bupivacaine hcl

Generic: bupivacaine hydrochloride

Labeler: xellia pharmaceuticals usa llc
NDC Directory HUMAN PRESCRIPTION DRUG ANDA Inactive Finished

Drug Facts

Product Profile

Brand Name bupivacaine hcl
Generic Name bupivacaine hydrochloride
Labeler xellia pharmaceuticals usa llc
Dosage Form INJECTION, SOLUTION
Routes
PERINEURAL
Active Ingredients

bupivacaine hydrochloride 2.5 mg/mL

Manufacturer
Xellia Pharmaceuticals USA LLC

Identifiers & Regulatory

Product NDC 70594-116
Product ID 70594-116_6776a37a-5872-4c0c-b039-6d93e3604e7c
Product Type HUMAN PRESCRIPTION DRUG
Marketing Category ANDA
Application Number ANDA091503
Listing Expiration 2026-12-31
Marketing Start 2023-08-01

Pharmacologic Class

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

Normalized Code Variants

Searchable formats for this product NDC code

Digits Only 70594116
Hyphenated Format 70594-116

Supplemental Identifiers

RxCUI
1012396 1012404
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 hcl (source: ndc)
Generic Name bupivacaine hydrochloride (source: ndc)
Application Number ANDA091503 (source: ndc)
Routes
PERINEURAL
source: ndc

Resolved Composition

Strengths
  • 2.5 mg/mL
source: ndc
Packaging
  • 50 mL in 1 VIAL, MULTI-DOSE (70594-116-01)
source: ndc

Packages (1)

70594-116-01 50 mL in 1 VIAL, MULTI-DOSE (70594-116-01)

Ingredients (1)

bupivacaine hydrochloride (2.5 mg/mL)

Linked Drug Pages (1)

Bupivacaine HCl ndc-match (0.9)

Raw FDA Data

View complete raw FDA NDC JSON payload 
{"route": ["PERINEURAL"], "spl_id": "6776a37a-5872-4c0c-b039-6d93e3604e7c", "openfda": {"unii": ["7TQO7W3VT8"], "rxcui": ["1012396", "1012404"], "spl_set_id": ["3335dabe-66d5-440b-a59a-b62993030e0f"], "manufacturer_name": ["Xellia Pharmaceuticals USA LLC"], "is_original_packager": [true]}, "finished": true, "packaging": [{"sample": false, "description": "50 mL in 1 VIAL, MULTI-DOSE (70594-116-01)", "package_ndc": "70594-116-01", "marketing_start_date": "20230801"}], "brand_name": "Bupivacaine HCl", "product_id": "70594-116_6776a37a-5872-4c0c-b039-6d93e3604e7c", "dosage_form": "INJECTION, SOLUTION", "pharm_class": ["Amide Local Anesthetic [EPC]", "Amides [CS]", "Local Anesthesia [PE]"], "product_ndc": "70594-116", "generic_name": "Bupivacaine Hydrochloride", "labeler_name": "Xellia Pharmaceuticals USA LLC", "product_type": "HUMAN PRESCRIPTION DRUG", "brand_name_base": "Bupivacaine HCl", "active_ingredients": [{"name": "BUPIVACAINE HYDROCHLORIDE", "strength": "2.5 mg/mL"}], "application_number": "ANDA091503", "marketing_category": "ANDA", "marketing_start_date": "20230801", "listing_expiration_date": "20261231"}