lidocaine and prilocaine (0121-1002)

Drug Facts

Product Profile

Brand Name lidocaine and prilocaine

Generic Name lidocaine and prilocaine

Labeler pai holdings, llc dba pai pharma

Dosage Form CREAM

Routes

TOPICAL

Active Ingredients

lidocaine 25 mg/g, prilocaine 25 mg/g

Manufacturer

PAI Holdings, LLC dba PAI Pharma

Identifiers & Regulatory

Product NDC 0121-1002

Product ID 0121-1002_1beba651-25b0-4be2-88b2-c85b655ee5c3

Product Type HUMAN PRESCRIPTION DRUG

Marketing Category ANDA

Application Number ANDA205887

Marketing Start 2025-02-06

Marketing End 2026-08-31

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 01211002

Hyphenated Format 0121-1002

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 ANDA205887 (source: ndc)

Routes

TOPICAL

source: ndc

Resolved Composition

Strengths

25 mg/g

source: ndc

Packaging

1 TUBE in 1 CARTON (0121-1002-30) / 30 g in 1 TUBE

source: ndc

Packages (1)

0121-1002-30 1 TUBE in 1 CARTON (0121-1002-30) / 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": "1beba651-25b0-4be2-88b2-c85b655ee5c3", "openfda": {"nui": ["N0000175682", "M0000897", "N0000175426", "N0000175976"], "unii": ["98PI200987", "046O35D44R"], "rxcui": ["197877"], "spl_set_id": ["58204dfe-f18d-41c4-80e4-eae54fe8d583"], "pharm_class_cs": ["Amides [CS]"], "pharm_class_pe": ["Local Anesthesia [PE]"], "pharm_class_epc": ["Amide Local Anesthetic [EPC]", "Antiarrhythmic [EPC]"], "manufacturer_name": ["PAI Holdings, LLC dba PAI Pharma"], "is_original_packager": [true]}, "finished": true, "packaging": [{"sample": false, "description": "1 TUBE in 1 CARTON (0121-1002-30)  / 30 g in 1 TUBE", "package_ndc": "0121-1002-30", "marketing_end_date": "20260831", "marketing_start_date": "20250206"}], "brand_name": "Lidocaine and Prilocaine", "product_id": "0121-1002_1beba651-25b0-4be2-88b2-c85b655ee5c3", "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": "0121-1002", "generic_name": "Lidocaine and Prilocaine", "labeler_name": "PAI Holdings, LLC dba PAI Pharma", "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": "ANDA205887", "marketing_category": "ANDA", "marketing_end_date": "20260831", "marketing_start_date": "20250206"}