FDA.reportPublic FDA data

Lidocaine Hydrochloride

Product NDC
31722-117
11-digit product format
317220117
Labeler code
31722
Product ID
31722-117_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
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 HYDROCHLORIDE ANHYDROUS10 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
31722-117-02Lidocaine Hydrochloride2 mL in 1 VIAL, SINGLE-DOSEINJECTION, SOLUTION27
31722-117-05Lidocaine Hydrochloride5 mL in 1 VIAL, SINGLE-DOSEINJECTION, SOLUTION57
31722-117-30Lidocaine Hydrochloride30 mL in 1 VIAL, SINGLE-DOSEINJECTION, SOLUTION307
31722-117-31Lidocaine Hydrochloride25 in 1 CARTONINJECTION, SOLUTION257
31722-117-32Lidocaine Hydrochloride25 in 1 CARTONINJECTION, SOLUTION257
31722-117-33Lidocaine Hydrochloride25 in 1 CARTONINJECTION, SOLUTION257
31722-117-34Lidocaine Hydrochloride10 in 1 CARTONINJECTION, SOLUTION107
31722-117-35Lidocaine Hydrochloride10 in 1 CARTONINJECTION, SOLUTION107

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
31722-117-02ML - Milliliter31722-117b5484cd7-8f09-4035-bbf8-21335370a41f12024-11-05
31722-117-05ML - Milliliter31722-1170cae139b-754e-40f5-90fd-e2f6888f138a12024-11-05
31722-117-30ML - Milliliter31722-117a02c5206-adb1-4c57-aa0a-be7d3809e38c12024-10-04
31722-117-31ML - Milliliter31722-117c83539cd-c0ca-43e8-a463-95ecdbe4807f12024-11-05
31722-117-32ML - Milliliter31722-11797890141-8481-4331-a3d2-ad9c00546b7412024-11-05
31722-117-33ML - Milliliter31722-1177f47712f-c09e-4f25-bcce-6dfb546863dd12024-10-04
31722-117-34ML - Milliliter31722-11756003ba1-d7d9-4b50-85a7-b5e28c89529412024-11-05
31722-117-35ML - Milliliter31722-1171db62775-53df-485f-80e4-b9b94c5e34bc12024-11-05

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
31722-117LIDOCAINE HYDROCHLORIDE (LIDOCAINE HYDROCHLORIDE) INJECTION, SOLUTION [CAMBER PHARMACEUTICALS, INC.]6Current NDC, Legacy NDC, 8 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
31722-117-02317220117022 mL in 1 VIAL, SINGLE-DOSE2 mlHistorical
31722-117-05317220117055 mL in 1 VIAL, SINGLE-DOSE5 mlHistorical
31722-117-303172201173030 mL in 1 VIAL, SINGLE-DOSE30 mlHistorical
31722-117-313172201173125 VIAL, SINGLE-DOSE in 1 CARTON (31722-117-31) / 2 mL in 1 VIAL, SINGLE-DOSE (31722-117-02) 2021-11-080000-00-00NoNoCurrent
31722-117-323172201173225 VIAL, SINGLE-DOSE in 1 CARTON (31722-117-32) / 5 mL in 1 VIAL, SINGLE-DOSE (31722-117-05) 2021-11-080000-00-00NoNoCurrent
31722-117-333172201173325 VIAL, SINGLE-DOSE in 1 CARTON (31722-117-33) / 30 mL in 1 VIAL, SINGLE-DOSE (31722-117-30) 2023-12-05NoNoHistorical
31722-117-343172201173410 VIAL, SINGLE-DOSE in 1 CARTON (31722-117-34) / 2 mL in 1 VIAL, SINGLE-DOSE (31722-117-02) 2024-04-09NoNoHistorical
31722-117-353172201173510 VIAL, SINGLE-DOSE in 1 CARTON (31722-117-35) / 5 mL in 1 VIAL, SINGLE-DOSE (31722-117-05) 2024-04-09NoNoHistorical