FDA.reportPublic FDA data

Lidocaine Hydrochloride

Product NDC
31722-118
11-digit product format
317220118
Labeler code
31722
Product ID
31722-118_50208e47-95d1-c01a-e063-6294a90a7ecd
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
Lidocaine Hydrochloride
Dosage form
INJECTION, SOLUTION
Route
EPIDURAL; INFILTRATION; INTRACAUDAL; PERINEURAL
Labeler
Camber Pharmaceuticals, Inc.
Application
ANDA214339
Marketing category
ANDA
Marketing start
2021-11-08
Substance
LIDOCAINE HYDROCHLORIDE ANHYDROUS
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 HYDROCHLORIDE ANHYDROUS20 mg/mL

Harmonized Identifiers#

Field, Values table
FieldValues
UniiEC2CNF7XFP
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
31722-118-02Lidocaine Hydrochloride2 mL in 1 VIAL, SINGLE-DOSEINJECTION, SOLUTION27
31722-118-05Lidocaine Hydrochloride5 mL in 1 VIAL, SINGLE-DOSEINJECTION, SOLUTION57
31722-118-31Lidocaine Hydrochloride25 in 1 CARTONINJECTION, SOLUTION257
31722-118-32Lidocaine Hydrochloride25 in 1 CARTONINJECTION, SOLUTION257
31722-118-33Lidocaine Hydrochloride10 in 1 CARTONINJECTION, SOLUTION107
31722-118-34Lidocaine Hydrochloride10 in 1 CARTONINJECTION, SOLUTION107

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
31722-118-02ML - Milliliter31722-118faf2ec1b-e142-49e6-960d-571e35ff348d12024-11-05
31722-118-05ML - Milliliter31722-118fa31d9b6-b3e6-4883-bd4f-633f04b6364912024-11-05
31722-118-31ML - Milliliter31722-118358fca4d-5a57-410d-9ef3-d088961b51e212024-11-05
31722-118-32ML - Milliliter31722-118c5861da5-d787-49c1-9863-5b1f4ead3ead12024-11-05
31722-118-33ML - Milliliter31722-11890cc21cb-080b-444f-8d3f-37da75b3f0ba12024-11-05
31722-118-34ML - Milliliter31722-118cebb4d44-6287-452b-8be3-a1a047fefce612024-11-05

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
31722-118LIDOCAINE HYDROCHLORIDE (LIDOCAINE HYDROCHLORIDE) INJECTION, SOLUTION [CAMBER PHARMACEUTICALS, INC.]6Current NDC, Legacy NDC, 6 package rows20250528_7f202319-effa-4dd8-b871-e720b75f4a83.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
1737568lidocaine HCl 1 % in 2 ML InjectionPSN7f202319-effa-4dd8-b871-e720b75f4a837
1737562lidocaine HCl 1 % in 30 ML InjectionPSN7f202319-effa-4dd8-b871-e720b75f4a837
1737566lidocaine HCl 1 % in 5 ML InjectionPSN7f202319-effa-4dd8-b871-e720b75f4a837
1737757lidocaine HCl 2 % in 2 ML InjectionPSN7f202319-effa-4dd8-b871-e720b75f4a837
1737761lidocaine HCl 2 % in 5 ML InjectionPSN7f202319-effa-4dd8-b871-e720b75f4a837
17375682 ML lidocaine hydrochloride 10 MG/ML InjectionSCD7f202319-effa-4dd8-b871-e720b75f4a837
17377572 ML lidocaine hydrochloride 20 MG/ML InjectionSCD7f202319-effa-4dd8-b871-e720b75f4a837
173756230 ML lidocaine hydrochloride 10 MG/ML InjectionSCD7f202319-effa-4dd8-b871-e720b75f4a837
17375665 ML lidocaine hydrochloride 10 MG/ML InjectionSCD7f202319-effa-4dd8-b871-e720b75f4a837
17377615 ML lidocaine hydrochloride 20 MG/ML InjectionSCD7f202319-effa-4dd8-b871-e720b75f4a837
1737568lidocaine HCl 1 % per 2 ML InjectionSY7f202319-effa-4dd8-b871-e720b75f4a837
1737562lidocaine HCl 1 % per 30 ML InjectionSY7f202319-effa-4dd8-b871-e720b75f4a837
1737566lidocaine HCl 1 % per 5 ML InjectionSY7f202319-effa-4dd8-b871-e720b75f4a837
1737761lidocaine HCl 100 MG per 5 ML InjectionSY7f202319-effa-4dd8-b871-e720b75f4a837
1737757lidocaine HCl 2 % per 2 ML InjectionSY7f202319-effa-4dd8-b871-e720b75f4a837
1737761lidocaine HCl 2 % per 5 ML InjectionSY7f202319-effa-4dd8-b871-e720b75f4a837
1737568lidocaine HCl 20 MG per 2 ML InjectionSY7f202319-effa-4dd8-b871-e720b75f4a837
1737562lidocaine HCl 300 MG per 30 ML InjectionSY7f202319-effa-4dd8-b871-e720b75f4a837
1737757lidocaine HCl 40 MG per 2 ML InjectionSY7f202319-effa-4dd8-b871-e720b75f4a837
1737566lidocaine HCl 50 MG per 5 ML InjectionSY7f202319-effa-4dd8-b871-e720b75f4a837

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
31722-118-02317220118022 mL in 1 VIAL, SINGLE-DOSE2 mlHistorical
31722-118-05317220118055 mL in 1 VIAL, SINGLE-DOSE5 mlHistorical
31722-118-313172201183125 VIAL, SINGLE-DOSE in 1 CARTON (31722-118-31) / 2 mL in 1 VIAL, SINGLE-DOSE (31722-118-02) 2021-11-080000-00-00NoNoCurrent
31722-118-323172201183225 VIAL, SINGLE-DOSE in 1 CARTON (31722-118-32) / 5 mL in 1 VIAL, SINGLE-DOSE (31722-118-05) 2021-11-080000-00-00NoNoCurrent
31722-118-333172201183310 VIAL, SINGLE-DOSE in 1 CARTON (31722-118-33) / 2 mL in 1 VIAL, SINGLE-DOSE (31722-118-02) 2024-04-09NoNoHistorical
31722-118-343172201183410 VIAL, SINGLE-DOSE in 1 CARTON (31722-118-34) / 5 mL in 1 VIAL, SINGLE-DOSE (31722-118-05) 2024-04-09NoNoHistorical