bupivacaine hydrochloride

Generic: bupivacaine hydrochloride

Labeler: eugia us llc
NDC Directory HUMAN PRESCRIPTION DRUG ANDA Inactive Finished

Drug Facts

Product Profile

Brand Name bupivacaine hydrochloride
Generic Name bupivacaine hydrochloride
Labeler eugia us llc
Dosage Form INJECTION, SOLUTION
Routes
EPIDURAL INTRACAUDAL
Active Ingredients

bupivacaine hydrochloride 5 mg/mL

Manufacturer
Eugia US LLC

Identifiers & Regulatory

Product NDC 55150-169
Product ID 55150-169_39649703-e633-4a20-ba71-0c04dbf8ff2a
Product Type HUMAN PRESCRIPTION DRUG
Marketing Category ANDA
Application Number ANDA203895
Listing Expiration 2026-12-31
Marketing Start 2013-11-05

Pharmacologic Class

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

Normalized Code Variants

Searchable formats for this product NDC code

Digits Only 55150169
Hyphenated Format 55150-169

Supplemental Identifiers

RxCUI
1012396 1012404 1724786 1724787 1724880 1724884 1725078 1725082
UPC
0355150170302 0355150250509 0355150249503 0355150168309 0355150169108 0355150167104 0355150172306 0355150171101
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 ANDA203895 (source: ndc)
Routes
EPIDURAL INTRACAUDAL
source: ndc

Resolved Composition

Strengths
  • 5 mg/mL
source: ndc
Packaging
  • 25 VIAL, SINGLE-DOSE in 1 CARTON (55150-169-10) / 10 mL in 1 VIAL, SINGLE-DOSE
source: ndc

Packages (1)

55150-169-10 25 VIAL, SINGLE-DOSE in 1 CARTON (55150-169-10) / 10 mL in 1 VIAL, SINGLE-DOSE

Ingredients (1)

bupivacaine hydrochloride (5 mg/mL)

Linked Drug Pages (1)

Bupivacaine Hydrochloride ndc-match (0.9)

Raw FDA Data

View complete raw FDA NDC JSON payload 
{"route": ["EPIDURAL", "INTRACAUDAL"], "spl_id": "39649703-e633-4a20-ba71-0c04dbf8ff2a", "openfda": {"upc": ["0355150170302", "0355150250509", "0355150249503", "0355150168309", "0355150169108", "0355150167104", "0355150172306", "0355150171101"], "unii": ["7TQO7W3VT8"], "rxcui": ["1012396", "1012404", "1724786", "1724787", "1724880", "1724884", "1725078", "1725082"], "spl_set_id": ["ffecf450-1f01-4721-8e10-251385852612"], "manufacturer_name": ["Eugia US LLC"], "is_original_packager": [true]}, "finished": true, "packaging": [{"sample": false, "description": "25 VIAL, SINGLE-DOSE in 1 CARTON (55150-169-10)  / 10 mL in 1 VIAL, SINGLE-DOSE", "package_ndc": "55150-169-10", "marketing_start_date": "20131105"}], "brand_name": "Bupivacaine Hydrochloride", "product_id": "55150-169_39649703-e633-4a20-ba71-0c04dbf8ff2a", "dosage_form": "INJECTION, SOLUTION", "pharm_class": ["Amide Local Anesthetic [EPC]", "Amides [CS]", "Local Anesthesia [PE]"], "product_ndc": "55150-169", "generic_name": "Bupivacaine Hydrochloride", "labeler_name": "Eugia US LLC", "product_type": "HUMAN PRESCRIPTION DRUG", "brand_name_base": "Bupivacaine Hydrochloride", "active_ingredients": [{"name": "BUPIVACAINE HYDROCHLORIDE", "strength": "5 mg/mL"}], "application_number": "ANDA203895", "marketing_category": "ANDA", "marketing_start_date": "20131105", "listing_expiration_date": "20261231"}