FDA.reportPublic FDA data

Prazosin Hydrochloride

Product NDC
10135-668
11-digit product format
101350668
Labeler code
10135
Product ID
10135-668_441dd676-fc13-c6ce-e063-6294a90a82a7
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
Prazosin Hydrochloride
Dosage form
CAPSULE
Route
ORAL
Labeler
Marlex Pharmaceuticals Inc
Application
ANDA210971
Marketing category
ANDA
Marketing start
2018-10-01
Substance
PRAZOSIN HYDROCHLORIDE
Active strength
5 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 HYDROCHLORIDE5 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

FDA-Initiated Inactive NDC Indexing#

NDC, Effective, Action table
NDCEffectiveActionDocumentIndexing SPLRelated label
10135-668-012026-01-29C16284748780-19d75b9d1-0d6e-f424-e053-dadaa90a57cePrazosin Hydrochloride Capsules
10135-668-692026-01-29C16284748780-19d75b9d1-0d6e-f424-e053-dadaa90a57cePrazosin Hydrochloride Capsules
10135-668-012022-12-16C16284748780-19d75b9d1-0d6e-f424-e053-dadaa90a57cePrazosin Hydrochloride Capsules
10135-668-692022-12-16C16284748780-19d75b9d1-0d6e-f424-e053-dadaa90a57cePrazosin Hydrochloride Capsules
10135-668-012020-01-31C16284748780-19d75b9d1-0d6e-f424-e053-dadaa90a57cePrazosin Hydrochloride Capsules
10135-668-692020-01-31C16284748780-19d75b9d1-0d6e-f424-e053-dadaa90a57cePrazosin Hydrochloride Capsules

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
10135-668-01Prazosin Hydrochloride100 in 1 BOTTLECAPSULE1005
10135-668-69Prazosin Hydrochloride250 in 1 BOTTLECAPSULE2505

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
10135-668-01EA - Each10135-6687c4a2e6f-568c-4d1c-8986-dfbcd74b670d12018-11-06
10135-668-69EA - Each10135-668d89e2dbe-c742-4ab1-abf5-695d5bd979df12018-11-06

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
10135-668PRAZOSIN HYDROCHLORIDE CAPSULE [MARLEX PHARMACEUTICALS INC]4Current NDC, Legacy NDC, 2 package rows20241018_1c28c337-6dbb-46bd-aa86-dbcd34e3f6e6.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
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

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
10135-668-0110135066801100 CAPSULE in 1 BOTTLE (10135-668-01) 100 capsule2018-10-010000-00-00NoNoCurrent
10135-668-6910135066869250 CAPSULE in 1 BOTTLE (10135-668-69) 250 capsule2018-10-010000-00-00NoNoCurrent