Lidocaine

Product NDC
50436-0473
11-digit product format
504360473
Labeler code
50436
Product ID
50436-0473_dc462017-0054-4d05-b607-93805601edd4
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
Lidocaine
Dosage form
OINTMENT
Route
TOPICAL
Labeler
Unit Dose Services
Application
ANDA207810
Marketing category
ANDA
Marketing start
2017-03-10
Marketing end
0000-00-00
Substance
LIDOCAINE
Active strength
50 mg/g
Pharmacologic classes
Amide Local Anesthetic [EPC], Amides [CS], Antiarrhythmic [EPC], Local Anesthesia [PE]
NDC exclude flag
No
Listing certified through
2023-12-31
Current FDA listing
Historical FDA.report record

FDA-Initiated Inactive NDC Indexing#

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
50436-0473-1Lidocaine50 g in 1 TUBEOINTMENT504
50436-0473-1Lidocaine1 in 1 CARTONOINTMENT14
50436-0473-2Lidocaine1 in 1 CARTONOINTMENT14
50436-0473-2Lidocaine35.44 g in 1 TUBEOINTMENT35.444

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
50436-0473-1GM - Gram50436-0473a5985931-322c-409d-bd44-914e3710a49412021-10-08
50436-0473-2GM - Gram50436-0473b7001bd3-9532-40be-b3f2-239873226b7912022-08-04

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
50436-0473LIDOCAINE OINTMENT [UNIT DOSE SERVICES]4Legacy NDC, 4 package rows20220612_abf864dd-e75f-4a02-8caf-3ad816cd540b.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
1543069lidocaine 5 % Topical OintmentPSNabf864dd-e75f-4a02-8caf-3ad816cd540b4
1543069lidocaine 0.05 MG/MG Topical OintmentSCDabf864dd-e75f-4a02-8caf-3ad816cd540b4
1543069lidocaine 5 % Topical OintmentSYabf864dd-e75f-4a02-8caf-3ad816cd540b4

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
50436-0473-1504360473011 TUBE in 1 CARTON (50436-0473-1) > 50 g in 1 TUBE1 tube2021-08-240000-00-00NoNoCurrent
50436-0473-2504360473021 TUBE in 1 CARTON (50436-0473-2) > 35.44 g in 1 TUBE1 tube2022-06-010000-00-00NoNoCurrent