Prazosin Hydrochloride

Product NDC
71610-981
11-digit product format
716100981
Labeler code
71610
Product ID
71610-981_4870e80e-e51f-5029-e063-6394a90a0fb5
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
Prazosin Hydrochloride
Dosage form
CAPSULE
Route
ORAL
Labeler
Aphena Pharma Solutions - Tennessee, LLC
Application
ANDA213052
Marketing category
ANDA
Marketing start
2023-03-31
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
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 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
71610-981-60Prazosin Hydrochloride90 in 1 BOTTLECAPSULE901
71610-981-80Prazosin Hydrochloride180 in 1 BOTTLECAPSULE1801

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
71610-981-60EA - Each71610-9811dcadea3-866b-4307-b79c-5ced09815a2212026-03-17
71610-981-80EA - Each71610-98142777e72-77d7-44ec-bf0a-efae228a8cae12026-03-17

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
312594prazosin HCl 2 MG Oral CapsulePSN4870ed0b-abde-5ae5-e063-6394a90ad0ba1
312594prazosin 2 MG Oral CapsuleSCD4870ed0b-abde-5ae5-e063-6394a90ad0ba1
312594prazosin (as prazosin HCl) 2 MG Oral CapsuleSY4870ed0b-abde-5ae5-e063-6394a90ad0ba1

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startSampleExclude flagStatus
71610-981-607161009816090 CAPSULE in 1 BOTTLE (71610-981-60) 90 capsule2026-01-13NoNoHistorical
71610-981-8071610098180180 CAPSULE in 1 BOTTLE (71610-981-80) 180 capsule2026-01-13NoNoHistorical