bupivacine hcl

Generic: bupivacaine hydrochloride

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

Drug Facts

Product Profile

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

bupivacaine hydrochloride 7.5 mg/mL

Manufacturer
Xellia Pharmaceuticals USA LLC

Identifiers & Regulatory

Product NDC 70594-121
Product ID 70594-121_afc179ac-71b9-4021-8b71-3372bf590e4a
Product Type HUMAN PRESCRIPTION DRUG
Marketing Category ANDA
Application Number ANDA091487
Listing Expiration 2026-12-31
Marketing Start 2023-06-01

Pharmacologic Class

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

Normalized Code Variants

Searchable formats for this product NDC code

Digits Only 70594121
Hyphenated Format 70594-121

Supplemental Identifiers

RxCUI
1724786 1724787 1724880 1724884 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 bupivacine hcl (source: ndc)
Generic Name bupivacaine hydrochloride (source: ndc)
Application Number ANDA091487 (source: ndc)
Routes
EPIDURAL INTRACAUDAL PERINEURAL
source: ndc

Resolved Composition

Strengths
  • 7.5 mg/mL
source: ndc
Packaging
  • 30 mL in 1 VIAL, SINGLE-DOSE (70594-121-01)
source: ndc

Packages (1)

70594-121-01 30 mL in 1 VIAL, SINGLE-DOSE (70594-121-01)

Ingredients (1)

bupivacaine hydrochloride (7.5 mg/mL)

Linked Drug Pages (1)

Bupivacaine HCl, BUPIVACAINE HCl, Bupivacine HCl ndc-match (0.9)

Raw FDA Data

View complete raw FDA NDC JSON payload 
{"route": ["EPIDURAL", "INTRACAUDAL", "PERINEURAL"], "spl_id": "afc179ac-71b9-4021-8b71-3372bf590e4a", "openfda": {"unii": ["7TQO7W3VT8"], "rxcui": ["1724786", "1724787", "1724880", "1724884", "1725078", "1725082"], "spl_set_id": ["f29c905e-9a55-446f-a89d-860ad9ade7ad"], "manufacturer_name": ["Xellia Pharmaceuticals USA LLC"], "is_original_packager": [true]}, "finished": true, "packaging": [{"sample": false, "description": "30 mL in 1 VIAL, SINGLE-DOSE (70594-121-01)", "package_ndc": "70594-121-01", "marketing_start_date": "20230601"}], "brand_name": "Bupivacine HCl", "product_id": "70594-121_afc179ac-71b9-4021-8b71-3372bf590e4a", "dosage_form": "INJECTION, SOLUTION", "pharm_class": ["Amide Local Anesthetic [EPC]", "Amides [CS]", "Local Anesthesia [PE]"], "product_ndc": "70594-121", "generic_name": "Bupivacaine hydrochloride", "labeler_name": "Xellia Pharmaceuticals USA LLC", "product_type": "HUMAN PRESCRIPTION DRUG", "brand_name_base": "Bupivacine HCl", "active_ingredients": [{"name": "BUPIVACAINE HYDROCHLORIDE", "strength": "7.5 mg/mL"}], "application_number": "ANDA091487", "marketing_category": "ANDA", "marketing_start_date": "20230601", "listing_expiration_date": "20261231"}