FDA.reportPublic FDA data

Cardura

Product NDC
0049-2080
Requested package NDC
0049-2080-10
11-digit product format
000492080
Labeler code
0049
Product ID
0049-2080_36e114e8-4a87-4dfd-988c-4d2362ac06bb
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
doxazosin
Dosage form
TABLET, MULTILAYER, EXTENDED RELEASE
Route
ORAL
Labeler
Roerig
Application
NDA021269
Marketing category
NDA
Marketing start
2022-04-26
Marketing end
0000-00-00
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
2023-12-31
Current FDA listing
Historical FDA.report record

NDC auxiliary status#

Explicit status records from FDA unfinished, excluded, and compounder auxiliary files. Absence of a row is not itself a regulatory status. Browse every current auxiliary row, including rows without a usable NDC. · Browse every captured source and parsed snapshot.

Current NDC status page 1 of 1 · 1 matching rows.

Dataset, Scope, Product NDC table
DatasetScopeProduct NDCPackage NDCCodeStatusReporting periodSource date
excluded packagepackage0049-20800049-2080-10DDiscontinued by firm2026-08-03

Source provenance: Browse the complete Orange Book source catalog · source snapshot 1.

Orange Book products#

Current product rows page 1 of 1 · 2 matching rows.

Application-product, Trade name, Ingredient table
Application-productTrade nameIngredientStrengthDosage form / routeTE codesRLD / RSApproval date
N021269-001CARDURA XLDOXAZOSIN MESYLATEEQ 4MG BASETABLET, EXTENDED RELEASE / ORALRLD2005-02-22
N021269-002CARDURA XLDOXAZOSIN MESYLATEEQ 8MG BASETABLET, EXTENDED RELEASE / ORALRLD, RS2005-02-22

Observed Orange Book product history#

Observed FDA ZIP history: Each table is queried independently by exact application/product key from successfully parsed Orange Book snapshots. Capture times identify archived source observations; absence or a change between snapshots is not inferred. FDA publication files that were not recoverable as structured ZIP data are not represented as states.

Captured, Edition, Application-product table
CapturedEditionApplication-productTrade nameStrengthDosage form / routeProduct TE source textRLD / RSApproval dateSource SHA-256
2026-08-01 22:54:322026-06N021269-001CARDURA XLEQ 4MG BASETABLET, EXTENDED RELEASE / ORALRLD2005-02-22a50c72e98297…
2026-08-01 22:54:322026-06N021269-002CARDURA XLEQ 8MG BASETABLET, EXTENDED RELEASE / ORALRLD, RS2005-02-22a50c72e98297…

openFDA label cross-check#

Cross-check layer: openFDA label JSON enriches search and identifies hydration gaps. The DailyMed Structured Product Label remains the canonical label presentation on FDA.report. Every label matching the complete exact-identifier union is deduplicated and paginated below.

Matched openFDA labels page 1 of 1 · 1 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
Cardura XLDOXAZOSIN MESYLATEViatris Specialty LLC355bcdce-0481-48ba-8ebd-2009106aaf772023-05-15Warnings, Adverse reactionsExact identifier
application applno (NDA): 021269
application number: NDA021269

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
0049-2080-10EA - Each0049-2080ae96ee75-dff7-4002-9db4-c4e24347311a12022-05-04

DailyMed Socrata Ingredients#

Ingredient, Type, UNII table
IngredientTypeUNIIDailyMed labelSPL versionUploaded
DOXAZOSIN MESYLATEACTIVE INGREDIENT86P6PQK0MUCARDURA XL (DOXAZOSIN MESYLATE) TABLET, MULTILAYER, EXTENDED RELEASE [ROERIG]9
DOXAZOSINACTIVE MOIETYNW1291F1W8CARDURA XL (DOXAZOSIN MESYLATE) TABLET, MULTILAYER, EXTENDED RELEASE [ROERIG]9
CELLULOSE ACETATEINACTIVE INGREDIENT3J2P07GVB6CARDURA XL (DOXAZOSIN MESYLATE) TABLET, MULTILAYER, EXTENDED RELEASE [ROERIG]9
FERRIC OXIDE REDINACTIVE INGREDIENT1K09F3G675CARDURA XL (DOXAZOSIN MESYLATE) TABLET, MULTILAYER, EXTENDED RELEASE [ROERIG]9
FERROSOFERRIC OXIDEINACTIVE INGREDIENTXM0M87F357CARDURA XL (DOXAZOSIN MESYLATE) TABLET, MULTILAYER, EXTENDED RELEASE [ROERIG]9
HYPROMELLOSESINACTIVE INGREDIENT3NXW29V3WOCARDURA XL (DOXAZOSIN MESYLATE) TABLET, MULTILAYER, EXTENDED RELEASE [ROERIG]9
MAGNESIUM STEARATEINACTIVE INGREDIENT70097M6I30CARDURA XL (DOXAZOSIN MESYLATE) TABLET, MULTILAYER, EXTENDED RELEASE [ROERIG]9
POLYETHYLENE GLYCOLSINACTIVE INGREDIENT3WJQ0SDW1ACARDURA XL (DOXAZOSIN MESYLATE) TABLET, MULTILAYER, EXTENDED RELEASE [ROERIG]9
SODIUM CHLORIDEINACTIVE INGREDIENT451W47IQ8XCARDURA XL (DOXAZOSIN MESYLATE) TABLET, MULTILAYER, EXTENDED RELEASE [ROERIG]9
TITANIUM DIOXIDEINACTIVE INGREDIENT15FIX9V2JPCARDURA XL (DOXAZOSIN MESYLATE) TABLET, MULTILAYER, EXTENDED RELEASE [ROERIG]9

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionMarketing startMarketing endSampleExclude flagStatus
0049-2080-100004920801030 TABLET, MULTILAYER, EXTENDED RELEASE in 1 BOTTLE (0049-2080-10) 2022-04-260000-00-00NoNoCurrent