FDA.reportPublic FDA data

Lidocaine Hydrochloride

Product NDC
0409-4278
11-digit product format
004094278
Labeler code
0409
Product ID
0409-4278_78818553-f818-42a1-81b9-e5a5a5da5a27
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
LIDOCAINE HYDROCHLORIDE
Dosage form
INJECTION, SOLUTION
Route
INFILTRATION; INTRAVENOUS
Labeler
Hospira, Inc.
Application
ANDA088328
Marketing category
ANDA
Marketing start
2005-06-30
Substance
LIDOCAINE HYDROCHLORIDE
Active strength
5 mg/mL
Pharmacologic classes
Amide Local Anesthetic [EPC], Amides [CS], Antiarrhythmic [EPC], Local Anesthesia [PE]
NDC exclude flag
No
Listing certified through
2027-12-31
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 HYDROCHLORIDE5 mg/mL

Harmonized Identifiers#

Field, Values table
FieldValues
UniiV13007Z41A
Rxcui1010033, 1010671, 1010900, 1737343, 1737562, 1737566, 1737568, 1737636, 1737757, 1737763

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
0409-4278-01Lidocaine Hydrochloride25 in 1 TRAYINJECTION, SOLUTION2546
0409-4278-16Lidocaine Hydrochloride50 mL in 1 VIAL, SINGLE-DOSEINJECTION, SOLUTION5046

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
0409-4278-01ML - Milliliter0409-4278e972ed0a-e278-4d99-83ec-2b29c680e04012012-07-24
0409-4278-16ML - Milliliter0409-427801b8afee-2fcd-48b1-9552-4219a43ea0a012017-07-07

DailyMed Socrata Ingredients#

Ingredient, Type, UNII table
IngredientTypeUNIIDailyMed labelSPL versionUploaded
LIDOCAINE HYDROCHLORIDEACTIVE INGREDIENTV13007Z41ALIDOCAINE HYDROCHLORIDE INJECTION, SOLUTION [HOSPIRA, INC.]13
LIDOCAINEACTIVE MOIETY98PI200987LIDOCAINE HYDROCHLORIDE INJECTION, SOLUTION [HOSPIRA, INC.]13
HYDROCHLORIC ACIDINACTIVE INGREDIENTQTT17582CBLIDOCAINE HYDROCHLORIDE INJECTION, SOLUTION [HOSPIRA, INC.]13
METHYLPARABENINACTIVE INGREDIENTA2I8C7HI9TLIDOCAINE HYDROCHLORIDE INJECTION, SOLUTION [HOSPIRA, INC.]13
SODIUM CHLORIDEINACTIVE INGREDIENT451W47IQ8XLIDOCAINE HYDROCHLORIDE INJECTION, SOLUTION [HOSPIRA, INC.]13
SODIUM HYDROXIDEINACTIVE INGREDIENT55X04QC32ILIDOCAINE HYDROCHLORIDE INJECTION, SOLUTION [HOSPIRA, INC.]13
WATERINACTIVE INGREDIENT059QF0KO0RLIDOCAINE HYDROCHLORIDE INJECTION, SOLUTION [HOSPIRA, INC.]13

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
0409-4278LIDOCAINE HYDROCHLORIDE INJECTION, SOLUTION [HOSPIRA, INC.]44Current NDC, Legacy NDC, 2 package rows20241206_3b2dd84e-cee8-4e58-d494-395a65a353a0.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
1737343lidocaine HCl 0.5 % in 50 ML InjectionPSN3b2dd84e-cee8-4e58-d494-395a65a353a046
1010900lidocaine HCl 0.5 % Injectable SolutionPSN3b2dd84e-cee8-4e58-d494-395a65a353a046
1737568lidocaine HCl 1 % in 2 ML InjectionPSN3b2dd84e-cee8-4e58-d494-395a65a353a046
1737562lidocaine HCl 1 % in 30 ML InjectionPSN3b2dd84e-cee8-4e58-d494-395a65a353a046
1737566lidocaine HCl 1 % in 5 ML InjectionPSN3b2dd84e-cee8-4e58-d494-395a65a353a046
1010033lidocaine HCl 1 % Injectable SolutionPSN3b2dd84e-cee8-4e58-d494-395a65a353a046
1737636lidocaine HCl 1.5 % in 20 ML InjectionPSN3b2dd84e-cee8-4e58-d494-395a65a353a046
1737763lidocaine HCl 2 % in 10 ML InjectionPSN3b2dd84e-cee8-4e58-d494-395a65a353a046
1737757lidocaine HCl 2 % in 2 ML InjectionPSN3b2dd84e-cee8-4e58-d494-395a65a353a046
1010671lidocaine HCl 2 % Injectable SolutionPSN3b2dd84e-cee8-4e58-d494-395a65a353a046
173776310 ML lidocaine hydrochloride 20 MG/ML InjectionSCD3b2dd84e-cee8-4e58-d494-395a65a353a046
17375682 ML lidocaine hydrochloride 10 MG/ML InjectionSCD3b2dd84e-cee8-4e58-d494-395a65a353a046
17377572 ML lidocaine hydrochloride 20 MG/ML InjectionSCD3b2dd84e-cee8-4e58-d494-395a65a353a046
173763620 ML lidocaine hydrochloride 15 MG/ML InjectionSCD3b2dd84e-cee8-4e58-d494-395a65a353a046
173756230 ML lidocaine hydrochloride 10 MG/ML InjectionSCD3b2dd84e-cee8-4e58-d494-395a65a353a046
17375665 ML lidocaine hydrochloride 10 MG/ML InjectionSCD3b2dd84e-cee8-4e58-d494-395a65a353a046
173734350 ML lidocaine hydrochloride 5 MG/ML InjectionSCD3b2dd84e-cee8-4e58-d494-395a65a353a046
1010033lidocaine hydrochloride 10 MG/ML Injectable SolutionSCD3b2dd84e-cee8-4e58-d494-395a65a353a046
1010671lidocaine hydrochloride 20 MG/ML Injectable SolutionSCD3b2dd84e-cee8-4e58-d494-395a65a353a046
1010900lidocaine hydrochloride 5 MG/ML Injectable SolutionSCD3b2dd84e-cee8-4e58-d494-395a65a353a046
1737343lidocaine HCl 0.5 % per 50 ML InjectionSY3b2dd84e-cee8-4e58-d494-395a65a353a046
1737568lidocaine HCl 1 % per 2 ML InjectionSY3b2dd84e-cee8-4e58-d494-395a65a353a046
1737562lidocaine HCl 1 % per 30 ML InjectionSY3b2dd84e-cee8-4e58-d494-395a65a353a046
1737566lidocaine HCl 1 % per 5 ML InjectionSY3b2dd84e-cee8-4e58-d494-395a65a353a046
1737636lidocaine HCl 1.5 % per 20 ML InjectionSY3b2dd84e-cee8-4e58-d494-395a65a353a046
1737763lidocaine HCl 2 % per 10 ML InjectionSY3b2dd84e-cee8-4e58-d494-395a65a353a046
1737757lidocaine HCl 2 % per 2 ML InjectionSY3b2dd84e-cee8-4e58-d494-395a65a353a046
1737568lidocaine HCl 20 MG per 2 ML InjectionSY3b2dd84e-cee8-4e58-d494-395a65a353a046
1737763lidocaine HCl 200 MG per 10 ML InjectionSY3b2dd84e-cee8-4e58-d494-395a65a353a046
1737343lidocaine HCl 250 MG per 50 ML InjectionSY3b2dd84e-cee8-4e58-d494-395a65a353a046
1737636lidocaine HCl 300 MG per 20 ML InjectionSY3b2dd84e-cee8-4e58-d494-395a65a353a046
1737562lidocaine HCl 300 MG per 30 ML InjectionSY3b2dd84e-cee8-4e58-d494-395a65a353a046
1737757lidocaine HCl 40 MG per 2 ML InjectionSY3b2dd84e-cee8-4e58-d494-395a65a353a046
1737566lidocaine HCl 50 MG per 5 ML InjectionSY3b2dd84e-cee8-4e58-d494-395a65a353a046
1010900lidocaine hydrochloride 0.5 % Injectable SolutionSY3b2dd84e-cee8-4e58-d494-395a65a353a046
1010033lidocaine hydrochloride 1 % Injectable SolutionSY3b2dd84e-cee8-4e58-d494-395a65a353a046
1010671lidocaine hydrochloride 2 % Injectable SolutionSY3b2dd84e-cee8-4e58-d494-395a65a353a046
1737343lidocaine HCl 0.5 % in 50 ML InjectionPSNee21518e-b3ed-405a-ac3b-bfe753893dba6
173734350 ML lidocaine hydrochloride 5 MG/ML InjectionSCDee21518e-b3ed-405a-ac3b-bfe753893dba6
1737343lidocaine HCl 0.5 % per 50 ML InjectionSYee21518e-b3ed-405a-ac3b-bfe753893dba6
1737343lidocaine HCl 250 MG per 50 ML InjectionSYee21518e-b3ed-405a-ac3b-bfe753893dba6
1737343lidocaine HCl 0.5 % in 50 ML InjectionPSNe52fe254-8872-35ce-e053-2a95a90a339e2
173734350 ML lidocaine hydrochloride 5 MG/ML InjectionSCDe52fe254-8872-35ce-e053-2a95a90a339e2
1737343lidocaine HCl 0.5 % per 50 ML InjectionSYe52fe254-8872-35ce-e053-2a95a90a339e2
1737343lidocaine HCl 250 MG per 50 ML InjectionSYe52fe254-8872-35ce-e053-2a95a90a339e2

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
0409-4278-010040942780125 VIAL, SINGLE-DOSE in 1 TRAY (0409-4278-01) / 50 mL in 1 VIAL, SINGLE-DOSE (0409-4278-16) 2005-06-300000-00-00NoNoCurrent
0409-4278-160040942781650 mL in 1 VIAL, SINGLE-DOSE50 mlHistorical