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 RETROBULBAR
Active Ingredients

bupivacaine hydrochloride 7.5 mg/mL

Manufacturer
Hospira, Inc.

Identifiers & Regulatory

Product NDC 0409-1165
Product ID 0409-1165_3c6a5b9f-4ea0-4ccd-a384-a90e4ad379e7
Product Type HUMAN PRESCRIPTION DRUG
Marketing Category ANDA
Application Number ANDA070585
Listing Expiration 2026-12-31
Marketing Start 2005-06-08

Pharmacologic Class

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

Normalized Code Variants

Searchable formats for this product NDC code

Digits Only 04091165
Hyphenated Format 0409-1165

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 (source: ndc)
Generic Name bupivacaine hydrochloride (source: ndc)
Application Number ANDA070585 (source: ndc)
Routes
EPIDURAL RETROBULBAR
source: ndc

Resolved Composition

Strengths
  • 7.5 mg/mL
source: ndc
Packaging
  • 25 VIAL, SINGLE-DOSE in 1 TRAY (0409-1165-01) / 10 mL in 1 VIAL, SINGLE-DOSE (0409-1165-18)
  • 25 VIAL, SINGLE-DOSE in 1 TRAY (0409-1165-02) / 30 mL in 1 VIAL, SINGLE-DOSE (0409-1165-19)
source: ndc

Packages (2)

0409-1165-01 25 VIAL, SINGLE-DOSE in 1 TRAY (0409-1165-01) / 10 mL in 1 VIAL, SINGLE-DOSE (0409-1165-18) 0409-1165-02 25 VIAL, SINGLE-DOSE in 1 TRAY (0409-1165-02) / 30 mL in 1 VIAL, SINGLE-DOSE (0409-1165-19)

Ingredients (1)

bupivacaine hydrochloride (7.5 mg/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", "RETROBULBAR"], "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 VIAL, SINGLE-DOSE in 1 TRAY (0409-1165-01)  / 10 mL in 1 VIAL, SINGLE-DOSE (0409-1165-18)", "package_ndc": "0409-1165-01", "marketing_start_date": "20051206"}, {"sample": false, "description": "25 VIAL, SINGLE-DOSE in 1 TRAY (0409-1165-02)  / 30 mL in 1 VIAL, SINGLE-DOSE (0409-1165-19)", "package_ndc": "0409-1165-02", "marketing_start_date": "20050608"}], "brand_name": "Bupivacaine Hydrochloride", "product_id": "0409-1165_3c6a5b9f-4ea0-4ccd-a384-a90e4ad379e7", "dosage_form": "INJECTION, SOLUTION", "pharm_class": ["Amide Local Anesthetic [EPC]", "Amides [CS]", "Local Anesthesia [PE]"], "product_ndc": "0409-1165", "generic_name": "BUPIVACAINE HYDROCHLORIDE", "labeler_name": "Hospira, Inc.", "product_type": "HUMAN PRESCRIPTION DRUG", "brand_name_base": "Bupivacaine Hydrochloride", "active_ingredients": [{"name": "BUPIVACAINE HYDROCHLORIDE", "strength": "7.5 mg/mL"}], "application_number": "ANDA070585", "marketing_category": "ANDA", "marketing_start_date": "20050608", "listing_expiration_date": "20261231"}