bupivacaine hci and epinephrine

Generic: bupivacaine hci and epinephrine

Labeler: hf acquisition co llc, dba healthfirst
NDC Directory HUMAN PRESCRIPTION DRUG ANDA Inactive Finished

Drug Facts

Product Profile

Brand Name bupivacaine hci and epinephrine
Generic Name bupivacaine hci and epinephrine
Labeler hf acquisition co llc, dba healthfirst
Dosage Form INJECTION, SOLUTION
Routes
PERINEURAL
Active Ingredients

bupivacaine hydrochloride 5 mg/mL, epinephrine bitartrate .005 mg/mL

Manufacturer
HF Acquisition Co LLC, DBA HealthFirst

Identifiers & Regulatory

Product NDC 51662-1399
Product ID 51662-1399_10328ddf-6e3b-c9e0-e063-6294a90a52ed
Product Type HUMAN PRESCRIPTION DRUG
Marketing Category ANDA
Application Number ANDA070968
Listing Expiration 2026-12-31
Marketing Start 2019-12-09

Pharmacologic Class

Classes
adrenergic alpha-agonists [moa] adrenergic beta-agonists [moa] amide local anesthetic [epc] amides [cs] catecholamine [epc] catecholamines [cs] local anesthesia [pe] alpha-adrenergic agonist [epc] beta-adrenergic agonist [epc]

Normalized Code Variants

Searchable formats for this product NDC code

Digits Only 516621399
Hyphenated Format 51662-1399

Supplemental Identifiers

UPC
0363323463014
UNII
7TQO7W3VT8 30Q7KI53AK

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 hci and epinephrine (source: ndc)
Generic Name bupivacaine hci and epinephrine (source: ndc)
Application Number ANDA070968 (source: ndc)
Routes
PERINEURAL
source: ndc

Resolved Composition

Strengths
  • 5 mg/mL
  • .005 mg/mL
source: ndc
Packaging
  • 50 mL in 1 VIAL, MULTI-DOSE (51662-1399-1)
  • 1 VIAL, MULTI-DOSE in 1 POUCH (51662-1399-2) / 50 mL in 1 VIAL, MULTI-DOSE
  • 25 POUCH in 1 CASE (51662-1399-3) / 1 VIAL, MULTI-DOSE in 1 POUCH / 50 mL in 1 VIAL, MULTI-DOSE
source: ndc

Packages (3)

51662-1399-1 50 mL in 1 VIAL, MULTI-DOSE (51662-1399-1) 51662-1399-2 1 VIAL, MULTI-DOSE in 1 POUCH (51662-1399-2) / 50 mL in 1 VIAL, MULTI-DOSE 51662-1399-3 25 POUCH in 1 CASE (51662-1399-3) / 1 VIAL, MULTI-DOSE in 1 POUCH / 50 mL in 1 VIAL, MULTI-DOSE

Ingredients (2)

bupivacaine hydrochloride (5 mg/mL) epinephrine bitartrate (.005 mg/mL)

Linked Drug Pages (1)

BUPIVACAINE HCI AND EPINEPHRINE ndc-match (0.9)

Raw FDA Data

View complete raw FDA NDC JSON payload 
{"route": ["PERINEURAL"], "spl_id": "10328ddf-6e3b-c9e0-e063-6294a90a52ed", "openfda": {"upc": ["0363323463014"], "unii": ["7TQO7W3VT8", "30Q7KI53AK"], "spl_set_id": ["99516811-56e2-9c8a-e053-2a95a90ac9cb"], "manufacturer_name": ["HF Acquisition Co LLC, DBA HealthFirst"]}, "finished": true, "packaging": [{"sample": false, "description": "50 mL in 1 VIAL, MULTI-DOSE (51662-1399-1)", "package_ndc": "51662-1399-1", "marketing_start_date": "20191209"}, {"sample": false, "description": "1 VIAL, MULTI-DOSE in 1 POUCH (51662-1399-2)  / 50 mL in 1 VIAL, MULTI-DOSE", "package_ndc": "51662-1399-2", "marketing_start_date": "20210126"}, {"sample": false, "description": "25 POUCH in 1 CASE (51662-1399-3)  / 1 VIAL, MULTI-DOSE in 1 POUCH / 50 mL in 1 VIAL, MULTI-DOSE", "package_ndc": "51662-1399-3", "marketing_start_date": "20210126"}], "brand_name": "BUPIVACAINE HCI AND EPINEPHRINE", "product_id": "51662-1399_10328ddf-6e3b-c9e0-e063-6294a90a52ed", "dosage_form": "INJECTION, SOLUTION", "pharm_class": ["Adrenergic alpha-Agonists [MoA]", "Adrenergic beta-Agonists [MoA]", "Amide Local Anesthetic [EPC]", "Amides [CS]", "Catecholamine [EPC]", "Catecholamines [CS]", "Local Anesthesia [PE]", "alpha-Adrenergic Agonist [EPC]", "beta-Adrenergic Agonist [EPC]"], "product_ndc": "51662-1399", "generic_name": "BUPIVACAINE HCI AND EPINEPHRINE", "labeler_name": "HF Acquisition Co LLC, DBA HealthFirst", "product_type": "HUMAN PRESCRIPTION DRUG", "brand_name_base": "BUPIVACAINE HCI AND EPINEPHRINE", "active_ingredients": [{"name": "BUPIVACAINE HYDROCHLORIDE", "strength": "5 mg/mL"}, {"name": "EPINEPHRINE BITARTRATE", "strength": ".005 mg/mL"}], "application_number": "ANDA070968", "marketing_category": "ANDA", "marketing_start_date": "20191209", "listing_expiration_date": "20261231"}