INGREDIENT767IP0Y5NHPRAZOSIN HYDROCHLORIDE CAPSULE [APHENA PHARMA SOLUTIONS - TENNESSEE, LLC]1
D&C YELLOW NO. 10INACTIVE INGREDIENT35SW5USQ3GPRAZOSIN HYDROCHLORIDE CAPSULE [APHENA PHARMA SOLUTIONS - TENNESSEE, LLC]1
FD&C BLUE NO. 1INACTIVE INGREDIENTH3R47K3TBDPRAZOSIN HYDROCHLORIDE CAPSULE [APHENA PHARMA SOLUTIONS - TENNESSEE, LLC]1
FD&C RED NO. 40INACTIVE INGREDIENTWZB9127XOAPRAZOSIN HYDROCHLORIDE CAPSULE [APHENA PHARMA SOLUTIONS - TENNESSEE, LLC]1
FERRIC OXIDE REDINACTIVE INGREDIENT1K09F3G675PRAZOSIN HYDROCHLORIDE CAPSULE [APHENA PHARMA SOLUTIONS - TENNESSEE, LLC]1
FERRIC OXIDE YELLOWINACTIVE INGREDIENTEX438O2MRTPRAZOSIN HYDROCHLORIDE CAPSULE [APHENA PHARMA SOLUTIONS - TENNESSEE, LLC]1
FERROSOFERRIC OXIDEINACTIVE INGREDIENTXM0M87F357PRAZOSIN HYDROCHLORIDE CAPSULE [APHENA PHARMA SOLUTIONS - TENNESSEE, LLC]1
GELATININACTIVE INGREDIENT2G86QN327LPRAZOSIN HYDROCHLORIDE CAPSULE [APHENA PHARMA SOLUTIONS - TENNESSEE, LLC]1
LACTOSE MONOHYDRATEINACTIVE INGREDIENTEWQ57Q8I5XPRAZOSIN HYDROCHLORIDE CAPSULE [APHENA PHARMA SOLUTIONS - TENNESSEE, LLC]1
MAGNESIUM STEARATEINACTIVE INGREDIENT70097M6I30PRAZOSIN HYDROCHLORIDE CAPSULE [APHENA PHARMA SOLUTIONS - TENNESSEE, LLC]1
PROPYLENE GLYCOLINACTIVE INGREDIENT6DC9Q167V3PRAZOSIN HYDROCHLORIDE CAPSULE [APHENA PHARMA SOLUTIONS - TENNESSEE, LLC]1
SHELLACINACTIVE INGREDIENT46N107B71OPRAZOSIN HYDROCHLORIDE CAPSULE [APHENA PHARMA SOLUTIONS - TENNESSEE, LLC]1
SILICON DIOXIDEINACTIVE INGREDIENTETJ7Z6XBU4PRAZOSIN HYDROCHLORIDE CAPSULE [APHENA PHARMA SOLUTIONS - TENNESSEE, LLC]1
TITANIUM DIOXIDEINACTIVE INGREDIENT15FIX9V2JPPRAZOSIN HYDROCHLORIDE CAPSULE [APHENA PHARMA SOLUTIONS - TENNESSEE, LLC]1

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
43353-868PRAZOSIN HYDROCHLORIDE CAPSULE [APHENA PHARMA SOLUTIONS - TENNESSEE, LLC]1Legacy NDC, 2 package rows20140415_4db5fdc0-f5a2-49f0-8129-bad6e7c2f998.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
312594prazosin HCl 2 MG Oral CapsulePSN4db5fdc0-f5a2-49f0-8129-bad6e7c2f9981
312594prazosin 2 MG Oral CapsuleSCD4db5fdc0-f5a2-49f0-8129-bad6e7c2f9981
312594prazosin (as prazosin HCl) 2 MG Oral CapsuleSY4db5fdc0-f5a2-49f0-8129-bad6e7c2f9981

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionStatus
43353-868-604335308686090 in 1 BOTTLE, PLASTICHistorical
43353-868-8043353086880180 in 1 BOTTLE, PLASTICHistorical