lidocaine and prilocaine

Generic: lidocaine and prilocaine

Labeler: viona pharmaceuticals inc
NDC Directory HUMAN PRESCRIPTION DRUG ANDA Inactive Finished

Drug Facts

Product Profile

Brand Name lidocaine and prilocaine
Generic Name lidocaine and prilocaine
Labeler viona pharmaceuticals inc
Dosage Form CREAM
Routes
TOPICAL
Active Ingredients

lidocaine 25 mg/g, prilocaine 25 mg/g

Manufacturer
Viona Pharmaceuticals Inc

Identifiers & Regulatory

Product NDC 72578-165
Product ID 72578-165_75557294-3cf2-4c4a-860b-91855833c518
Product Type HUMAN PRESCRIPTION DRUG
Marketing Category ANDA
Application Number ANDA219120
Listing Expiration 2026-12-31
Marketing Start 2025-01-01

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 72578165
Hyphenated Format 72578-165

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 ANDA219120 (source: ndc)
Routes
TOPICAL
source: ndc

Resolved Composition

Strengths
  • 25 mg/g
source: ndc
Packaging
  • 1 TUBE in 1 CARTON (72578-165-06) / 30 g in 1 TUBE
  • 5 TUBE in 1 CARTON (72578-165-96) / 5 g in 1 TUBE (72578-165-05)
source: ndc

Packages (2)

72578-165-06 1 TUBE in 1 CARTON (72578-165-06) / 30 g in 1 TUBE 72578-165-96 5 TUBE in 1 CARTON (72578-165-96) / 5 g in 1 TUBE (72578-165-05)

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": "75557294-3cf2-4c4a-860b-91855833c518", "openfda": {"nui": ["N0000175682", "M0000897", "N0000175426", "N0000175976"], "unii": ["98PI200987", "046O35D44R"], "rxcui": ["197877"], "spl_set_id": ["0a3b26d3-7a32-4403-88ab-0924356b5214"], "pharm_class_cs": ["Amides [CS]"], "pharm_class_pe": ["Local Anesthesia [PE]"], "pharm_class_epc": ["Amide Local Anesthetic [EPC]", "Antiarrhythmic [EPC]"], "manufacturer_name": ["Viona Pharmaceuticals Inc"], "is_original_packager": [true]}, "finished": true, "packaging": [{"sample": false, "description": "1 TUBE in 1 CARTON (72578-165-06)  / 30 g in 1 TUBE", "package_ndc": "72578-165-06", "marketing_start_date": "20250101"}, {"sample": false, "description": "5 TUBE in 1 CARTON (72578-165-96)  / 5 g in 1 TUBE (72578-165-05)", "package_ndc": "72578-165-96", "marketing_start_date": "20250101"}], "brand_name": "Lidocaine and prilocaine", "product_id": "72578-165_75557294-3cf2-4c4a-860b-91855833c518", "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": "72578-165", "generic_name": "Lidocaine and prilocaine", "labeler_name": "Viona 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": "ANDA219120", "marketing_category": "ANDA", "marketing_start_date": "20250101", "listing_expiration_date": "20261231"}