FDA.reportPublic FDA data

Lidocaine

Product NDC
71335-1971
11-digit product format
713351971
Labeler code
71335
Product ID
71335-1971_03bcee4d-5c75-4224-bed0-7484506eeada
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
Lidocaine
Dosage form
PATCH
Route
TOPICAL
Labeler
Bryant Ranch Prepack
Application
ANDA206463
Marketing category
ANDA
Marketing start
2020-08-25
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
Lidocaine
Listing expiration
2026-12-31

Active Ingredients#

Ingredient, Strength table
IngredientStrength
LIDOCAINE700 mg/1

Harmonized Identifiers#

Field, Values table
FieldValues
Unii98PI200987
Rxcui1745091

DailyMed Product Concepts#

Product concept, Relation, Version table
Product conceptRelationVersionEffective
f52be47f-7aa7-46c0-b1fa-50c18dd50206Product name120201029

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
71335-1971-1Lidocaine30 in 1 POUCHPATCH30102
71335-1971-2Lidocaine3 in 1 POUCHPATCH3102
71335-1971-3Lidocaine9 in 1 POUCHPATCH9102
71335-1971-4Lidocaine10 in 1 POUCHPATCH10102
71335-1971-5Lidocaine14 in 1 POUCHPATCH14102

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
71335-1971-3EA - Each71335-1971fa6483c1-7a5b-449c-85f5-a89566f154b612024-02-14
71335-1971-5EA - Each71335-1971f264b295-4d65-4b59-8aee-88302ff67f2212024-02-14

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
71335-1971LIDOCAINE PATCH [BRYANT RANCH PREPACK]102Current NDC, Legacy NDC, 5 package rows20240509_b4db5684-988f-44c4-a81e-5c04b8b0f6e7.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
1745091lidocaine 5 % Medicated PatchPSNb4db5684-988f-44c4-a81e-5c04b8b0f6e7102
1745091lidocaine 0.05 MG/MG Medicated PatchSCDb4db5684-988f-44c4-a81e-5c04b8b0f6e7102
1745091lidocaine 5 % Medicated PatchSYb4db5684-988f-44c4-a81e-5c04b8b0f6e7102

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
71335-1971-17133519710130 PATCH in 1 POUCH (71335-1971-1) 30 patch2021-10-210000-00-00NoNoCurrent
71335-1971-2713351971023 PATCH in 1 POUCH (71335-1971-2) 3 patch2021-10-210000-00-00NoNoCurrent
71335-1971-3713351971039 PATCH in 1 POUCH (71335-1971-3) 9 patch2021-10-210000-00-00NoNoCurrent
71335-1971-47133519710410 PATCH in 1 POUCH (71335-1971-4) 10 patch2021-10-210000-00-00NoNoCurrent
71335-1971-57133519710514 PATCH in 1 POUCH (71335-1971-5) 14 patch2021-10-210000-00-00NoNoCurrent