Bupivacaine Hydrochloride

Generic: Bupivacaine Hydrochloride

Labeler: Steriscience Specialties Private Limited
NDC Directory HUMAN PRESCRIPTION DRUG ANDA Active

Drug Facts

Product Profile

Brand Name Bupivacaine Hydrochloride
Generic Name Bupivacaine Hydrochloride
Labeler Steriscience Specialties Private Limited
Dosage Form INJECTION, SOLUTION
Routes
EPIDURAL RETROBULBAR
Active Ingredients

BUPIVACAINE HYDROCHLORIDE 7.5 mg/mL

Identifiers & Regulatory

Product NDC 82449-228
Product ID 82449-228_fd5b79e0-ca88-d729-e053-6294a90a200b
Product Type HUMAN PRESCRIPTION DRUG
Marketing Category ANDA
Application Number ANDA091487
Listing Expiration 2026-12-31
Marketing Start 2023-06-09

Normalized Code Variants

Searchable formats for this product NDC code

Digits Only 82449228
Hyphenated Format 82449-228

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 ANDA091487 (source: ndc)
Routes
EPIDURAL RETROBULBAR
source: ndc

Resolved Composition

Strengths
  • 7.5 mg/mL
source: ndc
Packaging
  • 1 VIAL in 1 CARTON (82449-228-01) / 30 mL in 1 VIAL
source: ndc

Packages (1)

82449-228-01 1 VIAL in 1 CARTON (82449-228-01) / 30 mL in 1 VIAL

Ingredients (1)

BUPIVACAINE HYDROCHLORIDE (7.5 mg/mL)

Linked Drug Pages (1)

Bupivacaine Hydrochloride ndc-match (0.9)

Raw FDA Data

View complete raw FDA NDC JSON payload 
{"route": ["EPIDURAL", "RETROBULBAR"], "spl_id": "fd5b79e0-ca88-d729-e053-6294a90a200b", "openfda": {"upc": ["0382449226013", "0382449225016", "0382449223012", "0382449227010", "0382449224019", "0382449228017"], "unii": ["7TQO7W3VT8"], "rxcui": ["1724786", "1724787", "1724880", "1724884", "1725078", "1725082"], "spl_set_id": ["dfa56ae0-72a5-4294-bd29-25bdb9549f9b"], "manufacturer_name": ["Steriscience Specialties Private Limited"], "is_original_packager": [true]}, "finished": true, "packaging": [{"sample": false, "description": "1 VIAL in 1 CARTON (82449-228-01)  / 30 mL in 1 VIAL", "package_ndc": "82449-228-01", "marketing_start_date": "20230609"}], "brand_name": "Bupivacaine Hydrochloride", "product_id": "82449-228_fd5b79e0-ca88-d729-e053-6294a90a200b", "dosage_form": "INJECTION, SOLUTION", "pharm_class": ["Amide Local Anesthetic [EPC]", "Amides [CS]", "Local Anesthesia [PE]"], "product_ndc": "82449-228", "generic_name": "Bupivacaine Hydrochloride", "labeler_name": "Steriscience Specialties Private Limited", "product_type": "HUMAN PRESCRIPTION DRUG", "brand_name_base": "Bupivacaine Hydrochloride", "active_ingredients": [{"name": "BUPIVACAINE HYDROCHLORIDE", "strength": "7.5 mg/mL"}], "application_number": "ANDA091487", "marketing_category": "ANDA", "marketing_start_date": "20230609", "listing_expiration_date": "20261231"}