FDA.reportPublic FDA data

Doxazosin

Product NDC
70518-3667
11-digit product format
705183667
Labeler code
70518
Product ID
70518-3667_4f6f1909-4268-45e9-e063-6394a90a0128
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
Doxazosin
Dosage form
TABLET
Route
ORAL
Labeler
REMEDYREPACK INC.
Application
ANDA075580
Marketing category
ANDA
Marketing start
2023-03-01
Substance
DOXAZOSIN MESYLATE
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
Doxazosin
Listing expiration
2027-12-31

Active Ingredients#

Ingredient, Strength table
IngredientStrength
DOXAZOSIN MESYLATE2 mg/1

Harmonized Identifiers#

Field, Values table
FieldValues
Unii86P6PQK0MU
Rxcui197626

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
70518-3667-0Doxazosin30 in 1 BLISTER PACKTABLET305
70518-3667-1Doxazosin90 in 1 BOTTLE, PLASTICTABLET905

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
197626doxazosin mesylate 2 MG Oral TabletPSN30a6bb83-f91b-4c4f-a849-4f2be3735a0e5
197626doxazosin 2 MG Oral TabletSCD30a6bb83-f91b-4c4f-a849-4f2be3735a0e5
197626doxazosin (as doxazosin mesylate) 2 MG Oral TabletSY30a6bb83-f91b-4c4f-a849-4f2be3735a0e5

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startSampleExclude flagStatus
70518-3667-07051836670030 in 1 BLISTER PACKHistorical
70518-3667-17051836670190 TABLET in 1 BOTTLE, PLASTIC (70518-3667-1) 90 tablet2026-04-14NoNoHistorical