FDA.reportPublic FDA data

Lidocaine and Prilocaine

Product NDC
46708-582
11-digit product format
467080582
Labeler code
46708
Product ID
46708-582_59488591-1d11-453f-b2f2-b2a47825819a
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
Lidocaine and Prilocaine
Dosage form
CREAM
Route
TOPICAL
Labeler
Alembic Pharmaceuticals Limited
Application
ANDA213923
Marketing category
ANDA
Marketing start
2025-04-03
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
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
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
46708-582-04Lidocaine and Prilocaine5 g in 1 TUBECREAM51
46708-582-04Lidocaine and Prilocaine1 in 1 CARTONCREAM11
46708-582-31Lidocaine and Prilocaine1 in 1 CARTONCREAM11
46708-582-31Lidocaine and Prilocaine30 g in 1 TUBECREAM301

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
46708-582LIDOCAINE AND PRILOCAINE CREAM [ALEMBIC PHARMACEUTICALS LIMITED]1Current NDC, 4 package rows20250410_54198bf6-c93c-42cd-9b2b-63918eb32880.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
197877lidocaine 2.5 % / prilocaine 2.5 % Topical CreamPSN54198bf6-c93c-42cd-9b2b-63918eb328801
197877lidocaine 25 MG/ML / prilocaine 25 MG/ML Topical CreamSCD54198bf6-c93c-42cd-9b2b-63918eb328801
197877lidocaine 2.5 % / prilocaine 2.5 % Topical CreamSY54198bf6-c93c-42cd-9b2b-63918eb328801

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startSampleExclude flagStatus
46708-582-04467080582041 TUBE in 1 CARTON (46708-582-04) / 5 g in 1 TUBE1 tube2025-04-03NoNoCurrent
46708-582-31467080582311 TUBE in 1 CARTON (46708-582-31) / 30 g in 1 TUBE1 tube2025-04-03NoNoCurrent