Doxazosin

Product NDC
68382-783
11-digit product format
683820783
Labeler code
68382
Product ID
68382-783_92ead971-9de8-4240-b2c7-fc2e9abac7dd
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
Doxazosin
Dosage form
TABLET
Route
ORAL
Labeler
Zydus Pharmaceuticals USA Inc.
Application
ANDA208719
Marketing category
ANDA
Marketing start
2017-08-31
Substance
DOXAZOSIN MESYLATE
Active strength
1 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 MESYLATE1 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
68382-783-01Doxazosin100 in 1 BOTTLETABLET1004
68382-783-06Doxazosin30 in 1 BOTTLETABLET304
68382-783-10Doxazosin1000 in 1 BOTTLETABLET10004
68382-783-30Doxazosin10 in 1 BLISTER PACKTABLET104
68382-783-77Doxazosin10 in 1 CARTONTABLET104

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
68382-783-01EA - Each68382-783c206724c-df31-490b-9d3a-d9e02c83b03f12018-03-08
68382-783-10EA - Each68382-783c25b3680-a036-4c46-a5d5-c733f5c6998712018-03-08

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
68382-783DOXAZOSIN TABLET [ZYDUS PHARMACEUTICALS USA INC.]4Current NDC, Legacy NDC, 5 package rows20230921_e4758bf9-b9d4-4268-beb8-0d7e06890895.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
197625doxazosin mesylate 1 MG Oral TabletPSNe4758bf9-b9d4-4268-beb8-0d7e068908954
197626doxazosin mesylate 2 MG Oral TabletPSNe4758bf9-b9d4-4268-beb8-0d7e068908954
197627doxazosin mesylate 4 MG Oral TabletPSNe4758bf9-b9d4-4268-beb8-0d7e068908954
197628doxazosin mesylate 8 MG Oral TabletPSNe4758bf9-b9d4-4268-beb8-0d7e068908954
197625doxazosin 1 MG Oral TabletSCDe4758bf9-b9d4-4268-beb8-0d7e068908954
197626doxazosin 2 MG Oral TabletSCDe4758bf9-b9d4-4268-beb8-0d7e068908954
197627doxazosin 4 MG Oral TabletSCDe4758bf9-b9d4-4268-beb8-0d7e068908954
197628doxazosin 8 MG Oral TabletSCDe4758bf9-b9d4-4268-beb8-0d7e068908954
197625doxazosin (as doxazosin mesylate) 1 MG Oral TabletSYe4758bf9-b9d4-4268-beb8-0d7e068908954
197626doxazosin (as doxazosin mesylate) 2 MG Oral TabletSYe4758bf9-b9d4-4268-beb8-0d7e068908954
197627doxazosin (as doxazosin mesylate) 4 MG Oral TabletSYe4758bf9-b9d4-4268-beb8-0d7e068908954
197628doxazosin (as doxazosin mesylate) 8 MG Oral TabletSYe4758bf9-b9d4-4268-beb8-0d7e068908954
197625doxazosin mesylate 1 MG Oral TabletPSNad7a234d-c1c2-44a1-830e-f97e202cbeab3
197625doxazosin 1 MG Oral TabletSCDad7a234d-c1c2-44a1-830e-f97e202cbeab3
197625doxazosin (as doxazosin mesylate) 1 MG Oral TabletSYad7a234d-c1c2-44a1-830e-f97e202cbeab3

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
68382-783-0168382078301100 TABLET in 1 BOTTLE (68382-783-01) 100 tablet2017-08-310000-00-00NoNoCurrent
68382-783-066838207830630 TABLET in 1 BOTTLE (68382-783-06) 30 tablet2017-08-310000-00-00NoNoCurrent
68382-783-10683820783101000 TABLET in 1 BOTTLE (68382-783-10) 1000 tablet2017-08-310000-00-00NoNoCurrent
68382-783-306838207833010 in 1 BLISTER PACKHistorical
68382-783-776838207837710 BLISTER PACK in 1 CARTON (68382-783-77) / 10 TABLET in 1 BLISTER PACK (68382-783-30) 10 blister pack2017-08-310000-00-00NoNoCurrent