FDA.reportPublic FDA data

Lidocaine Hydrochloride

Product NDC
63739-170
11-digit product format
637390170
Labeler code
63739
Product ID
63739-170_2e9ea4d1-65b6-f07d-e063-6394a90a4b20
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
Lidocaine Hydrochloride
Dosage form
SOLUTION
Route
INTRAVENOUS
Labeler
McKesson Corporation dba SKY Packaging
Application
ANDA212821
Marketing category
ANDA
Marketing start
2022-06-22
Marketing end
2026-11-19
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
Current FDA listing
Yes

Additional Listing Data#

Finished product
Yes
Brand name base
Lidocaine Hydrochloride

Active Ingredients#

Ingredient, Strength table
IngredientStrength
LIDOCAINE HYDROCHLORIDE10 mg/mL

Harmonized Identifiers#

Field, Values table
FieldValues
UniiV13007Z41A
Rxcui1737566

DailyMed Product Concepts#

Product concept, Relation, Version table
Product conceptRelationVersionEffective
860a93dc-4863-49cc-b284-6bbe8191bc48Product name420250214
eaba870a-6a9d-442e-8643-87b3f558a451Product name120250117
9b4cf230-fd05-41d5-98c6-5db9ecb27b86Product name120230117
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

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
63739-170-13Lidocaine Hydrochloride5 mL in 1 VIALSOLUTION56
63739-170-24Lidocaine Hydrochloride10 in 1 BOXSOLUTION106
63739-170-27Lidocaine Hydrochloride25 in 1 BOXSOLUTION256

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
63739-170-13ML - Milliliter63739-17041daa9bf-f91f-43bd-be06-de372569ca5912025-12-16
63739-170-24ML - Milliliter63739-170fd548d72-363b-4d69-9553-5ae1c9fd0e7512023-02-06
63739-170-27ML - Milliliter63739-170c60e740e-b2ed-4f48-af8b-f90f9aa856de12023-03-13

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
63739-170LIDOCAINE HYDROCHLORIDE SOLUTION [MCKESSON CORPORATION DBA SKY PACKAGING]6Current NDC, Legacy NDC, 3 package rows20250223_e1eabd6b-9bb8-646f-e053-2a95a90a7b83.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
1737566lidocaine HCl 1 % in 5 ML InjectionPSNe1eabd6b-9bb8-646f-e053-2a95a90a7b836
17375665 ML lidocaine hydrochloride 10 MG/ML InjectionSCDe1eabd6b-9bb8-646f-e053-2a95a90a7b836
1737566lidocaine HCl 1 % per 5 ML InjectionSYe1eabd6b-9bb8-646f-e053-2a95a90a7b836
1737566lidocaine HCl 50 MG per 5 ML InjectionSYe1eabd6b-9bb8-646f-e053-2a95a90a7b836

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
63739-170-13637390170135 mL in 1 VIAL5 mlHistorical
63739-170-246373901702410 VIAL in 1 BOX (63739-170-24) / 5 mL in 1 VIAL (63739-170-13) 10 vial2022-06-222026-10-04NoNoCurrent
63739-170-276373901702725 VIAL in 1 BOX (63739-170-27) / 5 mL in 1 VIAL (63739-170-13) 25 vial2022-09-162026-11-19NoNoCurrent