FDA.reportPublic FDA data

Lidocaine hydrochloride

Product NDC
31722-116
11-digit product format
317220116
Labeler code
31722
Product ID
31722-116_4f57a343-a57e-f9bf-e063-6394a90a3eb2
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
Lidocaine hydrochloride
Dosage form
INJECTION, SOLUTION
Route
INFILTRATION; PERINEURAL
Labeler
Camber Pharmaceuticals, Inc.
Application
ANDA214336
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
Rxcui1010033, 1010671

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
31722-116-20Lidocaine hydrochloride20 mL in 1 VIAL, MULTI-DOSEINJECTION, SOLUTION209
31722-116-31Lidocaine hydrochloride25 in 1 CARTONINJECTION, SOLUTION259
31722-116-32Lidocaine hydrochloride10 in 1 CARTONINJECTION, SOLUTION109
31722-116-33Lidocaine hydrochloride25 in 1 CARTONINJECTION, SOLUTION259
31722-116-34Lidocaine hydrochloride10 in 1 CARTONINJECTION, SOLUTION109
31722-116-50Lidocaine hydrochloride50 mL in 1 VIAL, MULTI-DOSEINJECTION, SOLUTION509

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
31722-116-20ML - Milliliter31722-11684c04230-9cc1-4c1a-863f-cf9a79ffae8c12025-03-04
31722-116-31ML - Milliliter31722-11622cc0fba-0f13-48ab-88d5-41c61c74a94312024-08-12
31722-116-32ML - Milliliter31722-116d27c130a-fd26-4fdf-93af-6f1e9bdf2ecc12024-11-05
31722-116-33ML - Milliliter31722-116ae787746-5a12-4d74-b43b-e4b76b5409b312024-11-05
31722-116-34ML - Milliliter31722-116f11c66f0-fe9a-4985-a7db-b34e4e54aa5012024-11-05
31722-116-50ML - Milliliter31722-116fa91a7c5-1af1-4162-b416-0028493e71b512025-03-04

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
31722-116LIDOCAINE HYDROCHLORIDE (LIDOCAINE HYDROCHLORIDE) INJECTION, SOLUTION [CAMBER PHARMACEUTICALS, INC.]7Current NDC, Legacy NDC, 6 package rows20250527_9a1418e2-b208-4e5c-b5f8-21b3a691a578.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
1010033lidocaine HCl 1 % Injectable SolutionPSN9a1418e2-b208-4e5c-b5f8-21b3a691a5789
1010671lidocaine HCl 2 % Injectable SolutionPSN9a1418e2-b208-4e5c-b5f8-21b3a691a5789
1010033lidocaine hydrochloride 10 MG/ML Injectable SolutionSCD9a1418e2-b208-4e5c-b5f8-21b3a691a5789
1010671lidocaine hydrochloride 20 MG/ML Injectable SolutionSCD9a1418e2-b208-4e5c-b5f8-21b3a691a5789
1010033lidocaine hydrochloride 1 % Injectable SolutionSY9a1418e2-b208-4e5c-b5f8-21b3a691a5789
1010671lidocaine hydrochloride 2 % Injectable SolutionSY9a1418e2-b208-4e5c-b5f8-21b3a691a5789
1010033lidocaine HCl 1 % Injectable SolutionPSNcfbca641-aeee-4dc8-a340-30c53d3b023b1
1010033lidocaine HCl 1 % Injectable SolutionPSNfa7dedcd-d78b-45f2-9dd7-f273043167d01
1010033lidocaine hydrochloride 10 MG/ML Injectable SolutionSCDcfbca641-aeee-4dc8-a340-30c53d3b023b1
1010033lidocaine hydrochloride 10 MG/ML Injectable SolutionSCDfa7dedcd-d78b-45f2-9dd7-f273043167d01
1010033lidocaine hydrochloride 1 % Injectable SolutionSYcfbca641-aeee-4dc8-a340-30c53d3b023b1
1010033lidocaine hydrochloride 1 % Injectable SolutionSYfa7dedcd-d78b-45f2-9dd7-f273043167d01

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
31722-116-203172201162020 mL in 1 VIAL, MULTI-DOSE20 mlHistorical
31722-116-313172201163125 VIAL, MULTI-DOSE in 1 CARTON (31722-116-31) / 20 mL in 1 VIAL, MULTI-DOSE (31722-116-20) 2021-11-080000-00-00NoNoCurrent
31722-116-323172201163210 VIAL, MULTI-DOSE in 1 CARTON (31722-116-32) / 20 mL in 1 VIAL, MULTI-DOSE (31722-116-20) 2023-12-13NoNoHistorical
31722-116-333172201163325 VIAL, MULTI-DOSE in 1 CARTON (31722-116-33) / 50 mL in 1 VIAL, MULTI-DOSE (31722-116-50) 2023-12-13NoNoHistorical
31722-116-343172201163410 VIAL, MULTI-DOSE in 1 CARTON (31722-116-34) / 50 mL in 1 VIAL, MULTI-DOSE (31722-116-50) 2023-12-13NoNoHistorical
31722-116-503172201165050 mL in 1 VIAL, MULTI-DOSE50 mlHistorical