FDA.reportPublic FDA data

Lidocaine Hydrochloride

Product NDC
72572-372
11-digit product format
725720372
Labeler code
72572
Product ID
72572-372_c510230e-f26c-4250-a5e6-0afb2afb61b6
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
Lidocaine Hydrochloride
Dosage form
INJECTION, SOLUTION
Route
EPIDURAL; INFILTRATION; INTRACAUDAL
Labeler
Civica, Inc.
Application
ANDA084625
Marketing category
ANDA
Marketing start
2019-12-10
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 Hydrochloride
Listing expiration
2027-12-31

Active Ingredients#

Ingredient, Strength table
IngredientStrength
LIDOCAINE HYDROCHLORIDE20 mg/mL

Harmonized Identifiers#

Field, Values table
FieldValues
UniiV13007Z41A

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
72572-372-01Lidocaine Hydrochloride5 mL in 1 VIAL, SINGLE-DOSEINJECTION, SOLUTION52
72572-372-25Lidocaine Hydrochloride25 in 1 CARTONINJECTION, SOLUTION252

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
72572-372-01ML - Milliliter72572-37229b814a0-7424-42f3-a3ff-ea08e112dec912020-01-03
72572-372-25ML - Milliliter72572-372825ef2b8-2932-4b06-9e9f-2b0b72a68f3312020-01-03

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
72572-372LIDOCAINE HYDROCHLORIDE INJECTION, SOLUTION LIDOCAINE HYDROCHLORIDE INJECTION, SOLUTION [CIVICA, INC.]2Current NDC, Legacy NDC, 2 package rows20241207_3c3b3888-fad3-440b-b627-6f79a2f4668f.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
1737566lidocaine HCl 1 % in 5 ML InjectionPSN3c3b3888-fad3-440b-b627-6f79a2f4668f2
1737761lidocaine HCl 2 % in 5 ML InjectionPSN3c3b3888-fad3-440b-b627-6f79a2f4668f2
17375665 ML lidocaine hydrochloride 10 MG/ML InjectionSCD3c3b3888-fad3-440b-b627-6f79a2f4668f2
17377615 ML lidocaine hydrochloride 20 MG/ML InjectionSCD3c3b3888-fad3-440b-b627-6f79a2f4668f2
1737566lidocaine HCl 1 % per 5 ML InjectionSY3c3b3888-fad3-440b-b627-6f79a2f4668f2
1737761lidocaine HCl 100 MG per 5 ML InjectionSY3c3b3888-fad3-440b-b627-6f79a2f4668f2
1737761lidocaine HCl 2 % per 5 ML InjectionSY3c3b3888-fad3-440b-b627-6f79a2f4668f2
1737566lidocaine HCl 50 MG per 5 ML InjectionSY3c3b3888-fad3-440b-b627-6f79a2f4668f2

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
72572-372-01725720372015 mL in 1 VIAL, SINGLE-DOSE5 mlHistorical
72572-372-257257203722525 VIAL, SINGLE-DOSE in 1 CARTON (72572-372-25) / 5 mL in 1 VIAL, SINGLE-DOSE (72572-372-01) 2019-12-100000-00-00NoNoCurrent