FDA.reportPublic FDA data

Lidocaine Hydrochloride

Product NDC
0409-2066
11-digit product format
004092066
Labeler code
0409
Product ID
0409-2066_55b04269-e58a-4df8-a18c-4643c2e1433a
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
Lidocaine Hydrochloride
Dosage form
INJECTION, SOLUTION
Route
EPIDURAL; INFILTRATION; INTRACAUDAL; PERINEURAL
Labeler
Hospira, Inc.
Application
ANDA040078
Marketing category
ANDA
Marketing start
2005-09-07
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
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 HYDROCHLORIDE20 mg/mL

Harmonized Identifiers#

Field, Values table
FieldValues
UniiV13007Z41A
Rxcui1737761

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
0409-2066-05Lidocaine Hydrochloride10 in 1 CARTONINJECTION, SOLUTION1025
0409-2066-10Lidocaine Hydrochloride5 mL in 1 VIAL, SINGLE-DOSEINJECTION, SOLUTION525

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
0409-2066-05ML - Milliliter0409-206606d744e6-822c-4143-b8ad-928a0fb8662f12012-07-24
0409-2066-10ML - Milliliter0409-206662776618-7266-4c2c-8848-4405197d931712017-07-07

DailyMed Socrata Ingredients#

Ingredient, Type, UNII table
IngredientTypeUNIIDailyMed labelSPL versionUploaded
Lidocaine HydrochlorideACTIVE INGREDIENTV13007Z41ALIDOCAINE HYDROCHLORIDE INJECTION, SOLUTION [HOSPIRA, INC.]11
LidocaineACTIVE MOIETY98PI200987LIDOCAINE HYDROCHLORIDE INJECTION, SOLUTION [HOSPIRA, INC.]11
Hydrochloric AcidINACTIVE INGREDIENTQTT17582CBLIDOCAINE HYDROCHLORIDE INJECTION, SOLUTION [HOSPIRA, INC.]11
Sodium ChlorideINACTIVE INGREDIENT451W47IQ8XLIDOCAINE HYDROCHLORIDE INJECTION, SOLUTION [HOSPIRA, INC.]11
Sodium HydroxideINACTIVE INGREDIENT55X04QC32ILIDOCAINE HYDROCHLORIDE INJECTION, SOLUTION [HOSPIRA, INC.]11
WaterINACTIVE INGREDIENT059QF0KO0RLIDOCAINE HYDROCHLORIDE INJECTION, SOLUTION [HOSPIRA, INC.]11

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
0409-2066LIDOCAINE HYDROCHLORIDE INJECTION, SOLUTION [HOSPIRA, INC.]24Current NDC, Legacy NDC, 2 package rows20230630_9c18eaf1-4a0b-4916-70b2-88a827494711.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
1737761lidocaine HCl 2 % in 5 ML InjectionPSN9c18eaf1-4a0b-4916-70b2-88a82749471125
17377615 ML lidocaine hydrochloride 20 MG/ML InjectionSCD9c18eaf1-4a0b-4916-70b2-88a82749471125
1737761lidocaine HCl 100 MG per 5 ML InjectionSY9c18eaf1-4a0b-4916-70b2-88a82749471125
1737761lidocaine HCl 2 % per 5 ML InjectionSY9c18eaf1-4a0b-4916-70b2-88a82749471125
1737761lidocaine HCl 2 % in 5 ML InjectionPSN8c63be55-5de4-7f72-e053-2995a90a102e4
17377615 ML lidocaine hydrochloride 20 MG/ML InjectionSCD8c63be55-5de4-7f72-e053-2995a90a102e4
1737761lidocaine HCl 100 MG per 5 ML InjectionSY8c63be55-5de4-7f72-e053-2995a90a102e4
1737761lidocaine HCl 2 % per 5 ML InjectionSY8c63be55-5de4-7f72-e053-2995a90a102e4
1737761lidocaine HCl 2 % in 5 ML InjectionPSN48c18a90-9d53-d200-e063-6394a90a12711
17377615 ML lidocaine hydrochloride 20 MG/ML InjectionSCD48c18a90-9d53-d200-e063-6394a90a12711
1737761lidocaine HCl 100 MG per 5 ML InjectionSY48c18a90-9d53-d200-e063-6394a90a12711
1737761lidocaine HCl 2 % per 5 ML InjectionSY48c18a90-9d53-d200-e063-6394a90a12711

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
0409-2066-050040920660510 VIAL, SINGLE-DOSE in 1 CARTON (0409-2066-05) / 5 mL in 1 VIAL, SINGLE-DOSE (0409-2066-10) 2005-09-070000-00-00NoNoCurrent
0409-2066-10004092066105 mL in 1 VIAL, SINGLE-DOSE5 mlHistorical