Doxazosin

Product NDC
16571-168
11-digit product format
165710168
Labeler code
16571
Product ID
16571-168_c7ae6273-26c7-4116-a42a-5c82e1b59849
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
Doxazosin
Dosage form
TABLET
Route
ORAL
Labeler
Rising Pharma Holdings, Inc.
Application
ANDA212727
Marketing category
ANDA
Marketing start
2024-05-20
Substance
DOXAZOSIN MESYLATE
Active strength
8 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
Doxazosin
Listing expiration
2026-12-31

Active Ingredients#

Ingredient, Strength table
IngredientStrength
DOXAZOSIN MESYLATE8 mg/1

Harmonized Identifiers#

Field, Values table
FieldValues
Unii86P6PQK0MU
Rxcui197625, 197626, 197627, 197628

DailyMed Product Concepts#

Product concept, Relation, Version table
Product conceptRelationVersionEffective
07a517fc-5845-3816-0f81-0a121804ec9eProduct name620250107
171dd63c-7eea-ede4-c010-4c25ba0a1087Product name120140508

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
16571-168-01Doxazosin100 in 1 BOTTLETABLET1002

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
16571-168DOXAZOSIN TABLET [RISING PHARMA HOLDINGS, INC.]2Current NDC, 1 package rows20240620_508b908e-8d80-422e-8ec0-2081185f4c95.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
197625doxazosin mesylate 1 MG Oral TabletPSN508b908e-8d80-422e-8ec0-2081185f4c952
197626doxazosin mesylate 2 MG Oral TabletPSN508b908e-8d80-422e-8ec0-2081185f4c952
197627doxazosin mesylate 4 MG Oral TabletPSN508b908e-8d80-422e-8ec0-2081185f4c952
197628doxazosin mesylate 8 MG Oral TabletPSN508b908e-8d80-422e-8ec0-2081185f4c952
197625doxazosin 1 MG Oral TabletSCD508b908e-8d80-422e-8ec0-2081185f4c952
197626doxazosin 2 MG Oral TabletSCD508b908e-8d80-422e-8ec0-2081185f4c952
197627doxazosin 4 MG Oral TabletSCD508b908e-8d80-422e-8ec0-2081185f4c952
197628doxazosin 8 MG Oral TabletSCD508b908e-8d80-422e-8ec0-2081185f4c952
197625doxazosin (as doxazosin mesylate) 1 MG Oral TabletSY508b908e-8d80-422e-8ec0-2081185f4c952
197626doxazosin (as doxazosin mesylate) 2 MG Oral TabletSY508b908e-8d80-422e-8ec0-2081185f4c952
197627doxazosin (as doxazosin mesylate) 4 MG Oral TabletSY508b908e-8d80-422e-8ec0-2081185f4c952
197628doxazosin (as doxazosin mesylate) 8 MG Oral TabletSY508b908e-8d80-422e-8ec0-2081185f4c952

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startSampleExclude flagStatus
16571-168-0116571016801100 TABLET in 1 BOTTLE (16571-168-01) 100 tablet2024-05-20NoNoCurrent