bupivacaine

Generic: bupivacaine

Labeler: jiangsu hengrui pharmaceuticals co., ltd.
NDC Directory HUMAN PRESCRIPTION DRUG ANDA Inactive Finished

Drug Facts

Product Profile

Brand Name bupivacaine
Generic Name bupivacaine
Labeler jiangsu hengrui pharmaceuticals co., ltd.
Dosage Form INJECTION, SUSPENSION, LIPOSOMAL
Routes
INFILTRATION
Active Ingredients

bupivacaine 13.3 mg/mL

Manufacturer
Jiangsu Hengrui Pharmaceuticals Co., Ltd.

Identifiers & Regulatory

Product NDC 57884-3252
Product ID 57884-3252_1c5d9dbb-0d16-6893-e063-6394a90ad989
Product Type HUMAN PRESCRIPTION DRUG
Marketing Category ANDA
Application Number ANDA214348
Listing Expiration 2026-12-31
Marketing Start 2024-07-01

Pharmacologic Class

Established (EPC)
amide local anesthetic [epc]
Chemical Structure
amides [cs]
Physiologic Effect
local anesthesia [pe]

Normalized Code Variants

Searchable formats for this product NDC code

Digits Only 578843252
Hyphenated Format 57884-3252

Supplemental Identifiers

RxCUI
1191508 1745061
UPC
0357884325119 0357884325218
UNII
Y8335394RO
NUI
N0000175682 M0000897 N0000175976

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 (source: ndc)
Generic Name bupivacaine (source: ndc)
Application Number ANDA214348 (source: ndc)
Routes
INFILTRATION
source: ndc

Resolved Composition

Strengths
  • 13.3 mg/mL
source: ndc
Packaging
  • 10 VIAL in 1 CARTON (57884-3252-1) / 20 mL in 1 VIAL
source: ndc

Packages (1)

57884-3252-1 10 VIAL in 1 CARTON (57884-3252-1) / 20 mL in 1 VIAL

Ingredients (1)

bupivacaine (13.3 mg/mL)

Linked Drug Pages (1)

Bupivacaine ndc-match (0.9)

Raw FDA Data

View complete raw FDA NDC JSON payload 
{"route": ["INFILTRATION"], "spl_id": "1c5d9dbb-0d16-6893-e063-6394a90ad989", "openfda": {"nui": ["N0000175682", "M0000897", "N0000175976"], "upc": ["0357884325119", "0357884325218"], "unii": ["Y8335394RO"], "rxcui": ["1191508", "1745061"], "spl_set_id": ["0af296bb-1599-4b35-b66b-994924d3e898"], "pharm_class_cs": ["Amides [CS]"], "pharm_class_pe": ["Local Anesthesia [PE]"], "pharm_class_epc": ["Amide Local Anesthetic [EPC]"], "manufacturer_name": ["Jiangsu Hengrui Pharmaceuticals Co., Ltd."], "is_original_packager": [true]}, "finished": true, "packaging": [{"sample": false, "description": "10 VIAL in 1 CARTON (57884-3252-1)  / 20 mL in 1 VIAL", "package_ndc": "57884-3252-1", "marketing_start_date": "20240701"}], "brand_name": "Bupivacaine", "product_id": "57884-3252_1c5d9dbb-0d16-6893-e063-6394a90ad989", "dosage_form": "INJECTION, SUSPENSION, LIPOSOMAL", "pharm_class": ["Amide Local Anesthetic [EPC]", "Amides [CS]", "Local Anesthesia [PE]"], "product_ndc": "57884-3252", "generic_name": "Bupivacaine", "labeler_name": "Jiangsu Hengrui Pharmaceuticals Co., Ltd.", "product_type": "HUMAN PRESCRIPTION DRUG", "brand_name_base": "Bupivacaine", "active_ingredients": [{"name": "BUPIVACAINE", "strength": "13.3 mg/mL"}], "application_number": "ANDA214348", "marketing_category": "ANDA", "marketing_start_date": "20240701", "listing_expiration_date": "20261231"}