marcaine with epinephrine

Generic: bupivacaine hydrochloride and epinephrine

Labeler: hospira, inc.
NDC Directory HUMAN PRESCRIPTION DRUG NDA Inactive Finished

Drug Facts

Product Profile

Brand Name marcaine with epinephrine
Generic Name bupivacaine hydrochloride and epinephrine
Labeler hospira, inc.
Dosage Form INJECTION, SOLUTION
Routes
EPIDURAL INTRACAUDAL PERINEURAL
Active Ingredients

bupivacaine hydrochloride 5 mg/mL, epinephrine bitartrate .0091 mg/mL

Manufacturer
Hospira, Inc.

Identifiers & Regulatory

Product NDC 0409-4208
Product ID 0409-4208_14ec85dc-0263-44d1-9267-66fa072cff8d
Product Type HUMAN PRESCRIPTION DRUG
Marketing Category NDA
Application Number NDA016964
Listing Expiration 2026-12-31
Marketing Start 2022-09-26

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 04094208
Hyphenated Format 0409-4208

Supplemental Identifiers

RxCUI
1012377 1012381 1012384 1012388 1672917 1672919 1673242 1673243 1867594 1867596 1867612 1867614
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 marcaine with epinephrine (source: ndc)
Generic Name bupivacaine hydrochloride and epinephrine (source: ndc)
Application Number NDA016964 (source: ndc)
Routes
EPIDURAL INTRACAUDAL PERINEURAL
source: ndc

Resolved Composition

Strengths
  • 5 mg/mL
  • .0091 mg/mL
source: ndc
Packaging
  • 10 VIAL, SINGLE-DOSE in 1 CARTON (0409-4208-10) / 30 mL in 1 VIAL, SINGLE-DOSE (0409-4208-01)
source: ndc

Packages (1)

0409-4208-10 10 VIAL, SINGLE-DOSE in 1 CARTON (0409-4208-10) / 30 mL in 1 VIAL, SINGLE-DOSE (0409-4208-01)

Ingredients (2)

bupivacaine hydrochloride (5 mg/mL) epinephrine bitartrate (.0091 mg/mL)

Linked Drug Pages (1)

Marcaine with Epinephrine ndc-match (0.9)

Raw FDA Data

View complete raw FDA NDC JSON payload 
{"route": ["EPIDURAL", "INTRACAUDAL", "PERINEURAL"], "spl_id": "14ec85dc-0263-44d1-9267-66fa072cff8d", "openfda": {"unii": ["7TQO7W3VT8", "30Q7KI53AK"], "rxcui": ["1012377", "1012381", "1012384", "1012388", "1672917", "1672919", "1673242", "1673243", "1867594", "1867596", "1867612", "1867614"], "spl_set_id": ["93cf0914-de08-4ec6-8f8c-d663243b9958"], "manufacturer_name": ["Hospira, Inc."], "is_original_packager": [true]}, "finished": true, "packaging": [{"sample": false, "description": "10 VIAL, SINGLE-DOSE in 1 CARTON (0409-4208-10)  / 30 mL in 1 VIAL, SINGLE-DOSE (0409-4208-01)", "package_ndc": "0409-4208-10", "marketing_start_date": "20220926"}], "brand_name": "Marcaine with Epinephrine", "product_id": "0409-4208_14ec85dc-0263-44d1-9267-66fa072cff8d", "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": "0409-4208", "generic_name": "BUPIVACAINE HYDROCHLORIDE AND EPINEPHRINE", "labeler_name": "Hospira, Inc.", "product_type": "HUMAN PRESCRIPTION DRUG", "brand_name_base": "Marcaine with Epinephrine", "active_ingredients": [{"name": "BUPIVACAINE HYDROCHLORIDE", "strength": "5 mg/mL"}, {"name": "EPINEPHRINE BITARTRATE", "strength": ".0091 mg/mL"}], "application_number": "NDA016964", "marketing_category": "NDA", "marketing_start_date": "20220926", "listing_expiration_date": "20261231"}