bupivacaine hydrochloride and epinephrine (0409-9042)

Drug Facts

Product Profile

Brand Name bupivacaine hydrochloride and epinephrine

Generic Name bupivacaine hydrochloride and epinephrine

Labeler hospira, inc.

Dosage Form INJECTION, SOLUTION

Routes

EPIDURAL INFILTRATION INTRACAUDAL PERINEURAL

Active Ingredients

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

Manufacturer

Hospira, Inc.

Identifiers & Regulatory

Product NDC 0409-9042

Product ID 0409-9042_6e442bfd-d3da-4913-8585-ce3485644364

Product Type HUMAN PRESCRIPTION DRUG

Marketing Category ANDA

Application Number ANDA071165

Listing Expiration 2027-12-31

Marketing Start 2005-06-15

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 04099042

Hyphenated Format 0409-9042

Supplemental Identifiers

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 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

10 VIAL, SINGLE-DOSE in 1 CARTON (0409-9042-01) / 10 mL in 1 VIAL, SINGLE-DOSE (0409-9042-11)
25 VIAL, SINGLE-DOSE in 1 TRAY (0409-9042-17) / 30 mL in 1 VIAL, SINGLE-DOSE (0409-9042-16)

source: ndc

Packages (2)

0409-9042-01 10 VIAL, SINGLE-DOSE in 1 CARTON (0409-9042-01) / 10 mL in 1 VIAL, SINGLE-DOSE (0409-9042-11) 0409-9042-17 25 VIAL, SINGLE-DOSE in 1 TRAY (0409-9042-17) / 30 mL in 1 VIAL, SINGLE-DOSE (0409-9042-16)

Ingredients (2)

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

Linked Drug Pages (1)

Bupivacaine Hydrochloride, 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": "6e442bfd-d3da-4913-8585-ce3485644364", "openfda": {"unii": ["7TQO7W3VT8", "30Q7KI53AK"], "spl_set_id": ["02a845c3-4521-4926-e397-25ab536e7cf6"], "manufacturer_name": ["Hospira, Inc."], "is_original_packager": [true]}, "finished": true, "packaging": [{"sample": false, "description": "10 VIAL, SINGLE-DOSE in 1 CARTON (0409-9042-01)  / 10 mL in 1 VIAL, SINGLE-DOSE (0409-9042-11)", "package_ndc": "0409-9042-01", "marketing_start_date": "20050826"}, {"sample": false, "description": "25 VIAL, SINGLE-DOSE in 1 TRAY (0409-9042-17)  / 30 mL in 1 VIAL, SINGLE-DOSE (0409-9042-16)", "package_ndc": "0409-9042-17", "marketing_start_date": "20110321"}], "brand_name": "Bupivacaine Hydrochloride and Epinephrine", "product_id": "0409-9042_6e442bfd-d3da-4913-8585-ce3485644364", "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": "0409-9042", "generic_name": "BUPIVACAINE HYDROCHLORIDE AND EPINEPHRINE", "labeler_name": "Hospira, 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": "20050615", "listing_expiration_date": "20271231"}