Qutenza

Product NDC
72512-928
11-digit product format
725120928
Labeler code
72512
Product ID
72512-928_d641ea90-cf4f-46b5-b309-1f06d4352086
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
capsaicin
Dosage form
KIT
Labeler
Averitas Pharma Inc
Application
NDA022395
Marketing category
NDA
Marketing start
2018-10-30
NDC exclude flag
No
Listing certified through
2027-12-31
Current FDA listing
Yes

Additional Listing Data#

Finished product
Yes
Brand name base
Qutenza
Listing expiration
2027-12-31

Harmonized Identifiers#

Field, Values table
FieldValues
Rxcui1039679, 1039681

DailyMed Product Concepts#

Product concept, Relation, Version table
Product conceptRelationVersionEffective
473d070d-1c38-488e-b991-c4d1bf45aab8Product name120210201

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
72512-920-00Qutenza1 in 1 POUCHPATCH179 mg in 179mg13
72512-920-00Qutenza1 in 1 CARTONPATCH179 mg in 179mg13
72512-928-01Qutenza1 in 1 CARTONKIT113

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
72512-928-01EA - Each72512-928100d1877-bacc-4197-8c97-81884dc0455712019-09-05

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
72512-928QUTENZA (CAPSAICIN) KIT [AVERITAS PHARMA INC]11Current NDC, Legacy NDC, 3 package rows20240810_3ffbbcb0-ad93-4f15-bb38-5da76a71c735.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
1039679capsaicin 8 % Medicated PatchPSN3ffbbcb0-ad93-4f15-bb38-5da76a71c73513
1039681Qutenza 8 % Medicated PatchPSN3ffbbcb0-ad93-4f15-bb38-5da76a71c73513
1039681capsaicin 0.08 MG/MG Medicated Patch [Qutenza]SBD3ffbbcb0-ad93-4f15-bb38-5da76a71c73513
1039679capsaicin 0.08 MG/MG Medicated PatchSCD3ffbbcb0-ad93-4f15-bb38-5da76a71c73513
1039679capsaicin 8 % Medicated PatchSY3ffbbcb0-ad93-4f15-bb38-5da76a71c73513
1039681Qutenza 8 % Medicated PatchSY3ffbbcb0-ad93-4f15-bb38-5da76a71c73513

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
72512-920-00725120920001 in 1 POUCHHistorical
72512-928-01725120928011 KIT in 1 CARTON (72512-928-01) * 1 POUCH in 1 CARTON (72512-920-00) / 1 PATCH in 1 POUCH / 179 mg in 1 PATCH * 50 g in 1 TUBE1 kit2018-10-300000-00-00NoNoCurrent