bupivacaine hydrochloride and epinephrine

Generic: bupivacaine hydrochloride and epinephrine

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

Drug Facts

Product Profile

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

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

Manufacturer
Hospira, Inc.

Identifiers & Regulatory

Product NDC 0409-9043
Product ID 0409-9043_6e442bfd-d3da-4913-8585-ce3485644364
Product Type HUMAN PRESCRIPTION DRUG
Marketing Category ANDA
Application Number ANDA071167
Listing Expiration 2027-12-31
Marketing Start 2005-11-29

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 04099043
Hyphenated Format 0409-9043

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 ANDA071167 (source: ndc)
Routes
INFILTRATION PERINEURAL
source: ndc

Resolved Composition

Strengths
  • 2.5 mg/mL
  • 5 ug/mL
source: ndc
Packaging
  • 25 CARTON in 1 BOX (0409-9043-01) / 1 VIAL, MULTI-DOSE in 1 CARTON (0409-9043-11) / 50 mL in 1 VIAL, MULTI-DOSE
source: ndc

Packages (1)

0409-9043-01 25 CARTON in 1 BOX (0409-9043-01) / 1 VIAL, MULTI-DOSE in 1 CARTON (0409-9043-11) / 50 mL in 1 VIAL, MULTI-DOSE

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": ["INFILTRATION", "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": "25 CARTON in 1 BOX (0409-9043-01)  / 1 VIAL, MULTI-DOSE in 1 CARTON (0409-9043-11)  / 50 mL in 1 VIAL, MULTI-DOSE", "package_ndc": "0409-9043-01", "marketing_start_date": "20051129"}], "brand_name": "Bupivacaine Hydrochloride and Epinephrine", "product_id": "0409-9043_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": "0409-9043", "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": "ANDA071167", "marketing_category": "ANDA", "marketing_start_date": "20051129", "listing_expiration_date": "20271231"}