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
PERINEURAL
Active Ingredients

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

Manufacturer
Hospira, Inc.

Identifiers & Regulatory

Product NDC 0409-9046
Product ID 0409-9046_3c6a5b9f-4ea0-4ccd-a384-a90e4ad379e7
Product Type HUMAN PRESCRIPTION DRUG
Marketing Category ANDA
Application Number ANDA071170
Listing Expiration 2026-12-31
Marketing Start 2005-07-26

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 04099046
Hyphenated Format 0409-9046

Supplemental Identifiers

RxCUI
1012377 1012384 1012396 1012404 1672917 1672919 1724786 1724787 1724880 1724884 1725078 1725082 1867594 1867596
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 ANDA071170 (source: ndc)
Routes
PERINEURAL
source: ndc

Resolved Composition

Strengths
  • 5 mg/mL
  • 5 ug/mL
source: ndc
Packaging
  • 25 CARTON in 1 BOX (0409-9046-01) / 1 VIAL, MULTI-DOSE in 1 CARTON (0409-9046-11) / 50 mL in 1 VIAL, MULTI-DOSE
source: ndc

Packages (1)

Ingredients (2)

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

Linked Drug Pages (1)

Raw FDA Data

View complete raw FDA NDC JSON payload
{"route": ["PERINEURAL"], "spl_id": "3c6a5b9f-4ea0-4ccd-a384-a90e4ad379e7", "openfda": {"unii": ["7TQO7W3VT8", "30Q7KI53AK"], "rxcui": ["1012377", "1012384", "1012396", "1012404", "1672917", "1672919", "1724786", "1724787", "1724880", "1724884", "1725078", "1725082", "1867594", "1867596"], "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 (0409-9046-01)  / 1 VIAL, MULTI-DOSE in 1 CARTON (0409-9046-11)  / 50 mL in 1 VIAL, MULTI-DOSE", "package_ndc": "0409-9046-01", "marketing_start_date": "20050726"}], "brand_name": "Bupivacaine Hydrochloride and Epinephrine", "product_id": "0409-9046_3c6a5b9f-4ea0-4ccd-a384-a90e4ad379e7", "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": "0409-9046", "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": "5 mg/mL"}, {"name": "EPINEPHRINE BITARTRATE", "strength": "5 ug/mL"}], "application_number": "ANDA071170", "marketing_category": "ANDA", "marketing_start_date": "20050726", "listing_expiration_date": "20261231"}