LIDOCAINE

Product NDC
46708-424
11-digit product format
467080424
Labeler code
46708
Product ID
46708-424_aadb4c01-e981-4bcc-8c74-2d50676a05c9
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
LIDOCAINE
Dosage form
OINTMENT
Route
TOPICAL
Labeler
Alembic Pharmaceuticals Limited
Application
ANDA211469
Marketing category
ANDA
Marketing start
2025-02-11
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
Rxcui1543069

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
46708-424-30LIDOCAINE1 in 1 CARTONOINTMENT11
46708-424-30LIDOCAINE30 g in 1 TUBEOINTMENT301
46708-424-35LIDOCAINE1 in 1 CARTONOINTMENT11
46708-424-35LIDOCAINE35.44 g in 1 TUBEOINTMENT35.441
46708-424-50LIDOCAINE50 g in 1 JAROINTMENT501

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
46708-424LIDOCAINE OINTMENT [ALEMBIC PHARMACEUTICALS LIMITED]1Current NDC, 5 package rows20250213_071b2cfd-07ad-46a3-8808-87080d545fd3.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
1543069lidocaine 5 % Topical OintmentPSN071b2cfd-07ad-46a3-8808-87080d545fd31
1543069lidocaine 0.05 MG/MG Topical OintmentSCD071b2cfd-07ad-46a3-8808-87080d545fd31
1543069lidocaine 5 % Topical OintmentSY071b2cfd-07ad-46a3-8808-87080d545fd31

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startSampleExclude flagStatus
46708-424-30467080424301 TUBE in 1 CARTON (46708-424-30) / 30 g in 1 TUBE1 tube2025-02-11NoNoCurrent
46708-424-35467080424351 TUBE in 1 CARTON (46708-424-35) / 35.44 g in 1 TUBE1 tube2025-02-11NoNoCurrent
46708-424-504670804245050 g in 1 JAR (46708-424-50) 50 g2025-02-11NoNoCurrent