LIDODERM

Product NDC
61959-001
11-digit product format
619590001
Labeler code
61959
Product ID
61959-001_eedfe43b-1019-19a0-e053-2995a90a7696
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
Lidocaine Patch 5%
Dosage form
PATCH
Route
TOPICAL
Labeler
TPU Pharma, Inc.
Application
NDA020612
Marketing category
NDA
Marketing start
2023-03-01
Substance
LIDOCAINE
Active strength
700 mg/1
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
LIDODERM
Listing expiration
2026-12-31

Active Ingredients#

Ingredient, Strength table
IngredientStrength
LIDOCAINE700 mg/1

Harmonized Identifiers#

Field, Values table
FieldValues
Unii98PI200987
Rxcui1011705, 1745091

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
61959-001-01LIDODERM1 in 1 POUCHPATCH13
61959-001-30LIDODERM30 in 1 CARTONPATCH303

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
61959-001-01EA - Each61959-001b40ddb1f-54e4-4fa4-b80b-23fc29c20ef612023-05-05
61959-001-30EA - Each61959-00139d1b6c9-556a-42ba-9de1-94c22e711e5c12023-05-05

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
61959-001LIDODERM (LIDOCAINE PATCH 5%) PATCH [TPU PHARMA, INC.]3Current NDC, Legacy NDC, 2 package rows20230301_db0092f5-02a0-4076-ac32-969f075a6ab1.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
1745091lidocaine 5 % Medicated PatchPSNdb0092f5-02a0-4076-ac32-969f075a6ab13
1011705Lidoderm 5 % Medicated PatchPSNdb0092f5-02a0-4076-ac32-969f075a6ab13
1011705lidocaine 0.05 MG/MG Medicated Patch [Lidoderm]SBDdb0092f5-02a0-4076-ac32-969f075a6ab13
1745091lidocaine 0.05 MG/MG Medicated PatchSCDdb0092f5-02a0-4076-ac32-969f075a6ab13
1745091lidocaine 5 % Medicated PatchSYdb0092f5-02a0-4076-ac32-969f075a6ab13
1011705Lidoderm 0.05 MG/MG Medicated PatchSYdb0092f5-02a0-4076-ac32-969f075a6ab13
1011705Lidoderm 5 % Medicated PatchSYdb0092f5-02a0-4076-ac32-969f075a6ab13

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
61959-001-01619590001011 in 1 POUCHHistorical
61959-001-306195900013030 POUCH in 1 CARTON (61959-001-30) / 1 PATCH in 1 POUCH (61959-001-01) 30 pouch2023-03-010000-00-00NoNoCurrent