FDA.reportPublic FDA data

Lidocaine Hydrochloride

Product NDC
84769-0001
11-digit product format
847690001
Labeler code
84769
Product ID
84769-0001_302f313a-e838-a040-e063-6394a90ae806
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
lidocaine hydrochloride
Dosage form
SOLUTION
Route
INTRAVENOUS
Labeler
Novagenix Labs LLC
Application
ANDA212821
Marketing category
ANDA
Marketing start
2025-03-31
Substance
LIDOCAINE HYDROCHLORIDE
Active strength
10 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 Hydrochloride
Listing expiration
2026-12-31

Active Ingredients#

Ingredient, Strength table
IngredientStrength
LIDOCAINE HYDROCHLORIDE10 mg/mL

Harmonized Identifiers#

Field, Values table
FieldValues
UniiV13007Z41A
Rxcui1737566, 1737761

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
84769-0001-1Lidocaine Hydrochloride5 mL in 1 VIAL, SINGLE-DOSESOLUTION51
84769-0001-2Lidocaine Hydrochloride10 in 1 BOXSOLUTION101

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
84769-0001LIDOCAINE HYDROCHLORIDE SOLUTION [NOVAGENIX LABS LLC]1Current NDC, 2 package rows20250331_7567ffb5-953a-4be9-9a02-c5a50dcd9306.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
1737566lidocaine HCl 1 % in 5 ML InjectionPSN7567ffb5-953a-4be9-9a02-c5a50dcd93061
1737761lidocaine HCl 2 % in 5 ML InjectionPSN7567ffb5-953a-4be9-9a02-c5a50dcd93061
17375665 ML lidocaine hydrochloride 10 MG/ML InjectionSCD7567ffb5-953a-4be9-9a02-c5a50dcd93061
17377615 ML lidocaine hydrochloride 20 MG/ML InjectionSCD7567ffb5-953a-4be9-9a02-c5a50dcd93061
1737566lidocaine HCl 1 % per 5 ML InjectionSY7567ffb5-953a-4be9-9a02-c5a50dcd93061
1737761lidocaine HCl 100 MG per 5 ML InjectionSY7567ffb5-953a-4be9-9a02-c5a50dcd93061
1737761lidocaine HCl 2 % per 5 ML InjectionSY7567ffb5-953a-4be9-9a02-c5a50dcd93061
1737566lidocaine HCl 50 MG per 5 ML InjectionSY7567ffb5-953a-4be9-9a02-c5a50dcd93061

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startSampleExclude flagStatus
84769-0001-1847690001015 mL in 1 VIAL, SINGLE-DOSE5 mlHistorical
84769-0001-28476900010210 VIAL, SINGLE-DOSE in 1 BOX (84769-0001-2) / 5 mL in 1 VIAL, SINGLE-DOSE (84769-0001-1) 2025-03-31NoNoHistorical