POLOCAINE (MEPIVACAINE HCl)

Product NDC
51662-1535
11-digit product format
516621535
Labeler code
51662
Product ID
51662-1535_1034d0b4-c691-2b1c-e063-6394a90a6d8e
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
POLOCAINE (MEPIVACAINE HCl)
Dosage form
INJECTION, SOLUTION
Route
INFILTRATION
Labeler
HF Acquisition Co LLC, DBA HealthFirst
Application
ANDA089410
Marketing category
ANDA
Marketing start
2021-05-10
Substance
MEPIVACAINE HYDROCHLORIDE
Active strength
20 mg/mL
Pharmacologic classes
Amide Local Anesthetic [EPC], Amides [CS], 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
POLOCAINE (MEPIVACAINE HCl)
Listing expiration
2026-12-31

Active Ingredients#

Ingredient, Strength table
IngredientStrength
MEPIVACAINE HYDROCHLORIDE20 mg/mL

Harmonized Identifiers#

Field, Values table
FieldValues
Unii4VFX2L7EM5
Rxcui1012737

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

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
51662-1535-2POLOCAINE (MEPIVACAINE HCl)50 mL in 1 VIAL, MULTI-DOSEINJECTION, SOLUTION503
51662-1535-2POLOCAINE (MEPIVACAINE HCl)1 in 1 POUCHINJECTION, SOLUTION13
51662-1535-3POLOCAINE (MEPIVACAINE HCl)21 in 1 BOXINJECTION, SOLUTION213

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
51662-1535POLOCAINE (MEPIVACAINE HCL) INJECTION, SOLUTION [HF ACQUISITION CO LLC, DBA HEALTHFIRST]3Current NDC, Legacy NDC, 3 package rows20240201_c20406a6-5611-59e4-e053-2995a90a3c8f.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
1012737mepivacaine HCl 2 % Injectable SolutionPSNc20406a6-5611-59e4-e053-2995a90a3c8f3
1012737mepivacaine hydrochloride 20 MG/ML Injectable SolutionSCDc20406a6-5611-59e4-e053-2995a90a3c8f3
1012737mepivacaine HCl 2 % Injectable SolutionSYc20406a6-5611-59e4-e053-2995a90a3c8f3

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
51662-1535-25166215350250 mL in 1 VIAL, MULTI-DOSE50 mlHistorical
51662-1535-35166215350321 POUCH in 1 BOX (51662-1535-3) / 1 VIAL, MULTI-DOSE in 1 POUCH (51662-1535-2) / 50 mL in 1 VIAL, MULTI-DOSE21 pouch2021-05-100000-00-00NoNoCurrent