sensorcaine

Generic: bupivacaine hydrochloride and epinephrine bitartrate

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

Drug Facts

Product Profile

Brand Name sensorcaine
Generic Name bupivacaine hydrochloride and epinephrine bitartrate
Labeler fresenius kabi usa, llc
Dosage Form INJECTION, SOLUTION
Routes
PERINEURAL
Active Ingredients

bupivacaine hydrochloride 5 mg/mL, epinephrine bitartrate .005 mg/mL

Manufacturer
Fresenius Kabi USA, LLC

Identifiers & Regulatory

Product NDC 63323-463
Product ID 63323-463_cc1f6507-eb3e-4398-a1d3-0c56a2099e6b
Product Type HUMAN PRESCRIPTION DRUG
Marketing Category ANDA
Application Number ANDA070968
Listing Expiration 2026-12-31
Marketing Start 2010-11-19

Pharmacologic Class

Classes
adrenergic alpha-agonists [moa] adrenergic beta-agonists [moa] amide local anesthetic [epc] amides [cs] catecholamine [epc] catecholamines [cs] local anesthesia [pe] alpha-adrenergic agonist [epc] beta-adrenergic agonist [epc]

Normalized Code Variants

Searchable formats for this product NDC code

Digits Only 63323463
Hyphenated Format 63323-463

Supplemental Identifiers

RxCUI
1012377 1012384 1012413 1012417 1724786 1724787 1724809 1724810 1867594 1867596 1867618 1867620
UPC
0363323472030 0363323461010 0363323463014 0363323468026 0363323472016 0363323468019
UNII
7TQO7W3VT8 30Q7KI53AK

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 sensorcaine (source: ndc)
Generic Name bupivacaine hydrochloride and epinephrine bitartrate (source: ndc)
Application Number ANDA070968 (source: ndc)
Routes
PERINEURAL
source: ndc

Resolved Composition

Strengths
  • 5 mg/mL
  • .005 mg/mL
source: ndc
Packaging
  • 25 VIAL, MULTI-DOSE in 1 TRAY (63323-463-57) / 50 mL in 1 VIAL, MULTI-DOSE (63323-463-01)
source: ndc

Packages (1)

63323-463-57 25 VIAL, MULTI-DOSE in 1 TRAY (63323-463-57) / 50 mL in 1 VIAL, MULTI-DOSE (63323-463-01)

Ingredients (2)

bupivacaine hydrochloride (5 mg/mL) epinephrine bitartrate (.005 mg/mL)

Linked Drug Pages (1)

SENSORCAINE, SENSORCAINE MPF ndc-match (0.9)

Raw FDA Data

View complete raw FDA NDC JSON payload 
{"route": ["PERINEURAL"], "spl_id": "cc1f6507-eb3e-4398-a1d3-0c56a2099e6b", "openfda": {"upc": ["0363323472030", "0363323461010", "0363323463014", "0363323468026", "0363323472016", "0363323468019"], "unii": ["7TQO7W3VT8", "30Q7KI53AK"], "rxcui": ["1012377", "1012384", "1012413", "1012417", "1724786", "1724787", "1724809", "1724810", "1867594", "1867596", "1867618", "1867620"], "spl_set_id": ["bc61a9a6-0a4e-48a9-b908-e5e66b9f23eb"], "manufacturer_name": ["Fresenius Kabi USA, LLC"], "is_original_packager": [true]}, "finished": true, "packaging": [{"sample": false, "description": "25 VIAL, MULTI-DOSE in 1 TRAY (63323-463-57)  / 50 mL in 1 VIAL, MULTI-DOSE (63323-463-01)", "package_ndc": "63323-463-57", "marketing_start_date": "20101119"}], "brand_name": "SENSORCAINE", "product_id": "63323-463_cc1f6507-eb3e-4398-a1d3-0c56a2099e6b", "dosage_form": "INJECTION, SOLUTION", "pharm_class": ["Adrenergic alpha-Agonists [MoA]", "Adrenergic beta-Agonists [MoA]", "Amide Local Anesthetic [EPC]", "Amides [CS]", "Catecholamine [EPC]", "Catecholamines [CS]", "Local Anesthesia [PE]", "alpha-Adrenergic Agonist [EPC]", "beta-Adrenergic Agonist [EPC]"], "product_ndc": "63323-463", "generic_name": "BUPIVACAINE HYDROCHLORIDE and EPINEPHRINE BITARTRATE", "labeler_name": "Fresenius Kabi USA, LLC", "product_type": "HUMAN PRESCRIPTION DRUG", "brand_name_base": "SENSORCAINE", "active_ingredients": [{"name": "BUPIVACAINE HYDROCHLORIDE", "strength": "5 mg/mL"}, {"name": "EPINEPHRINE BITARTRATE", "strength": ".005 mg/mL"}], "application_number": "ANDA070968", "marketing_category": "ANDA", "marketing_start_date": "20101119", "listing_expiration_date": "20261231"}