lidocaine hydrochloride and epinephrine (0404-9891)

Drug Facts

Product Profile

Brand Name lidocaine hydrochloride and epinephrine

Generic Name lidocaine hydrochloride and epinephrine

Labeler henry schein, inc.

Dosage Form INJECTION, SOLUTION

Routes

INFILTRATION

Active Ingredients

epinephrine 10 ug/mL, lidocaine hydrochloride 10 mg/mL

Manufacturer

Henry Schein, Inc.

Identifiers & Regulatory

Product NDC 0404-9891

Product ID 0404-9891_baf9aefe-ec87-47b6-aed9-28e2a6f9af7c

Product Type HUMAN PRESCRIPTION DRUG

Marketing Category ANDA

Application Number ANDA089644

Listing Expiration 2026-12-31

Marketing Start 2022-01-12

Pharmacologic Class

Established (EPC)

alpha-adrenergic agonist [epc] beta-adrenergic agonist [epc] catecholamine [epc]

Mechanism of Action

adrenergic alpha-agonists [moa] adrenergic beta-agonists [moa]

Chemical Structure

catecholamines [cs]

Normalized Code Variants

Searchable formats for this product NDC code

Digits Only 04049891

Hyphenated Format 0404-9891

Supplemental Identifiers

RxCUI

1010751

UNII

YKH834O4BH V13007Z41A

NUI

N0000000209 N0000000245 N0000175552 N0000175555 N0000175570 M0003647

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 hydrochloride and epinephrine (source: ndc)

Generic Name lidocaine hydrochloride and epinephrine (source: ndc)

Application Number ANDA089644 (source: ndc)

Routes

INFILTRATION

source: ndc

Resolved Composition

Strengths

10 ug/mL
10 mg/mL

source: ndc

Packaging

1 VIAL, MULTI-DOSE in 1 BAG (0404-9891-20) / 30 mL in 1 VIAL, MULTI-DOSE
1 VIAL, MULTI-DOSE in 1 BAG (0404-9891-50) / 50 mL in 1 VIAL, MULTI-DOSE

source: ndc

Packages (2)

0404-9891-20 1 VIAL, MULTI-DOSE in 1 BAG (0404-9891-20) / 30 mL in 1 VIAL, MULTI-DOSE 0404-9891-50 1 VIAL, MULTI-DOSE in 1 BAG (0404-9891-50) / 50 mL in 1 VIAL, MULTI-DOSE

Ingredients (2)

epinephrine (10 ug/mL) lidocaine hydrochloride (10 mg/mL)

Linked Drug Pages (1)

Lidocaine Hydrochloride and Epinephrine ndc-match (0.9)

Raw FDA Data

View complete raw FDA NDC JSON payload

{"route": ["INFILTRATION"], "spl_id": "baf9aefe-ec87-47b6-aed9-28e2a6f9af7c", "openfda": {"nui": ["N0000000209", "N0000000245", "N0000175552", "N0000175555", "N0000175570", "M0003647"], "unii": ["YKH834O4BH", "V13007Z41A"], "rxcui": ["1010751"], "spl_set_id": ["c3490a23-14c4-43f7-b066-96a4c4298fde"], "pharm_class_cs": ["Catecholamines [CS]"], "pharm_class_epc": ["alpha-Adrenergic Agonist [EPC]", "beta-Adrenergic Agonist [EPC]", "Catecholamine [EPC]"], "pharm_class_moa": ["Adrenergic alpha-Agonists [MoA]", "Adrenergic beta-Agonists [MoA]"], "manufacturer_name": ["Henry Schein, Inc."]}, "finished": true, "packaging": [{"sample": false, "description": "1 VIAL, MULTI-DOSE in 1 BAG (0404-9891-20)  / 30 mL in 1 VIAL, MULTI-DOSE", "package_ndc": "0404-9891-20", "marketing_start_date": "20220112"}, {"sample": false, "description": "1 VIAL, MULTI-DOSE in 1 BAG (0404-9891-50)  / 50 mL in 1 VIAL, MULTI-DOSE", "package_ndc": "0404-9891-50", "marketing_start_date": "20220112"}], "brand_name": "Lidocaine Hydrochloride and Epinephrine", "product_id": "0404-9891_baf9aefe-ec87-47b6-aed9-28e2a6f9af7c", "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": "0404-9891", "generic_name": "Lidocaine Hydrochloride and Epinephrine", "labeler_name": "Henry Schein, Inc.", "product_type": "HUMAN PRESCRIPTION DRUG", "brand_name_base": "Lidocaine Hydrochloride and Epinephrine", "active_ingredients": [{"name": "EPINEPHRINE", "strength": "10 ug/mL"}, {"name": "LIDOCAINE HYDROCHLORIDE", "strength": "10 mg/mL"}], "application_number": "ANDA089644", "marketing_category": "ANDA", "marketing_start_date": "20220112", "listing_expiration_date": "20261231"}