lidocaine and prilocaine (0574-2042)

Drug Facts

Product Profile

Brand Name lidocaine and prilocaine

Generic Name lidocaine and prilocaine

Labeler padagis us llc

Dosage Form CREAM

Routes

TOPICAL

Active Ingredients

lidocaine 25 mg/g, prilocaine 25 mg/g

Manufacturer

Padagis US LLC

Identifiers & Regulatory

Product NDC 0574-2042

Product ID 0574-2042_34956622-5c99-447a-8bfc-611413e0ff55

Product Type HUMAN PRESCRIPTION DRUG

Marketing Category ANDA

Application Number ANDA212482

Listing Expiration 2026-12-31

Marketing Start 2022-12-20

Pharmacologic Class

Established (EPC)

amide local anesthetic [epc] antiarrhythmic [epc]

Chemical Structure

amides [cs]

Physiologic Effect

local anesthesia [pe]

Normalized Code Variants

Searchable formats for this product NDC code

Digits Only 05742042

Hyphenated Format 0574-2042

Supplemental Identifiers

RxCUI

197877

UNII

98PI200987 046O35D44R

NUI

N0000175682 M0000897 N0000175426 N0000175976

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 and prilocaine (source: ndc)

Generic Name lidocaine and prilocaine (source: ndc)

Application Number ANDA212482 (source: ndc)

Routes

TOPICAL

source: ndc

Resolved Composition

Strengths

25 mg/g

source: ndc

Packaging

1 TUBE in 1 CARTON (0574-2042-30) / 30 g in 1 TUBE

source: ndc

Packages (1)

0574-2042-30 1 TUBE in 1 CARTON (0574-2042-30) / 30 g in 1 TUBE

Ingredients (2)

lidocaine (25 mg/g) prilocaine (25 mg/g)

Linked Drug Pages (1)

LIDOCAINE AND PRILOCAINE ndc-match (0.9)

Raw FDA Data

View complete raw FDA NDC JSON payload

{"route": ["TOPICAL"], "spl_id": "34956622-5c99-447a-8bfc-611413e0ff55", "openfda": {"nui": ["N0000175682", "M0000897", "N0000175426", "N0000175976"], "unii": ["98PI200987", "046O35D44R"], "rxcui": ["197877"], "spl_set_id": ["6e1635f7-dcae-441b-bbf7-495661fb66ae"], "pharm_class_cs": ["Amides [CS]"], "pharm_class_pe": ["Local Anesthesia [PE]"], "pharm_class_epc": ["Amide Local Anesthetic [EPC]", "Antiarrhythmic [EPC]"], "manufacturer_name": ["Padagis US LLC"], "is_original_packager": [true]}, "finished": true, "packaging": [{"sample": false, "description": "1 TUBE in 1 CARTON (0574-2042-30)  / 30 g in 1 TUBE", "package_ndc": "0574-2042-30", "marketing_start_date": "20221220"}], "brand_name": "LIDOCAINE AND PRILOCAINE", "product_id": "0574-2042_34956622-5c99-447a-8bfc-611413e0ff55", "dosage_form": "CREAM", "pharm_class": ["Amide Local Anesthetic [EPC]", "Amide Local Anesthetic [EPC]", "Amides [CS]", "Amides [CS]", "Antiarrhythmic [EPC]", "Local Anesthesia [PE]", "Local Anesthesia [PE]"], "product_ndc": "0574-2042", "generic_name": "Lidocaine and Prilocaine", "labeler_name": "Padagis US LLC", "product_type": "HUMAN PRESCRIPTION DRUG", "brand_name_base": "LIDOCAINE AND PRILOCAINE", "active_ingredients": [{"name": "LIDOCAINE", "strength": "25 mg/g"}, {"name": "PRILOCAINE", "strength": "25 mg/g"}], "application_number": "ANDA212482", "marketing_category": "ANDA", "marketing_start_date": "20221220", "listing_expiration_date": "20261231"}