bupivacaine hydrochloride

Generic: bupivacaine hydrochloride

Labeler: henry schein, inc
NDC Directory HUMAN PRESCRIPTION DRUG ANDA Inactive Finished

Drug Facts

Product Profile

Brand Name bupivacaine hydrochloride
Generic Name bupivacaine hydrochloride
Labeler henry schein, inc
Dosage Form INJECTION, SOLUTION
Routes
PERINEURAL
Active Ingredients

bupivacaine hydrochloride 5 mg/mL

Manufacturer
Henry Schein, Inc

Identifiers & Regulatory

Product NDC 0404-9827
Product ID 0404-9827_31c130fb-e9c0-4e60-997a-e2d7921fdd93
Product Type HUMAN PRESCRIPTION DRUG
Marketing Category ANDA
Application Number ANDA070597
Listing Expiration 2026-12-31
Marketing Start 2022-01-09

Pharmacologic Class

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

Normalized Code Variants

Searchable formats for this product NDC code

Digits Only 04049827
Hyphenated Format 0404-9827

Supplemental Identifiers

RxCUI
1012404
UNII
7TQO7W3VT8

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 ANDA070597 (source: ndc)
Routes
PERINEURAL
source: ndc

Resolved Composition

Strengths
  • 5 mg/mL
source: ndc
Packaging
  • 1 VIAL, MULTI-DOSE in 1 BAG (0404-9827-50) / 50 mL in 1 VIAL, MULTI-DOSE
source: ndc

Packages (1)

0404-9827-50 1 VIAL, MULTI-DOSE in 1 BAG (0404-9827-50) / 50 mL in 1 VIAL, MULTI-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": ["PERINEURAL"], "spl_id": "31c130fb-e9c0-4e60-997a-e2d7921fdd93", "openfda": {"unii": ["7TQO7W3VT8"], "rxcui": ["1012404"], "spl_set_id": ["496ccd9e-d1c3-4b5a-93b6-0c457faa1589"], "manufacturer_name": ["Henry Schein, Inc"]}, "finished": true, "packaging": [{"sample": false, "description": "1 VIAL, MULTI-DOSE in 1 BAG (0404-9827-50)  / 50 mL in 1 VIAL, MULTI-DOSE", "package_ndc": "0404-9827-50", "marketing_start_date": "20220109"}], "brand_name": "Bupivacaine Hydrochloride", "product_id": "0404-9827_31c130fb-e9c0-4e60-997a-e2d7921fdd93", "dosage_form": "INJECTION, SOLUTION", "pharm_class": ["Amide Local Anesthetic [EPC]", "Amides [CS]", "Local Anesthesia [PE]"], "product_ndc": "0404-9827", "generic_name": "Bupivacaine Hydrochloride", "labeler_name": "Henry Schein, Inc", "product_type": "HUMAN PRESCRIPTION DRUG", "brand_name_base": "Bupivacaine Hydrochloride", "active_ingredients": [{"name": "BUPIVACAINE HYDROCHLORIDE", "strength": "5 mg/mL"}], "application_number": "ANDA070597", "marketing_category": "ANDA", "marketing_start_date": "20220109", "listing_expiration_date": "20261231"}