marcaine with epinephrine

Generic: bupivacaine hydrochloride and epinephrine bitartrate

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

Drug Facts

Product Profile

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

bupivacaine hydrochloride 2.5 mg/mL, epinephrine bitartrate .0091 mg/mL

Manufacturer
Henry Schein, Inc.

Identifiers & Regulatory

Product NDC 0404-9908
Product ID 0404-9908_2950b33e-2ee2-4f43-9c08-3c5edef9caae
Product Type HUMAN PRESCRIPTION DRUG
Marketing Category NDA
Application Number NDA016964
Listing Expiration 2027-12-31
Marketing Start 2022-01-13

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 04049908
Hyphenated Format 0404-9908

Supplemental Identifiers

RxCUI
1867596
UNII
7TQO7W3VT8 30Q7KI53AK

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 bitartrate (source: ndc)
Application Number NDA016964 (source: ndc)
Routes
EPIDURAL INFILTRATION INTRACAUDAL PERINEURAL
source: ndc

Resolved Composition

Strengths
  • 2.5 mg/mL
  • .0091 mg/mL
source: ndc
Packaging
  • 1 VIAL, SINGLE-DOSE in 1 BAG (0404-9908-30) / 30 mL in 1 VIAL, SINGLE-DOSE
source: ndc

Packages (1)

0404-9908-30 1 VIAL, SINGLE-DOSE in 1 BAG (0404-9908-30) / 30 mL in 1 VIAL, SINGLE-DOSE

Ingredients (2)

bupivacaine hydrochloride (2.5 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", "INFILTRATION", "INTRACAUDAL", "PERINEURAL"], "spl_id": "2950b33e-2ee2-4f43-9c08-3c5edef9caae", "openfda": {"unii": ["7TQO7W3VT8", "30Q7KI53AK"], "rxcui": ["1867596"], "spl_set_id": ["d0d51133-882c-4f9e-ba1c-f037226305a1"], "manufacturer_name": ["Henry Schein, Inc."]}, "finished": true, "packaging": [{"sample": false, "description": "1 VIAL, SINGLE-DOSE in 1 BAG (0404-9908-30)  / 30 mL in 1 VIAL, SINGLE-DOSE", "package_ndc": "0404-9908-30", "marketing_start_date": "20220113"}], "brand_name": "MARCAINE WITH EPINEPHRINE", "product_id": "0404-9908_2950b33e-2ee2-4f43-9c08-3c5edef9caae", "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": "0404-9908", "generic_name": "bupivacaine hydrochloride and epinephrine bitartrate", "labeler_name": "Henry Schein, Inc.", "product_type": "HUMAN PRESCRIPTION DRUG", "brand_name_base": "MARCAINE WITH EPINEPHRINE", "active_ingredients": [{"name": "BUPIVACAINE HYDROCHLORIDE", "strength": "2.5 mg/mL"}, {"name": "EPINEPHRINE BITARTRATE", "strength": ".0091 mg/mL"}], "application_number": "NDA016964", "marketing_category": "NDA", "marketing_start_date": "20220113", "listing_expiration_date": "20271231"}