bupivacaine hydrochloride

Generic: bupivacaine hydrochloride

Labeler: brookfield pharmaceuticals, llc.
NDC Directory HUMAN PRESCRIPTION DRUG ANDA Inactive Finished

Drug Facts

Product Profile

Brand Name bupivacaine hydrochloride
Generic Name bupivacaine hydrochloride
Labeler brookfield pharmaceuticals, llc.
Dosage Form INJECTION
Routes
SUBARACHNOID
Active Ingredients

bupivacaine hydrochloride 7.5 mg/mL

Manufacturer
Brookfield Pharmaceuticals, LLC.

Identifiers & Regulatory

Product NDC 71351-022
Product ID 71351-022_484033d6-ca7d-f0fd-e063-6294a90a7890
Product Type HUMAN PRESCRIPTION DRUG
Marketing Category ANDA
Application Number ANDA212822
Listing Expiration 2027-12-31
Marketing Start 2022-10-31

Pharmacologic Class

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

Normalized Code Variants

Searchable formats for this product NDC code

Digits Only 71351022
Hyphenated Format 71351-022

Supplemental Identifiers

RxCUI
1724784
UPC
0371351022509 0371351022028 0371351022103
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 ANDA212822 (source: ndc)
Routes
SUBARACHNOID
source: ndc

Resolved Composition

Strengths
  • 7.5 mg/mL
source: ndc
Packaging
  • 10 AMPULE in 1 PACKAGE (71351-022-10) / 2 mL in 1 AMPULE (71351-022-02)
  • 50 AMPULE in 1 PACKAGE (71351-022-50) / 2 mL in 1 AMPULE (71351-022-02)
source: ndc

Packages (2)

71351-022-10 10 AMPULE in 1 PACKAGE (71351-022-10) / 2 mL in 1 AMPULE (71351-022-02) 71351-022-50 50 AMPULE in 1 PACKAGE (71351-022-50) / 2 mL in 1 AMPULE (71351-022-02)

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": ["SUBARACHNOID"], "spl_id": "484033d6-ca7d-f0fd-e063-6294a90a7890", "openfda": {"upc": ["0371351022509", "0371351022028", "0371351022103"], "unii": ["7TQO7W3VT8"], "rxcui": ["1724784"], "spl_set_id": ["e8b32972-6984-4f1c-e053-2995a90a3277"], "manufacturer_name": ["Brookfield Pharmaceuticals, LLC."], "is_original_packager": [true]}, "finished": true, "packaging": [{"sample": false, "description": "10 AMPULE in 1 PACKAGE (71351-022-10)  / 2 mL in 1 AMPULE (71351-022-02)", "package_ndc": "71351-022-10", "marketing_start_date": "20230223"}, {"sample": false, "description": "50 AMPULE in 1 PACKAGE (71351-022-50)  / 2 mL in 1 AMPULE (71351-022-02)", "package_ndc": "71351-022-50", "marketing_start_date": "20221031"}], "brand_name": "Bupivacaine Hydrochloride", "product_id": "71351-022_484033d6-ca7d-f0fd-e063-6294a90a7890", "dosage_form": "INJECTION", "pharm_class": ["Amide Local Anesthetic [EPC]", "Amides [CS]", "Local Anesthesia [PE]"], "product_ndc": "71351-022", "generic_name": "Bupivacaine hydrochloride", "labeler_name": "Brookfield Pharmaceuticals, LLC.", "product_type": "HUMAN PRESCRIPTION DRUG", "brand_name_base": "Bupivacaine Hydrochloride", "active_ingredients": [{"name": "BUPIVACAINE HYDROCHLORIDE", "strength": "7.5 mg/mL"}], "application_number": "ANDA212822", "marketing_category": "ANDA", "marketing_start_date": "20221031", "listing_expiration_date": "20271231"}