FDA.reportPublic FDA data

Prazosin Hydrochloride

Product NDC
71335-1085
11-digit product format
713351085
Labeler code
71335
Product ID
71335-1085_fd7eaf0b-8ba0-6192-e053-6294a90a89c2
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
Prazosin Hydrochloride
Dosage form
CAPSULE
Route
ORAL
Labeler
Bryant Ranch Prepack
Application
ANDA210971
Marketing category
ANDA
Marketing start
2018-10-03
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
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
71335-1085-1Prazosin Hydrochloride30 in 1 BOTTLECAPSULE304
71335-1085-2Prazosin Hydrochloride28 in 1 BOTTLECAPSULE284
71335-1085-3Prazosin Hydrochloride60 in 1 BOTTLECAPSULE604
71335-1085-4Prazosin Hydrochloride90 in 1 BOTTLECAPSULE904
71335-1085-5Prazosin Hydrochloride18 in 1 BOTTLECAPSULE184

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
71335-1085-1EA - Each71335-108565f8b253-dcdf-4c4b-b83e-99cb98ae025212023-12-05
71335-1085-3EA - Each71335-1085b6a16532-caf8-4efc-8b80-6cb04fa5734c12023-12-05

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
71335-1085PRAZOSIN HYDROCHLORIDE CAPSULE [BRYANT RANCH PREPACK]4Current NDC, Legacy NDC, 5 package rows20230608_59602472-65d1-4ad8-8dad-a96a0f4cae0c.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
312594prazosin HCl 2 MG Oral CapsulePSN59602472-65d1-4ad8-8dad-a96a0f4cae0c4
312594prazosin 2 MG Oral CapsuleSCD59602472-65d1-4ad8-8dad-a96a0f4cae0c4
312594prazosin (as prazosin HCl) 2 MG Oral CapsuleSY59602472-65d1-4ad8-8dad-a96a0f4cae0c4

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
71335-1085-17133510850130 CAPSULE in 1 BOTTLE (71335-1085-1) 30 capsule2019-02-010000-00-00NoNoCurrent
71335-1085-27133510850228 CAPSULE in 1 BOTTLE (71335-1085-2) 28 capsule2021-12-280000-00-00NoNoCurrent
71335-1085-37133510850360 CAPSULE in 1 BOTTLE (71335-1085-3) 60 capsule2019-11-200000-00-00NoNoCurrent
71335-1085-47133510850490 CAPSULE in 1 BOTTLE (71335-1085-4) 90 capsule2021-12-280000-00-00NoNoCurrent
71335-1085-57133510850518 CAPSULE in 1 BOTTLE (71335-1085-5) 18 capsule2021-12-280000-00-00NoNoCurrent