polocaine

Generic: mepivacaine hydrochloride

Labeler: dentsply pharmaceutical
NDC Directory HUMAN PRESCRIPTION DRUG ANDA Inactive Finished

Drug Facts

Product Profile

Brand Name polocaine
Generic Name mepivacaine hydrochloride
Labeler dentsply pharmaceutical
Dosage Form INJECTION, SOLUTION
Routes
SUBMUCOSAL
Active Ingredients

mepivacaine hydrochloride 30 mg/mL

Manufacturer
Dentsply Pharmaceutical

Identifiers & Regulatory

Product NDC 66312-441
Product ID 66312-441_fc3879ee-0f0f-40d9-b127-12001b54b998
Product Type HUMAN PRESCRIPTION DRUG
Marketing Category ANDA
Application Number ANDA088387
Listing Expiration 2026-12-31
Marketing Start 1984-10-10

Pharmacologic Class

Classes
amide local anesthetic [epc] amides [cs] local anesthesia [pe]

Normalized Code Variants

Searchable formats for this product NDC code

Digits Only 66312441
Hyphenated Format 66312-441

Supplemental Identifiers

RxCUI
1012756 1305263
UNII
4VFX2L7EM5

Packaging Origin

Original Packager
true

Resolved Product View

Precedence rule: structured NDC data is preferred, falling back to linked label metadata when unavailable. Source tags show the origin of each value.

Resolved Identity

Brand Name polocaine (source: ndc)
Generic Name mepivacaine hydrochloride (source: ndc)
Application Number ANDA088387 (source: ndc)
Routes
SUBMUCOSAL
source: ndc

Resolved Composition

Strengths
  • 30 mg/mL
source: ndc
Packaging
  • 50 CARTRIDGE in 1 CARTON (66312-441-16) / 1.7 mL in 1 CARTRIDGE
source: ndc

Packages (1)

66312-441-16 50 CARTRIDGE in 1 CARTON (66312-441-16) / 1.7 mL in 1 CARTRIDGE

Ingredients (1)

mepivacaine hydrochloride (30 mg/mL)

Linked Drug Pages (1)

Polocaine ndc-match (0.9)

Raw FDA Data

View complete raw FDA NDC JSON payload 
{"route": ["SUBMUCOSAL"], "spl_id": "fc3879ee-0f0f-40d9-b127-12001b54b998", "openfda": {"unii": ["4VFX2L7EM5"], "rxcui": ["1012756", "1305263"], "spl_set_id": ["25074a6a-7f67-4ad8-86e0-2afe23ec5d04"], "manufacturer_name": ["Dentsply Pharmaceutical"], "is_original_packager": [true]}, "finished": true, "packaging": [{"sample": false, "description": "50 CARTRIDGE in 1 CARTON (66312-441-16)  / 1.7 mL in 1 CARTRIDGE", "package_ndc": "66312-441-16", "marketing_start_date": "19841010"}], "brand_name": "Polocaine", "product_id": "66312-441_fc3879ee-0f0f-40d9-b127-12001b54b998", "dosage_form": "INJECTION, SOLUTION", "pharm_class": ["Amide Local Anesthetic [EPC]", "Amides [CS]", "Local Anesthesia [PE]"], "product_ndc": "66312-441", "generic_name": "Mepivacaine Hydrochloride", "labeler_name": "Dentsply Pharmaceutical", "product_type": "HUMAN PRESCRIPTION DRUG", "brand_name_base": "Polocaine", "active_ingredients": [{"name": "MEPIVACAINE HYDROCHLORIDE", "strength": "30 mg/mL"}], "application_number": "ANDA088387", "marketing_category": "ANDA", "marketing_start_date": "19841010", "listing_expiration_date": "20261231"}