FDA.reportPublic FDA data

LIDOCAINE HYDROCHLORIDE

Product NDC
0264-9376
11-digit product format
002649376
Labeler code
0264
Product ID
0264-9376_21658976-c912-45c1-9969-2fa865576b81
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
LIDOCAINE HYDROCHLORIDE
Dosage form
INJECTION
Route
INFILTRATION
Labeler
B. Braun Medical Inc.
Application
ANDA208474
Marketing category
ANDA
Marketing start
2018-08-03
Substance
LIDOCAINE HYDROCHLORIDE ANHYDROUS
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 HYDROCHLORIDE ANHYDROUS10 mg/mL

Harmonized Identifiers#

Field, Values table
FieldValues
UniiEC2CNF7XFP
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
0264-9376-88LIDOCAINE HYDROCHLORIDE5 mL in 1 AMPULEINJECTION57
0264-9376-88LIDOCAINE HYDROCHLORIDE5 in 1 CARTONINJECTION57

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
0264-9376LIDOCAINE HYDROCHLORIDE INJECTION [B. BRAUN MEDICAL INC.]7Current NDC, Legacy NDC, 2 package rows20221029_e0e479e6-4c94-44d0-8074-d0ee7b2bde22.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
1737566lidocaine HCl 1 % in 5 ML InjectionPSNe0e479e6-4c94-44d0-8074-d0ee7b2bde227
17375665 ML lidocaine hydrochloride 10 MG/ML InjectionSCDe0e479e6-4c94-44d0-8074-d0ee7b2bde227
1737566lidocaine HCl 1 % per 5 ML InjectionSYe0e479e6-4c94-44d0-8074-d0ee7b2bde227
1737566lidocaine HCl 50 MG per 5 ML InjectionSYe0e479e6-4c94-44d0-8074-d0ee7b2bde227

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
0264-9376-88002649376885 AMPULE in 1 CARTON (0264-9376-88) / 5 mL in 1 AMPULE5 ampule2018-08-030000-00-00NoNoCurrent