bupivacaine hydrochloride

Generic: bupivacaine hydrochloride

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

Drug Facts

Product Profile

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

bupivacaine hydrochloride 2.5 mg/mL

Manufacturer
Hospira, Inc.

Identifiers & Regulatory

Product NDC 0409-1159
Product ID 0409-1159_40bfa804-5f31-4bd2-b1e3-dcf428710dc1
Product Type HUMAN PRESCRIPTION DRUG
Marketing Category ANDA
Application Number ANDA070583
Listing Expiration 2026-12-31
Marketing Start 2015-08-11

Pharmacologic Class

Classes
amide local anesthetic [epc] amides [cs] local anesthesia [pe]

Normalized Code Variants

Searchable formats for this product NDC code

Digits Only 04091159
Hyphenated Format 0409-1159

Supplemental Identifiers

RxCUI
1725078 1725082
UNII
7TQO7W3VT8

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 (source: ndc)
Generic Name bupivacaine hydrochloride (source: ndc)
Application Number ANDA070583 (source: ndc)
Routes
EPIDURAL INFILTRATION INTRACAUDAL PERINEURAL
source: ndc

Resolved Composition

Strengths
  • 2.5 mg/mL
source: ndc
Packaging
  • 25 VIAL, SINGLE-DOSE in 1 TRAY (0409-1159-10) / 30 mL in 1 VIAL, SINGLE-DOSE (0409-1159-09)
source: ndc

Packages (1)

0409-1159-10 25 VIAL, SINGLE-DOSE in 1 TRAY (0409-1159-10) / 30 mL in 1 VIAL, SINGLE-DOSE (0409-1159-09)

Ingredients (1)

bupivacaine hydrochloride (2.5 mg/mL)

Linked Drug Pages (2)

BUPIVACAINE HYDROCHLORIDE ndc-match (0.9) 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": "40bfa804-5f31-4bd2-b1e3-dcf428710dc1", "openfda": {"unii": ["7TQO7W3VT8"], "rxcui": ["1725078", "1725082"], "spl_set_id": ["bb44c7e1-d911-4788-908f-09b7b271969b"], "manufacturer_name": ["Hospira, Inc."], "is_original_packager": [true]}, "finished": true, "packaging": [{"sample": false, "description": "25 VIAL, SINGLE-DOSE in 1 TRAY (0409-1159-10)  / 30 mL in 1 VIAL, SINGLE-DOSE (0409-1159-09)", "package_ndc": "0409-1159-10", "marketing_start_date": "20150811"}], "brand_name": "BUPIVACAINE HYDROCHLORIDE", "product_id": "0409-1159_40bfa804-5f31-4bd2-b1e3-dcf428710dc1", "dosage_form": "INJECTION, SOLUTION", "pharm_class": ["Amide Local Anesthetic [EPC]", "Amides [CS]", "Local Anesthesia [PE]"], "product_ndc": "0409-1159", "generic_name": "bupivacaine hydrochloride", "labeler_name": "Hospira, Inc.", "product_type": "HUMAN PRESCRIPTION DRUG", "brand_name_base": "BUPIVACAINE HYDROCHLORIDE", "active_ingredients": [{"name": "BUPIVACAINE HYDROCHLORIDE", "strength": "2.5 mg/mL"}], "application_number": "ANDA070583", "marketing_category": "ANDA", "marketing_start_date": "20150811", "listing_expiration_date": "20261231"}