FDA.reportPublic FDA data

Lidocaine

Product NDC
63629-5094
11-digit product format
636295094
Labeler code
63629
Product ID
63629-5094_c6770218-eb44-4dc9-8d8d-b206e584ed93
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
Lidocaine
Dosage form
PATCH
Route
TOPICAL
Labeler
Bryant Ranch Prepack
Application
ANDA200675
Marketing category
ANDA
Marketing start
2013-09-15
Substance
LIDOCAINE
Active strength
50 mg/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
Lidocaine
Listing expiration
2026-12-31

Active Ingredients#

Ingredient, Strength table
IngredientStrength
LIDOCAINE50 mg/g

Harmonized Identifiers#

Field, Values table
FieldValues
Unii98PI200987
Rxcui1745091

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
f52be47f-7aa7-46c0-b1fa-50c18dd50206Product name120201029
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
63629-5094-1Lidocaine1 g in 1 POUCHPATCH11015
63629-5094-1Lidocaine30 in 1 CARTONPATCH301015
63629-5094-2Lidocaine3 in 1 CARTONPATCH31015
63629-5094-2Lidocaine1 g in 1 POUCHPATCH11015
63629-5094-3Lidocaine9 in 1 CARTONPATCH91015
63629-5094-3Lidocaine1 g in 1 POUCHPATCH11015
63629-5094-4Lidocaine10 in 1 CARTONPATCH101015
63629-5094-4Lidocaine1 g in 1 POUCHPATCH11015
63629-5094-5Lidocaine1 g in 1 POUCHPATCH11015
63629-5094-5Lidocaine14 in 1 CARTONPATCH141015

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
63629-5094-1EA - Each63629-50946f7d4696-73a8-44d7-aa19-27c312c5374212016-04-04
63629-5094-2EA - Each63629-50946deac20a-88fa-4b75-a793-671396df260412024-02-14
63629-5094-3EA - Each63629-5094d9214895-34c7-49ec-b3c5-3f7985b4c0a312024-02-14
63629-5094-5EA - Each63629-5094d841ec1d-3e20-4ec4-a8e6-24314791bbf412024-02-14

DailyMed Socrata Ingredients#

Ingredient, Type, UNII table
IngredientTypeUNIIDailyMed labelSPL versionUploaded
LIDOCAINEACTIVE INGREDIENT98PI200987LIDOCAINE PATCH [BRYANT RANCH PREPACK]1000
LIDOCAINEACTIVE MOIETY98PI200987LIDOCAINE PATCH [BRYANT RANCH PREPACK]1000
CARBOXYMETHYLCELLULOSE SODIUMINACTIVE INGREDIENTK679OBS311LIDOCAINE PATCH [BRYANT RANCH PREPACK]1000
DIHYDROXYALUMINUM AMINOACETATEINACTIVE INGREDIENTDO250MG0W6LIDOCAINE PATCH [BRYANT RANCH PREPACK]1000
EDETATE DISODIUMINACTIVE INGREDIENT7FLD91C86KLIDOCAINE PATCH [BRYANT RANCH PREPACK]1000
GELATININACTIVE INGREDIENT2G86QN327LLIDOCAINE PATCH [BRYANT RANCH PREPACK]1000
GLYCERININACTIVE INGREDIENTPDC6A3C0OXLIDOCAINE PATCH [BRYANT RANCH PREPACK]1000
KAOLININACTIVE INGREDIENT24H4NWX5COLIDOCAINE PATCH [BRYANT RANCH PREPACK]1000
METHYLPARABENINACTIVE INGREDIENTA2I8C7HI9TLIDOCAINE PATCH [BRYANT RANCH PREPACK]1000
POLYVINYL ALCOHOLINACTIVE INGREDIENT532B59J990LIDOCAINE PATCH [BRYANT RANCH PREPACK]1000
PROPYLENE GLYCOLINACTIVE INGREDIENT6DC9Q167V3LIDOCAINE PATCH [BRYANT RANCH PREPACK]1000
PROPYLPARABENINACTIVE INGREDIENTZ8IX2SC1OHLIDOCAINE PATCH [BRYANT RANCH PREPACK]1000
SORBITOLINACTIVE INGREDIENT506T60A25RLIDOCAINE PATCH [BRYANT RANCH PREPACK]1000
TARTARIC ACIDINACTIVE INGREDIENTW4888I119HLIDOCAINE PATCH [BRYANT RANCH PREPACK]1000
UREAINACTIVE INGREDIENT8W8T17847WLIDOCAINE PATCH [BRYANT RANCH PREPACK]1000

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
63629-5094LIDOCAINE PATCH [BRYANT RANCH PREPACK]1015Current NDC, Legacy NDC, 10 package rows20231117_6d7fdc43-e493-449e-9af6-825e584b547a.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
1745091lidocaine 5 % Medicated PatchPSN6d7fdc43-e493-449e-9af6-825e584b547a1015
1745091lidocaine 0.05 MG/MG Medicated PatchSCD6d7fdc43-e493-449e-9af6-825e584b547a1015
1745091lidocaine 5 % Medicated PatchSY6d7fdc43-e493-449e-9af6-825e584b547a1015

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
63629-5094-16362950940130 POUCH in 1 CARTON (63629-5094-1) / 1 g in 1 POUCH30 pouch2013-09-200000-00-00NoNoCurrent
63629-5094-2636295094023 POUCH in 1 CARTON (63629-5094-2) / 1 g in 1 POUCH3 pouch2013-09-200000-00-00NoNoCurrent
63629-5094-3636295094039 POUCH in 1 CARTON (63629-5094-3) / 1 g in 1 POUCH9 pouch2013-09-200000-00-00NoNoCurrent
63629-5094-46362950940410 POUCH in 1 CARTON (63629-5094-4) / 1 g in 1 POUCH10 pouch2013-09-200000-00-00NoNoCurrent
63629-5094-56362950940514 POUCH in 1 CARTON (63629-5094-5) / 1 g in 1 POUCH14 pouch2021-04-140000-00-00NoNoCurrent