bupivacaine hydrochloride and epinephrine (0404-9828)

Drug Facts

Product Profile

Brand Name bupivacaine hydrochloride and epinephrine

Generic Name bupivacaine hydrochloride and epinephrine

Labeler henry schein, inc.

Dosage Form INJECTION, SOLUTION

Routes

EPIDURAL INFILTRATION INTRACAUDAL PERINEURAL

Active Ingredients

bupivacaine hydrochloride 2.5 mg/mL, epinephrine bitartrate 5 ug/mL

Manufacturer

Henry Schein, Inc.

Identifiers & Regulatory

Product NDC 0404-9828

Product ID 0404-9828_d06af667-46dd-4cf0-84fa-87e9be2d6d77

Product Type HUMAN PRESCRIPTION DRUG

Marketing Category ANDA

Application Number ANDA071165

Listing Expiration 2026-12-31

Marketing Start 2022-01-09

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 04049828

Hyphenated Format 0404-9828

Supplemental Identifiers

RxCUI

1012377

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 bupivacaine hydrochloride and epinephrine (source: ndc)

Generic Name bupivacaine hydrochloride and epinephrine (source: ndc)

Application Number ANDA071165 (source: ndc)

Routes

EPIDURAL INFILTRATION INTRACAUDAL PERINEURAL

source: ndc

Resolved Composition

Strengths

2.5 mg/mL
5 ug/mL

source: ndc

Packaging

1 VIAL, SINGLE-DOSE in 1 BAG (0404-9828-30) / 30 mL in 1 VIAL, SINGLE-DOSE

source: ndc

Packages (1)

0404-9828-30 1 VIAL, SINGLE-DOSE in 1 BAG (0404-9828-30) / 30 mL in 1 VIAL, SINGLE-DOSE

Ingredients (2)

bupivacaine hydrochloride (2.5 mg/mL) epinephrine bitartrate (5 ug/mL)

Linked Drug Pages (1)

Bupivacaine Hydrochloride and Epinephrine ndc-match (0.9)

Raw FDA Data

View complete raw FDA NDC JSON payload

{"route": ["EPIDURAL", "INFILTRATION", "INTRACAUDAL", "PERINEURAL"], "spl_id": "d06af667-46dd-4cf0-84fa-87e9be2d6d77", "openfda": {"unii": ["7TQO7W3VT8", "30Q7KI53AK"], "rxcui": ["1012377"], "spl_set_id": ["a1a96ebb-31f2-43d5-8dd9-b0cc0d9cbd50"], "manufacturer_name": ["Henry Schein, Inc."]}, "finished": true, "packaging": [{"sample": false, "description": "1 VIAL, SINGLE-DOSE in 1 BAG (0404-9828-30)  / 30 mL in 1 VIAL, SINGLE-DOSE", "package_ndc": "0404-9828-30", "marketing_start_date": "20220109"}], "brand_name": "Bupivacaine Hydrochloride and Epinephrine", "product_id": "0404-9828_d06af667-46dd-4cf0-84fa-87e9be2d6d77", "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": "0404-9828", "generic_name": "Bupivacaine Hydrochloride and Epinephrine", "labeler_name": "Henry Schein, Inc.", "product_type": "HUMAN PRESCRIPTION DRUG", "brand_name_base": "Bupivacaine Hydrochloride and Epinephrine", "active_ingredients": [{"name": "BUPIVACAINE HYDROCHLORIDE", "strength": "2.5 mg/mL"}, {"name": "EPINEPHRINE BITARTRATE", "strength": "5 ug/mL"}], "application_number": "ANDA071165", "marketing_category": "ANDA", "marketing_start_date": "20220109", "listing_expiration_date": "20261231"}