FDA.reportPublic FDA data

Lidocaine Hydrochloride

Product NDC
55150-163
11-digit product format
551500163
Labeler code
55150
Product ID
55150-163_bab2ea79-0aed-4f48-8b4e-f864f8b82fb8
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
Lidocaine Hydrochloride
Dosage form
INJECTION, SOLUTION
Route
EPIDURAL; INFILTRATION; INTRACAUDAL; PERINEURAL
Labeler
Eugia US LLC
Application
ANDA203082
Marketing category
ANDA
Marketing start
2013-03-14
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
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 HYDROCHLORIDE10 mg/mL

Harmonized Identifiers#

Field, Values table
FieldValues
UniiV13007Z41A
Rxcui1737562, 1737566, 1737568, 1737757, 1737761

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
55150-163-25Lidocaine Hydrochloride30 mL in 1 VIAL, SINGLE-DOSEINJECTION, SOLUTION3013
55150-163-25Lidocaine Hydrochloride25 in 1 CARTONINJECTION, SOLUTION2513
55150-163-30Lidocaine Hydrochloride30 mL in 1 VIAL, SINGLE-DOSEINJECTION, SOLUTION3013
55150-163-30Lidocaine Hydrochloride1 in 1 CARTONINJECTION, SOLUTION113
55150-163-00Lidocaine Hydrochloride30 mL in 1 VIAL, SINGLE-DOSEINJECTION, SOLUTION302
55150-163-00Lidocaine Hydrochloride1 in 1 CARTONINJECTION, SOLUTION12
55150-163-24Lidocaine Hydrochloride25 in 1 CARTONINJECTION, SOLUTION252
55150-163-24Lidocaine Hydrochloride30 mL in 1 VIAL, SINGLE-DOSEINJECTION, SOLUTION302

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
55150-163-00ML - Milliliter55150-163fc884418-b727-43bf-9eb6-53cde33827dd12025-07-08
55150-163-30ML - Milliliter55150-163aca5872d-6301-4f05-9a7b-8b6b3668c79012014-01-04

DailyMed Socrata Ingredients#

Ingredient, Type, UNII table
IngredientTypeUNIIDailyMed labelSPL versionUploaded
LIDOCAINE HYDROCHLORIDEACTIVE INGREDIENTV13007Z41ALIDOCAINE HYDROCHLORIDE INJECTION, SOLUTION [AUROMEDICS PHARMA LLC]3
LIDOCAINEACTIVE MOIETY98PI200987LIDOCAINE HYDROCHLORIDE INJECTION, SOLUTION [AUROMEDICS PHARMA LLC]3
HYDROCHLORIC ACIDINACTIVE INGREDIENTQTT17582CBLIDOCAINE HYDROCHLORIDE INJECTION, SOLUTION [AUROMEDICS PHARMA LLC]3
SODIUM CHLORIDEINACTIVE INGREDIENT451W47IQ8XLIDOCAINE HYDROCHLORIDE INJECTION, SOLUTION [AUROMEDICS PHARMA LLC]3
SODIUM HYDROXIDEINACTIVE INGREDIENT55X04QC32ILIDOCAINE HYDROCHLORIDE INJECTION, SOLUTION [AUROMEDICS PHARMA LLC]3
WATERINACTIVE INGREDIENT059QF0KO0RLIDOCAINE HYDROCHLORIDE INJECTION, SOLUTION [AUROMEDICS PHARMA LLC]3

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
55150-163LIDOCAINE HYDROCHLORIDE INJECTION, SOLUTION [EUGIA US LLC]11Current NDC, Legacy NDC, 4 package rows20250420_89701fac-7536-4f16-87fb-f4cc121e74ee.zip
55150-163LIDOCAINE HYDROCHLORIDE INJECTION, SOLUTION [EUGIA US LLC]1Current NDC, Legacy NDC, 4 package rows20250202_9916b09d-a116-469d-92d5-60e50ea9782b.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
1737568lidocaine HCl 1 % in 2 ML InjectionPSN89701fac-7536-4f16-87fb-f4cc121e74ee13
1737562lidocaine HCl 1 % in 30 ML InjectionPSN89701fac-7536-4f16-87fb-f4cc121e74ee13
1737566lidocaine HCl 1 % in 5 ML InjectionPSN89701fac-7536-4f16-87fb-f4cc121e74ee13
1737757lidocaine HCl 2 % in 2 ML InjectionPSN89701fac-7536-4f16-87fb-f4cc121e74ee13
1737761lidocaine HCl 2 % in 5 ML InjectionPSN89701fac-7536-4f16-87fb-f4cc121e74ee13
17375682 ML lidocaine hydrochloride 10 MG/ML InjectionSCD89701fac-7536-4f16-87fb-f4cc121e74ee13
17377572 ML lidocaine hydrochloride 20 MG/ML InjectionSCD89701fac-7536-4f16-87fb-f4cc121e74ee13
173756230 ML lidocaine hydrochloride 10 MG/ML InjectionSCD89701fac-7536-4f16-87fb-f4cc121e74ee13
17375665 ML lidocaine hydrochloride 10 MG/ML InjectionSCD89701fac-7536-4f16-87fb-f4cc121e74ee13
17377615 ML lidocaine hydrochloride 20 MG/ML InjectionSCD89701fac-7536-4f16-87fb-f4cc121e74ee13
1737568lidocaine HCl 1 % per 2 ML InjectionSY89701fac-7536-4f16-87fb-f4cc121e74ee13
1737562lidocaine HCl 1 % per 30 ML InjectionSY89701fac-7536-4f16-87fb-f4cc121e74ee13
1737566lidocaine HCl 1 % per 5 ML InjectionSY89701fac-7536-4f16-87fb-f4cc121e74ee13
1737761lidocaine HCl 100 MG per 5 ML InjectionSY89701fac-7536-4f16-87fb-f4cc121e74ee13
1737757lidocaine HCl 2 % per 2 ML InjectionSY89701fac-7536-4f16-87fb-f4cc121e74ee13
1737761lidocaine HCl 2 % per 5 ML InjectionSY89701fac-7536-4f16-87fb-f4cc121e74ee13
1737568lidocaine HCl 20 MG per 2 ML InjectionSY89701fac-7536-4f16-87fb-f4cc121e74ee13
1737562lidocaine HCl 300 MG per 30 ML InjectionSY89701fac-7536-4f16-87fb-f4cc121e74ee13
1737757lidocaine HCl 40 MG per 2 ML InjectionSY89701fac-7536-4f16-87fb-f4cc121e74ee13
1737566lidocaine HCl 50 MG per 5 ML InjectionSY89701fac-7536-4f16-87fb-f4cc121e74ee13
1737568lidocaine HCl 1 % in 2 ML InjectionPSN9916b09d-a116-469d-92d5-60e50ea9782b2
1737562lidocaine HCl 1 % in 30 ML InjectionPSN9916b09d-a116-469d-92d5-60e50ea9782b2
1737562lidocaine HCl 1 % in 30 ML InjectionPSNf4c19cf5-c8b1-5e9f-e053-2995a90aee532
1737566lidocaine HCl 1 % in 5 ML InjectionPSN9916b09d-a116-469d-92d5-60e50ea9782b2
1737757lidocaine HCl 2 % in 2 ML InjectionPSN9916b09d-a116-469d-92d5-60e50ea9782b2
1737761lidocaine HCl 2 % in 5 ML InjectionPSN9916b09d-a116-469d-92d5-60e50ea9782b2
17375682 ML lidocaine hydrochloride 10 MG/ML InjectionSCD9916b09d-a116-469d-92d5-60e50ea9782b2
17377572 ML lidocaine hydrochloride 20 MG/ML InjectionSCD9916b09d-a116-469d-92d5-60e50ea9782b2
173756230 ML lidocaine hydrochloride 10 MG/ML InjectionSCDf4c19cf5-c8b1-5e9f-e053-2995a90aee532
173756230 ML lidocaine hydrochloride 10 MG/ML InjectionSCD9916b09d-a116-469d-92d5-60e50ea9782b2
17375665 ML lidocaine hydrochloride 10 MG/ML InjectionSCD9916b09d-a116-469d-92d5-60e50ea9782b2
17377615 ML lidocaine hydrochloride 20 MG/ML InjectionSCD9916b09d-a116-469d-92d5-60e50ea9782b2
1737568lidocaine HCl 1 % per 2 ML InjectionSY9916b09d-a116-469d-92d5-60e50ea9782b2
1737562lidocaine HCl 1 % per 30 ML InjectionSYf4c19cf5-c8b1-5e9f-e053-2995a90aee532
1737562lidocaine HCl 1 % per 30 ML InjectionSY9916b09d-a116-469d-92d5-60e50ea9782b2
1737566lidocaine HCl 1 % per 5 ML InjectionSY9916b09d-a116-469d-92d5-60e50ea9782b2
1737761lidocaine HCl 100 MG per 5 ML InjectionSY9916b09d-a116-469d-92d5-60e50ea9782b2
1737757lidocaine HCl 2 % per 2 ML InjectionSY9916b09d-a116-469d-92d5-60e50ea9782b2
1737761lidocaine HCl 2 % per 5 ML InjectionSY9916b09d-a116-469d-92d5-60e50ea9782b2
1737568lidocaine HCl 20 MG per 2 ML InjectionSY9916b09d-a116-469d-92d5-60e50ea9782b2
1737562lidocaine HCl 300 MG per 30 ML InjectionSY9916b09d-a116-469d-92d5-60e50ea9782b2
1737562lidocaine HCl 300 MG per 30 ML InjectionSYf4c19cf5-c8b1-5e9f-e053-2995a90aee532
1737757lidocaine HCl 40 MG per 2 ML InjectionSY9916b09d-a116-469d-92d5-60e50ea9782b2
1737566lidocaine HCl 50 MG per 5 ML InjectionSY9916b09d-a116-469d-92d5-60e50ea9782b2

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionMarketing startMarketing endSampleExclude flagStatus
55150-163-00551500163001 VIAL, SINGLE-DOSE in 1 CARTON (55150-163-00) / 30 mL in 1 VIAL, SINGLE-DOSE2013-03-14NoNoCurrent
55150-163-245515001632425 VIAL, SINGLE-DOSE in 1 CARTON (55150-163-24) / 30 mL in 1 VIAL, SINGLE-DOSE2013-03-14NoNoCurrent
55150-163-255515001632525 VIAL, SINGLE-DOSE in 1 CARTON (55150-163-25) / 30 mL in 1 VIAL, SINGLE-DOSE2013-03-14NoNoCurrent
55150-163-30551500163301 VIAL, SINGLE-DOSE in 1 CARTON (55150-163-30) / 30 mL in 1 VIAL, SINGLE-DOSE2013-03-140000-00-00NoNoCurrent