marcaine

Generic: bupivacaine hydrochloride and epinephrine bitartrate

Labeler: septodont, inc.
NDC Directory HUMAN PRESCRIPTION DRUG ANDA Inactive Finished

Drug Facts

Product Profile

Brand Name marcaine
Generic Name bupivacaine hydrochloride and epinephrine bitartrate
Labeler septodont, inc.
Dosage Form INJECTION, SOLUTION
Routes
SUBMUCOSAL
Active Ingredients

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

Manufacturer
Septodont, Inc.

Identifiers & Regulatory

Product NDC 0362-0557
Product ID 0362-0557_2095bcd0-0dc6-4b6e-a86c-23140421e3d0
Product Type HUMAN PRESCRIPTION DRUG
Marketing Category ANDA
Application Number ANDA077250
Listing Expiration 2026-12-31
Marketing Start 2018-06-12

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 03620557
Hyphenated Format 0362-0557

Supplemental Identifiers

RxCUI
1670365 1673142
UNII
AKA908P8J1 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 marcaine (source: ndc)
Generic Name bupivacaine hydrochloride and epinephrine bitartrate (source: ndc)
Application Number ANDA077250 (source: ndc)
Routes
SUBMUCOSAL
source: ndc

Resolved Composition

Strengths
  • 5 mg/mL
  • .005 mg/mL
source: ndc
Packaging
  • 50 CARTRIDGE in 1 CARTON (0362-0557-05) / 1.8 mL in 1 CARTRIDGE
source: ndc

Packages (1)

0362-0557-05 50 CARTRIDGE in 1 CARTON (0362-0557-05) / 1.8 mL in 1 CARTRIDGE

Ingredients (2)

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

Linked Drug Pages (1)

Marcaine ndc-match (0.9)

Raw FDA Data

View complete raw FDA NDC JSON payload 
{"route": ["SUBMUCOSAL"], "spl_id": "2095bcd0-0dc6-4b6e-a86c-23140421e3d0", "openfda": {"unii": ["AKA908P8J1", "30Q7KI53AK"], "rxcui": ["1670365", "1673142"], "spl_set_id": ["3e196aa4-0b01-44db-9267-98a995b54743"], "manufacturer_name": ["Septodont, Inc."], "is_original_packager": [true]}, "finished": true, "packaging": [{"sample": false, "description": "50 CARTRIDGE in 1 CARTON (0362-0557-05)  / 1.8 mL in 1 CARTRIDGE", "package_ndc": "0362-0557-05", "marketing_start_date": "20180612"}], "brand_name": "Marcaine", "product_id": "0362-0557_2095bcd0-0dc6-4b6e-a86c-23140421e3d0", "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": "0362-0557", "generic_name": "bupivacaine hydrochloride and epinephrine bitartrate", "labeler_name": "Septodont, Inc.", "product_type": "HUMAN PRESCRIPTION DRUG", "brand_name_base": "Marcaine", "active_ingredients": [{"name": "BUPIVACAINE HYDROCHLORIDE ANHYDROUS", "strength": "5 mg/mL"}, {"name": "EPINEPHRINE BITARTRATE", "strength": ".005 mg/mL"}], "application_number": "ANDA077250", "marketing_category": "ANDA", "marketing_start_date": "20180612", "listing_expiration_date": "20261231"}