polocaine

Generic: mepivacaine hydrochloride

Labeler: fresenius kabi usa, llc
NDC Directory HUMAN PRESCRIPTION DRUG ANDA Inactive Finished

Drug Facts

Product Profile

Brand Name polocaine
Generic Name mepivacaine hydrochloride
Labeler fresenius kabi usa, llc
Dosage Form INJECTION, SOLUTION
Routes
INFILTRATION
Active Ingredients

mepivacaine hydrochloride 10 mg/mL

Manufacturer
Fresenius Kabi USA, LLC

Identifiers & Regulatory

Product NDC 63323-283
Product ID 63323-283_b3d50315-0f09-4294-a788-990036dfc45c
Product Type HUMAN PRESCRIPTION DRUG
Marketing Category ANDA
Application Number ANDA089407
Listing Expiration 2026-12-31
Marketing Start 2009-07-20

Pharmacologic Class

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

Normalized Code Variants

Searchable formats for this product NDC code

Digits Only 63323283
Hyphenated Format 63323-283

Supplemental Identifiers

RxCUI
1012722 1012726 1012731 1012735 1012737 1012741 1866503 1866515 1866524 1866531
UPC
0363323260019 0363323296018 0363323283018 0363323293017 0363323294014
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 ANDA089407 (source: ndc)
Routes
INFILTRATION
source: ndc

Resolved Composition

Strengths
  • 10 mg/mL
source: ndc
Packaging
  • 25 VIAL, MULTI-DOSE in 1 TRAY (63323-283-57) / 50 mL in 1 VIAL, MULTI-DOSE (63323-283-01)
source: ndc

Packages (1)

63323-283-57 25 VIAL, MULTI-DOSE in 1 TRAY (63323-283-57) / 50 mL in 1 VIAL, MULTI-DOSE (63323-283-01)

Ingredients (1)

mepivacaine hydrochloride (10 mg/mL)

Linked Drug Pages (1)

Polocaine-MPF, Polocaine ndc-match (0.9)

Raw FDA Data

View complete raw FDA NDC JSON payload 
{"route": ["INFILTRATION"], "spl_id": "b3d50315-0f09-4294-a788-990036dfc45c", "openfda": {"upc": ["0363323260019", "0363323296018", "0363323283018", "0363323293017", "0363323294014"], "unii": ["4VFX2L7EM5"], "rxcui": ["1012722", "1012726", "1012731", "1012735", "1012737", "1012741", "1866503", "1866515", "1866524", "1866531"], "spl_set_id": ["a27d0815-ae6b-4a21-a8f5-564c01e83814"], "manufacturer_name": ["Fresenius Kabi USA, LLC"], "is_original_packager": [true]}, "finished": true, "packaging": [{"sample": false, "description": "25 VIAL, MULTI-DOSE in 1 TRAY (63323-283-57)  / 50 mL in 1 VIAL, MULTI-DOSE (63323-283-01)", "package_ndc": "63323-283-57", "marketing_start_date": "20090720"}], "brand_name": "Polocaine", "product_id": "63323-283_b3d50315-0f09-4294-a788-990036dfc45c", "dosage_form": "INJECTION, SOLUTION", "pharm_class": ["Amide Local Anesthetic [EPC]", "Amides [CS]", "Local Anesthesia [PE]"], "product_ndc": "63323-283", "generic_name": "MEPIVACAINE HYDROCHLORIDE", "labeler_name": "Fresenius Kabi USA, LLC", "product_type": "HUMAN PRESCRIPTION DRUG", "brand_name_base": "Polocaine", "active_ingredients": [{"name": "MEPIVACAINE HYDROCHLORIDE", "strength": "10 mg/mL"}], "application_number": "ANDA089407", "marketing_category": "ANDA", "marketing_start_date": "20090720", "listing_expiration_date": "20261231"}