FDA.reportPublic FDA data

Trubrexa Patch ER

Product NDC
72189-541
11-digit product format
721890541
Labeler code
72189
Product ID
72189-541_1367f190-670b-d2de-e063-6394a90abb13
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
Trubrexa Patch ER
Dosage form
PATCH
Route
TRANSDERMAL
Labeler
Direct_Rx
Marketing category
UNAPPROVED DRUG OTHER
Marketing start
2024-03-11
Substance
CAPSAICIN; LIDOCAINE
Active strength
.00025; .0475 g/g; g/g
Pharmacologic classes
Amide Local Anesthetic [EPC], Amides [CS], Antiarrhythmic [EPC], Local Anesthesia [PE]
NDC exclude flag
No
Listing certified through
2026-12-31
Current FDA listing
Yes

Additional Listing Data#

Finished product
Yes
Brand name base
Trubrexa Patch ER
Listing expiration
2026-12-31

Active Ingredients#

Ingredient, Strength table
IngredientStrength
CAPSAICIN.00025 g/g
LIDOCAINE.0475 g/g

Harmonized Identifiers#

Field, Values table
FieldValues
UniiS07O44R1ZM, 98PI200987
Rxcui2667457

DailyMed Product Concepts#

Product concept, Relation, Version table
Product conceptRelationVersionEffective
070fbed5-7088-434a-a7ce-f2a64d8d40acProduct name220260107
bee66ce1-adb7-9d3b-67d9-582e4c54e80fProduct name520250819
860a93dc-4863-49cc-b284-6bbe8191bc48Product name420250214
eaba870a-6a9d-442e-8643-87b3f558a451Product name120250117
9b4cf230-fd05-41d5-98c6-5db9ecb27b86Product name120230117
7d755fa1-1087-4dcd-98f0-6d4bba479a57Product name320210602
473d070d-1c38-488e-b991-c4d1bf45aab8Product name120210201
aed701d5-9c75-dfaf-7154-cde46179faeaProduct name920200313
fa8b5901-e681-426f-82fe-54f6d81ec698Product name420180619
332d03e4-aa24-4b11-841a-02bf41081920Product name120171221
c08ab52f-2fc8-4409-9d9f-ed8edc0bd070Product name120171221
68ed98f8-24c2-44a0-944a-6d36e82ce25aProduct name120141222
1cd42bc2-a430-c72b-636d-991b235fbf80Product name120140508
49fa150c-f0de-cce7-3d9c-993ed81c5698Product name120140508
4d7ae718-ed00-bae8-2abe-9eaec1eef7ffProduct name120140508
9137811f-f279-8640-5aeb-99fa2145d64dProduct name120140508

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
72189-541-11Trubrexa Patch ER2.7 g in 1 PATCHPATCH2.71

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
72189-541-11EA - Each72189-54134fd210b-c959-4285-8e6c-ccc23fc7ad8c12024-04-05

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
72189-541TRUBREXA PATCH ER PATCH [DIRECT_RX]1Current NDC, 1 package rows20240316_1367f190-670a-d2de-e063-6394a90abb13.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
2667457lidocaine 4.75 % / capsaicin 0.025 % Medicated PatchPSN1367f190-670a-d2de-e063-6394a90abb131
2667457capsaicin 0.00025 MG/MG / lidocaine 0.0475 MG/MG Medicated PatchSCD1367f190-670a-d2de-e063-6394a90abb131
2667457capsaicin 0.025 % / lidocaine 4.75 % Medicated PatchSY1367f190-670a-d2de-e063-6394a90abb131

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startSampleExclude flagStatus
72189-541-11721890541112.7 g in 1 PATCH (72189-541-11) 2.7 g2024-03-11NoNoCurrent