lidocaine

Generic: lidocaine hydrochloride and epinephrine bitartrate

Labeler: ndc, inc.
NDC Directory HUMAN PRESCRIPTION DRUG ANDA Inactive Finished

Drug Facts

Product Profile

Brand Name lidocaine
Generic Name lidocaine hydrochloride and epinephrine bitartrate
Labeler ndc, inc.
Dosage Form INJECTION, SOLUTION
Routes
SUBMUCOSAL
Active Ingredients

epinephrine bitartrate .01 mg/mL, lidocaine hydrochloride 20 mg/mL

Manufacturer
NDC, Inc.

Identifiers & Regulatory

Product NDC 43128-105
Product ID 43128-105_222918bc-0d60-4764-bf13-ffe037637e74
Product Type HUMAN PRESCRIPTION DRUG
Marketing Category ANDA
Application Number ANDA088390
Listing Expiration 2026-12-31
Marketing Start 2015-04-10

Pharmacologic Class

Classes
adrenergic alpha-agonists [moa] adrenergic beta-agonists [moa] amide local anesthetic [epc] amides [cs] antiarrhythmic [epc] 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 43128105
Hyphenated Format 43128-105

Supplemental Identifiers

RxCUI
1293648
UNII
30Q7KI53AK V13007Z41A

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 lidocaine (source: ndc)
Generic Name lidocaine hydrochloride and epinephrine bitartrate (source: ndc)
Application Number ANDA088390 (source: ndc)
Routes
SUBMUCOSAL
source: ndc

Resolved Composition

Strengths
  • .01 mg/mL
  • 20 mg/mL
source: ndc
Packaging
  • 50 CARTRIDGE in 1 CARTON (43128-105-15) / 1.7 mL in 1 CARTRIDGE
source: ndc

Packages (1)

43128-105-15 50 CARTRIDGE in 1 CARTON (43128-105-15) / 1.7 mL in 1 CARTRIDGE

Ingredients (2)

epinephrine bitartrate (.01 mg/mL) lidocaine hydrochloride (20 mg/mL)

Linked Drug Pages (1)

LIDOCAINE ndc-match (0.9)

Raw FDA Data

View complete raw FDA NDC JSON payload 
{"route": ["SUBMUCOSAL"], "spl_id": "222918bc-0d60-4764-bf13-ffe037637e74", "openfda": {"unii": ["30Q7KI53AK", "V13007Z41A"], "rxcui": ["1293648"], "spl_set_id": ["937e9341-e604-4ca7-98e1-fc7c659d82e9"], "manufacturer_name": ["NDC, Inc."], "is_original_packager": [true]}, "finished": true, "packaging": [{"sample": false, "description": "50 CARTRIDGE in 1 CARTON (43128-105-15)  / 1.7 mL in 1 CARTRIDGE", "package_ndc": "43128-105-15", "marketing_start_date": "20150410"}], "brand_name": "LIDOCAINE", "product_id": "43128-105_222918bc-0d60-4764-bf13-ffe037637e74", "dosage_form": "INJECTION, SOLUTION", "pharm_class": ["Adrenergic alpha-Agonists [MoA]", "Adrenergic beta-Agonists [MoA]", "Amide Local Anesthetic [EPC]", "Amides [CS]", "Antiarrhythmic [EPC]", "Catecholamine [EPC]", "Catecholamines [CS]", "Local Anesthesia [PE]", "alpha-Adrenergic Agonist [EPC]", "beta-Adrenergic Agonist [EPC]"], "product_ndc": "43128-105", "generic_name": "Lidocaine Hydrochloride and Epinephrine Bitartrate", "labeler_name": "NDC, Inc.", "product_type": "HUMAN PRESCRIPTION DRUG", "brand_name_base": "LIDOCAINE", "active_ingredients": [{"name": "EPINEPHRINE BITARTRATE", "strength": ".01 mg/mL"}, {"name": "LIDOCAINE HYDROCHLORIDE", "strength": "20 mg/mL"}], "application_number": "ANDA088390", "marketing_category": "ANDA", "marketing_start_date": "20150410", "listing_expiration_date": "20261231"}