FDA.reportPublic FDA data

Lidocaine and prilocaine

Product NDC
70771-1872
11-digit product format
707711872
Labeler code
70771
Product ID
70771-1872_3e051555-68e1-43e0-98ec-28eecdc81699
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
Lidocaine and prilocaine
Dosage form
CREAM
Route
TOPICAL
Labeler
Zydus Lifesciences Limited
Application
ANDA219120
Marketing category
ANDA
Marketing start
2025-01-01
Substance
LIDOCAINE; PRILOCAINE
Active strength
25; 25 mg/g; mg/g
Pharmacologic classes
Amide Local Anesthetic [EPC], Amide Local Anesthetic [EPC], Amides [CS], Amides [CS], Antiarrhythmic [EPC], Local Anesthesia [PE], 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 and prilocaine
Listing expiration
2026-12-31

Active Ingredients#

Ingredient, Strength table
IngredientStrength
LIDOCAINE25 mg/g
PRILOCAINE25 mg/g

Harmonized Identifiers#

Field, Values table
FieldValues
Unii98PI200987, 046O35D44R
Rxcui197877

DailyMed Product Concepts#

Product concept, Relation, Version table
Product conceptRelationVersionEffective
bee66ce1-adb7-9d3b-67d9-582e4c54e80fProduct name520250819
49fa150c-f0de-cce7-3d9c-993ed81c5698Product name120140508

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
70771-1872-2Lidocaine and prilocaine1 in 1 CARTONCREAM11
70771-1872-2Lidocaine and prilocaine30 g in 1 TUBECREAM301
70771-1872-5Lidocaine and prilocaine5 g in 1 TUBECREAM51
70771-1872-8Lidocaine and prilocaine5 in 1 CARTONCREAM51

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
70771-1872LIDOCAINE AND PRILOCAINE CREAM [ZYDUS LIFESCIENCES LIMITED]1Current NDC, 4 package rows20250101_f85ec4ed-4a1b-4680-ace1-b2a0b1114af5.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
197877lidocaine 2.5 % / prilocaine 2.5 % Topical CreamPSNf85ec4ed-4a1b-4680-ace1-b2a0b1114af51
197877lidocaine 25 MG/ML / prilocaine 25 MG/ML Topical CreamSCDf85ec4ed-4a1b-4680-ace1-b2a0b1114af51
197877lidocaine 2.5 % / prilocaine 2.5 % Topical CreamSYf85ec4ed-4a1b-4680-ace1-b2a0b1114af51

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startSampleExclude flagStatus
70771-1872-2707711872021 TUBE in 1 CARTON (70771-1872-2) / 30 g in 1 TUBE1 tube2025-01-01NoNoHistorical
70771-1872-5707711872055 g in 1 TUBE5 gHistorical
70771-1872-8707711872085 TUBE in 1 CARTON (70771-1872-8) / 5 g in 1 TUBE (70771-1872-5) 5 tube2025-01-01NoNoHistorical