FDA.reportPublic FDA data

Lidocaine

Product NDC
72485-611
11-digit product format
724850611
Labeler code
72485
Product ID
72485-611_2fc7be3a-f473-d1d9-e063-6394a90a82ff
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
Lidocaine Hydrochloride
Dosage form
JELLY
Route
TOPICAL
Labeler
ARMAS PHARMACEUTICALS INC.
Application
ANDA040433
Marketing category
ANDA
Marketing start
2025-03-02
Substance
LIDOCAINE HYDROCHLORIDE
Active strength
20 mg/mL
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
LIDOCAINE HYDROCHLORIDE20 mg/mL

Harmonized Identifiers#

Field, Values table
FieldValues
UniiV13007Z41A
Rxcui1011852

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
72485-611-10Lidocaine1 in 1 CARTONJELLY12
72485-611-10Lidocaine5 mL in 1 TUBEJELLY52
72485-611-30Lidocaine1 in 1 CARTONJELLY12
72485-611-30Lidocaine30 mL in 1 TUBE, WITH APPLICATORJELLY302
72485-611-31Lidocaine10 in 1 CARTONJELLY102
72485-611-31Lidocaine5 mL in 1 TUBEJELLY52

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
72485-611-10ML - Milliliter72485-61138504ebd-ce87-4171-8d37-23ace3e13c4812025-12-16
72485-611-30ML - Milliliter72485-61198f25a79-03dc-489f-adae-5b3510e6b61d12025-05-14
72485-611-31ML - Milliliter72485-611cd2325e9-bb0d-4adc-971d-82e7cc0e751c12025-12-16

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
72485-611LIDOCAINE (LIDOCAINE HYDROCHLORIDE) JELLY [ARMAS PHARMACEUTICALS INC.]2Current NDC, 6 package rows20250309_2f6e0f3d-ceaf-a853-e063-6394a90a8efb.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
1011852lidocaine HCl 2 % Topical GelPSN2f6e0f3d-ceaf-a853-e063-6394a90a8efb2
1011852lidocaine hydrochloride 0.02 MG/MG Topical GelSCD2f6e0f3d-ceaf-a853-e063-6394a90a8efb2
1011852lidocaine hydrochloride 2 % Topical JellySY2f6e0f3d-ceaf-a853-e063-6394a90a8efb2

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startSampleExclude flagStatus
72485-611-10724850611101 TUBE in 1 CARTON (72485-611-10) / 5 mL in 1 TUBE1 tube2025-03-02NoNoCurrent
72485-611-30724850611301 TUBE, WITH APPLICATOR in 1 CARTON (72485-611-30) / 30 mL in 1 TUBE, WITH APPLICATOR2025-03-02NoNoCurrent
72485-611-317248506113110 TUBE in 1 CARTON (72485-611-31) / 5 mL in 1 TUBE10 tube2025-03-02NoNoCurrent