POLOCAINE (MEPIVACAINE HCl)

Product NDC
51662-1534
11-digit product format
516621534
Labeler code
51662
Product ID
51662-1534_1034b916-15a5-44be-e063-6394a90a2c0b
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
POLOCAINE (MEPIVACAINE HCl)
Dosage form
INJECTION, SOLUTION
Route
INFILTRATION
Labeler
HF Acquisition Co LLC, DBA HealthFirst
Application
ANDA089407
Marketing category
ANDA
Marketing start
2021-05-11
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
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 HYDROCHLORIDE10 mg/mL

Harmonized Identifiers#

Field, Values table
FieldValues
Unii4VFX2L7EM5
Rxcui1012722

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
51662-1534-2POLOCAINE (MEPIVACAINE HCl)50 mL in 1 VIAL, MULTI-DOSEINJECTION, SOLUTION503
51662-1534-2POLOCAINE (MEPIVACAINE HCl)1 in 1 POUCHINJECTION, SOLUTION13
51662-1534-3POLOCAINE (MEPIVACAINE HCl)25 in 1 BOXINJECTION, SOLUTION253

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
51662-1534POLOCAINE (MEPIVACAINE HCL) INJECTION, SOLUTION [HF ACQUISITION CO LLC, DBA HEALTHFIRST]3Current NDC, Legacy NDC, 3 package rows20240201_c21a4c3a-82c0-0bfb-e053-2995a90a2b65.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
1012722mepivacaine HCl 1 % Injectable SolutionPSNc21a4c3a-82c0-0bfb-e053-2995a90a2b653
1012722mepivacaine hydrochloride 10 MG/ML Injectable SolutionSCDc21a4c3a-82c0-0bfb-e053-2995a90a2b653
1012722mepivacaine hydrochloride 1 % Injectable SolutionSYc21a4c3a-82c0-0bfb-e053-2995a90a2b653

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
51662-1534-25166215340250 mL in 1 VIAL, MULTI-DOSE50 mlHistorical
51662-1534-35166215340325 POUCH in 1 BOX (51662-1534-3) / 1 VIAL, MULTI-DOSE in 1 POUCH (51662-1534-2) / 50 mL in 1 VIAL, MULTI-DOSE25 pouch2021-05-110000-00-00NoNoCurrent