Polocaine

Product NDC
50090-4517
11-digit product format
500904517
Labeler code
50090
Product ID
50090-4517_1960a2b0-b70c-403b-aeab-ba52ac15ae13
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
MEPIVACAINE HYDROCHLORIDE
Dosage form
INJECTION, SOLUTION
Route
INFILTRATION
Labeler
A-S Medication Solutions
Application
ANDA089407
Marketing category
ANDA
Marketing start
2009-07-20
Marketing end
0000-00-00
Substance
MEPIVACAINE HYDROCHLORIDE
Active strength
10 mg/mL
Pharmacologic classes
Amide Local Anesthetic [EPC],Amides [CS],Local Anesthesia [PE]
NDC exclude flag
No
Listing certified through
2021-12-31
Current FDA listing
Historical FDA.report record

DailyMed Product Concepts#

Product concept, Relation, Version table
Product conceptRelationVersionEffective
2a6327eb-55be-3f7d-6c02-d7451033ded4Product name120140508
c9232c8e-ce6a-0381-9a9f-9f12074ca339Product name120140508
d6039924-e573-fcdd-4fd1-ec85172a4599Product name120140508

FDA-Initiated Inactive NDC Indexing#

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
50090-4517-0Polocaine50 mL in 1 VIAL, MULTI-DOSEINJECTION, SOLUTION504

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
50090-4517-0ML - Milliliter50090-45178be362a0-d3b8-4130-bf04-4a4ae05fb30c12022-07-06

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
50090-4517POLOCAINE (MEPIVACAINE HYDROCHLORIDE) INJECTION, SOLUTION [A-S MEDICATION SOLUTIONS]4Legacy NDC, 1 package rows20200714_643a8a85-e7c6-4f09-a179-0a8e63de1bac.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
1012722mepivacaine HCl 1 % Injectable SolutionPSN643a8a85-e7c6-4f09-a179-0a8e63de1bac4
1012726Polocaine 1 % Injectable SolutionPSN643a8a85-e7c6-4f09-a179-0a8e63de1bac4
1012726mepivacaine hydrochloride 10 MG/ML Injectable Solution [Polocaine]SBD643a8a85-e7c6-4f09-a179-0a8e63de1bac4
1012722mepivacaine hydrochloride 10 MG/ML Injectable SolutionSCD643a8a85-e7c6-4f09-a179-0a8e63de1bac4
1012722mepivacaine hydrochloride 1 % Injectable SolutionSY643a8a85-e7c6-4f09-a179-0a8e63de1bac4
1012726Polocaine 1 % Injectable SolutionSY643a8a85-e7c6-4f09-a179-0a8e63de1bac4
1012726Polocaine 10 MG/ML Injectable SolutionSY643a8a85-e7c6-4f09-a179-0a8e63de1bac4

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
50090-4517-05009045170050 mL in 1 VIAL, MULTI-DOSE (50090-4517-0) 50 ml2019-09-110000-00-00NoNoCurrent