FDA.reportPublic FDA data

Lidocaine Hydrochloride

Product NDC
0121-4950
11-digit product format
001214950
Labeler code
0121
Product ID
0121-4950_8bd8bb07-066a-4c8c-ac5b-76f746318a49
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
Lidocaine Hydrochloride
Dosage form
SOLUTION
Route
ORAL
Labeler
PAI Holdings, LLC dba PAI Pharma
Application
ANDA218138
Marketing category
ANDA
Marketing start
2024-02-20
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
2026-12-31
Current FDA listing
Yes

Additional Listing Data#

Finished product
Yes
Brand name base
Lidocaine Hydrochloride
Listing expiration
2026-12-31

Active Ingredients#

Ingredient, Strength table
IngredientStrength
LIDOCAINE HYDROCHLORIDE20 mg/mL

Harmonized Identifiers#

Field, Values table
FieldValues
UniiV13007Z41A
Rxcui1010739

DailyMed Product Concepts#

Product concept, Relation, Version table
Product conceptRelationVersionEffective
860a93dc-4863-49cc-b284-6bbe8191bc48Product name420250214
eaba870a-6a9d-442e-8643-87b3f558a451Product name120250117
9b4cf230-fd05-41d5-98c6-5db9ecb27b86Product name120230117
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

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
0121-4950-15Lidocaine Hydrochloride15 mL in 1 CUP, UNIT-DOSESOLUTION1513
0121-4950-40Lidocaine Hydrochloride4 in 1 CASESOLUTION413
0121-4950-40Lidocaine Hydrochloride10 in 1 TRAYSOLUTION1013

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
0121-4950-15ML - Milliliter0121-4950dec8cb2e-de7c-4603-9a64-79ccf7278a6112024-03-12
0121-4950-40ML - Milliliter0121-4950f7ff7bef-d1a7-42eb-af09-f96ba52b16e612024-03-12

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
0121-4950LIDOCAINE HYDROCHLORIDE SOLUTION [PAI HOLDINGS, LLC DBA PAI PHARMA]13Current NDC, 3 package rows20250507_d5e23ede-957c-4a32-b1c6-268acb773c31.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
1010739lidocaine HCl 2 % Mucous Membrane Topical SolutionPSNd5e23ede-957c-4a32-b1c6-268acb773c3113
1010739lidocaine hydrochloride 20 MG/ML Mucous Membrane Topical SolutionSCDd5e23ede-957c-4a32-b1c6-268acb773c3113
1010739lidocaine HCl 2 % Oral Topical SolutionSYd5e23ede-957c-4a32-b1c6-268acb773c3113
1010739lidocaine HCl 2 % Oromucosal SolutionSYd5e23ede-957c-4a32-b1c6-268acb773c3113

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startSampleExclude flagStatus
0121-4950-150012149501515 mL in 1 CUP, UNIT-DOSE15 mlHistorical
0121-4950-40001214950404 TRAY in 1 CASE (0121-4950-40) / 10 CUP, UNIT-DOSE in 1 TRAY / 15 mL in 1 CUP, UNIT-DOSE (0121-4950-15) 4 tray2024-02-20NoNoHistorical