lidocaine and prilocaine (0168-0357)

Drug Facts

Product Profile

Brand Name lidocaine and prilocaine

Generic Name lidocaine and prilocaine

Labeler e. fougera & co. a division of fougera pharmaceuticals inc.

Dosage Form CREAM

Routes

TOPICAL

Active Ingredients

lidocaine 25 mg/g, prilocaine 25 mg/g

Manufacturer

E. Fougera & Co. a division of Fougera Pharmaceuticals Inc.

Identifiers & Regulatory

Product NDC 0168-0357

Product ID 0168-0357_e6c81752-e34b-48ca-8fca-b1212660d9a5

Product Type HUMAN PRESCRIPTION DRUG

Marketing Category ANDA

Application Number ANDA076453

Listing Expiration 2026-12-31

Marketing Start 2003-08-18

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 01680357

Hyphenated Format 0168-0357

Supplemental Identifiers

RxCUI

197877

UPC

0301680357300

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 ANDA076453 (source: ndc)

Routes

TOPICAL

source: ndc

Resolved Composition

Strengths

25 mg/g

source: ndc

Packaging

1 TUBE in 1 CARTON (0168-0357-30) / 30 g in 1 TUBE
1 TUBE in 1 CARTON (0168-0357-55) / 5 g in 1 TUBE (0168-0357-05)
1 TUBE in 1 CARTON (0168-0357-56) / 5 g in 1 TUBE (0168-0357-05)

source: ndc

Packages (3)

0168-0357-30 1 TUBE in 1 CARTON (0168-0357-30) / 30 g in 1 TUBE 0168-0357-55 1 TUBE in 1 CARTON (0168-0357-55) / 5 g in 1 TUBE (0168-0357-05) 0168-0357-56 1 TUBE in 1 CARTON (0168-0357-56) / 5 g in 1 TUBE (0168-0357-05)

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": "e6c81752-e34b-48ca-8fca-b1212660d9a5", "openfda": {"nui": ["N0000175682", "M0000897", "N0000175426", "N0000175976"], "upc": ["0301680357300"], "unii": ["98PI200987", "046O35D44R"], "rxcui": ["197877"], "spl_set_id": ["833cd52c-6470-49c4-937f-1393971f4db9"], "pharm_class_cs": ["Amides [CS]"], "pharm_class_pe": ["Local Anesthesia [PE]"], "pharm_class_epc": ["Amide Local Anesthetic [EPC]", "Antiarrhythmic [EPC]"], "manufacturer_name": ["E. Fougera & Co. a division of Fougera Pharmaceuticals Inc."], "is_original_packager": [true]}, "finished": true, "packaging": [{"sample": false, "description": "1 TUBE in 1 CARTON (0168-0357-30)  / 30 g in 1 TUBE", "package_ndc": "0168-0357-30", "marketing_start_date": "20030818"}, {"sample": false, "description": "1 TUBE in 1 CARTON (0168-0357-55)  / 5 g in 1 TUBE (0168-0357-05)", "package_ndc": "0168-0357-55", "marketing_start_date": "20040721"}, {"sample": false, "description": "1 TUBE in 1 CARTON (0168-0357-56)  / 5 g in 1 TUBE (0168-0357-05)", "package_ndc": "0168-0357-56", "marketing_start_date": "20040721"}], "brand_name": "Lidocaine and Prilocaine", "product_id": "0168-0357_e6c81752-e34b-48ca-8fca-b1212660d9a5", "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": "0168-0357", "generic_name": "lidocaine and prilocaine", "labeler_name": "E. Fougera & Co. a division of Fougera Pharmaceuticals Inc.", "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": "ANDA076453", "marketing_category": "ANDA", "marketing_start_date": "20030818", "listing_expiration_date": "20261231"}